Tetmodis

Leaflet attached to the packaging: information for the user

Tetmodis, 25 mg, tablets

Tetrabenazine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tetmodis and what is it used for
• 2. Important information before taking Tetmodis
• 3. How to take Tetmodis
• 4. Possible side effects
• 5. How to store Tetmodis
• 6. Contents of the pack and other information

1. What is Tetmodis and what is it used for

Tetmodis is a medicine belonging to a group of medicines used to treat nervous system disorders.
Tetmodis is used to treat diseases that cause sudden, irregular, uncontrolled movements (hyperkinetic movement disorders in Huntington's disease).

2. Important information before taking Tetmodis

When not to take Tetmodis

• if the patient is allergic to tetrabenazine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking reserpine (a medicine used to treat high blood pressure and psychotic states)
• if the patient is taking medicines that belong to a group of medicines called monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression)
• if the patient has liver function disorders
• if the patient has symptoms similar to Parkinson's disease
• if the patient suffers from depression
• if the patient has thoughts of self-harm or suicidal thoughts;
• if the patient is breastfeeding
• if the patient has a pheochromocytoma (adrenal gland tumor)
• if the patient has prolactin-dependent tumors, such as pituitary or breast cancer.

Warnings and precautions

Before starting to take Tetmodis, the patient should discuss it with their doctor or pharmacist:

• if the patient has ever had hand tremors and jerky movements of the hands and feet, called parkinsonism;
• if the patient has a high level of prolactin in the blood (hyperprolactinemia);
• if the patient is prone to a sudden drop in blood pressure when standing up or stretching;
• if the patient has been found to be a slow or moderate metabolizer using the CYP2D6 enzyme, as they may need to take a different dose of Tetmodis;
• if the patient has a heart condition known as long QT syndrome or has had arrhythmias;
• if the patient experiences psychiatric disorders, such as disorientation or delusions, or stiffness and elevated body temperature, which may indicate the possibility of developing a condition called malignant neuroleptic syndrome. If these symptoms occur, the patient should contact their doctor immediately;
• if the patient experiences an unpleasant feeling of inner restlessness, a strong need to be in constant motion, or coordination disorders;
• it should be remembered that Tetmodis binds to melanin-containing tissues, which may affect the eyes.

Children

Tetmodis is not recommended for use in children.

Tetmodis and other medicines

The patient should tell their doctor about all the medicines they have taken recently, including those that are available without a prescription.
The patient should be particularly careful when taking Tetmodis with levodopa (a medicine used to treat Parkinson's disease).
Tetmodis should not be taken with reserpine.
The patient should stop taking MAOIs 14 days before starting treatment with tetrabenazine.
It is not recommended to take this medicine with certain types of antidepressants, alcohol, opioids, beta-blockers, antihypertensive medicines (medicines used to treat high blood pressure), sedatives, and neuroleptics (medicines used to treat mental disorders).
Medicines that belong to the group of CYP2D6 isoenzyme inhibitors (e.g., fluoxetine, paroxetine, terbinafine, moclobemide, and quinidine) may increase the plasma concentration of active dihydrotetrabenazine metabolites. If the patient is taking these medicines, it may be necessary to reduce the dose of Tetmodis.
The patient should be particularly careful when taking Tetmodis with medicines that are known to prolong the QTc interval in the electrocardiogram, including certain medicines used to treat mental disorders (neuroleptics), some antibiotics (e.g., gatifloxacin, moxifloxacin), and some medicines used to treat arrhythmias (e.g., quinidine, procainamide, amiodarone, sotalol).

Tetmodis with food and alcohol

Drinking alcohol while taking Tetmodis may cause excessive drowsiness.

Pregnancy and breastfeeding

Tetmodis should not be taken by pregnant or breastfeeding women. If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine.

Driving and using machines

Tetmodis may cause drowsiness and therefore affect the ability to drive and use machines to a varying degree, depending on the dose and individual sensitivity.

Tetmodis contains lactose

The tablets contain lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Tetmodis

Tetmodis should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.
The tablet(s) should be swallowed with water or a non-alcoholic drink.
Adults
Huntington's disease
The recommended initial dose is half a tablet (12.5 mg) once to three times a day. The dose may be increased by half a tablet every three or four days until the optimal effect is observed or intolerance symptoms appear (drowsiness, parkinsonism, depression).
The maximum daily dose is 8 tablets (200 mg) per day.
If there is no improvement in the patient's condition after taking the maximum dose for seven days, it is unlikely that the medicine will be effective.
Elderly patients
The standard dose was administered to elderly patients without any adverse effects. However, the occurrence of symptoms similar to Parkinson's disease is common.
Use in children
The medicine is not recommended for use in children.
Patients with renal impairment
Tetmodis is not recommended for use in this group of patients.

