TETMODIS 25 mg TABLETS

2. What you need to know before you take Tetmodis

Do not take Tetmodis

• if you are allergic to tetrabenazina or any of the other ingredients of Tetmodis (listed in section 6)
• if you are using reserpine (a type of antihypertensive and antipsychotic medication)
• if you are using a medicine belonging to the group of drugs called monoamine oxidase inhibitors (MAOIs) (a medicine for treating depression)
• if you have liver failure
• if you have parkinsonian symptoms
• if you have depression
• if you have thoughts of self-harm or suicide
• if you are breastfeeding
• if you have pheochromocytoma (a tumor of the adrenal gland)
• if you have prolactin-dependent tumors (e.g., pituitary tumor or breast cancer)

Warnings and precautions

Talk to your doctor or pharmacist before taking Tetmodis

• if you have ever had tremors in your hands and erratic movements of your arms and legs, known as parkinsonism
• if you have high levels of prolactin in your blood (hyperprolactinemia)
• if you are prone to sudden drops in blood pressure when standing up or stretching
• if you know you are a slow or intermediate metabolizer of an enzyme called CYP2D6, as you may need a different dose
• if you have a heart condition known as long QT syndrome or if you have or have had heart rhythm problems
• if you start to experience mental changes such as confusion or hallucinations, or if you notice stiffness in your muscles and fever, as you may be developing a condition called malignant neuroleptic syndrome. If you experience these symptoms, contact your doctor immediately
• if you start to feel unpleasant feelings of inner restlessness, an urgent need to be constantly moving, or coordination disorders
• note that Tetmodis binds to melanin-containing tissues, which may affect your eyes

Children

Tetmodis is not recommended for use in children.

Other medicines and Tetmodis

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

Be careful if you use Tetmodis with levodopa (a medicine for treating Parkinson's disease)

Do not use Tetmodis with reserpine

Treatment with monoamine oxidase inhibitors should be stopped 14 days before starting treatment with tetrabenazina

It is not recommended to use this medicine with certain types of antidepressants, alcohol, opioids, beta-blockers, antihypertensive drugs (medicines for treating high blood pressure), hypnotics, or neuroleptics (medicines for treating psychotic disorders)

Drugs that are CYP2D6 inhibitors (such as fluoxetine, paroxetine, terbinafine, moclobemide, and quinidine) may increase the plasma concentrations of the active metabolite dihydrotetrabenazina. If you take these medicines, it may be necessary to reduce the dose of Tetmodis

Be careful if you use Tetmodis with drugs that prolong the QTc interval in the ECG, including some medicines for mental disorders (neuroleptics), as well as certain antibiotics (gatifloxacin, moxifloxacin, etc.) and drugs used to treat heart rhythm problems (quinidine, procainamide, amiodarone, sotalol, etc.)

Taking Tetmodis with food and alcohol

If you drink alcohol during treatment with Tetmodis, you may feel abnormal drowsiness

Pregnancy and breastfeeding

Tetmodis should not be taken during pregnancy or breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking Tetmodis

Driving and using machines

Tetmodis may cause drowsiness and, therefore, may affect your performance when driving or using machines, with varying degrees depending on the dose and individual susceptibility

These tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine

3. How to take Tetmodis

Follow exactly the administration instructions of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again

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

Adults

Huntington's chorea

The recommended initial dose is half a tablet (12.5 mg) 1 to 3 times a day. This can be increased by half a tablet every 3 or 4 days until the optimal effect is observed or until intolerance effects occur (sedation, parkinsonism, depression)

The maximum daily dose is 8 tablets (200 mg)

If you have taken the maximum dose for a period of 7 days and your condition has not improved, it is unlikely that the medicine will provide a benefit

Elderly patients

The standard dose has been administered to elderly patients without apparent adverse effects

However, parkinsonian-type adverse effects are common

Use in children

Treatment is not recommended in children

Patients with renal disorders

Tetmodis is not recommended for use in this group of patients

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

If you take more Tetmodis than you should

If you take more Tetmodis than you should, you may develop symptoms such as drowsiness, sweating, low blood pressure, or very low body temperature (hypothermia). Your doctor will treat the symptoms

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 915 620 420

If you forget to take Tetmodis

If you forget to take a dose, do not take a double dose to make up for the forgotten dose. Instead, continue with the next dose as usual

If you stop taking Tetmodis

Do not stop taking Tetmodis unless your doctor tells you to. A malignant neuroleptic syndrome has been described after abrupt interruption of tetrabenazina administration

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

4. Possible side effects

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

The following adverse reactions are presented by frequency:

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

Drowsiness (with higher doses), depression, parkinsonian syndrome (uncontrollable movements of hands, arms, legs, and head, with higher doses)

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

Confusion, anxiety, insomnia, low blood pressure, dysphagia (difficulty swallowing), nausea, vomiting, diarrhea, constipation

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

Mental changes such as confusion or hallucinations, muscle stiffness, fever

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

A disorder called malignant neuroleptic syndrome: if you start to experience mental changes such as confusion or hallucinations, or if you experience muscle stiffness and fever, you may be developing a disorder called malignant neuroleptic syndrome

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

Muscle damage

The available data do not allow an estimate of the incidence of the following adverse effects (frequency unknown):

Disorientation, nervousness, coordination problems, feeling that you cannot stay still, either standing or sitting (akathisia), uncontrolled muscle spasms (dystonia), dizziness, memory loss, decreased heart rate, dizziness when standing up quickly, stomach pain, dry mouth, low body temperature

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine

5. Storing Tetmodis

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 blister after the abbreviation EXP. The expiry date is the last day of the month stated

Store in the original package to protect from light

Do not store above 25°C

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment

6. Package contents and further information

Composition of Tetmodis

• The active substance is tetrabenazina

Each tablet contains 25 mg of tetrabenazina

• The other ingredients are: pregelatinized corn starch, lactose monohydrate, talc, yellow iron oxide E172, magnesium stearate

Appearance and packaging

Yellow, round tablet with a score line on one side and marked with "TE25" on the other

Packaged in white bottles with a "twist-off" closure containing 112 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Walter Ritter GmbH + Co. KG

Spaldingstraße 110 B

20097 Hamburg

Germany

Manufacturer:

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2

1190 Vienna, Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria: Tetmodis 25 mg Tabletten

Belgium: Tetrabenazine Walter Ritter 25 mg tabletten

Bulgaria: Tetmodis 25 mg ????????

Czech Republic: Tetmodis

Denmark: Tetmodis 25 mg tabletter

Estonia: Tetmodis 25 mg tablet

Finland: Tetmodis 25 mg tablets

France: Comprimés Tetmodis 25 mg

Germany: Tetmodis 25 mg Tabletten

Greece: Tetmodis 25 mg δισκ?α

Hungary: Motetis 25 mg tabletta

Ireland: Tetmodis 25 mg tablets

Italy: Tetmodis compresse da 25 mg

Latvia: Tetmodis 25 mg tabletes

Lithuania: Tetmodis 25 mg tabletės

Netherlands: Tetmodis 25 mg tabletten

Poland: Tetmodis 25 mg tabletki

Portugal: Comprimidos de Tetmodis 25 mg

Romania: Tetmodis, tablete, 25 mg

Slovakia: Tetmodis 25 mg tableta

Slovenia: Tetmodis 25 mg tablete

Spain: Tetmodis 25 mg comprimidos EFG

Sweden: Tetmodis 25 mg tablet

United Kingdom: Tetmodis 25 mg tablets

Date of last revision of this leaflet September 2021

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/