CLOPIXOL TABLETS 10MG

GB-619210

PACKAGE LEAFLET: INFORMATION FOR THE USER

Clopixol Tablets 2 mg, 10 mg and 25 mg film-coated tablets Zuclopenthixol (as dihydrochloride) Read all of this leaflet carefully before you start taking 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. 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 are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist In this leaflet: 1. What Clopixol Tablets are and what they are used for 2. Before you take Clopixol Tablets 3. How to take Clopixol Tablets 4. Possible side effects 5. How to store Clopixol tablets 6. Further information 1.WHAT CLOPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR How do Clopixol Tablets work? Clopixol tablets belong to a group of medicines known as antipsychotics (also called neuroleptics). These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of your illness. What are Clopixol Tablets used for? Clopixol tablets are used for the treatment of schizophrenia and other psychoses. Your doctor, however, may prescribe Clopixol tablets for another purpose. Ask your doctor if you have any questions about why Clopixol tablets have been prescribed for you. 2.BEFORE YOU TAKE CLOPIXOL TABLETS Do not take Clopixol Tablets If you are allergic (hypersensitive) to zuclopenthixol, other thioxanthine drugs or antipsychotic drugs or any of the other ingredients of Clopixol Tablets (see What Clopixol Tablets contain). Consult your doctor if you think you might be If you are feeling less alert than usual, or are drowsy or sleepy, or have serious problems with your blood circulation Take special care with Clopixol Tablets If you have a heart condition, including an irregular heart beat (such as a slower heart beat); have had a recent heart attack or have problems that cause ankle swelling or shortness of breath If you have severe breathing problems (such as asthma or bronchitis) If you have liver, kidney or thyroid problems If you suffer from epilepsy, or have been told that you are at risk of having fits (for example because of a brain injury or because of alcohol withdrawal) If you suffer from Parkinsons disease, or myasthenia gravis (a condition causing severe muscular weakness) If you have an enlarged prostate or suffer from a condition known as phaeochromocytoma (a rare type of cancer of a gland near the kidney) If you suffer from glaucoma (raised pressure within the eye) If you have risk factors for stroke (e.g. smoking, hypertension) If you have too little potassium or magnesium in your blood or a family history of irregular heart beats If you use other antipsychotic medicines If you suffer from diabetes If you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.

Piperazine (used to treat worm infections) Levodopa or other medicines used to treat Parkinsons disease Sibutramine (used to reduce appetite) Digoxin (to control heart rhythm) Corticosteroids (e.g. prednisolone) Medicines used to lower the blood pressure such as hydralazine, alpha blockers (e.g. doxazosin) beta blockers, methyldopa, clonidine or guanethidine Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in your blood) Medicines known to increase the concentration of zuclopenthixol in your blood Medicines used to treat epilepsy Medicines used to treat diabetes Clopixol tablets can reduce the effect of adrenaline (epinephrine) and similar drugs. Tell your doctor, dentist, surgeon or anaesthetist before any operation as Clopixol tablets can increase the effects of general anaesthetics, muscle relaxing drugs and drugs used to prevent clots. Do Clopixol Tablets interact with alcohol? Clopixol tablets may increase the sedative effects of alcohol making you drowsier. It is recommended not to drink alcohol during treatment with Clopixol tablets. Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or think you may be pregnant, tell your doctor. Clopixol should not be used during pregnancy, unless clearly necessary. Your newborn baby might show side effects if this medicine is used. The following symptoms may occur in newborn babies, of mothers that have used Clopixol Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. Breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. If you are breast-feeding, ask your doctor for advice. Clopixol tablets should not be used when breast-feeding, as small amounts of the medicine can pass into the breast milk. Driving and using machines There is a risk of feeling drowsy and dizzy when using Clopixol tablets, especially at the start of your treatment. If this happens do not drive or use any tools or machines until you know you are not affected in this way. Do not drive if you have blurred vision. Important information about some of the ingredients in Clopixol Tablets This product contains lactose. If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Clopixol tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea. 3.HOW TO TAKE CLOPIXOL TABLETS Always take Clopixol tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose varies and depends on the severity of the illness. The total amount of tablets you need to take each day will be split into at least two doses (for example a morning and evening dose). Adults Daily doses of Clopixol tablets range from 4 mg to 150 mg. The daily dose at the start of treatment is usually 20 mg to 30 mg each day. This dose is then usually adjusted to between 20 mg and 50 mg each day. The maximum dosage per single dose is 40 mg. If you have liver problems the level of zuclopenthixol in your blood may be checked. Elderly patients (above 65 years) The initial dose is between a quarter and a half of the adult dose. Children Clopixol tablets are not recommended for children. It may take between four and six months before you feel better. Your doctor will decide the duration of treatment. If you feel that the effect of Clopixol tablets is too strong or weak, talk to your doctor or pharmacist. It is important that you continue to receive your medicine at regular intervals even if you are feeling completely well, because the underlying illness may persist for a long time.