Overdose of Tetmodis

In case of an overdose of Tetmodis, patients may experience drowsiness, sweating, low blood pressure, and extremely low body temperature (hypothermia). The doctor will provide symptomatic treatment.

Missed dose of Tetmodis

The patient should not take a double dose to make up for a missed dose. Instead, they should simply continue treatment by taking the next dose at the usual time.

Stopping treatment with Tetmodis

The patient should not stop taking Tetmodis without their doctor's advice. Cases of malignant neuroleptic syndrome have been observed after sudden discontinuation of tetrabenazine.
If the patient has any doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The following side effects are listed according to the MedDRA classification and frequency of occurrence:

Very common (may affect more than 1 in 10 people):
Drowsiness (after higher doses), depression, symptoms similar to Parkinson's disease (uncontrolled movements of the hands, arms, legs, and head, after higher doses).
Common (may affect up to 1 in 10 people):
Disorientation, nervousness, insomnia, low blood pressure, dysphagia (difficulty swallowing), nausea, vomiting, diarrhea, constipation.
Uncommon (may affect up to 1 in 100 people):
Psychiatric disorders, such as disorientation or hallucinations, muscle stiffness, fever.
Rare (may affect up to 1 in 1,000 people):
A disorder called malignant neuroleptic syndrome: if the patient experiences symptoms such as disorientation or hallucinations, or muscle stiffness and fever, it may indicate the development of malignant neuroleptic syndrome.
Very rare (may affect up to 1 in 10,000 people):
Muscle damage.
For the following side effects, the frequency cannot be estimated from the available data:
disorientation, nervousness, coordination disorders, need to be in constant motion (akathisia), uncontrolled muscle contractions (dystonia), dizziness, memory loss, slow heart rate, dizziness when standing up quickly from a lying or sitting position, abdominal pain, dry mouth, decreased body temperature.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to: Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al.
Jerozolimskie 181C, PL-02 222 Warsaw,
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tetmodis

Keep out of sight and reach of children.
Do not take Tetmodis after the expiry date stated on the bottle or carton. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tetmodis contains

• Active substance: tetrabenazine.
• Each tablet contains 25 mg of tetrabenazine.
• Other ingredients are: corn starch, lactose monohydrate, talc, yellow iron oxide (E172), magnesium stearate.

What Tetmodis looks like and contents of the pack

Yellow, round, with a dividing line on one side and the inscription "TE25" on the back of the tablet.
The tablets are packed in a screw-top bottle containing 112 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Walter Ritter GmbH +Co.KG
Spaldingstr. 110 B
20097 Hamburg
Germany
Manufacturer:
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna, Austria
This medicine has been authorized in the Member States of the European Economic Area under the following names:
Austria:
Tetmodis 25 mg tablets
Belgium:
Tetrabenazine AOP Orphan Pharmaceuticals 25 mg tablets
Bulgaria:
ТЕТМОДИС 25 mg tablets
Denmark:
Tetmodis 25 mg tablets
Estonia:
Tetmodis 25 mg tablets
Finland:
Tetmodis 25 mg tablets
France:
Tetmodis 25 mg tablets
Greece:
Tetmodis 25 mg tablets
Spain:
Tetmodis 25 mg tablets
Netherlands:
Tetmodis 25 mg tablets
Ireland:
Tetmodis 25 mg tablets
Lithuania:
Tetmodis 25 mg tablets
Latvia:
Tetmodis 25 mg tablets
Germany:
Tetmodis 25 mg tablets
Poland:
Tetmodis 25 mg tablets
Portugal:
Tetmodis 25 mg tablets
Czech Republic: Tetmodis
Romania:
Tetmodis, 25 mg tablets
Slovakia:
Tetmodis 25 mg tablets
Slovenia:
Tetmodis 25 mg tablets
Sweden:
Tetmodis 25 mg tablets
Hungary:
Motetis 25 mg tablets
United Kingdom: Tetmodis 25 mg tablets

Date of last revision of the leaflet: