TETMODIS 25MG TABLETS

Active substance: TETRABENAZINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tetmodis 25 mg tablets
Tetrabenazine

Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What Tetmodis is and what it is used for
2. Before you take Tetmodis
3. How to take Tetmodis
4. Possible side effects
5. How to store Tetmodis
6. Further information
1. WHAT TETMODIS IS AND WHAT IT IS USED
FOR
Tetmodis is a medicine belonging to the group
treating disorders of the nervous system.
Tetmodis is used for the treatment of diseases
causing jerky, irregular, uncontrollable movements
(hyperkinetic motor disorders with Huntington’s
chorea).
2. BEFORE YOU TAKE TETMODIS
Do not take Tetmodis
- if you are allergic (hypersensitive) to
tetrabenazine or any of the other ingredients of
Tetmodis 25 mg tablets.
- 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 a depression
- 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
Take special care with Tetmodis
- if you are suffering from mild to severe hepatic
impairment.
- 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.
Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Take special care 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 stopped 14 days before the treatment with
tetrabenazine starts.
It is not recommended to use this medicine with
certain types of antidepressants, alcohol,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) may
result in increased plasma concentrations of the
active metabolite dihydrotetrabenazine, why they
should only be combined with caution. A reduction
of the tetrabenazine dose may be necessary.

Take special care if you use Tetmodis together
with 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).
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine. Your doctor will decide after
taking all risks and benefits into account, if you
may use Tetmodis during pregnancy. Tetmodis
must not be taken by breast feeding mothers.
Driving and using machines
Tetmodis may cause drowsiness and therefore
may modify your performance at driving and using
machines to a varying degree, depending on the
dose and individual susceptibility.
Important information about some of the
ingredients of Tetmodis
These 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 TETMODIS
Always take Tetmodis exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Adults
Huntington’s chorea
The recommended starting dose is half a tablet
(12.5 mg) one to three times a day. This can
be increased every three or four days by half a
tablet until the optimal effect is observed or up to
the occurrence of intolerance effects (sedation,
Parkinsonism, depression).
The maximum daily dose is 8 tablets (200 mg) a
day.
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.
The elderly
The standard dosage has been administered to elderly patients without apparent side effects. However, Parkinson-like side effects are common.
Children
The treatment is not recommended in children.
Patients with hepatic disorder
Patients with mild to moderate hepatic disorders
should start with half a tablet a day. For patients
with severe hepatic disorders, additional caution
is necessary.
Patient with renal disorder
Tetmodis is not recommended for use in this
patient group.
Swallow 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 drowsiness, sweating, low blood
pressure, and extremely low body temperature
(hypothermia). Your doctor will treat the signs.
If you forget to take Tetmodis
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 Tetmodis
Do not stop taking Tetmodis unless your doctor
tells you to. A neuroleptic malignant syndrome
has been described after abrupt withdrawal of
tetrabenazine.
If you have any further question 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 undesirable effects are ranked
according to system organ class and to their
frequency:
very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated
from the available data

Very common:
Drowsiness (with higher dosages), depression,
Parkinson-like syndrome (uncontrollable movements of the hands, arms, legs and head, with
higher dosages)
Common:
Confusion, anxiety, sleeplessness, low blood pressure, dysphagia (difficulty in swallowing), nausea,
vomiting, diarrhoea, obstipation
Uncommon:
Mental changes such as confusion or hallucinations,
muscular rigidity, fever, autonomic dysfunction
Rare:
Neuroleptic malignant syndrome (NMS) (neurological disorder)

Very rare:
Skeletal muscle damage
For the following side-effects, it is not possible to
estimate the incidence from available data:
Disorientation, nervousness, ataxia, akathisia,
dystonia, dizziness, amnesia, bradycardia, epigastric pain, dry mouth
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. HOW TO STORE TETMODIS
Keep out of the reach and sight of children.
Do not use Tetmodis after the expiry date which
is stated on the bottle and carton. The expiry date
refers to the last day of that month.
Store in the original package in order to protect
from light.
This medicinal product does not require any
special temperature storage conditions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. FURTHER INFORMATION
What Tetmodis contains
- The active substance is tetrabenazine.
- Each tablet contains 25 mg tetrabenazine.
- The other ingredients are: pregelatinised maize
starch, lactose monohydrate, talc, iron oxide
yellow E172, magnesium stearate.
What Tetmodis looks like and contents of the
pack
Yellow, round, flat tablets with one-side breaking
score in white twist-off bottles with 112 tablets.
Marketing
Authorisation
Holder
Manufacturer
Marketing Authorisation Holder:
AOP Orphan Pharmaceuticals AG
Wilhelminenstraße 91/II f
1160 Vienna, Austria

and

Manufacturer:
Trommsdorff GmbH & Co. KG Arzneimittel, 52477
Alsdorf, Germany
Distributed in the UK and Ireland by
Beacon Pharmaceuticals Ltd.
85, High St., TN1 1YG, UK

This medicinal product is authorised in the Member States of the EEA under the following names:
Austria:
Tetmodis 25 mg Tabletten
Belgium:
Tetrabenazine Orpha-Devel Handels und Vertriebs 25 mg tabletten
Bulgaria:
Tetmodis 25 mg таблетки
Czech Republic: Tetmodis 25 mg tablety
Denmark:
Tetmodis 25 mg tabletter
Estonia:
Tetmodis 25 mg tablett
Finland:
Tetmodis 25 mg taletti
France:
Comprimés Tetmodis 25 mg
Germany:
Tetmodis 25 mg Tabletten
Greece:
Tetmodis 25 mg δισκία
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
Sweden:
Tetmodis 25 mg tablett
United Kingdom: Tetmodis 25 mg tablets

This leaflet was last approved in September 2013

5012659/02-130x

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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