Xenazine

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

• 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.
• 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.

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.
• If you have a heart condition known as long QT syndrome. Tetrabenazine should be used with caution with other medicines known to prolong QT syndrome (listed in Other medicines and Xenazine 25) and in patients with congenital QT syndromes and a history of cardiac arrhythmias.
• 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.
• 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-than-normal blood levels of the hormone prolactin – the hormone responsible for lactation).
• If you have problems digesting certain sugars, such as galactose.
• 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.

Xenazine 25 should normally not be used in children.

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.

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).
• 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.

Drinking alcohol while you are taking Xenazine 25 may cause you to feel abnormally sleepy.

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.

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.

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.

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.

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.

Your doctor will decide the best dose for elderly patients.

If your doctor decides your child should take this medicine, your doctor will tell you how much to take.

• 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.
• 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.

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

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.

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.

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.
• 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.

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.

Frequency Unknown

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

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

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).
• 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.
• 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.
• Abnormal liver test results, which may indicate liver damage.
• Weakness.
• Dizziness and postural hypotension (sudden dizziness and fainting when standing up).
• Increased appetite, increased body weight.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

• 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).

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.

The holder of the Marketing Authorisation is

Xenazine 25 is manufactured by

This product is distributed in the United Kingdom by