aripiprazole: package leaflet

For patients

Package leaflet, verbatim

Abilify

Package leaflet: ABILIFY 5 mg tablets / ABILIFY 10 mg tablets / ABILIFY 15 mg tablets / ABILIFY 30 mg tablets

1. What ABILIFY is and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterised by symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

ABILIFY is used to treat adults and adolescents aged 13 years and older who suffer from a condition with symptoms such as feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents this condition from returning in patients who have responded to the treatment with ABILIFY.

2. What you need to know before you take ABILIFY

Do not take ABILIFY
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking ABILIFY.

Suicidal thoughts and behaviours have been reported during treatment with this medicine. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself before or after taking ABILIFY.

fits (seizures) since your doctor may want to monitor you more closely
involuntary, irregular muscle movements, especially in the face
cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
past experience with excessive gambling

If you notice you are gaining weight, develop unusual movements, experience somnolence that interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose.

This medicine may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are an elderly patient or have some debility.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.

Taking ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.

Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
pain killers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.

ABILIFY with food, drink and alcohol
This medicine can be taken regardless of meals.
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used ABILIFY in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

If you are taking ABILIFY, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see section 4).
This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.

ABILIFY contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take ABILIFY

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents

This medicine may be started at a low dose with the oral solution (liquid) form.
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.

Try to take ABILIFY at the same time each day. It does not matter whether you take it with or without food. Always take the tablet with water and swallow it whole.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.

If you take more ABILIFY than you should
If you realise you have taken more ABILIFY than your doctor has recommended (or if someone else has taken some of your ABILIFY), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

Patients who have taken too much of this medicine have experienced the following symptoms:
- rapid heartbeat, agitation/aggressiveness, problems with speech.
- unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:
- acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
- muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take ABILIFY
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY
Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to keep still, difficulty sitting still,
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
uncontrollable twitching, jerking or writhing movements,
trembling,
headache,
tiredness,
sleepiness,

light-headedness,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
indigestion,
feeling sick,
more saliva in mouth than normal,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increased or decreased blood levels of the hormone prolactin,
too much sugar in the blood,
depression,
altered or increased sexual interest,
uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heartbeat,
a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

low levels of white blood cells,
low levels of blood platelets,
allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizure,
serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
speech disorder,
fixation of the eyeballs in one position,
sudden unexplained death,
life-threatening irregular heartbeat,
heart attack,
slower heartbeat,
blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),

- spasm of the muscles around the voice box,
- inflammation of the pancreas,
- difficulty swallowing,
- diarrhoea,
- abdominal discomfort,
- stomach discomfort,
- liver failure,
- inflammation of the liver,
- yellowing of the skin and white part of eyes,
- reports of abnormal liver tests values,
- skin rash,
- skin sensitivity to light,
- baldness,
- excessive sweating,
- serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
- abnormal muscle breakdown which can lead to kidney problems,
- muscle pain,
- stiffness,
- involuntary loss of urine (incontinence),
- difficulty in passing urine,
- withdrawal symptoms in newborn babies in case of exposure during pregnancy,
- prolonged and/or painful erection,
- difficulty controlling core body temperature or overheating,
- chest pain,
- swelling of hands, ankles or feet,
- in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away.
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater than 1 in 100 patients).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ABILIFY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ABILIFY contains
- The active substance is aripiprazole.

Each tablet contains 5 mg of aripiprazole.

Each tablet contains 10 mg of aripiprazole.

Each tablet contains 15 mg of aripiprazole.

Each tablet contains 30 mg of aripiprazole.

- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.
Tablet coat
ABILIFY 5 mg tablets:
Indigo carmine aluminium lake (E 132)
ABILIFY 10 mg tablets:
Red iron oxide (E 172)
ABILIFY 15 mg tablets:
Yellow iron oxide (E 172)
ABILIFY 30 mg tablets:
Red iron oxide (E 172)

What ABILIFY looks like and contents of the pack
ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007’ and ‘5’ on one side.
ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008’ and ‘10’ on one side.
ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009’ and ‘15’ on one side.
ABILIFY 30 mg tablets are round and pink, marked with ‘A-011’ and ‘30’ on one side.

ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, 49 × 1, 56 × 1, or 98 × 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60
Lietuva
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
България
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Luxembourg/Luxemburg
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60
Česká republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Magyarország
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Danmark
Otsuka Pharma Scandinavia AB
Tlf.: +46 (0) 8 545 286 60
Malta
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Deutschland
Otsuka Pharma GmbH
Tel: +49 (0) 69 1700 860
Nederland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Eesti
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Norge
Otsuka Pharma Scandinavia AB
Tlf: +46 (0) 8 545 286 60
Ελλάδα
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Österreich
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
España
Otsuka Pharmaceutical, S.A.
Tel: +34 93 550 01 00
Polska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00
Portugal
Lundbeck Portugal Lda
Tel: +351 (0) 21 00 45 900
Hrvatska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
România
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ireland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Slovenija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ísland
Vistor ehf.
Sími: +354 (0) 535 7000
Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0) 2 0063 2710
Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46 (0) 8 545 286 60
Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60

Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Package leaflet: ABILIFY 10 mg orodispersible tablets / ABILIFY 15 mg orodispersible tablets / ABILIFY 30 mg orodispersible tablets

1. What ABILIFY is and what it is used for

2. What you need to know before you take ABILIFY

Do not take ABILIFY
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking ABILIFY.

involuntary, irregular muscle movements, especially in the face
cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
past experience with excessive gambling

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Taking ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
pain killers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.

ABILIFY with food, drink and alcohol
This medicine can be taken regardless of meals.
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

ABILIFY contains aspartame
ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame in each tablet.
ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame in each tablet.
ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg aspartame in each tablet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

ABILIFY contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

ABILIFY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium- free’.

3. How to take ABILIFY

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

Use in children and adolescents
This medicine may be started at a low dose with the oral solution (liquid) form.
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.

If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.

Try to take ABILIFY at the same time each day. It does not matter whether you take it with or without food.

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid.
Alternatively, disperse the tablet in water and drink the resulting suspension.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take ABILIFY
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY
Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to keep still, difficulty sitting still,
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
uncontrollable twitching, jerking or writhing movements,
trembling,
headache,
tiredness,
sleepiness,
light-headedness,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
indigestion,
feeling sick,
more saliva in mouth than normal,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increased or decreased blood levels of the hormone prolactin,
too much sugar in the blood,
depression,
altered or increased sexual interest,
uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heartbeat,
a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

low levels of white blood cells,
low levels of blood platelets,
allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, suicide attempt and suicide,
feeling aggressive,
agitation,

- nervousness,
- combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
- seizure,
- serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
- speech disorder,
- fixation of the eyeballs in one position,
- sudden unexplained death,
- life-threatening irregular heartbeat,
- heart attack,
- slower heartbeat,
- blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
- high blood pressure,
- fainting,
- accidental inhalation of food with risk of pneumonia (lung infection),
- spasm of the muscles around the voice box,
- inflammation of the pancreas,
- difficulty swallowing,
- diarrhoea,
- abdominal discomfort,
- stomach discomfort,
- liver failure,
- inflammation of the liver,
- yellowing of the skin and white part of eyes,
- reports of abnormal liver tests values,
- skin rash,
- skin sensitivity to light,
- baldness,
- excessive sweating,
- serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
- abnormal muscle breakdown which can lead to kidney problems,
- muscle pain,
- stiffness,
- involuntary loss of urine (incontinence),
- difficulty in passing urine,
- withdrawal symptoms in newborn babies in case of exposure during pregnancy,
- prolonged and/or painful erection,
- difficulty controlling core body temperature or overheating,
- chest pain,
- swelling of hands, ankles or feet,
- in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away.
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of

managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

5. How to store ABILIFY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ABILIFY contains
- The active substance is aripiprazole.

