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XENAZINE 25

Active substance(s): TETRABENAZINE / TETRABENAZINE

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Xenazine 25 is manufactured by Recipharm
Fontaine, Rue des Près Potets, 21121 FontaineLès-Dijon, France.

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Lift here to read.
Do not detach
from pack.

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 January 2017.

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 because it contains important
information for you.

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pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

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6. Contents of the pack and further
information
What Xenazine 25 contains
• The active substance in the tablets is
tetrabenazine. Each tablet contains 25 mg of
tetrabenazine.
• The other ingredients are maize starch, lactose
monohydrate, talc, magnesium stearate and the
colorant iron oxide yellow (E172).

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In this leaflet:

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1. What Xenazine 25 is and what it is used for
2. What you need to know before you take
Xenazine 25
3. How to take Xenazine 25
4. Possible side effects
5. How to store Xenazine 25
6. Contents of the pack and further information

Xenazine 25 contains a substance called
tetrabenazine. This affects some of the chemicals

• Abnormal liver test results, which may indicate
liver damage.
• Weakness.
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.

• 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 of the side effects, talk to your
doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.

5. How to store Xenazine 25

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• Keep this medicine out of the reach and sight
of children.
• Do not use Xenazine 25 after the expiry date
which is stated on the label after EXP. The
expiry date refers to the last day of that month.
• Do not store above 30°C.
• 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.
• Medicines should not be disposed of via
wastewater or household waste. Ask your

1. What Xenazine 25 is and what it is
used for

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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.
Xenazine 25 is supplied in bottles which each
contains 112 tablets.
Marketing Authorisation Holder and
Manufacturer
The holder of the Marketing Authorisation is
Lundbeck UK LLP, 2nd Floor, Building 3, Abbey
View, Everard Close, St. Albans, AL1 2PS, United
Kingdom

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that are released by the nerves in the brain which
helps to control jerky and irregular movements of
the body (called chorea).
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.
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.

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• Some medicines used to treat certain mental
health conditions (antipsychotics) can cause
tardive dyskinesia.
• 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.

• Uncontrolled rolling of the eyes, Sensitivity to
sunlight, Blurred vision (due to hypertension)
Allergic reaction, interactions with other
medicines, abnormal sensitivity or allergy to
the medicine.
• Dehydration.
• Excess salivation.
• Cough.
• Pneumonia with choking (pneumonia
aspiration).
• Dry mouth.
• Excessive sweating.
• Rash, Itching, Hives.

• If you have been diagnosed as having
depression that has been untreated or difficult
to treat.
• If you are taking antidepressants which belong
to the group of medicines called monoamine
oxidase inhibitors or MAOIs, or have taken
them at any time in the last two weeks.
• If you have liver trouble.
• If you have been diagnosed as having
parkinsonism and hypokinetic-rigid syndrome.
The signs of parkinsonism are trembling in the
hands or jerky movements in the arms and legs.

• A cough that often brings up mucus, as well
as shortness of breath, wheezing, and chest
tightness (bronchitis).
• Diarrhoea.
• Vomiting.
• Constipation.
• Pain when passing urine.
• Bruising, cuts.
• Self-inflicted injuries.
Rare (Likely to affect less than 1 in 1,000 people
who take Xenazine 25)
• Difficulty in swallowing.

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• Urge to urinate with a possible burning
sensation (urinary tract infection).
• Problems with or having no menstrual periods.
• Generally feeling unwell.
• Fever, high temperature or feeling hot.
• Weight loss.
• Taking more medicine than prescribed by your
doctor (see If you take more Xenazine 25
than you should).
Frequency Unknown
• Memory loss.
• Feeling dizzy when standing up after sitting or
lying down.

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2. What you need to know before you
take Xenazine 25
Before you start taking Xenazine 25, please read
the information given below. If you think that any
of this information applies to you, or you 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 (listed in section 6).
• If you are actively suicidal (feel like killing
yourself).
• If you are breast-feeding.

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Very Rare (Likely to affect less than 1 in 10,000
people who take Xenazine 25)
• Frequent infections such as fever, severe chills,
sore throat, or mouth ulcers.
• Feeling aggressive or angry.
• Nervousness.
• Sleep disorder.
• Clumsiness and lack of coordination, affecting
balance and manner of walking, limb or eye
movements and/or speech.
• Tremor.
• Fast or irregular heartbeats (palpitations).

Warnings and Precautions
Talk to your doctor before taking Xenazine 25:
• If you have been diagnosed with depression or
have thought about or tried to commit suicide.
• If you have ever had depression.
• If you start to experience angry or aggressive
behavior.


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• If you have a recent history of chest pain or
heart disease.
• If you have ever had trembling in the hands and
jerky movements in the arms and legs, known
as parkinsonism.
• 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 start to have difficulty in swallowing.

• Cough, sore throat, runny nose, nasal congestion,
headache, low grade fever, facial pressure and
sneezing (upper respiratory tract infection).
• Feeling sick.
• Tiredness.
• Fall.
Common (Likely to affect more than 1 in 100
people who take Xenazine 25)
• Decreased appetite.
• Feeling agitated or irritable.
• Anxiety characterized by intrusive thoughts
that produce uneasiness, apprehension, fear,
or worry and by repetitive behaviours aimed
at reducing

• If you know that you are a slow or intermediate
metaboliser of an enzyme called CYP2D6,
because a different dose may be applicable
for you.