Please talk to your doctor, even if these statements were applicable to you at any time in the past. Taking other medicines The following medicines should not be taken at the same time as Clopixol tablets: Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium) Other antipsychotic medicines Medicines may affect the actions of other medicines and this can sometimes cause serious adverse reactions. Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. Tricyclic antidepressants Barbiturates or other medicines that make you feel drowsy Anticoagulant drugs used to prevent blood clots (e.g. warfarin) Anticholinergic drugs (contained in some cold, allergy or travel sickness remedies as well as other medicines) Metoclopramide (used to treat nausea and other stomach conditions)

-

000000

000000

GB-619210

If you stop your treatment too soon your symptoms may return. If you take more Clopixol Tablets than you should If you think that you or anyone else may have taken too many Clopixol tablets contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the Clopixol container with you if you go to a doctor or hospital. Symptoms of overdose may include: Drowsiness Unconsciousness Muscle movements or stiffness Fits Low blood pressure, weak pulse, fast heart rate, pale skin, restlessness High or low body temperature Changes in heart beat including irregular heart beat or slow heart rate If you forget to take Clopixol Tablets If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. 4.POSSIBLE SIDE EFFECTS Like all medicines, Clopixol tablets can cause side effects, although not everybody gets them. Elderly patients tend to be more likely to suffer from some of these effects than younger patients and this may mean your treatment is supervised more closely. Serious side effects Stop taking Clopixol and seek medical advice immediately if you have any of the following allergic reactions: Difficulty in breathing Swelling of the face, lips, tongue or throat which causes difficulty in swallowing or breathing Severe itching of the skin (with raised lumps) Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately. If you get any of the following symptoms you should contact your doctor immediately as your dose may need to be reduced or stopped: High fever, unusual stiffness of the muscles and changes in consciousness, especially if occurring with sweating and fast heart rate. These symptoms may be signs of a rare but serious condition called neuroleptic malignant syndrome that has been reported with the use of Clopixol and similar medicines Unusual movements of the mouth and tongue as these may be early signs of a condition known as tardive dyskinesia Unusual muscle movements (such as circular movements of the eyes), stiffness, tremor and restlessness (for example difficulty in sitting or standing still) as these may be signs of a so-called "extrapyramidal" reaction Any yellowing of the skin and the white in the eyes (jaundice); your liver may be affected



C hanges in skin colour B ruising under the skin M uscle pain R aised blood levels of glucose, lipids or the hormone prolactin L oss of control of blood sugar levels C hanges in appetite or weight L ow blood pressure H ot flushes G eneral weakness or pain, tiredness or feeling unwell I ncreased thirst R educed or increased body temperature (including fever) A bnormal liver function tests L iver enlargement U nexpected excretion of breast milk I nsomnia, abnormal dreams or nightmares D epression or anxiety N ervousness or agitation A pathy C hanges to your sex drive M en may experience breast enlargement or problems with ejaculation or erections (including prolonged erections) W omen may experience an absence of menstrual periods, vaginal dryness or problems with orgasms

As with other medicines that work in a way similar to zuclopenthixol (the active ingredient of Clopixol tablets), rare cases of the following side effects have been reported: Slow heartbeat and abnormal ECG heart tracing Life threatening irregular heart beats In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death. In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics. If any of the side effects are troubling, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5.HOW TO STORE CLOPIXOL TABLETS Keep Clopixol tablets in the original container out of the reach and sight of children. Do not use these tablets after the expiry date that is printed on the label. The expiry date refers to the last day of that month. 2 mg tablets: Do not store above 25C. 10 and 25 mg tablets: Do not store above 30C. Protect from light and moisture. 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 Clopixol Tablets contain The active substance is zuclopenthixol dihydrochloride. Each tablet contains 2 mg, 10 mg or 25 mg of zuclopenthixol. The other ingredients are potato starch, lactose, microcrystalline cellulose, copolyvidone, glycerol, talc, hydrogenated castor oil, magnesium stearate, methylhydroxypropyl cellulose, macrogol, titanium dioxide (E171) and the red colour E172 (iron oxide). What Clopixol Tablets look like and contents of the pack Description of Clopixol film-coated tablets: The 2 mg film-coated tablets are round, biconvex, pale red. The 10 mg film-coated tablets are round, biconvex, light red-brown. The 25 mg film-coated tablets are round, biconvex, redbrown. Clopixol tablets are available in plastic containers or glass bottles containing 100 tablets. These tablets are manufactured by: H. Lundbeck A/S Ottiliavej 9 DK-2500 Valby Denmark For any information about this medicine, please contact the Marketing Authorisation holder: Lundbeck Limited Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LG UK This leaflet was last approved in
Jan/2011. To request a copy of this leaflet in braille, large print or audio please call free of charge: 0800 198 5000 Please be ready to give the following information: Product name Product code number Clopixol Tablets 2 mg PL 0458/0027 Clopixol Tablets 10 mg PL 0458/0028 Clopixol Tablets 25 mg PL 0458/0029 This is a service provided by the Royal National Institute of Blind People.

Other side effects Side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment. hrobbing or fast heartbeats T eduction in blood platelets (which increases the risk of R bleeding or bruising) and other blood cell changes rowsiness D oss of co-ordination or altered muscle movements L (including unusual movements of the mouth, tongue and eyeballs) remor T tiff or floppy muscles (including stiff jaw and neck S muscles) izziness or vertigo D H eadache or migraine umbness or tingling in the arms and legs N oor concentration, loss of memory or confusion P changed walking pattern A bnormal reflexes A igidity of the whole body R ainting F peech problems S its F nlarged pupils or blurred, abnormal vision E ensitive hearing or ringing in the ears (tinnitus) S tuffy nose S hortness of breath S ry mouth or increase in saliva D eeling sick or vomiting F ndigestion or stomach pain I latulence (wind), constipation or diarrhoea F bnormal urination (increases or decreases in the A frequency or amount) ncreased sweating or greasy skin I tching, rashes or skin reactions (including sensitivity to I sunlight)

000000

000000