Each orodispersible tablet contains 10 mg of aripiprazole.

Each orodispersible tablet contains 15 mg of aripiprazole.

Each orodispersible tablet contains 30 mg of aripiprazole.

- The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silicon dioxide, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavour (contains lactose), tartaric acid and magnesium stearate.
Tablet coat
ABILIFY 10 mg orodispersible tablets:
Red iron oxide (E 172)
ABILIFY 15 mg orodispersible tablets:
Yellow iron oxide (E 172)
ABILIFY 30 mg orodispersible tablets:
Red iron oxide (E 172)

What ABILIFY looks like and contents of the pack
ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"’ on one side and ‘10’ on the other.
ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"’ on one side and ‘15’ on the other.
ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"’ on one side and ‘30’ on the other.

ABILIFY orodispersible tablets are supplied in perforated unit dose blisters packed in cartons containing 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Hrvatska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
România
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ireland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Slovenija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ísland
Vistor ehf.
Sími: +354 (0) 535 7000
Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0) 2 0063 2710
Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46 (0) 8 545 286 60
Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60
Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Package leaflet: ABILIFY 1 mg/mL oral solution

1. What ABILIFY is and what it is used for

2. What you need to know before you take ABILIFY

Do not take ABILIFY
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking ABILIFY.

Before treatment with ABILIFY, tell your doctor if you suffer from
- high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
- fits (seizures) since your doctor may want to monitor you more closely
- involuntary, irregular muscle movements, especially in the face
- cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure

blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
past experience with excessive gambling

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Taking ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body products an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
pain killers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.

ABILIFY with food, drink and alcohol
This medicine can be taken regardless of meals. However, the oral solution should not be diluted with other liquids or mixed with any food prior to administration.
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

ABILIFY contains fructose
This medicine contains 200 mg of fructose in each mL. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Fructose may damage teeth.

ABILIFY contains sucrose
This medicine contains 400 mg of sucrose in each mL. This should be taken into account in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Sucrose may be harmful to the teeth.

ABILIFY contains parahydroxybenzoates
May cause allergic reactions (possibly delayed).

ABILIFY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially

‘sodium-free’.

3. How to take ABILIFY

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 mL solution (corresponding to 15 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mL (i.e.
30 mg) once a day.

Use in children and adolescents
The recommended dose for adolescents is 10 mL solution (corresponding to 10 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mL (i.e.
30 mg) once a day.

The dose of ABILIFY must be measured using the calibrated cup or the 2 mL calibrated dropping pipette supplied in the carton.

If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist.

Try to take ABILIFY at the same time each day. It does not matter whether you take it with or without food. However, you should not dilute with other liquids or mix with other food prior to taking ABILIFY oral solution.

Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.

Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take ABILIFY
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

If you stop taking ABILIFY
Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to keep still, difficulty sitting still,
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
uncontrollable twitching, jerking or writhing movements,
trembling,
headache,
tiredness,
sleepiness,
light-headedness,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
indigestion,
feeling sick,
more saliva in mouth than normal,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increased or decreased blood levels of the hormone prolactin,
too much sugar in the blood,
depression,
altered or increased sexual interest,
uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heartbeat,
a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
hiccups.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

low levels of white blood cells,
low levels of blood platelets,
allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,

- combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
- seizure,
- serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
- speech disorder,
- fixation of the eyeballs in one position,
- sudden unexplained death,
- life-threatening irregular heartbeat,
- heart attack,
- slower heartbeat,
- blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
- high blood pressure,
- fainting,
- accidental inhalation of food with risk of pneumonia (lung infection),
- spasm of the muscles around the voice box,
- inflammation of the pancreas,
- difficulty swallowing,
- diarrhoea,
- abdominal discomfort,
- stomach discomfort,
- liver failure,
- inflammation of the liver,
- yellowing of the skin and white part of eyes,
- reports of abnormal liver tests values,
- skin rash,
- skin sensitivity to light,
- baldness,
- excessive sweating,
- serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
- abnormal muscle breakdown which can lead to kidney problems,
- muscle pain,
- stiffness,
- involuntary loss of urine (incontinence),
- difficulty in passing urine,
- withdrawal symptoms in newborn babies in case of exposure during pregnancy,
- prolonged and/or painful erection,
- difficulty controlling core body temperature or overheating,
- chest pain,
- swelling of hands, ankles or feet,
- in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away.
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

5. How to store ABILIFY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the bottle and on the carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.
Use within 6 months after first opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ABILIFY contains
- The active substance is aripiprazole.
Each mL contains 1 mg of aripiprazole.

The other ingredients are disodium edetate, fructose, glycerin, lactic acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sucrose, purified water, and orange flavour.

What ABILIFY looks like and contents of the pack
ABILIFY 1 mg/mL oral solution is a clear, colourless to light yellow liquid supplied in bottles with polypropylene child-resistant closure containing 50 mL, 150 mL or 480 mL per bottle.

Each carton contains one bottle and both a calibrated polypropylene measuring cup and a calibrated polypropylene low-density polyethylene dropping pipette.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ísland
Vistor ehf.
Sími: +354 (0) 535 7000
Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0) 2 0063 2710
Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46 (0) 8 545 286 60
Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60
Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Package leaflet: ABILIFY 7.5 mg/mL solution for injection

1. What ABILIFY is and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. ABILIFY is used to treat quickly symptoms of agitation and distressing behaviour that may occur in a disease characterised by symptoms such as:
- hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.
- feeling "high", having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

ABILIFY is given when treatment with oral formulations is not appropriate. Your doctor will change your treatment to oral ABILIFY as soon as appropriate.

2. What you need to know before you are given ABILIFY

Do not use ABILIFY
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before you are given ABILIFY.

cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
past experience with excessive gambling

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.

Tell the doctor or nurse if you feel dizzy or faint after the injection. You will probably need to lie down until you feel better. The doctor may also want to measure your blood pressure and pulse.

Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and ABILIFY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Receiving ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
pain killers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.

A combination of ABILIFY with medicines taken for anxiety might make you feel drowsy or dizzy.
Only take other medicines while you are on ABILIFY if your doctor tells you that you can.

ABILIFY with food, drink and alcohol
This medicine can be given regardless of meals.
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

If you are receiving ABILIFY, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are receiving this medicine.

ABILIFY contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.

3. How ABILIFY is given

Your doctor will decide how much ABILIFY you need and how long you need it for. The recommended dose is 9.75 mg (1.3 mL) for the first injection. Up to three injections in 24 hours may be given. The total dose of ABILIFY (all formulations) should not exceed 30 mg per day.

ABILIFY is ready to use. The correct amount of solution will be injected into your muscle by your doctor or nurse.

If you are given more ABILIFY than you need
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much. If you see more than one doctor, be sure to tell them that you are receiving ABILIFY.

Patients who have been given too much of this medicine have experienced the following symptoms:
- rapid heartbeat, agitation/aggressiveness, problems with speech.
- unusual movements (especially of the face or tongue) and reduced level of consciousness.

Contact your doctor or hospital immediately if you experience any of the above.

