What Tetmodis is and what it is used for
Tetmodis is a medicine that belongs to a group of medicines used to treat disorders of the nervous system.
Tetmodis is used to treat disorders that cause jerky, irregular, uncontrollable movements (hyperkinetic movement disorders with Huntington’s chorea).
The tetrabenazine contained in Tetmodis may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Tetmodis
Do not take Tetmodis
- if you are allergic to tetrabenazine or any of the other ingredients in Tetmodis 25 mg tablets (listed in section 6).
- if you are using reserpine (medicine to treat high blood pressure and psychotic conditions).
- if you are using medicines belonging to a group of medicines called monoamine oxidase (MAO) inhibitors (medicines used to treat depression).
- if you have impaired liver function
- if you suffer from Parkinson’s-like symptoms.
- if you have depression.
- if you have thoughts of harming yourself.
- if you are breastfeeding.
- if you suffer from pheochromocytoma (tumor of the adrenal gland).
- if you suffer from prolactin-dependent tumors, e.g. pituitary cancer or breast cancer.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tetmodis
- if you have ever had tremors in the hands and jerky movements of the arms and legs, known as parkinsonism
- if you suffer from a high concentration of prolactin in the blood ( hyperprolactinemia )
- if you are prone to a sudden drop in blood pressure when you stand up or stretch
- if you know that you have a slow or intermediate metabolism of an enzyme called CYP2D6, this may mean that a different dose is suitable for you.
- if you have a heart condition called long QT syndrome, or if you have or have had heart rhythm problems.
- if you start to have mental changes such as confusion or hallucinations or develop muscle stiffness and fever, you may be developing a condition called neuroleptic malignant syndrome. If you experience these symptoms, contact your doctor immediately.
- if you start to get an unpleasant feeling of inner restlessness, a compulsive need to be in constant movement, or disturbances in coordinating movements
- note that Tetmodis binds to tissue containing melanin, which may affect your eyes
Children
Tetmodis is not recommended for the treatment of children.
Other medicines and Tetmodis
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Be especially careful if you use Tetmodis together with levodopa (a medicine used to treat Parkinson’s disease ).
Do not use Tetmodis together with reserpine.
Treatment with MAO inhibitors should be discontinued 14 days before starting treatment with tetrabenazine.
The use of Tetmodis together with certain types of antidepressants, alcohol, opioids, beta-blockers, antihypertensive drugs (drugs for the treatment of high blood pressure ), sleeping pills, and neuroleptics (drugs for the treatment of mental disorders) is not recommended.
Drugs that inhibit CYP2D6 (eg fluoxetine, paroxetine, terbinafine, moclobemide, and quinidine) may cause increased plasma concentrations of the active metabolite a dihydro-tetrabenazine. If you are taking such medicines, you may need a lower dose of Tetmodis.
Be especially careful if you use Tetmodis with medicines known to prolong the QTc interval et in the EKG, including some medicines used to treat mental health conditions ( neuroleptics ), some antibiotics (eg gatifloxacin, moxifloxacin), and some medicines used to treat heart rhythm problems (eg quinidine, procainamide, amiodarone, sotalol).
Tetmodis with food and alcohol
Drinking alcohol while taking Tetmodis may make you feel abnormally tired.
Pregnancy and breastfeeding
Tetmodis should not be used during pregnancy or breastfeeding. If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
Tetmodis can cause drowsiness and thus alter your ability to drive and use machines, to varying degrees depending on the dose and individual susceptibility.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Tetmodis contains lactose
These tablets contain lactose. If you have been told by your doctor that you have an intolerance to certain types of sugar, contact your doctor before taking this medicine.
How to take Tetmodis
Always take Tetmodis as directed by your doctor. Ask your doctor or pharmacist if you are unsure. Swallow the tablet(s) with water or other non-alcoholic beverage.
Adults
Huntington’s chorea
The recommended starting dose is half a tablet (12.5 mg) one to three times a day. The dose can be increased by half a tablet every three or four days until the optimal effect is achieved or until symptoms of intolerance appear (drowsiness, Parkinsonism, depression).
The maximum daily dose is 8 tablets (200 mg) per day.
If you have taken the maximum dose for seven days and your condition has not improved, it is possible that this medicine will not help you.
