rasagiline: package leaflet

AZILECT contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. It can be used together with or without Levodopa (another medicine that is used to treat Parkinson’s disease).

With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. AZILECT helps to increase and sustain levels of dopamine in the brain.

Do not take AZILECT
- If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver problems.

Do not take the following medicines while taking AZILECT:
- Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g. St. John's Wort.
- Pethidine (a strong pain killer).
You must wait at least 14 days after stopping AZILECT treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions
Talk to your doctor before taking AZILECT
- If you have any liver problems
- You should speak with your doctor about any suspicious skin changes. Treatment with AZILECT may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking AZILECT and/or other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

AZILECT may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s disease). For further information please refer to section driving and using machines.

Children and adolescents
There is no relevant use of AZILECT in children and adolescents. Therefore, AZILECT is not recommended for use under the age of 18.

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

Especially tell your doctor if you are taking any of the following medicines:
- Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin- norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- The antibiotic ciprofloxacin used against infections
- The cough suppressant dextromethorphan
- Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine The use of AZILECT together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with AZILECT, you should wait at least 5 weeks after stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping AZILECT treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of AZILECT in the blood.

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 or pharmacist for advice before taking this medicine.

You should avoid taking AZILECT if you are pregnant, as the effects of AZILECT on pregnancy and the unborn child are not known.

Driving and using machines
Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with AZILECT may influence your ability to do so. AZILECT can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking AZILECT. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking AZILECT do not drive or operate machinery (see section 2).

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 of AZILECT is 1 tablet of 1 mg taken by mouth once daily. AZILECT may be taken with or without food.

If you take more AZILECT than you should
If you think that you may have taken too many AZILECT tablets, contact your doctor or pharmacist immediately. Take the AZILECT carton/ blister or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of AZILECT included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

If you forget to take AZILECT
Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

If you stop taking AZILECT
Do not stop taking AZILECT without first talking to your doctor.

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

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

Contact your doctor right away if you notice any of the following symptoms. You may need urgent medical advice or treatment:
- If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
- If you see or hear things which are not there (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)

Contact your doctor if you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)
- Involuntary movements (dyskinesia)
- Headache

Common (may affect up to 1 in 10 people)
- Abdominal pain
- Fall
- Allergy
- Fever
- Flu (influenza)
- General feeling of being unwell (malaise)
- Neck pain
- Chest pain (angina pectoris)
- Low blood pressure when rising to a standing position with symptoms like dizziness/light- headedness (orthostatic hypotension)
- Decreased appetite

• Constipation
• Dry mouth
• Nausea and vomiting
• Flatulence
• Abnormal results of blood tests (leucopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and muscle weakness of the hand (carpal tunnel syndrome)
• Decreased weight
• Abnormal dreams
• Difficulty in muscular coordination (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Runny nose (rhinitis)
• Irritation of the skin (dermatitis)
• Rash
• Bloodshot eyes (conjunctivitis)
• Urinary urgency

Uncommon (may affect up to 1 in 100 people)
- Stroke (cerebrovascular accident)
- Heart attack (myocardial infarction)
- Blistering rash (vesiculobullous rash)

Not known: frequency cannot be estimated from the available data
- Elevated blood pressure
- Excessive drowsiness
- Sudden onset of sleep

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.

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, bottle or blister after EXP.
The expiry date refers to the last day of that month.

Do not store above 30oC.

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.

What AZILECT contains
- The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate).
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.

What AZILECT looks like and contents of the pack
AZILECT tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.

The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets or in a bottle containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturers

Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

Teva Operations Poland Sp.z o.o.
ul. Mogilska 80
31-546 Krakow
Poland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS Α.Ε.
Τηλ: +30 2118805000

Österreich ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Teva Pharma, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS Α.Ε.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

This leaflet was last revised in {month YYYY}.

Rasagiline ratiopharm contains the active substance rasagiline and it is used for the treatment of Parkinson’s disease in adults. It can be used together with or without Levodopa (another medicine that is used to treat Parkinson’s disease).

With Parkinson’s disease, there is a loss of cells that produce dopamine in the brain. Dopamine is a chemical in the brain involved in movement control. Rasagiline ratiopharm helps to increase and sustain levels of dopamine in the brain.

Do not take Rasagiline ratiopharm
- If you are allergic to rasagiline or any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver problems.

Do not take the following medicines while taking Rasagiline ratiopharm:
- Monoamine oxidase (MAO) inhibitors (e.g. for treatment of depression or Parkinson’s disease, or used for any other indication), including medicinal and natural products without prescription e.g.
St. John's Wort.
- Pethidine (a strong pain killer).
You must wait at least 14 days after stopping Rasagiline ratiopharm treatment and starting treatment with MAO inhibitors or pethidine.

Warnings and precautions
Talk to your doctor before taking Rasagiline ratiopharm
- If you have any liver problems
- You should speak with your doctor about any suspicious skin changes. Treatment with Rasagiline ratiopharm may possibly increase the risk of skin cancer.

Tell your doctor if you or your family/carer notices that you are developing unusual behaviours where you cannot resist the impulse, urges or cravings to carry out certain harmful or detrimental activities to yourself or others. These are called impulse control disorders. In patients taking Rasagiline ratiopharm

and/or other medicines used to treat Parkinson’s disease, behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts or feelings have been observed. Your doctor may need to adjust or stop your dose (see section 4).

Rasagiline ratiopharm may cause drowsiness and may cause you to suddenly fall asleep during day time activities, especially if you are taking other dopaminergic medicinal products (used for the treatment of Parkinson’s disease). For further information please refer to section driving and using machines.

Children and adolescents
There is no relevant use of Rasagiline ratiopharm in children and adolescents. Therefore, Rasagiline ratiopharm is not recommended for use under the age of 18.

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

Especially tell your doctor if you are taking any of the following medicines:
- Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants)
- The antibiotic ciprofloxacin used against infections
- The cough suppressant dextromethorphan
- Sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine The use of Rasagiline ratiopharm together with the antidepressants containing fluoxetine or fluvoxamine should be avoided.
If you are starting treatment with Rasagiline ratiopharm, you should wait at least 5 weeks after stopping fluoxetine treatment.
If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline ratiopharm treatment.

Tell your doctor or pharmacist if you are smoking or intend to stop smoking. Smoking could decrease the amount of Rasagiline ratiopharm in the blood.

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 or pharmacist for advice before taking this medicine.

You should avoid taking Rasagiline ratiopharm if you are pregnant, as the effects of Rasagiline ratiopharm on pregnancy and the unborn child are not known.

Driving and using machines
Ask your doctor for advice before you drive and operate machines, since Parkinson’s disease itself as well as the treatment with Rasagiline ratiopharm may influence your ability to do so. Rasagiline ratiopharm can make you feel dizzy or drowsy; it can also cause episodes of sudden sleep onset.
This might be enhanced if you take other medicines to treat the symptoms of your Parkinson’s disease, or if you take medicines which can make you feel drowsy, or if you drink alcohol while taking Rasagiline ratiopharm. If you have experienced somnolence and/or episodes of sudden sleep onset before, or while taking Rasagiline ratiopharm do not drive or operate machinery (see section 2).

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 of Rasagiline ratiopharm is 1 tablet of 1 mg taken by mouth once daily.
Rasagiline ratiopharm may be taken with or without food.

If you take more Rasagiline ratiopharm than you should
If you think that you may have taken too many Rasagiline ratiopharm tablets, contact your doctor or pharmacist immediately. Take the Rasagiline ratiopharm carton/ blister or bottle with you to show the doctor or pharmacist.

Symptoms reported following overdose of Rasagiline ratiopharm included slightly euphoric mood (light form of mania), extremely high blood pressure and serotonin syndrome (see section 4).

If you forget to take Rasagiline ratiopharm
Do not take a double dose to make up for a forgotten dose. Take the next dose normally, when it is time to take it.

