Deutetrabenazine: package leaflet

Austedo is a medicine containing the active substance deutetrabenazine. It belongs to a group of medicines that treat disorders of the nervous system.

This medicine is used in adults to treat moderate to severe tardive dyskinesia. This is a condition that causes the face, tongue, or other body parts to make uncontrollable movements such as smacking of the lips, sticking out of the tongue and jerking or twisting of the arms and legs, and can develop with use of certain medicines.

Austedo decreases the uncontrollable movements associated with tardive dyskinesia by reducing the amount of dopamine, a messenger substance in the brain.

Do not take Austedo
­ if you are allergic to deutetrabenazine or any of the other ingredients of this medicine (listed in section 6).
­ if you have liver problems.
­ if you are taking
• reserpine (a medicine used to treat high blood pressure)
• a monoamine oxidase inhibitor (a medicine used to treat depression, Parkinson´s disease or bacterial infections) • another medicine that works in a similar way to Austedo to reduce your uncontrollable movements.
(see “Other medicines and Austedo”, in this section).

If you are not sure, talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Austedo
­ if you have or have had depression
­ if you have or have had an irregular heart rhythm
­ if you have a family history of a heart condition known as congenital long QT syndrome (abnormal electrical activity of the heart that affects its rhythm) ­ if you have a slow heart rate ­ if you have low levels of potassium or magnesium, as seen in your blood tests.

Talk to your doctor immediately while taking Austedo
­ if you start feeling sad, worthless, hopeless or helpless or start losing interest in seeing your friends or doing things you used to enjoy (symptoms of a depression). If these symptoms do not get better, your doctor might consider stopping Austedo. You may find it helpful to ask a relative or close friend to tell your doctor immediately if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
­ if you start experiencing a rapid onset of shortness of breath, heart palpitations (sensation of rapid or irregular heartbeat) or loss of consciousness. These may be symptoms of a heart rhythm disorder known as QTc prolongation.
­ if you start experiencing symptoms like high temperature, muscle stiffness, sweating, a lowered level of consciousness or very rapid or irregular heartbeat, low or high blood pressure. This is known as neuroleptic malignant syndrome, which can be life-threatening. Stop taking Austedo and talk to your doctor straight away. Your doctor will treat your symptoms.
­ if you get a condition where you feel a constant urge to move (akathisia) or if you experience shaking, muscle stiffness and slow movement (parkinsonism). Your doctor may need to adjust your dose or stop your treatment.

Talk to your doctor if you notice new skin or eye problems. Deutetrabenazine binds to body tissues that contain melanin (a pigment that gives colour to skin and eyes). This may possibly affect these tissues if the medicine is used long-term.

Children and adolescents
There is no relevant use of Austedo in children and adolescents.

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

Do not take this medicine if you are already taking
­ reserpine (a medicine used to treat high blood pressure). After your doctor has stopped reserpine you must wait at least 20 days after your last dose of reserpine before you can start taking Austedo.
­ a monoamine oxidase inhibitor (MAOI), e.g.
• moclobemide, tranylcypromine and isocarboxazid (medicines used to treat depression) • selegiline, rasagiline and safinamide (medicines used to treat Parkinson´s disease) • linezolid (medicine used to treat bacterial infections).
After your doctor has stopped the MAOI you must wait at least 14 days after your last dose of the MAOI before you can start taking Austedo.
­ another medicine that works in a similar way to Austedo to reduce your uncontrollable movements (e.g. tetrabenazine). Your doctor will decide and tell you what to do.