If you miss an injection of ABILIFY
It is important not to miss your dose. If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.

If you stop receiving ABILIFY
Do not stop your treatment just because you feel better. It is important that you carry on receiving ABILIFY solution for injection for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to keep still, difficulty sitting still,
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
uncontrollable twitching, jerking or writhing movements,
trembling,
headache,
tiredness,
sleepiness,
light-headedness,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
indigestion,
feeling sick,
more saliva in mouth than normal,
vomiting,
feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

increased or decreased blood levels of the hormone prolactin,
too much sugar in the blood,
depression,
altered or increased sexual interest,
uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
muscle disorder causing twisting movements (dystonia),
restless legs,
double vision,
eye sensitivity to light,
fast heartbeat,
increased diastolic blood pressure,
a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
hiccups,
dry mouth.

The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:

low levels of white blood cells,
low levels of blood platelets,
allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizure,
serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
speech disorder,
fixation of the eyeballs in one position,
sudden unexplained death,
life-threatening irregular heartbeat,
heart attack,
slower heartbeat,
blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing (if you notice any of these symptoms, seek medical advice immediately),
high blood pressure,
fainting,
accidental inhalation of food with risk of pneumonia (lung infection),
spasm of the muscles around the voice box,
inflammation of the pancreas,
difficulty swallowing,
diarrhoea,
abdominal discomfort,
stomach discomfort,
liver failure,
inflammation of the liver,

- yellowing of the skin and white part of eyes,
- reports of abnormal liver tests values,
- skin rash,
- skin sensitivity to light,
- baldness,
- excessive sweating,
- serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
- abnormal muscle breakdown which can lead to kidney problems,
- muscle pain,
- stiffness,
- involuntary loss of urine (incontinence),
- difficulty in passing urine,
- withdrawal symptoms in newborn babies in case of exposure during pregnancy,
- prolonged and/or painful erection,
- difficulty controlling core body temperature or overheating,
- chest pain,
- swelling of hands, ankles or feet,
- in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
- Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away.
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store ABILIFY

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the vial after EXP.
The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What ABILIFY contains
- The active substance is aripiprazole.
Each mL contains 7.5 mg aripiprazole.
A vial contains 9.75 mg (1.3 mL) aripiprazole.

The other ingredients are sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injections.

What ABILIFY looks like and contents of the pack
The ABILIFY solution for injection is a clear, colourless, aqueous solution.

Each carton contains one single-use type I glass vial with a rubber butyl stopper and a "tear-off" aluminium seal.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Zambon S.p.A.
Via della Chimica, 9
I-36100 Vicenza(VI)
Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Ελλάδα
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Österreich
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
España
Otsuka Pharmaceutical, S.A.
Tel: +34 93 550 01 00
Polska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00
Portugal
Lundbeck Portugal Lda
Tel: +351 (0) 21 00 45 900
Hrvatska
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
România
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ireland
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Slovenija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Ísland
Vistor ehf.
Sími: +354 (0) 535 7000
Slovenská republika
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Italia
Otsuka Pharmaceutical Italy S.r.l.
Tel: +39 (0) 2 0063 2710
Suomi/Finland
Otsuka Pharma Scandinavia AB
Puh/Tel: +46 (0) 8 545 286 60
Κύπρος
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 (0) 8 545 286 60
Latvija
Otsuka Pharmaceutical Netherlands B.V.
Tel: +31 (0) 20 85 46 555

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu.

Abilify Maintena

Package leaflet: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection

1. What Abilify Maintena is and what it is used for

Abilify Maintena contains the active substance aripiprazole in a vial. Aripiprazole belongs to a group of medicines called antipsychotics. Abilify Maintena is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with aripiprazole taken by mouth.

2. What you need to know before you are given Abilify Maintena

Do not use Abilify Maintena
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before you are given Abilify Maintena.

Before treatment with Abilify Maintena, tell your doctor if you suffer from

an acutely agitated state or a severely psychotic state
heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
fits (seizures) since your doctor may want to monitor you more closely
involuntary, irregular muscle movements, especially in the face

experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome)
dementia (loss of memory and other mental abilities) especially if you are elderly
cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring).
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
have any difficulty in swallowing
past experience with excessive gambling
severe liver problems.

If you notice you are gaining weight, develop unusual movements, experience sleepiness that interferes with normal daily activities, any difficulty in swallowing or have allergic symptoms, please talk to your doctor immediately.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Blood pressure-lowering medicines: Abilify Maintena may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.

Receiving Abilify Maintena with some medicines may mean the doctor will need to change your dose of Abilify Maintena or the other medicines. It is especially important to mention the following to your doctor:

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
medicines that are known to prolong QT prolongation.

These medicines may increase the risk of side effects or reduce the effect of Abilify Maintena; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
painkillers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine.

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

You should not be given Abilify Maintena if you are pregnant unless you have discussed this with your doctor. Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.

The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena in the last three months of their pregnancy (last trimester):
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.

If your baby develops any of these symptoms you need to contact your doctor.

If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breast- feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are receiving Abilify Maintena.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How Abilify Maintena is given

Abilify Maintena comes as a powder which your doctor or nurse will make into a suspension.

Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose.

There are two ways to start Abilify Maintena, your doctor will decide which way is right for you.
- If you are given one injection of Abilify Maintena on your first day the treatment with

aripiprazole by mouth is continued for 14 days after the first injection.
- If you are given two injections of Abilify Maintena on your first day, you will also take one tablet of aripiprazole by mouth at this visit.

After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.

Your doctor will give it to you as a single injection into the gluteal or deltoid muscle (buttock or shoulder) every month. You may feel a little pain during the injection. Your doctor will alternate the injections between your right and left side. The injections will not be given intravenously.

If you are given more Abilify Maintena than you should
This medicine will be given to you under medical supervision; it is therefore unlikely that you will be given too much. If you see more than one doctor, be sure to tell them that you are receiving Abilify Maintena.

Patients who have been given too much of this medicine have experienced the following symptoms:

rapid heartbeat, agitation/aggressiveness, problems with speech.
unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you miss an injection of Abilify Maintena
It is important not to miss your scheduled dose. You should be given an injection every month but not before the 26 days has passed from the last injection. If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.

If you stop receiving Abilify Maintena
Do not stop your treatment just because you feel better. It is important that you carry on receiving Abilify Maintena for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Tell your doctor immediately if you have any of the following serious side effects:

a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.
unusual movement mainly of the face or tongue, since your doctor may want to lower your dose.

if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you have a blood clot, which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness since this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes.
suicidal thoughts, behaviours or thoughts and feelings about hurting yourself.

