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REVOCON 25MG TABLETS

Active substance(s): TETRABENAZINE

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Package leaflet: information for the user

RevoconTM 25 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.
What is in this leaflet

Other medicines and Revocon tablets
Revocon tablets interact with a large number of other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines.
- Your doctor will be careful if you take Revocon tablets together with
- levodopa (a medicine used to treat Parkinson’s disease)
- drugs known to prolong the QTc interval including:
- some drugs used to treat mental health conditions (e.g.
chlorpromazine, thioridazine)
- certain antibiotics (e.g. gatifloxacin, moxifloxacin)
- some drugs used to treat problems with heart rhythm conditions
(e.g. quinidine, procainamide, amiodarone, sotalol).
- You should not be given Revocon tablets together with reserpine.
- Any treatment with MAO inhibitors should be stopped 14 days before
the treatment with tetrabenazine starts.
- Taking this medicine with certain types of antidepressants, alcohol,
strong opioids (pain killers), beta blockers, antihypertensive drugs
(medicine to treat high blood pressure), hypnotics and neuroleptics
(medicine to treat psychotic disorders) is not recommended.
- Some medicines (e.g. fluoxetine, paroxetine, terbinafine, moclobemide
and quinidine) may increase the level of tetrabenazine in the blood. If
you are taking a combination of these drugs your doctor will monitor
you carefully. A reduction of the tetrabenazine dose may be necessary.

1. What Revocon tablets are and what they are used for
2. What you need to know before you take Revocon tablets
3. How to take Revocon tablets
4. Possible side effects
5. How to store Revocon tablets
6. Contents of the pack and other information

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Revocon tablets during pregnancy.
Revocon tablets must not be taken by breast-feeding mothers.

1. What Revocon tablets are and what they are used for

Driving and using machines
Revocon tablets may cause drowsiness in some people. Do not drive or
use machinery if you are affected.

Revocon tablets are a medicine belonging to the group treating
disorders of the nervous system.
Revocon tablets are used for the treatment of the jerky, irregular,
uncontrollable movements of Huntington’s chorea.

Revocon tablets contain 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
the tablets.

2. What you need to know before you take Revocon tablets
Do not take Revocon tablets
- if you are allergic to tetrabenazine or any of the other ingredients
of this medicine (listed in section 6)
- if you take reserpine (medicine to control high blood pressure
and treat psychotic states)
- if you take MAO inhibitors (medicine to treat depression, see
also subsection ‘Taking other medicines’)
- if you suffer from Parkinson-like symptoms
- if you have 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.
Discuss this with your doctor if you are not sure.
Warnings and precautions
Talk to your doctor before taking Revocon tablets
- if you are pregnant
- if you have either kidney or liver problems
- if you have a heart condition known as long QT syndrome or if
you have or have had any 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 fever or
you sweat and have fluctuantions in blood pressure, you may be
developing a condition called Neuroleptic Malignant Syndrome. If
you have these symptoms please contact your doctor straight
away.

Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Swallow the tablet(s) with water or another non-alcoholic drink.
Adults
The dose that you need varies from person to person. The doctor will have
decided on the dose you need. The following is just a guide.

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3. How to take Revocon tablets

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 best effect is reached or if side effects such as sedation,
Parkinsonism or depression are noticed.
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, you should talk to your doctor.
The elderly
The standard dosage has been taken by elderly patients without apparent
ill effect. However, Parkinson-like side effects are common and may limit
the dose you can take.
Use in children
The treatment is not recommended in children.
Patients with liver disorder
Patients with mild to moderate liver disorder should start with half a tablet
a day. For patients with severe liver disorder, additional caution is
necessary. Your doctor will decide on the dose to give you.

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TM

Revocon
25 mg Tablets
ISS. 02/2013

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Revocon Tabs PIL-365x198mm-SUN-UK-REV-4-044BP0830E-Potrait-06-12-13
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Patients with kidney disorder
Revocon tablets are not recommended for use in this patient group.

5. How to store Revocon tablets
Keep this medicine out of the sight and reach of children, preferably in a
locked cupboard or medicine cabinet.

If you take more Revocon tablets than you should
If you take more Revocon tablets than you should, you may develop
drowsiness, sweating, low blood pressure, and extremely low body
temperature (hypothermia). Your doctor will treat the signs.

Revocon tablets should be stored below 25°C.
Do not use this medicine after the expiry date which is stated on the label.
The expiry date refers to the last day of that month. Return any medicine
left over to your pharmacist; only keep it if your doctor tells you to.

If you forget to take Revocon tablets
If you forget to take one dose, you should never make up for the missing
dose by taking a double dose next time. Just continue with the next dose
when it is due.

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.

If you stop taking Revocon tablets
Do not stop taking Revocon tablets unless your doctor tells you to. A
Neuroleptic Malignant Syndrome (described in Section 2) has been
described after abrupt withdrawal of tetrabenazine.

6. Contents of the pack and other information
What Revocon tablets contain
- The active substance is tetrabenazine.
- Each tablet contains 25 mg tetrabenazine.
- The other ingredients are: lactose monohydrate, maize starch,
microcrystalline cellulose, purified talc, magnesium stearate, colloidal
anhydrous silica, sodium starch glycolate (type A), iron oxide yellow
(E172).

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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Serious, very common side effects (affects more than 1 user in10)
Revocon tablets can cause depression or Parkinson-like syndrome
(uncontrollable movements of the hands, arms, legs and head, with higher
dosages). If this happens you must tell your doctor.
Serious, rare side effects (affects 1 to 10 users in 10,000)
Contact your doctor immediately if you develop Neuroleptic Malignant
Syndrome (described in Section 2).
Other side effects
Very common (affects more than 1 user in 10)
Drowsiness (with higher dosages).

What Revocon tablets look like and contents of the pack
Revocon tablets are light yellow, circular, flat tablets with a break line on
one side and SUN on the other side. The tablets can be divided into equal
halves.
Each bottle of Revocon tablets contains 112 tablets.
Marketing Authorisation Holder and Manufacturer
Sun Pharmaceutical Industries BV
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

044BP0830E

Common (affects 1 to 10 users in 100)
Confusion, anxiety, sleeplessness, low blood pressure, dysphagia
(difficulty in swallowing), nausea, vomiting, diarrhoea, constipation.
Uncommon (affects 1 to 10 users in 1,000)
Mental changes such as confusion or hallucinations, severe
extrapyramidal symptoms such as stiff limbs or trembling hands, fever.
Very rare (affects less than1 user in 10,000)
Muscle damage.

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This leaflet was last revised in 12/2013.

Not known (frequency cannot be estimated from the available data)
Disorientation, nervousness, ataxia and dystonia (loss of control of
movements, poor posture), akathisia (restlessness), dizziness,
forgetfulness, slow heart beat, stomach pain, dry mouth.
Reporting of side effects
If you get any of the side effects, talk to your doctor. 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.

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198 mm

100

95

75

25

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Revocon Tabs PIL-365x198mm-SUN-UK-REV-4-044BP0830E-Potrait-06-12-13
06/12/2013 12:43:47 PM

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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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