Tell your doctor if you are taking, have recently taken or might take
­ medicines to treat
• some mental or behavioural problems (e.g. psychosis, such as haloperidol, chlorpromazine, ziprasidone, promazine)

• nausea and vomiting (e.g. metoclopramide)
These medicines may increase the risk for symptoms such as shaking, muscle stiffness and slow movement (called parkinsonism), high temperature, muscle stiffness, low or high blood pressure and lowered level of consciousness (called neuroleptic malignant syndrome), or a constant urge to move (called akathisia).
­ medicines that can influence your heart rhythm (visible on electrocardiogram) also known as QTc prolongation, for example, medicines used to treat • an irregular heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol) • some mental or behavioural problems (e.g. phenothiazine derivatives, pimozide, haloperidol, droperidol, ziprasidone) • depression (e.g. amitriptyline, citalopram, escitalopram) • bacterial, fungal or other microbial infections (e.g. fluoroquinolones, triazole derivative (e.g.
voriconazole), erythromycin IV, pentamidine, antimalarial medicines)
• allergies (e.g. mizolastine, hydroxyzine)
­ medicines that have a sedating effect, for example, medicines
• to treat allergic conditions (e.g. diphenhydramine, dimenhydrinate)
• to help you sleep or to calm down (e.g. midazolam, diazepam, lorazepam)
• to treat severe pain (e.g. oxycodone, buprenorphine)
• to treat high blood pressure (e.g. clonidine, moxonidine)
• to treat depression (e.g. mirtazapine, amitriptyline, trazodone)
• to treat some mental or behavioural problems (e.g. promethazine, chlorprothixene) These medicines may increase the sedation and sleepiness which could be caused by Austedo.
­ medicines to treat an irregular heart rhythm (e.g. quinidine) or depression (e.g. paroxetine, fluoxetine and bupropion). These medicines can interfere with the breakdown of deutetrabenazine. Your doctor may decrease your dose of Austedo.
­ medicines to treat Parkinson’s disease (e.g. levodopa) and medicines that work in a similar way like levodopa (e.g. also to treat Parkinson’s disease and restless legs syndrome, e.g. pramipexole, ropinirole). These medicines may weaken the effect of Austedo.

Austedo with alcohol
It is not recommended to consume alcohol while you are being treated with Austedo, as it may increase the sedative effect and sleepiness that could be caused by this medicine.

Pregnancy and breast-feeding
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.

Austedo is not recommended during pregnancy and in women of childbearing potential not using contraception.

It is not known if deutetrabenazine passes into breast milk. Thus, a risk for the breast-fed baby cannot be excluded. You should discuss with your doctor if you can take Austedo while breast-feeding.

Driving and using machines
Austedo may cause sleepiness. Therefore, you should not perform activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, until you are on your maintenance dose of Austedo and you know how the medicine affects you.

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

Austedo contains sunset yellow FCF and/or allura red AC (see section 6 “What Austedo contains”) This medicine may cause allergic reactions.

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

Your doctor will decide what dose is appropriate for you.
When you first start taking Austedo, you will be given a treatment initiation pack which your doctor will use to gradually increase your dose. Treatment starts at 12 mg once daily for one week. After that, the dose should be increased to 24 mg once daily for another week. Then, the dose can be adjusted weekly if needed, increasing by 6 mg each time, until you have reached a dose that effectively controls your symptoms and is well-tolerated. This becomes your maintenance dose (usually between 24 mg and 48 mg per day).
Consult your doctor if your symptoms worsen or side effects occur.

The prolonged-release tablets are for oral use and can be taken with or without food.
Tablets must be swallowed whole with water, not chewed, crushed or divided.

The tablet does not dissolve completely after all of the active substance has been released and sometimes the tablet shell may appear in your stool. This is normal.

If you take more Austedo than you should
If you have taken more tablets than prescribed contact your doctor or nearest hospital straight away.
You may experience symptoms such as sleepiness, increase in movements, tiredness, difficulty sitting and standing still (agitation), restlessness, difficulty falling and staying asleep, or suicidal thoughts or ideas.

If you forget to take Austedo
If you have missed your daily dose for one day or several days in a row (but not for more than 7 days), continue taking your current dose the next day. Contact your doctor if there are any concerns or you are unsure what to do. Do not take a double dose to make up for a missed dose.
If you have missed your daily dose for more than one week ask your doctor how your treatment should be restarted.

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.

Please contact your doctor immediately if you start feeling sad, worthless, hopeless or helpless or start losing interest in seeing your friends or doing things you used to enjoy. These are symptoms of a depression or dysthymic disorder, which may occur commonly (may affect up to 1 in 10 people).

