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XENAZINE 25

Active substance(s): TETRABENAZINE

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36

This product is distributed in the United
Kingdom by Alliance Pharmaceuticals Ltd.,
Avonbridge House, Bath Road, Chippenham,
Wiltshire, SN15 2BB, UK.
This leaflet was last revised in
October 2015

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Xenazine 25
®

25 mg Tablets
Tetrabenazine

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Read all of this leaflet carefully before you start
using this medicine.
GB-532-01-25-13401 RP
606591F

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The other ingredients are maize starch,
lactose monohydrate, talc, magnesium
stearate and the colorant iron oxide yellow
(E172).
What Xenazine 25 looks like and
contents of the pack
Xenazine 25 tablets are round and
yellowish-buff in colour. They have ‘CL25’
stamped on one side and a single scoreline
on the other. The tablet can be divided into
equal halves.

In this leaflet:
Page
1. What Xenazine 25 is and what it is
used for
5
2. Before you take Xenazine 25
8
3. How to take Xenazine 25
17
4. Possible side effects
22
5. How to store Xenazine 25
31
6. Further information
33

5. HOW TO STORE XENAZINE 25

• Keep out of the reach and sight of children.
• Do not use Xenazine 25 after the expiry
date which is stated on the label. The expiry
date refers to the last day of that month.
• Do not store above 30ºC.
• REMEMBER this medicine is for you. Only
a doctor can prescribe it for you. Never
give it to others even if their symptoms
are the same as yours.

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Lift here to read.
Do not detach
from pack.

Xenazine 25 is supplied in bottles which
each contain 112 tablets.
Marketing Authorisation Holder and
Manufacturer
The holder of the Marketing Authorisation is
Lundbeck UK LLP,
Building K1, Timbold Drive, Kents Hill,
Milton Keynes, MK7 6BZ, UK.
Xenazine 25 is manufactured by Recipharm
Fontaine, Rue des Près Potets, 21121,
Fontaine-Lès-Dijon, France.

• 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.

• 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.

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1. WHAT XENAZINE 25 IS AND WHAT IT
IS USED FOR
Xenazine 25 contains a substance called
tetrabenazine. This affects some of the
chemicals that are released by the nerves in
the brain which helps to control jerky and
irregular movements of the body.
Xenazine 25 is used for the treatment of jerky,
irregular uncontrollable movements that can
be caused by conditions such as Huntington’s
chorea, senile chorea and hemiballismus.

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Please seek advice if any of the following
side effects becomes troublesome (cont.):
Frequency Unknown
• Feeling dizzy if you stand suddenly,
especially when first getting out of bed or
if you have been sitting for a long time
• Dry mouth
• Problems with swallowing
• Sweating
• Irregular menstrual periods in some women
• Feeling weak

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Before you start taking Xenazine 25, please
read the information which is given below.
If you think that any of this information
applies to you, or are not sure, please tell
your doctor, nurse or pharmacist.
Do not take Xenazine 25 if:
• You are allergic (hypersensitive) to
tetrabenazine or any of the other
ingredients of the medicine.

What Xenazine 25 contains
The active substance in the tablets is
tetrabenazine. Each tablet contains 25 mg
of tetrabenazine.

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Please seek advice as soon as possible if you
experience the following side effects (cont.):
Very Rare (Likely to affect less than 1 in
10,000 people who take Xenazine 25)
• A reduction in ability to fight infections
because of a lower level of white blood cells
• Uncontrolled rolling of the eyes
• Sensitivity to sunlight
Frequency Unknown
• Severe high blood pressure

Black
GB-532-01-25-13401 RP / REG
0676
Label 151x40 mm
Leaflet 54x40 mm
REG
2
GB-532-01-25-134 RP / 135759

REG_00062409 v.7.0

2015-10-08 / 07:41 / HESP

• A low temperature
• Severe high blood pressure
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.

2. BEFORE YOU TAKE XENAZINE 25

6. FURTHER INFORMATION

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Xenazine 25 is also used for treatment of
Tardive Dyskinesia:
• Tardive dyskinesia is a condition
characterised by uncontrollable
movements such as facial spasm,
grimacing, or peculiar tongue
movements.
• Some medicines used to treat certain
mental health conditions (antipsychotics)
can cause tardive dyskinesia.

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• Xenazine 25 should only be given to you
for treatment of tardive dyskinesia when
symptoms are moderate to severe,
disabling, and/or embarrassing in social
situations.
• Xenazine 25 should only be given to you
when symptoms persist even after your
doctor has stopped, changed, or reduced
the dose of your antipsychotic medication.

Please seek advice if any of the following
side effects becomes troublesome:
Frequency Unknown
• Jerky movements in the arms and legs
• Nervousness or restlessness
• Problems with co-ordination
• Forgetfulness
• Dizziness
• A slowing of the heart rate
• Feeling sick or actually being sick
• Stomach pain
• Diarrhoea or constipation

• You are breast-feeding.
• You have been diagnosed as having
depression and this has been difficult to treat.
• You are taking antidepressants which
belong to the group of drugs called
monoamine oxidase inhibitors or MAOIs,
or have taken them at any time in the last
two weeks.
• You have been diagnosed as having
parkinsonism and hypokinetic-rigid
syndrome (parkinsonism).

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Take special care with Xenazine 25
Please tell your doctor
• If you have been diagnosed with
depression or have thought about or tried
to commit suicide.
• If you have a heart condition known as
long QT syndrome.
• If you have liver or kidney trouble.

