PACKAGE LEAFLET

Package leaflet: Information for the user Tetrabenazine 12.5 mg tablets

tetrabenazine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Tetrabenazine is and what it is used for

2.    What you need to know before you take Tetrabenazine

3.    How to take Tetrabenazine

4.    Possible side effects

5.    How to store Tetrabenazine

6.    Contents of the pack and other information

1. What Tetrabenazine is and what it is used for

Tetrabenazine belongs to a group of medicines used to treat disorders of the nervous system. Tetrabenazine is used for the treatment of diseases causing jerky, irregular, uncontrollable movements (hyperkinetic motor disorders with Huntington’s chorea).

2. What you need to know before you take Tetrabenazine Do not take Tetrabenazine

-    if you are allergic (hypersensitive) to tetrabenazine or any of the other ingredients of this medicine (listed in section 6)

-    if you use reserpine (medicine to control high blood pressure and treat psychotic states)

-    if you use MAO inhibitors (medicine to treat depression)

-    if you suffer from Parkinson-like symptoms

-    if you have been diagnosed as having depression and this has not been treated or has been difficult to treat

-    if you are actively suicidal (feel like killing yourself)

-    if you are breast-feeding

-    if you suffer from pheochromocytoma (tumour of the adrenal gland)

-    if you suffer from pro-lactin-dependent tumours, e.g. pituitary or breast cancer.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tetrabenazine

-    if you know you are a slow or intermediate metaboliser of an enzyme called CYP2D6, because a different dose may be applicable to you

-    if you are suffering from mild to severe liver problems

-    if you have a heart condition known as long QT syndrome or if you have or have had problems with your heart rhythm

- If you start to have mental changes such as confusion or hallucinations, or develop stiffness in your muscles and a temperature, you may be developing a condition called Neuroleptic Malignant Syndrome. If you have these symptoms please contact your doctor straight away.

Other medicines and Tetrabenazine

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

Taking other medicines

Do not use Tetrabenazine together with reserpine.

Treatment with MAO inhibitors should be stopped 14 days before the treatment with Tetrabenazine starts, and MAO inhibitors should not be used until at least 14 days have elapsed after the treatment with Tetrabenazine has ended.

Talk to your doctor or pharmacist before you use Tetrabenazine together with

•    levodopa (a medicine used to treat Parkinson’s disease)

•    certain types of antidepressants, opioids, beta-blockers, antihypertensive drugs (medicine to treat high blood pressure), hypnotics and neuroleptics (medicine to treat psychotic disorders)

•    inhibitors of CYP2D6 (e.g. fluoxetine, paroxetine, terbinafine, moclobemide and quinidine). Use of these together with tetrabenazine may result in increased plasma concentrations of the active metabolite dihydrotetrabenazine; that is why they should only be combined with caution. A reduction of the tetrabenazine dose may be necessary.

•    drugs known to prolong the QTc interval in the ECG, including some drug used to treat mental health conditions (neuroleptics), certain antibiotics (e.g. gatifloxacin, moxifloxacin) and some drugs used to treat problems with heart rhythm conditions (e.g. quinidine, procainamide, amiodarone, sotalol).

Tetrabenazine with alcohol

Drinking alcohol while you are taking Tetrabenazine may cause you to feel abnormally sleepy. Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide after taking all risks and benefits into account, if you may use Tetrabenazine during pregnancy.

Tetrabenazine must not be taken by breast feeding mothers. If treatment with tetrabenazine is necessary, breast-feeding must be stopped..

Driving and using machines

Tetrabenazine may cause drowsiness and depending on how you respond to this medicine you may find that your ability to drive or operate machinery is affected.

Tetrabenazine contains lactose

Tetrabenazine tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Tetrabenazine

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

Adults

The recommended starting dose is 12.5 mg one to three times a day. This can be increased by 12.5 mg every three or four days as needed depending on your response to treatment.

The maximum daily dose is eight 25 mg tablets or sixteen 12.5 mg tablets (a total of 200 mg).

