Skip to Content

TETRABENAZINE 12.5 MG TABLETS

Active substance(s): TETRABENAZINE / TETRABENAZINE / TETRABENAZINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET

D 210

1

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

D 210

2

-

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.

D 210

3

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. Parkinsonlike 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
D 210

4

-

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.

D 210

5

-

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
names
Germany:
Tetrabenazin-neuraxpharm 12,5 mg Tabletten
Italy:
Tetrabenazina SUN 12,5 mg compresse
Netherlands:
Tetrabenazine SUN 12,5 mg tabletten
Spain:
Tetrabenazina SUN 12,5 mg comprimidos EFG
United Kingdom:
Tetrabenazine 12.5 mg tablets
This leaflet was last revised in 08/2016

D 210

6

Expand Transcript

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.

Hide