TETRABENAZINE Tablets

What is in this leaflet

This leaflet answers some common questions about Tetrabenazine Tablets. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of your taking Tetrabenazine Tablets against the benefits they expect it will have for you.

If you have any concerns about taking Tetrabenazine Tablets, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What Tetrabenazine Tablets are used for

Tetrabenazine is used for the treatment of diseases, which cause jerky, irregular, uncontrollable movements such as Huntington's chorea, senile chorea and hemiballismus.

Tetrabenazine affects some chemicals in the brain, and by doing so it helps to control jerky and irregular movements.

Your doctor may have prescribed Tetrabenazine Tablets for another use. Ask your doctor if you have any questions about why Tetrabenazine Tablets have been prescribed for you.

Tetrabenazine Tablets are not addictive.

Tetrabenazine Tablets are only available on a doctor's prescription.

Before you take Tetrabenazine Tablets

Tetrabenazine Tablets are not suitable for everyone.

When you must not take it

Do not take Tetrabenazine Tablets if:

• You are allergic to tetrabenazine or other ingredients of Tetrabenazine Tablets listed at the end of this leaflet.
• You are taking medicine containing reserpine.
• You are taking medicine containing levodopa (which is used to treat Parkinson's disease).
• You are being treated for Parkinson's disease.
• You are being treated for depression.
• You are taking central nervous system stimulants or depressants (including alcohol).

These warnings are extremely important as using more than one medicine at the same time can increase or reduce the effect of the medicines. For example, this medicine can increase the effect of some medicines for lowering high blood pressure or for depression (monoamine oxidase inhibitors).

• You are pregnant or breastfeeding.

Do not take Tetrabenazine Tablets after the expiry date printed on the bottle .

Do not take Tetrabenazine Tablets if the bottle seems to have been opened or the tablets do not look quite right (see Product Description).

Before you start to use it

• Tell your doctor if you have any allergies.
• Tell your doctor if you are pregnant or intend to become pregnant or to breastfeed.
• Tell your doctor if you suffer from any depression or Parkinson's disease.
• Tell your doctor if you have kidney or liver disease.[OA1]
• Taking other medicines

Tell your doctor if you are taking medicines containing reserpine , medicine for lowering blood pressure or any other medicines. This includes medicines you buy without a prescription from a pharmacy, supermarket or health food store.

How to take Tetrabenazine Tablets

Do not take Tetrabenazine Tablets to treat any condition other than that directed by your doctor.

Do not give Tetrabenazine tablets to anyone else, even if their symptoms seem the same as yours. It may harm them.

How much to take

The dose required varies from person to person. The usual starting dose in adults is one tablet twice a day. This may increase to a total of 200 mg (8 tablets) a day.

The doctor will decide the best dose for children and elderly patients.

DO NOT TAKE MORE THAN THE DOSE YOUR DOCTOR HAS RECOMMENDED.

You should not normally stop taking Tetrabenazine Tablets unless your doctor tells you to.

If you feel unwell during your course of treatment, tell your doctor.

If you forget to take Tetrabenazine Tablets

If you forget to take a dose of Tetrabenazine Tablets, leave out that dose completely. Take your next dose at the normal time it is due.

Do not take a double dose to make up for the dose that you missed.

If you have trouble remembering when to take Tetrabenazine Tablets, ask your pharmacist for some hints.

If you take too many Tetrabenazine Tablets

Telephone your doctor or go to casualty at your nearest hospital immediately if you think that you or anyone else may have taken too much Tetrabenazine Tablets even if there are no signs of discomfort or poisoning.

While you are taking Tetrabenazine Tablets

Things you must do

Make sure that all of your doctors and pharmacists know about your use of Tetrabenazine Tablets. Remind them if any new medicines are about to be started.

Swallow the tablet or tablets with water or another non-alcoholic drink.

Things that you must not do

Do not use Tetrabenazine Tablets to treat any complaint other than that directed by your doctor. It may not be safe to use Tetrabenazine Tablets for another complaint.

Tetrabenazine Tablets should only be used by the person for whom it was prescribed. Do not give Tetrabenazine Tablets to someone else even if their symptoms are the same. It may not be safe for another person to use Tetrabenazine Tablets.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Tetrabenazine Tablets. Like all medicines, Tetrabenazine Tablets may have some side effects. Sometimes they are serious, most to the time they are not.

Side effects can include:

• Sleepiness and drowsiness
• Depression
• Uncontrollable movements of the hands, arms, legs and head (similar to those in Parkinson's disease)
• Digestive problems
• Lowering of blood pressure

If these events persist, you should consult your doctor.

Tell your doctor immediately if you notice any of the following:

• Difficulty in swallowing
• Chocking attacks
• Stiffness or tightness in the arms or legs
• Confusion or having thoughts of irrational ideas not shared by others

Tetrabenazine may affect your ability to drive or operate machinery. Be careful driving or operating machinery until you know how tetrabenazine affects you.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell. Do not be alarmed by this list of possible side-effects. You may not experience any of them.

After using Tetrabenazine Tablets

Storage

• Keep Tetrabenazine Tablets in their bottle until it is time to take your dose. If you take them out of their container, they may not keep well.
• Keep Tetrabenazine Tablets in a cool dry place where the temperature stays below 30(C.
• Do not store it or any other medicine in the bathroom or near a sink.
• Do not leave it in the car on hot or cold days. Heat, cold and dampness can destroy some medicines.
• Keep Tetrabenazine Tablets where children cannot reach it. A locked cupboard at least one- and-a-half metres above the ground is a good to store medicines.

Disposal

• Return any unused medicine to your pharmacist.

Product description

What Tetrabenazine Tablets look like

Tetrabenazine Tablets 25 mg are buff. They are scored and marked with "CL" over "25".

Ingredients

Each Tetrabenazine Tablet contains 25 mg of the active ingredient, tetrabenazine, and 64 mg lactose.

Tetrabenazine Tablets also contain the following inactive ingredients:

Starch
Talc
Magnesium stearate
Iron oxide yellow CI77492

Tetrabenazine Tablets are available in plastic bottles containing 112 tablets.

Distributor

Tetrabenazine Tablets are distributed in Australia by:

Orphan Australia Pty. Ltd.
48 Kangan Drive
Berwick
Victoria 3806.

Under license from:

Cambridge Selfcare Diagnostics Ltd., UK.

This leaflet was prepared in January 1999.

Australian Registration Number: AUST R 13695