The side effects listed below may also occur after receiving Abilify Maintena.
Talk to your doctor or nurse if you are affected by any of these side effects:

Common side effects (may affect up to 1 in 10 people):

weight gain
diabetes mellitus
weight loss
feeling restless
feeling anxious
unable to keep still, difficulty sitting still
difficulty sleeping (insomnia)
jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
shaking or trembling
uncontrollable twitching, jerking or writhing movements
changes in your level of alertness, drowsiness
sleepiness
dizziness
headache
dry mouth
muscle stiffness
inability to have or maintain an erection during sexual intercourse
pain at the injection site, hardening of the skin at the injection site
weakness, loss of strength or extreme tiredness
during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)

Uncommon side effects (may affect up to 1 in 100 people):

low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
allergic reactions (hypersensitivity)
decreased or increased blood levels of the hormone prolactin
high blood sugar
increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol and low level of triglycerides
increased levels of insulin, a hormone regulating blood sugar levels
decreased or increased appetite
thoughts about suicide
mental disorder characterised by defective or lost contact with reality
hallucination
delusion
increased sexual interest
panic reaction
depression

- affect lability
- state of indifference with lack of emotion, feelings of emotional and mental discomfort
- sleep disorder
- grinding of teeth or clenching of the jaw
- reduced sexual interest (libido is decreased)
- altered mood
- muscle problems
- muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements. They usually affect the face and mouth first but can affect other parts of the body.
These could be signs of a condition called “tardive dyskinesia”.
- parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling
- movement problems
- extreme restlesness and restless legs
- distortion of the senses of taste and smell
- fixation of the eyeballs in one position
- blurred vision
- eye pain
- double vision
- eye sensitivity to light,
- abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, abnormal reading (ECG) of the heart
- high blood pressure
- dizziness when getting up from a lying or sitting position due to a drop in blood pressure
- cough
- hiccups
- gastroesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the esophagus (gullet or the tube that goes from mouth to stomach through which food passes), causing heartburn and possibly damaging the esophagus
- heartburn
- vomiting
- diarrhoea
- feeling sick
- stomach ache
- stomach discomfort
- constipation
- frequent bowel movement
- drooling, more saliva in mouth than normal
- abnormal hair loss
- acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening
- muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity
- joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth
- kidney stones, sugar (glucose) in urine
- spontaneous flow of milk from the breasts (galactorrhoea)
- enlargement of breast in men, breast tenderness, vaginal dryness
- fever
- loss of strength
- gait disturbance
- chest discomfort
- injection site reactions such as redness, swelling discomfort and injection site itching
- thirst
- sluggishness
- liver function tests may show abnormal results

during tests your doctor may find
higher amounts of liver enzymes
higher amounts of alanine aminotransferase
higher amounts of gamma-glutamyl transferase
higher amounts of bilirubin in your blood
higher amounts of aspartate aminotransferase
higher or lower amounts of blood glucose
higher amounts of glycosylated haemoglobin
lower amounts of cholesterol in your blood
lower amounts of triglycerides in your blood
a higher waist circumference

The following side effects have been reported since the marketing of medicines containing the same active substance that are taken by mouth but the frequency for them to occur is not known (frequency cannot be estimated from the available data):

- low levels of white blood cells
- allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash
- unusual heartbeat, sudden unexplained death, heart attack
- diabetic ketoacidosis (ketones in the blood and urine) or coma
- loss of appetite (anorexia), difficulty in swallowing
- low sodium level in the blood
- suicide attempt and suicide
- inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
- nervousness
- aggression
- neuroleptic malignant syndrome ( a syndrome with symptoms such as fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
- seizure (fits)
- serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
- speech disorders
- heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG) QT prolongation
- fainting
- symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing
- spasm of the muscles around the voice box
- accidental inhalation of food with risk of pneumonia (lung infection)
- inflammation of the pancreas
- difficulty swallowing
- liver failure
- jaundice (yellowing of the skin and white part of eyes)
- inflammation of the liver

rash
skin sensitivity to light
excessive sweating
serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
difficulty in passing urine
involuntary loss of urine (incontinence)
drug withdrawal symptoms in new-born infant
prolonged and/or painful erection
difficulty controlling core body temperature or overheating
chest pain
swelling of hands, ankles or feet
during tests your doctor may find
higher amounts alkaline phosphatase
fluctuating results during tests to measure glucose in your blood

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abilify Maintena

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial. The expiry date refers to the last day of that month.

Do not freeze.

The reconstituted suspension should be used immediately but may be stored below 25 °C for up to 4 hours in the vial. Do not store the reconstituted suspension in the syringe.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains
- The active substance is aripiprazole.
Each vial contains 300 mg aripiprazole.
After reconstitution each mL of suspension contains 200 mg aripiprazole.
Each vial contains 400 mg aripiprazole.
After reconstitution each mL of suspension contains 200 mg aripiprazole.

- The other ingredients are
Powder

Carmellose sodium, mannitol (E421), sodium dihydrogen phosphate monohydrate (E339), sodium hydroxide (E524) Solvent Water for injections

What Abilify Maintena looks like and contents of the pack
Abilify Maintena is a powder and solvent for prolonged-release suspension for injection.

Abilify Maintena comes as a white to off-white powder in a clear glass vial. Your doctor or nurse will make it into a suspension that will be given as an injection using the vial of solvent for Abilify Maintena that comes as a clear solution in a clear glass vial.

Single pack
Each single pack containing one vial of powder, 2 mL vial of solvent, one 3 mL luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 3 mL disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Multipack
Bundle pack of 3 single packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby
Denmark

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 79 79
Lietuva
Swixx Biopharma UAB
Tel: +370 (0)5 236 91 40
България
Swixx Biopharma EOOD
Teл.: +359 (0)2 4942 480
Luxembourg/Luxemburg
Lundbeck S.A.
Tél: +32 2 535 79 79
Česká republika
Swixx Biopharma s.r.o.
Tel: +420 (0)242 434 222
Magyarország
Swixx Biopharma Kft.
Tel.: +36 (0)1 9206 570
Danmark
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Malta
H. Lundbeck A/S
Tel: +45 36301311
Deutschland
Otsuka Pharma GmbH
Tel: +49 69 1700860
Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti
Swixx Biopharma OÜ
Tel: +372 (0)640 1030
Norge
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Ελλάδα
Swixx Biopharma Μ.Α.Ε
Τηλ: +30 (0)214 444 9670
Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033
España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20
Polska
Swixx Biopharma Sp. z o. o.
Tel.: +48 (0)22 4600 720
France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

Portugal
Lundbeck Portugal – Produtos Farmacêuticos,
Unipessoal Lda.
Tel: +351 21 00 45 900
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 (0)1 2078 500
România
Swixx Biopharma S.R.L
Tel: +40 (0)37 1530 850
Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 (0)1 2355 100
Ísland
Vistor ehf.
Sími: +354 (0)535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 (0)2 20833 600
Italia
Otsuka Pharmaceutical Italy S.r.l
Tel: +39 02 00 63 27 10
Suomi/Finland
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Κύπρος
Swixx Biopharma Μ.Α.Ε
Τηλ: +30 (0)214 444 9670
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Latvija
Swixx Biopharma SIA
Tel: +371 (0)6 616 47 50

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole

Important: the solvent vial contains an overfill.
- One 3 mL luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety needle with needle protection device.
- One 3 mL disposable syringe with luer lock tip.
- One vial adapter.
- One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device.
- One 38 mm (1.5 inch) 22 gauge hypodermic safety needle with needle protection device.
- One 51 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device.
- Syringe and needle instructions.

Step 2: Reconstitution of the powder a)
Remove the solvent and powder vial caps and wipe the tops with a sterile alcohol swab.
b)
Using the syringe with pre-attached needle, withdraw the pre-determined solvent volume from the vial of the solvent into the syringe.
300 mg vial:
Add 1.5 mL solvent to reconstitute the powder.
400 mg vial:
Add 1.9 mL solvent to reconstitute the powder.
A small amount of residual solvent will remain in the vial following withdrawal. Any excess should be discarded.

Water

c)
Slowly inject the solvent into the vial containing the powder.

d)
Withdraw air to equalise the pressure in the vial by pulling back slightly on the plunger.

e)
Subsequently, remove the needle from the vial.