Older
The usual dose has been given to elderly patients without clear side effects occurring. However, Parkinson-like effects are common.
Children
The treatment is not recommended for children.
Patients with renal failure
Tetmodis is not recommended for use in this patient group.
The tablet(s) should be swallowed with water or another non-alcoholic drink.
If you have taken too much Tetmodis
If you take too much Tetmodis, you may develop drowsiness, sweating, low blood pressure, and extremely low body temperature ( hypothermia ). Your doctor can treat these symptoms. If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment.
If you forget to take Tetmodis
Do not take a double dose to make up for a missed dose. Instead, you should simply continue with the next dose when it is due.
If you stop taking Tetmodis
Do not stop taking Tetmodis unless your doctor tells you to. Neuroleptic malignant syndrome (state of high fever, sweating, blood pressure fluctuations, muscle rigidity, and disturbances of consciousness) has been described after the abrupt discontinuation of tetrabenazine.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Tetmodis can cause side effects, although not everybody gets them.
Side effects are divided by frequency as follows:
Very common (may affect more than 1 in 10 users):
Drowsiness (with higher dose er), depression, Parkinson-like syndrome (uncontrollable movements of hands, arms, legs, and head, with higher dose er)
Common (may affect up to 1 in 10 users):
Confusion, restlessness, insomnia, low blood pressure, dysphagia (difficulty swallowing), nausea, vomiting, diarrhea, constipation
Uncommon (may affect up to 1 in 100 users):
Mental changes such as confusion or hallucinations, muscle stiffness, fever
Rare (may affect up to 1 in 1,000 users):
A condition called Neuroleptic Malignant Syndrome. If you start to experience disturbances of consciousness such as confusion or hallucinations or develop muscle stiffness or fever, you may have developed a condition called Neuroleptic Malignant Syndrome.
Very rare (may affect up to 1 in 10,000 users):
Muscle damage
Has been reported (occurring in an unknown number of users):
Disorientation, nervousness, inability to coordinate movements, inability to sit or stand still (akathisia), a movement disorder with involuntary spasms and abnormal posture ( dystonia ), dizziness, impaired memory, lower heart rate, dizziness when standing up quickly from lying or sitting posture, stomach pain, dry mouth, low body temperature.
How to store Tetmodis
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the can and carton. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive.
Store at a maximum of 25 °C.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with drugs that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tetrabenazine.
- Each tablet contains 25 mg of tetrabenazine.
- Other ingredients are pregelatinized corn starch, lactose monohydrate, talc, iron oxide yellow E172, and magnesium stearate.
Appearance and package sizes of the medicine
Yellow, round tablets with a score on one side and engraved with “TE25” on the other side.
Pack size: 112 tablets in a white jar with a screw cap.
Marketing Authorization Holder :
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
AT 1190 Vienna
Austria
Manufacturer :
AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
AT 1190 Vienna
Austria
This medicine is approved in the European Economic Area under the names
| Austria: | Tetmodis 25 mg Tablet |
| Belgium: | Tetrabenazine AOP Orphan Pharmaceuticals 25 mg tablet |
| Bulgaria: | Tetmodis 25 mg tablets |
| Czech Republic: | Tetmodis |
| Denmark: | Tetmodis 25 mg tablets |
| Estonia: | Tetmodis 25 mg tablet |
| Finland: | Tetmodis 25 mg tabletti |
| France: | Comprimés Tetmodis 25 mg |
| Germany: | Tetmodis 25 mg Tablet |
| Greece: | Tetmodis 25 mg δισκία |
| Hungary: | Motets 25 mg tablet |
| Ireland: | Tetrabenazine 25 mg tablets |
| Latvia: | Tetmodis 25 mg tablets |
| Lithuania: | Tetmodis 25 mg tabletės |
| Netherlands: | Tetmodis 25 mg tablet |
| Poland: | Tetmodis 25 mg tabletki |
| Portugal: | Comprimidos de Tetmodis 25 mg |
| Romania: | Tetmodis, tablete, 25 mg |
| Slovakia: | Tetmodis 25 mg tablet |
| Slovenia: | Tetmodis 25 mg tablete |
| Spain: | Tetmodis 25 mg comprimidos |
| Sweden: | Tetmodis 25 mg tablets |
| UK: | Tetrabenazine 25 mg tablets |