If you stop taking Rasagiline ratiopharm
Do not stop taking Rasagiline ratiopharm without first talking to your doctor.

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

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

Contact you doctor right away if you notice any of the following symptoms. You may need urgent medical advice or treatment:
- If you develop unusual behaviours such as compulsions, obsessive thoughts, addictive gambling, excessive shopping or spending, impulsive behaviour and an abnormally high sex drive or an increase in sexual thoughts (impulse control disorders) (see section 2).
- If you see or hear things which are not there (hallucinations).
- Any combination of hallucinations, fever, restlessness, tremor and sweating (serotonin syndrome)

Contact your doctor if you notice any suspicious skin changes because there may be an increased risk of skin cancer (melanoma) with the use of this medicine (see section 2).

Other side effects

Very common (may affect more than 1 in 10 people)
- Involuntary movements (dyskinesia)
- Headache

Common (may affect up to 1 in 10 people)
- Abdominal pain
- Fall
- Allergy
- Fever
- Flu (influenza)
- General feeling of being unwell (malaise)
- Neck pain
- Chest pain (angina pectoris)
- Low blood pressure when rising to a standing position with symptoms like dizziness/light- headedness (orthostatic hypotension)
- Decreased appetite
- Constipation
- Dry mouth
- Nausea and vomiting

• Flatulence
• Abnormal results of blood tests (leucopenia)
• Joint pain (arthralgia)
• Musculoskeletal pain
• Joint inflammation (arthritis)
• Numbness and muscle weakness of the hand (carpal tunnel syndrome)
• Decreased weight
• Abnormal dreams
• Difficulty in muscular coordination (balance disorder)
• Depression
• Dizziness (vertigo)
• Prolonged muscle contractions (dystonia)
• Runny nose (rhinitis)
• Irritation of the skin (dermatitis)
• Rash
• Bloodshot eyes (conjunctivitis)
• Urinary urgency

Uncommon (may affect up to 1 in 100 people)
- Stroke (cerebrovascular accident)
- Heart attack (myocardial infarction)
- Blistering rash (vesiculobullous rash)

Not known: frequency cannot be estimated from the available data
- Elevated blood pressure
- Excessive drowsiness
- Sudden onset of sleep

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.

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, bottle or blister after EXP.
The expiry date refers to the last day of that month.

Do not store above 30oC.

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.

What Rasagiline ratiopharm contains
- The active substance is rasagiline. Each tablet contains 1 mg rasagiline (as mesilate).
- The other ingredients are mannitol, colloidal anhydrous silica, maize starch, pregelatinised maize starch, stearic acid, talc.

What Rasagiline ratiopharm looks like and contents of the pack

Rasagiline ratiopharm tablets are presented as white to off-white, round, flat, bevelled tablets, debossed with “GIL” and “1” underneath on one side and plain on the other side.

The tablets are available in blister packs of 7, 10, 28, 30, 100 and 112 tablets, in perforated unit dose blister packs of 10 x 1, 30 x 1 and 100 x 1 tablets or in a bottle containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturers

Pliva Croatia Ltd.
Prilaz baruna Filipovica 25
10000 Zagreb
Croatia

Teva Operations Poland Sp.z o.o.
ul. Mogilska 80
31-546 Krakow
Poland

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

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Teл.: +359 24899585

Luxembourg/Luxemburg
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt.
Tel.: +36 12886400

Danmark
Teva Denmark A/S
Tlf.: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland ratiopharm GmbH
Tel: +49 73140202

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
TEVA HELLAS A.E.
Österreich ratiopharm Arzneimittel Vertriebs-GmbH

Τηλ: +30 2118805000

Tel: +43 1970070

España
Laboratorios Davur, S.L.U.
Tel: +34 913873280

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 223459300

France
Teva Santé
Tél: +33 155917800

Portugal
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550

Hrvatska
Pliva Hrvatska d.o.o.
Tel: +385 13720000

România
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
TEVA HELLAS A.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

This leaflet was last revised in MM/YYYY.