Please seek advice immediately or go to
your emergency department if you
experience the following side effects (cont.):
Frequency Unknown
• If you feel restless and feel that you can’t
sit or stand still you may have something
called akathisia. If you feel like this,
please contact your doctor.

Please tell your doctor (cont.)
• 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.
• If you have problems digesting certain
sugars, such as galactose.
• If you know that you are a slow or
intermediate metaboliser of an enzyme

Please seek advice immediately or go to
your emergency department if you
experience the following side effects (cont.):
Very Common (Likely to affect more than 1 in
10 people who take Xenazine 25)
• If you develop trembling or uncontrollable
movements in your hands, arms, legs
and head, drooling, problems swallowing
or problems with your balance, you may
have something called parkinsonism. If
you have any of these problems, please
contact your doctor.

Taking other medicines (cont.)
psychiatric conditions, strong painkillers
and medication to help sleep.
• Drugs used to treat high blood pressure.
• Some drugs used to treat mental health
conditions, certain antibiotics and some
drugs used to treat problems with heart
rhythm conditions.
Please tell your doctor if you are taking, or have
recently taken, any other medicines including
medicines obtained without a prescription. They

REG_00062409 v.7.0

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Please seek advice as soon as possible if
you experience the following side effects:
Very Common (Likely to affect more than 1 in
10 people who take Xenazine 25)
• Feeling very sleepy
Common (Likely to affect more than 1 in 100
people who take Xenazine 25)
• Problems with sleeping (insomnia)
• Some people taking Xenazine 25 may
become anxious, confused or disorientated.

• If you are taking medicine to treat mental
health conditions (antipsychotics) and
have uncontrollable movements including
facial spasm, grimacing, and peculiar
tongue movements, known as tardive
dyskinesia.
• If you have ever had trembling in the
hands and jerky movements in the arms
and legs, known as parkinsonism.

Very Rare (Likely to affect less than 1 in
10,000 people who take Xenazine 25)
• 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.

called CYP2D6, because a different dose
may be applicable for you.
Taking other medicines
Some medicines can cause problems if you
take them with Xenazine 25. These are:
• Levodopa used to treat Parkinson’s disease.
• Antidepressants which belong to the
group of drugs called monoamine oxidase
inhibitors (or MAOIs).
• Drugs which affect the brain and nervous
system including some drugs used to treat

Please seek advice immediately or go to
your emergency department if you
experience the following side effects:
Very Common (Likely to affect more than 1
in 10 people who take Xenazine 25)
• Xenazine 25 can cause depression, which
can lead to thoughts of committing suicide.
If you feel down or very sad you may be
starting to become depressed and you
should tell your doctor about this change.

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

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4. POSSIBLE SIDE EFFECTS

Like all medicines, Xenazine 25 can cause side
effects, although not everybody gets them.

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to your doctor who will explain the possible
effect of Xenazine 25 on your unborn child.
Driving and using machines
Xenazine 25 may cause drowsiness and other
side effects. Depending on how you respond
to this medicine, you may find that your ability
to drive a car or operate machinery is affected.
Important information about some of the
ingredients of Xenazine 25
These tablets contain lactose. If you have
been told by your doctor that you have an

If you take more Xenazine 25 than you
should
If you take too many tablets or someone
else accidentally takes your medicine,
contact your doctor, pharmacist or nearest
hospital straight away. Symptoms of
overdose include nausea, vomiting,
diarrhoea, sweating, dizziness, feeling cold,
confusion, hallucinations and drowsiness.

Dosage (cont.)
conditions such as Huntington’s chorea is one
tablet three times a day (a total of 75 mg).
This is usually increased by one tablet
a day every three or four days, to a
maximum of eight tablets a day (a total
of 200 mg).
• The recommended starting dose for people
with tardive dyskinesia is half a tablet (12.5 mg)
a day, which can be increased as needed
depending on your response to treatment.

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will tell you if you can take these medicines
while you are taking Xenazine 25.
Taking Xenazine 25 with food and drink
Drinking alcohol while you are taking
Xenazine 25 may cause you to feel
abnormally sleepy.
Pregnancy and breast-feeding
Xenazine 25 should not be taken during
pregnancy, or when breast-feeding. If you are
pregnant, think you might be pregnant or are
planning to become pregnant, you should talk

If you forget to take Xenazine 25
If you forget to take one dose, do not take a
double dose to make up for the forgotten
dose. Instead you should simply continue
with the next dose when it is due.
If you stop taking Xenazine 25
Your doctor will decide when your treatment
can be stopped. He will, most probably decide
to gradually reduce the dose. Therefore, you
will avoid side effects that may arise as a
result of suddenly stopping your medication.

intolerance to some sugars, contact your
doctor before taking this medicinal product.

3. HOW TO TAKE XENAZINE 25
Always take Xenazine 25 exactly as your
doctor has told you to. You should check with
your doctor or pharmacist if you are not sure.
The dose required varies from person to person.
Dosage
• The usual starting dose for adults with
uncontrollable movements caused by

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• These tablets will be stopped if there is no
clear benefit or if the side-effects become
too much for you.
• Do not change the prescribed dose
yourself. If you think the effect of your
medicine is too weak or too strong, talk to
your doctor. Always tell your doctor if you
want to stop taking your medicine.
• Your doctor will decide the best dose for
children and elderly patients.
• Swallow the tablet or tablets with water
or another non-alcoholic drink.

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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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