Very common (may affect more than 1 in 10 people)
­
Sleepiness (somnolence)

Common (may affect up to 1 in 10 people)
­
Infection of the parts of the body that collect and pass out urine, such as the bladder (urinary tract infection) ­ Inflammation of the nose and throat (nasopharyngitis) ­ Feeling anxious ­ Difficulty sleeping (insomnia) ­ Difficulty standing or sitting still (agitation) ­ Restlessness ­ A constant urge to move (akathisia) ­ Diarrhoea

­
Constipation
­
Dry mouth
­
Tiredness (fatigue)
­
Bruising (contusion)

Uncommon (may affect up to 1 in 100 people)
­
Movement symptoms similar to Parkinson’s disease such as shaking, muscle stiffness and slow movement (parkinsonism)

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 after EXP. The expiry date refers to the last day of that month.

Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg prolonged-release tablets (treatment initiation pack) Do not store above 30 °C.

Austedo 24 mg, 30 mg, 36 mg, 42 mg and 48 mg prolonged-release tablets (maintenance packs) This medicine does not require any special storage conditions.

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 Austedo contains

­
The active substance is deutetrabenazine.
Each prolonged release tablet contains either 12 mg, 24 mg, 30 mg, 36 mg, 42 mg or 48 mg deutetrabenazine.

­
The other ingredients are
Tablet:
butylhydroxyanisole (E 320), butylhydroxytoluene (E 321), macrogol high- molecular-mass 200K, macrogol high-molecular-mass 5000K, hypromellose 2910, sodium chloride, allura red AC (E 129), magnesium stearate, cellulose acetate, macrogol 3350, hydroxypropylcellulose.
Film-coating: poly(vinyl alcohol), titanium dioxide (E 171), macrogol 3350, talc Austedo 12 mg: indigo carmine (E 132) Austedo 24 mg: indigo carmine (E 132), allura red AC (E 129) Austedo 30 mg: sunset yellow FCF (E 110) Austedo 36 mg: indigo carmine (E 132), sunset yellow FCF (E 110), allura red AC (E 129) Austedo 42 mg: sunset yellow FCF (E 110), allura red AC (E 129) Austedo 48 mg: allura red AC (E 129).
See section 2 “Austedo contains sunset yellow FCF and/or allura red AC”.
Printing ink:
shellac, iron oxide black (E 172), propylene glycol.

What Austedo looks like and contents of the pack

Austedo 12 mg prolonged-release tablets are round, blue, film-coated, with a diameter of approximately 9 mm and “Q12” printed in black ink on one side.
Austedo 24 mg prolonged-release tablets are round, purple, film-coated, with a diameter of approximately 9 mm and “Q24” printed in black ink on one side.
Austedo 30 mg prolonged-release tablets are round, light orange, film-coated, with a diameter of approximately 10 mm and “Q30” printed in black ink on one side.
Austedo 36 mg prolonged-release tablets are round, light purple, film-coated, with a diameter of approximately 10 mm and “Q36” printed in black ink on one side.
Austedo 42 mg prolonged-release tablets are round, orange, film-coated, with a diameter of approximately 10 mm and “Q42” printed in black ink on one side.
Austedo 48 mg prolonged-release tablets are round, pink, film-coated, with a diameter of approximately 10 mm and “Q48” printed in black ink on one side.

Treatment initiation pack
Austedo 12 mg, 24 mg, 30 mg, 36 mg, 42 mg, 48 mg is available in a pack of 42 prolonged-release tablets containing two wallet cards one with 21 (7 x 12 mg, 7 x 24 mg, 7 x 30 mg) and another one with 21 (7 x 36 mg, 7 x 42 mg, 7 x 48 mg) prolonged-release tablets.

Maintenance packs
Austedo 24 mg, 30 mg, 36 mg, 42 mg, 48 mg are available in packs of 28 and 84 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
Kraków, 31-546
Poland

Teva Czech Industries s.r.o.
Ostravska 29, c.p. 305
747 70 Opava-Komarov
Czech Republic

For any information about this medicine, 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 HELLAS Α.Ε.
il-Greċja
Tel: +30 2118805000

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 915359180

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.

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