Engage the needle safety device by using the one-handed technique.
Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath.

Visually confirm that the needle is fully engaged into the needle protection sheath, and discard.

Cover
Discard

f)
Shake the vial vigorously for at least 30 seconds until the suspension appears uniform.

g)
Visually inspect the reconstituted suspension for particulate matter and discolouration prior to administration. The reconstituted medicine is a white to off-white, fluid suspension. Do not use if reconstituted suspension contains particulate matter or any discolouration.
h)
If the injection is not performed immediately after reconstitution, keep the vial below 25 °C for up to 4 hours and shake it vigorously for at least 60 seconds to re-suspend prior to injection.
i)
Do not store the reconstituted suspension in the syringe.

Step 3: Preparation prior to injection a)
Remove the cover, but not the adapter from the package.
b)
Using the vial adapter package to handle the vial adapter, attach the pre-packaged luer lock syringe to the vial adapter.

c)
Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package. Do not touch the spike tip of the adapter at any time.

Abilify Maintena

d)
Determine the recommended volume for injection.

Abilify Maintena 300 mg vial
Dose
Volume to Inject
---
---
300 mg
1.5 mL
200 mg
1.0 mL
160 mg
0.8 mL

Abilify Maintena 400 mg vial
Dose
Volume to Inject
400 mg
2.0 mL
300 mg
1.5 mL
200 mg
1.0 mL
160 mg
0.8 mL

e)
Wipe the top of the vial of the reconstituted suspension with a sterile alcohol swab.
f)
Place and hold the vial of the reconstituted suspension on a hard surface. Attach the adapter- syringe assembly to the vial by holding the outside of the adapter and pushing the adapter’s spike firmly through the rubber stopper, until the adapter snaps in place.
g)
Slowly withdraw the recommended volume from the vial into the luer lock syringe to allow for injection.

A small amount of excess product will remain in the vial.

Abilify Maintena

Step 4: Injection procedure a)
Detach the luer lock syringe containing the recommended volume of reconstituted Abilify Maintena suspension from the vial.

b)
Select one of the following hypodermic safety needles depending on the injection site and patient’s weight and attach the needle to the luer lock syringe containing the suspension for injection. Ensure the needle is firmly seated on the needle protection device with a push and clockwise twist and then pull the needle cap straight away from the needle.

Body type
Injection site
Needle size

Non-obese

Deltoid

25 mm (1 inch) 23 gauge

Gluteal

38 mm (1.5 inch) 22 gauge

Obese

Deltoid

38 mm (1.5 inch) 22 gauge

Gluteal

51 mm (2 inch) 21 gauge

c)
Slowly inject the recommended volume as a single intramuscular injection into the gluteal or deltoid muscle. Do not massage the injection site. Care must be taken to avoid inadvertent injection into the blood vessel. Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises.
For deep intramuscular gluteal or deltoid injection only.

deltoid gluteal

Remember to rotate sites of injections between the two gluteal or deltoid muscles.
If initiating with the two injection start, inject into two different sites in two different muscles.
DO NOT inject both injections concomitantly into the same deltoid or gluteal muscle.
For known CYP2D6 poor metabolisers administer in either two separate deltoid muscles or one deltoid and one gluteal muscle. DO NOT inject into two gluteal muscles.
Look for signs or symptoms of inadvertent intravenous administration.

Step 5: Procedures after injection
Engage the needle safety device as described in Step 2 e). Dispose of the vials, adapter, needles, and syringe appropriately after injection. The powder and solvent vials are for single-use only.

Cover
Discard

Package leaflet: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in / pre-filled syringe

1. What Abilify Maintena is and what it is used for

Abilify Maintena contains the active substance aripiprazole in a pre-filled syringe. Aripiprazole belongs to a group of medicines called antipsychotics. Abilify Maintena is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with aripiprazole taken by mouth.

2. What you need to know before you are given Abilify Maintena

Do not use Abilify Maintena
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before you are given Abilify Maintena.

Before treatment with Abilify Maintena, tell your doctor if you suffer from

an acutely agitated state or a severely psychotic state
heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes

fits (seizures) since your doctor may want to monitor you more closely
involuntary, irregular muscle movements, especially in the face
experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome)
dementia (loss of memory and other mental abilities) especially if you are elderly
cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring).
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
have any difficulty in swallowing
past experience with excessive gambling
severe liver problems.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other medicines.

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
medicines that are known to prolong QT prolongation.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
SSRI s (such as paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression
painkillers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine.

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

The following symptoms may occur in new-born babies, of mothers that have received Abilify Maintena in the last three months of their pregnancy(last trimester):
shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.

If your baby develops any of these symptoms you need to contact your doctor.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This should be considered in cases where full alertness is required, e.g., when driving a car or handling machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How Abilify Maintena is given

Abilify Maintena comes as a pre-filled syringe.

Your doctor will decide on the dose of Abilify Maintena that is right for you. The recommended starting dose is 400 mg unless your doctor decided to give you a lower starting or follow up dose.

There are two ways to start Abilify Maintena, your doctor will decide which way is right for you.
- If you are given one injection of Abilify Maintena on your first day the treatment with aripiprazole by mouth is continued for 14 days after the first injection.
- If you are given two injections of Abilify Maintena on your first day, you will also take one tablet of aripiprazole by mouth at this visit.

After that, treatment is given with injections of Abilify Maintena unless your doctor tells you otherwise.

Patients who have been given too much of this medicine have experienced the following symptoms:

rapid heartbeat, agitation/aggressiveness, problems with speech.
unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Tell your doctor immediately if you have any of the following serious side effects:

a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.

unusual movement mainly of the face or tongue, since your doctor may want to lower your dose.
if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you have a blood clot, which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness since this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes.
suicidal thoughts, behaviours or thoughts and feelings about hurting yourself.

The side effects listed below may also occur after receiving Abilify Maintena.
Talk to your doctor or nurse if you are affected by any of these side effects:
Common side effects (may affect up to 1 in 10 people):

weight gain
diabetes mellitus
weight loss
feeling restless
feeling anxious
unable to keep still, difficulty sitting still
difficulty sleeping (insomnia)
jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
shaking or trembling
uncontrollable twitching, jerking or writhing movements
changes in your level of alertness, drowsiness
sleepiness
dizziness
headache
dry mouth
muscle stiffness
inability to have or maintain an erection during sexual intercourse
pain at the injection site, hardening of the skin at the injection site
weakness, loss of strength or extreme tiredness
during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)

Uncommon side effects (may affect up to 1 in 100 people):

low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
allergic reactions (hypersensitivity)
decreased or increased blood levels of the hormone prolactin
high blood sugar
increased blood fats such as high cholesterol, high triglycerides and also low level of cholesterol and low level of triglycerides
increased levels of insulin, a hormone regulating blood sugar levels
decreased or increased appetite
thoughts about suicide
mental disorder characterised by defective or lost contact with reality
hallucination
delusion
increased sexual interest
panic reaction

