Xenazine 25
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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
Xenazine® 25
25 mg Tablets Tetrabenazine
Read all of this leaflet carefully before you start using this medicine.
GB-532-01-25-13401 RP 606591F
Xenazine 25 is supplied in bottles which each contain 112 tablets.
Marketing Authorisation Holder and Manufacturer
The holder of the Marketing Authorisation is .undbeck UK LLP,
Building K1, Timbold Drive, Kents Hill, Milton Keynes, MK7 6BZ, UK.
Xenazine 25 is manufactured by Recipharm :ontaine, Rue des Pres Potets, 21121, Fontaine-Les-Dijon, France.
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.
• A low temperature
• Severe high blood pressure
f any of the side effects gets serious, or if you notice any side effects not listed in this eaflet, please tell your doctor or pharmacist.
The other ingredients are maize starch, .actose 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.
• 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.
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
• 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.
1. What Xenazine 25 is and what it is
2. Before you take Xenazine 25 8
• 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.
6. FURTHER INFORMATION What Xenazine 25 contains
The active substance in the tablets is tetrabenazine. Each tablet contains 25 mg of tetrabenazine.
2. BEFORE YOU TAKE XENAZINE 25
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.
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
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 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.
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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 rregular movements of the body.
Xenazine 25 is used for the treatment of jerky, rregular uncontrollable movements that can be caused by conditions such as Huntington's chorea, senile chorea and hemiballismus.
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
• 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).
H. LundbeckA/S Ottiliavej 9 DK-2500Valby Denmark
Text & Graphics Fax: +45 3643 8240
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
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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 | ||
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10 people who take Xenazine 25) | ||
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• 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
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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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Xenazine 25 can cause side effects, although not everybody gets them.
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
• 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.
REG 00062409 v.7.0