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Other medicines and Xenazine 25
Tell your doctor if you are taking, have recently
taken, or might take any other medicines. Some
medicines can cause problems if you take them
with Xenazine 25.

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Very Rare (Likely to affect less than 1 in 10,000
people who take Xenazine 25)
• If you have tried to commit suicide.
• 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 intentionally hurt yourself or if
you have started to think about intentionally
hurting yourself.

• Medicines to help sleep (hypnotics).
• Medicines used to treat high blood pressure
(anti-hypertensives and beta blockers).
• Anti-depressant medicines such as fluoxetine,
paroxetine.
• Certain antibiotics e.g. gatifloxacin,
moxifloxacin.
• Some medicines used to treat problems
with heart rhythm conditions e.g. quinidine,
procainamide, amiodarone, sotalol.
Taking Xenazine 25 with food and drink
Drinking alcohol while you are taking Xenazine
25 may cause you to feel abnormally sleepy.

REG_00062409 v.8.0

• If you have a reaction with worm-like
movements of the tongue or other uncontrolled
movements of the mouth, tongue, cheeks, or
jaws, which may progress to the arms and legs
(tardive dyskinesia).
• If you feel restless, agitated, -or have difficulty
sitting still.
• If you experience dizziness or light-headedness
when standing.
• If you have hyperprolactinemia (higher-thannormal blood levels of the hormone prolactin
– the hormone responsible for lactation).
• If you have problems digesting certain sugars,
such as galactose.

Frequency Unknown
• If you have a severe increase in blood pressure
(hypertensive crisis).

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These are:
• Levodopa used to treat Parkinson’s disease.
• Antidepressants which belong to the group of
medicines called monoamine oxidase inhibitors
(or MAOIs). At least 14 days should lapse
between the discontinuation of MAOIs and
initiation of treatment with Xenazine 25.
• Medicines which affect the brain and nervous
system such as haloperidol, chlorpromazine,
and thioridazine (called neuroleptic medicines).
• Metoclopramide used to treat nausea and
vomiting.
• Strong painkillers such as morphine and
codeine (opiods).

become depressed and you should tell your
doctor about this change.
• If you feel restless and feel that you can’t sit
still, you may have something called akathisia.
If you feel like this, please contact your doctor.
Common (Likely to affect more than 1 in 100
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.

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.
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

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Depending on how you respond to this medicine,
you may find that your ability to drive a car or
operate machinery is affected.
Xenazine 25 contains lactose
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.

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• 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.

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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
uncontrollable muscle spasms affecting the eyes,
head, neck and body, uncontrolled rolling of the
eyes, excessive eye blinking, nausea, vomiting,

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Tardive Dyskinesia:
• The recommended starting dose is half a
tablet (12.5 mg) a day, which may be increased
by your doctor as needed depending on your
response to treatment.
Elderly patients
Your doctor will decide the best dose for elderly
patients.
Use in children
If your doctor decides your child should take this
medicine, your doctor will tell you how much
to take.

diarrhoea, sweating, dizziness, feeling cold,
confusion, hallucinations and drowsiness,
redness/inflammation, and tremor.

If you stop taking Xenazine 25
Your doctor will decide when your treatment can
be stopped. He may decide to gradually reduce
the dose, although it may not be necessary. This is
usually done so you avoid side effects that may arise
as a result of suddenly stopping your medication.

Always take Xenazine 25 exactly as your doctor
has told you to. Check with your doctor or
pharmacist if you are not sure. The dose required
varies from person to person.

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Pregnancy, breast-feeding and fertility
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 to
your doctor who will explain the possible effect of
Xenazine 25 on your unborn child.
When animals were tested, there was a delay in
fertility seen. The effect on fertility in humans has
not been tested. If you are concerned, ask you
doctor for advice.
Driving and using machines
Xenazine 25 may cause drowsiness and other
side effects.

If you forget to take Xenazine 25
Do not take a double dose to make up for a
forgotten dose. Instead you should simply
continue with the next dose when it is due.

3. How to take Xenazine 25

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)
• Anxiety, confusion or restlessness.
• Movement disorders.
• Sleepiness.
• Problems with sleeping (insomnia).
• Involuntary blinking or eye spasms.

Children
Xenazine 25 should normally not be used in
children.

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the associated anxiety (Obsessive Compulsive
Disorder).
Difficulty balancing.
Slowness in moving.
Uncontrollable muscle spasms affecting the
eyes, head, neck, and body.
Lack of energy.
Dizziness.
Difficulty in speaking.
Headache.
Fever, chills, shortness of breath, cough, chest
pain and dizziness, phlegm and occasionally
blood (pneumonia).
Shortness of breath.

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Adults
Uncontrollable movements caused by conditions
such as Huntington’s chorea:
• The recommended starting dose is half a tablet
(12.5 mg) to one tablet (25 mg) every day.
• The dose is usually increased gradually by your
doctor to a maximum of eight tablets a day (a
total of 200 mg), depending on any side effects
you may experience.
• Tablets should then be taken two or three times
daily, as instructed by your doctor.

Taking Xenazine 25
• The tablet can be divided into equal doses.
Swallow the tablet or tablets with water or
another non-alcoholic drink.
• For patients with uncontrollable movements
caused by conditions such as Huntington’s
chorea, if there is no improvement at the
maximum dose in seven days, it is unlikely that
the medicine will be of benefit to you. If you
have any concerns, please talk to your doctor.
• If you get certain side effects, your dosage will
be reduced.

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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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