- depression
- affect lability
- state of indifference with lack of emotion, feelings of emotional and mental discomfort
- sleep disorder
- grinding of teeth or clenching of the jaw
- reduced sexual interest (libido is decreased)
- altered mood
- muscle problems
- muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements. They usually affect the face and mouth first but can affect other parts of the body.
These could be signs of a condition called “tardive dyskinesia”.
- parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling
- movement problems
- extreme restlesness and restless legs
- distortion of the senses of taste and smell
- fixation of the eyeballs in one position
- blurred vision
- eye pain
- double vision
- eye sensitivity to light,
- abnormal heartbeat, slow or fast heart rate, abnormal electrical conduction of the heart, abnormal reading (ECG) of the heart
- high blood pressure
- dizziness when getting up from a lying or sitting position due to a drop in blood pressure
- cough
- hiccups
- gastroesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the esophagus (gullet or the tube that goes from mouth to stomach through which food passes), causing heartburn and possibly damaging the esophagus
- heartburn
- vomiting
- diarrhoea
- feeling sick
- stomach ache
- stomach discomfort
- constipation
- frequent bowel movement
- drooling, more saliva in mouth than normal
- abnormal hair loss
- acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening
- muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity
- joint pain ( arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth
- kidney stones, sugar (glucose) in urine
- spontaneous flow of milk from the breasts (galactorrhoea)
- enlargement of breast in men, breast tenderness, vaginal dryness
- fever
- loss of strength
- gait disturbance
- chest discomfort
- injection site reactions such as redness, swelling discomfort and injection site itching
- thirst
- sluggishness

liver function tests may show abnormal results
during tests your doctor may find
higher amounts of liver enzymes
higher amounts of alanine aminotransferase
higher amounts of gamma-glutamyl transferase
higher amounts of bilirubin in your blood
higher amounts of aspartate aminotransferase
higher or lower amounts of blood glucose
higher amounts of glycosylated haemoglobin
lower amounts of cholesterol in your blood
lower amounts of triglycerides in your blood
a higher waist circumference

inflammation of the liver
rash
skin sensitivity to light
excessive sweating
serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
difficulty in passing urine
involuntary loss of urine (incontinence)
drug withdrawal symptoms in new-born infant
prolonged and/or painful erection
difficulty controlling core body temperature or overheating
chest pain
swelling of hands, ankles or feet
during tests your doctor may find
higher amounts alkaline phosphatase
fluctuating results during tests to measure glucose in your blood

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abilify Maintena

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the pre-filled syringe.
The expiry date refers to the last day of that month.

Do not freeze.

Keep the pre-filled syringe in the outer carton in order to protect from light.

If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains
- The active substance is aripiprazole.
Each pre-filled syringe contains 300 mg aripiprazole.
After reconstitution each mL of suspension contains 200 mg aripiprazole.
Each pre-filled syringe contains 400 mg aripiprazole.
After reconstitution each mL of suspension contains 200 mg aripiprazole.

The other ingredients are

Powder
Carmellose sodium, mannitol (E421), sodium dihydrogen phosphate monohydrate (E339), sodium hydroxide (E524) Solvent Water for injections

What Abilify Maintena looks like and contents of the pack
Abilify Maintena comes in a pre-filled syringe containing a white to off-white powder in the front chamber and a clear solvent in the rear chamber. Your doctor will make it into a suspension that will be given as an injection.

Single pack
Each single pack containing one pre-filled syringe and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Multipack
Bundle pack of 3 single packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
H. Lundbeck A/S
Ottiliavej 9, 2500 Valby
Denmark

Elaiapharm
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis
06560 Valbonne
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tel: +49 69 1700860
Tel: +31 20 697 1901
Eesti
Swixx Biopharma OÜ
Tel: +372 (0)640 1030
Norge
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Ελλάδα
Swixx Biopharma Μ.Α.Ε
Τηλ: +30 (0)214 444 9670
Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033
España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20
Polska
Swixx Biopharma Sp. z o. o.
Tel.: +48 (0)22 4600 720
France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

Portugal
Lundbeck Portugal – Produtos Farmacêuticos,
Unipessoal Lda.
Tel: +351 21 00 45 900
Hrvatska
Swixx Biopharma d.o.o.
Tel: +385 (0)1 2078 500
România
Swixx Biopharma S.R.L
Tel: +40 (0)37 1530 850
Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800
Slovenija
Swixx Biopharma d.o.o.
Tel: +386 (0)1 2355 100
Ísland
Vistor ehf.
Sími: +354 (0)535 7000
Slovenská republika
Swixx Biopharma s.r.o.
Tel: +421 (0)2 20833 600
Italia
Otsuka Pharmaceutical Italy S.r.l
Tel: +39 02 00 63 27 10
Suomi/Finland
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Κύπρος
Swixx Biopharma Μ.Α.Ε
Τηλ: ++30 (0)214 444 9670
Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Latvija
Swixx Biopharma SIA
Tel: +371 (0)6 616 47 50

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------- The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole

Step 1: Preparation prior to reconstitution of the powder
Lay out and confirm that components listed below are provided:
- Abilify Maintena package leaflet and instructions for healthcare professionals.
- One Abilify Maintena pre-filled syringe.
- One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device.
- One 38 mm (1.5 inch) 22 gauge hypodermic safety needle with needle protection device.
- One 51 mm (2 inch) 21 gauge hypodermic safety needle with needle protection device.
- Syringe and needle instructions.

Step 2: Reconstitution of the powder a)
Push plunger rod slightly to engage threads. And then, rotate plunger rod until the rod stops rotating to release diluent. After plunger rod is at complete stop, middle stopper will be at the indicator line.

Indicator line

Plunger rod

b)
Vertically shake the syringe vigorously for 20 seconds until the reconstituted suspension appears uniform. The suspension should be injected immediately after reconstitution.

uniform milky white

20 seconds

c)
Visually inspect the syringe for particulate matter and discoloration prior to administration. The reconstituted product suspension should appear to be a uniform, homogeneous suspension that is opaque and milky-white in colour.

d)
If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours. Shake the syringe vigorously for at least 20 seconds to re-suspend prior to injection if the syringe has been left for more than 15 minutes.

Step 3: Injection procedure a)
Twist and pull off over-cap and tip-cap.

Twist + pull off
Over-cap

Tip-cap

Twist + pull off

b)
Select one of the following hypodermic safety needles depending on the injection site and patient’s weight.

Body type
Injection site
Needle size

Non-obese

Deltoid

25 mm (1 inch) 23 gauge

Gluteal
38 mm (1.5 inch) 22 gauge

Obese

Deltoid

38 mm (1.5 inch) 22 gauge

Gluteal
51 mm (2 inch) 21 gauge

c)
While holding the needle cap, ensure the needle is firmly seated on the safety device with a push and twist clockwise until snugly fitted.

Needle cap

d)
Then pull needle-cap straight up.

Needle cap

Pull

e)
Hold syringe upright and advance plunger rod slowly to expel the air. If it's not possible to advance plunger rod to expel the air, check that plunger rod is rotated to a complete stop. It is not possible to re-suspend after the air in the syringe is expelled.

*If there’s resistance or difficulty expelling air, check that plunger rod is rotated to a complete stop.

Expel air until suspension fills needle base*

f)
Slowly inject into the gluteal or deltoid muscle. Do not massage the injection site. Care must be taken to avoid inadvertent injection into the blood vessel. Do not inject into an area with signs of inflammation, skin damage, lumps and/or bruises. For deep intramuscular gluteal or deltoid injection only.

deltoid gluteal

Step 4: Procedures after injection
Engage the needle safety device. Dispose of the needle and pre-filled syringe appropriately after injection.