If you have taken the maximum dose for a period of seven days and your condition has not improved, it is unlikely that the medicinal product will be of benefit to you.

Swallow the tablet(s) with water or another non-alcoholic drink.

Use in elderly patients

The standard dosage has been administered to elderly patients without apparent ill effect. Parkinson-like adverse reactions are quite common in these patients.

Use in children

The treatment is not recommended in children.

Patients with liver disorders

Patients with mild to moderate hepatic disorders should start with 12.5 mg a day. For patients with severe hepatic disorders, additional caution is necessary.

Patients with kidney disorders

Tetrabenazine is not recommended for use in this patient group.

If you take more Tetrabenazine than you should

If you take more Tetrabenazine than you should, you may develop drowsiness, sweating, low blood pressure, and extremely low body temperature (hypothermia). Contact your doctor or pharmacist straight away. Your doctor will treat the symptoms.

If you forget to take Tetrabenazine

If you forget to take one dose, you should never make up for the missing dose by doubling it at the next time. Instead you should simply continue with the next dose when it is due.

If you stop taking Tetrabenazine

Do not stop taking Tetrabenazine unless your doctor tells you to. A neuroleptic malignant syndrome (NMS) has been described after abrupt withdrawal of tetrabenazine (see section 4, Rare side effects).

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

4.    Possible side effects

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

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

-    drowsiness (with higher dosages)

-    depression

-    Parkinson-like syndrome (uncontrollable movements of the hands, arms, legs and head, with higher dosages).

Common (may affect up to 1 in 10 people)

-    confusion

-    anxiety

-    sleeplessness

-    low blood pressure

-    dysphagia (difficulty in swallowing)

-    nausea

-    vomiting

-    diarrhoea

-    constipation

-    autonomic dysfunction (sweating and fluctuations in blood pressure).

Uncommon (may affect up to 1 in 100 people)

-    mental changes such as confusion or hallucinations

-    stiffness in your muscles

-    fever.

Rare (may affect up to 1    in    1,000 people)

-    a condition called Neuroleptic    Malignant Syndrome    (NMS).

If you start to have mental changes such as confusion or hallucinations, or develop stiffness in your muscles and a temperature, you may be developing a condition called Neuroleptic Malignant Syndrome (NMS). NMS has been described after abrupt withdrawal of tetrabenazine.

Very rare (may affect up to 1 in 10,000 people)

-    muscle damage.

Frequency unknown (not possible to estimate the incidence from available data)

-    disorientation

-    nervousness

-    coordination problems

-    uncontrollable and sometimes    painful muscle spasms (dystonia)

-    feeling that you cannot sit or stand still (akathisia)

-    dizziness

-    forgetfulness

-    slowing of the heart    rate

-    stomach pain

-    dry mouth.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tetrabenazine

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

This medicinal product 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.

6. Contents of the pack and other information

What Tetrabenazine contains

12.5 mg tablets

- The active substance is tetrabenazine. Each tablet contains 12.5 mg of tetrabenazine.

- The other ingredients are lactose anhydrous, maize starch, sodium starch glycolate, talc, silica, colloidal anhydrous, and magnesium stearate.

What Tetrabenazine looks like and contents of the pack

Tetrabenazine 12.5 mg tablets: This medicinal product is presented as a white to off-white, circular, flat faced bevelled edge uncoated tablet debossed with “1” on one side and plain on the other side.

Tetrabenazine is supplied in plastic tablet containers each containing 112 tablets.

Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87 2132 JH Hoofddorp The Netherlands

This medicinal product is authorised in the Member states of the EEA under the following

Tetrabenazin-neuraxpharm 12,5 mg Tabletten Tetrabenazina SUN 12,5 mg compresse Tetrabenazine SUN 12,5 mg tabletten Tetrabenazina SUN 12,5 mg comprimidos EFG Tetrabenazine 12.5 mg tablets

This leaflet was last revised in 08/2016

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