Cover
Discard

Package leaflet: Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe

1. What Abilify Maintena is and what it is used for

Abilify Maintena contains the active substance aripiprazole in a pre-filled syringe.
Aripiprazole belongs to a group of medicines called antipsychotics. Abilify Maintena is used to treat schizophrenia - a disease with symptoms such as hearing, seeing or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with this condition may also feel depressed, guilty, anxious or tense.

Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilised during treatment with aripiprazole.

If you have responded well to treatment with aripiprazole taken by mouth or the medicine Abilify Maintena, your doctor may start treatment with Abilify Maintena. It can help alleviate the symptoms of your disease and reduce the risk of your symptoms coming back.

2. What you need to know before you are given Abilify Maintena

Do not use Abilify Maintena
- if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or nurse before you are given Abilify Maintena.

Before treatment with this medicine, tell your doctor if you suffer from:

an acutely agitated state or a severely psychotic state
cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure

heart problems or have a history of stroke, especially if you know that you have other risks factors for stroke
blood clots, or family history of blood clots, as antipsychotics have been associated with formation of blood clots
irregular heartbeat or if someone else in your family has a history of irregular heartbeat (including so called QT prolongation seen with ECG monitoring)
involuntary, irregular muscle movements, especially in the face (tardive dykinesia)
experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome)
fits (seizures) since your doctor may want to monitor you more closely
dementia (loss of memory and other mental abilities) especially if you are elderly
high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
have any difficulty in swallowing
past experience with excessive gambling.

Children and adolescents
Do not use this medicine in children and adolescents under 18 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other medicines.

medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide, diltiazem)
antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, escitalopram, St. John's Wort)
antifungal medicines (such as itraconazole)
ketoconazole (used to treat Cushing’s syndrome when the body produces an excess of cortisol)
certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g., indinavir, ritonavir)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital primidone)
certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
medicines that are known to prolong QT prolongation.

triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, OCD and social phobia as well as migraine and pain
selective serotonin reuptake inhibitor/serotonin noradrenaline reuptake inhibitor (SSRI/SNRI s) such as paroxetine and fluoxetine used for depression, OCD, panic, and anxiety
other anti-depressants (such as venlafaxine and tryptophan) used in major depression
tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum) used as an herbal remedy for mild depression
painkillers (such as tramadol and pethidine) used for pain relief
triptans (such as sumatriptan and zolmitripitan) used for treating migraine.

These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.

The following symptoms may occur in new-born babies, of mothers that receive this medicine in the last three months of their pregnancy (last trimester):
Shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.

If your baby develops any of these symptoms you need to contact your doctor.

Driving and using machines
Dizziness and vision problems may occur during treatment with this medicine (see section 4). This should be considered in cases where full alertness is required, e.g., when driving or handling machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium- free’.

3. How Abilify Maintena is given

Abilify Maintena comes as a suspension in a pre-filled syringe which your doctor or nurse will administer.

Your doctor will decide on the dose that is right for you. The recommended starting dose is 960 mg injected once every 2 months (56 days after the previous injection) unless your doctor decided to give you a lower starting or follow up dose (720 mg) injected once every 2 months (56 days after the previous injection).

There are three ways to start Abilify Maintena 960 mg, your doctor will decide which way is right for you.
- If you received Abilify Maintena 400 mg 1 or more months before your doctor started treatment with Abilify Maintena 960 mg, your next dose may be replaced with one injection of Abilify Maintena 960 mg.
- If you are given one injection of Abilify Maintena 960 mg on your first day without administration of Abilify Maintena 400 mg 1 month before, the treatment with aripiprazole by mouth is continued for 14 days after the first injection.
- If you are given two injections (one of Abilify Maintena 960 mg and one of Abilify Maintena 400 mg) on your first day, you will also take one tablet of aripiprazole by mouth at this visit.
Your doctor will give the injections in two different sites.

After that, treatment is given with injections of Abilify Maintena 960 mg or 720 mg unless your doctor tells you otherwise.

Your doctor will give it to you as a single injection into the gluteal muscle (buttock) once every two months. You may feel a little pain during the injection. Your doctor will alternate the injections between your right and left side. The injections will not be given intravenously.

Patients who have been given too much of this medicine have experienced the following symptoms:

rapid heartbeat, agitation/aggressiveness, problems with speech.
unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating,
muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you miss an injection of Abilify Maintena
It is important not to miss your scheduled dose. You should be given an injection once every 2 months. If you miss an injection, you should contact your doctor to arrange your next injection as soon as you can.

If you stop receiving Abilify Maintena
Do not stop your treatment just because you feel better. It is important that you carry on receiving this medicine for as long as your doctor has told you to.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you have any of the following serious side effects:

a combination of any of these symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty talking, difficulty walking, muscle stiffness or shaking, fever, weakness, irritability, aggression, anxiety, increase in blood pressure, or seizures that can lead to unconsciousness.
unusual movement mainly of the face or tongue, since your doctor may want to lower your dose.
if you have symptoms such as swelling, pain, and redness in the leg, because this may mean you have a blood clot, which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness since this may be a sign of a condition called neuroleptic malignant syndrome (NMS).
thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes.
suicidal thoughts, behaviours or thoughts and feelings about hurting yourself.

The side effects listed below may also occur after receiving Abilify Maintena
Talk to your doctor or nurse if you are affected by any of these side effects:

Common side effects (may affect up to 1 in 10 people):

diabetes mellitus
feeling restless
feeling anxious
unable to keep still, difficulty sitting still
difficulty sleeping (insomnia)
jerky resistance to passive movement as muscles tense and relax, abnormally increased muscle tone, slow body movement
akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly)
shaking or trembling
uncontrollable twitching, jerking or writhing movements
changes in your level of alertness, drowsiness
sleepiness
dizziness
headache
dry mouth
muscle stiffness
inability to have or maintain an erection during sexual intercourse
pain at the injection site, hardening of the skin at the injection site
weakness, loss of strength or extreme tiredness
during blood tests your doctor may find higher amounts of creatine phosphokinase in your blood (enzyme important for muscle function)
weight gain
weight loss

Uncommon side effects (may affect up to 1 in 100 people):

- low level of a specific type of white blood cells (neutropenia), low haemoglobin or red blood cell count, low level of blood platelets
- allergic reactions (e.g., swelling in the mouth, tongue, face and throat, itching, hives)
- increased blood levels of the hormone prolactin
- high blood sugar
- increased blood fats such as high cholesterol and high triglycerides
- increased levels of insulin, a hormone regulating blood sugar levels
- decreased or increased appetite
- thoughts about suicide
- mental disorder characterised by defective or lost contact with reality
- hallucination (e.g. seeing and hearing things that are not real)
- delusion (e.g. believing things that are not true)
- increased sexual interest (may lead to behaviour of significant concern to you or to others)
- panic reaction
- depression
- affect lability
- state of indifference with lack of emotion, feelings of emotional and mental discomfort
- sleep disorder
- grinding of teeth or clenching of the jaw
- reduced sexual interest (libido is decreased)
- altered mood
- muscle problems
- muscle movements that you cannot control such as grimacing, lip-smacking and tongue movements. They usually affect the face and mouth first but can affect other parts of the body.
These could be signs of a condition called “tardive dyskinesia”.
- parkinsonism - medical condition with many various symptoms which include decreased or slow movements, slowness of thought, jerks when bending the limbs (cogwheel rigidity), shuffling, hurried steps, shaking, little or no facial expression, muscle stiffness, drooling
- movement problems
- extreme restlessness and restless legs
- fixation of the eyeballs in one position
- blurred vision
- eye pain
- double vision
- eye sensitivity to light
- distortion of the senses of taste and smell
- abnormal heartbeat, slow or fast heart rate
- high blood pressure
- dizziness when getting up from a lying or sitting position due to a drop in blood pressure
- cough
- hiccups
- gastrooesophageal reflux disease. Excess amount of gastric juice flowing back (refluxes) into the oesophagus (gullet or the tube that goes from mouth to stomach through which food passes), causing heartburn and possibly damaging the oesophagus
- heartburn
- vomiting
- diarrhoea
- feeling sick
- stomach ache
- stomach discomfort
- constipation
- frequent bowel movement
- drooling, more saliva in mouth than normal
- abnormal hair loss
- acne, skin condition of the face where the nose and cheeks are unusually red, eczema, skin hardening

muscle rigidity, muscle spasms, muscle twitching, muscle tightness, muscle pain (myalgia), pain in extremity
joint pain (arthralgia), back pain, decreased range of motion of joints, stiff neck, limited opening of mouth
kidney stones, sugar (glucose) in urine
spontaneous flow of milk from the breasts (galactorrhoea)
enlargement of breast in men, breast tenderness, vaginal dryness
fever
loss of strength
gait disturbance
chest discomfort
injection site reactions such as redness, swelling, discomfort and injection site itching
thirst
sluggishness
during tests your doctor may find
higher or lower amounts of blood glucose
higher amounts of glycosylated haemoglobin
a higher waist circumference
lower amounts of cholesterol in your blood
lower amounts of triglycerides in your blood
lower amounts of white blood cells and neutrophils in your blood
higher amounts of liver enzymes
lower amounts of the hormone prolactin in your blood
abnormal reading (ECG) of the heart (e.g. T wave amplitude decreased or inverted)
higher amounts of alanine aminotransferase
higher amounts of gamma-glutamyl transferase
higher amounts of bilirubin in your blood
higher amounts of aspartate aminotransferase
liver function tests may show abnormal results

- low levels of white blood cells
- decreased appetite
- low sodium level in the blood
- suicide and suicide attempt
- inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences
- uncontrollable excessive shopping
- binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
- a tendency to wander away
Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.
- nervousness
- aggression
- neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate)
- seizure (fits)
- serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
- speech disorders
- diabetic ketoacidosis (ketones in the blood and urine) or coma

fainting
heart problems including stopping of the heart, torsades de pointes, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart
symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing
spasm in your throat that can lead to a feeling as though a large object is stuck in your throat
spasm of the muscles around the voice box
accidental inhalation of food with risk of pneumonia (lung infection)
inflammation of the pancreas
difficulty in swallowing
liver failure
jaundice (yellowing of the skin and white part of eyes)
inflammation of the liver
rash
skin sensitivity to light
excessive sweating
serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia).
muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis)
difficulty in passing urine
involuntary loss of urine (incontinence)
withdrawal symptoms in new-born infant
prolonged and/or painful erection
sudden unexplained death
difficulty controlling core body temperature or overheating
chest pain
swelling of hands, ankles or feet
during tests your doctor may find
fluctuating results during tests to measure glucose in your blood
QT prolongation (an abnormal readings during heart examination (ECG))
higher amounts of alkaline phosphatase in your blood

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abilify Maintena

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the pre-filled syringe.
The expiry date refers to the last day of that month.

Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains
- The active substance is aripiprazole.

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Each pre-filled syringe contains 720 mg aripiprazole.

Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe Each pre-filled syringe contains 960 mg aripiprazole.

- The other ingredients are:
Carmellose sodium, macrogol, povidone (E1201), sodium chloride, sodium dihydrogen phosphate monohydrate (E339), sodium hydroxide (E524), water for injections.(see section 2, Abilify Maintena contains sodium)

What Abilify Maintena looks like and contents of the pack
Abilify Maintena is a prolonged-release suspension for injection in a pre-filled syringe.

Abilify Maintena is a white to off-white prolonged-release suspension for injection in a pre-filled syringe.

Pack size
Each 720 mg pack contains one pre-filled syringe, and two sterile safety needles: one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Each 960 mg pack contains one pre-filled syringe and two sterile safety needles: one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis
06560 Valbonne
France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Danmark
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Malta
H. Lundbeck A/S
Tel: +45 36301311
Deutschland
Otsuka Pharma GmbH
Tel: +49 69 1700860
Nederland
Lundbeck B.V.
Tel: +31 20 697 1901
Eesti
Swixx Biopharma OÜ
Tel: +372 (0)640 1030
Norge
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660
Ελλάδα
Swixx Biopharma Μ.Α.Ε
Τηλ: +30 (0)214 444 9670
Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033
España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20
Polska
Swixx Biopharma Sp. z o. o.
Tel.: +48 (0)22 4600 720
France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
http://www.ema.europa.eu.

--------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:

INSTRUCTIONS FOR HEALTH CARE PROFESSIONALS

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Abilify Maintena 720 mg prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 960 mg prolonged-release suspension for injection in pre-filled syringe aripiprazole

To be administered by a healthcare professional once every 2 months. Read complete

instructions prior to use.
- The suspension for injection is for single use only.
- For intramuscular use. Gluteal injection only. Do not administer by any other route.
- Prior to administration, visually inspect the syringe for particulate matter and discolouration.
- The suspension should appear to be a uniform, homogeneous suspension that is opaque and

milky-white in colour. Do not use Abilify Maintena if it is discoloured, or particulate matter is present.

Contents of kit

Confirm that components listed below are provided:
- One pre-filled syringe containing either Abilify Maintena 960 mg or 720 mg prolonged-release

injectable suspension and two safety needles.
- One sterile 38 mm (1.5 inch) 22 gauge needle with black needle hub.
- One sterile 51 mm (2 inch) 21 gauge needle with green needle hub.

Prepare for injection


Remove the syringe from the package.

Tap the syringe on your hand at least 10 times.

After tapping, shake the syringe vigorously for at least 10 seconds.

Select the appropriate needle

For gluteal intramuscular administration only.

Needle selection is determined by patient body type.

Body type
Needle size
Needle shield colour
Non-obese (BMI < 28 kg/m2)
38 mm, 22 gauge
Black
Obese (BMI > 28 kg/m2)
51 mm, 21 gauge
Green

Attach the needle

Twist and pull off the pre-filled syringe tip-cap.
While holding the base of the needle, ensure the needle is firmly seated on the safety device

with a push and gently twist clockwise until SECURELY fitted.

Expel air

When you are ready to administer the injection, hold the syringe upright and remove the needle

cap by pulling straight up. Do not twist the needle cap as this may loosen the needle from

the syringe.

Slowly advance the plunger rod upward to expel the air and until the suspension fills the needle base.
Inject immediately after expelling air from syringe.

Inject the dose

Slowly inject the entire contents intramuscularly into the gluteal muscle of the patient. Do not

administer by any other route.
- Do not massage the injection site.

Remember to rotate sites of injections between the two gluteal muscles.
If initiating with the two injection start, inject into two different gluteal muscle. DO NOT inject

both injections concomitantly into the same gluteal muscle.

Look for signs or symptoms of inadvertent intravenous administration.

Disposal procedure

After injection, engage the needle safety device by pressing the safety shield on a hard surface

to cover and lock shield over the needle.

Immediately discard used syringe and unused needle in an approved sharps container.
Unused needle should not be saved for future use.

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.