RISPERIDONE 1MG FILM-COATED TABLETS

can lower blood pressure Medicines for Parkinson's disease (such as levodopa) Water tablets (diuretics) used for heart problems or swelling of parts of your body due to a build up of too PACKAGE LEAFLET: INFORMATION FOR THE USER much fluid (such as furosemide or chlorothiazide). Risperidone taken by itself or with furosemide, may Read all of this leaflet carefully before you start taking this have an increased risk of stroke or death in elderly medicine. people with dementia. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or The following medicines may reduce the effect of pharmacist. Risperidone This medicine has been prescribed for you. Do not pass it Rifampicin (a medicine for treating some infections) on to others. It may harm them, even if their symptoms Carbamazepine, phenytoin (medicines for epilepsy) are the same as yours. Phenobarbital. If any of the side effects get serious, or if you notice any If you start or stop taking such medicines you may need a side effects not listed in this leaflet, please tell your different dose of Risperidone. doctor or pharmacist. The following medicines may increase the effect of IN THIS LEAFLET: Risperidone Quinidine (used for certain types of heart disease) 1. What Risperidone is and what it is used for Antidepressants such as paroxetine, fluoxetines, 2. Before you take Risperidone tricyclic antidepressants 3. How to take Risperidone Medicines known as beta blockers (used to treat high 4. Possible side effects blood pressure) 5. How to store Risperidone Phenothiazines (e.g. used to treat psychosis or to calm 6. Further Information down) Cimetidine, ranitidine (blockers of the acidity of stomach). WHAT RISPERIDONE IS AND WHAT IT IS USED FOR If you start or stop taking such medicines you may need a different dose of Risperidone. Risperidone belongs to a group of medicines called If you are not sure if any of the above applies to you, talk anti-psychotics. to your doctor or pharmacist before using Risperidone. Risperidone is used to treat the following: Taking Risperidone with food and drink Schizophrenia, where you may see, hear or feel things that are not there, believe things that are not true or feel You can take this medicine with or without food. You should avoid drinking alcohol when taking Risperidone. unusually suspicious, or confused Mania, where you may feel very excited, elated, agitated, Pregnancy and breast-feeding enthusiastic or hyperactive Mania occurs in an illness Talk to your doctor before using Risperidone if you are called bipolar disorder pregnant, trying to become pregnant or breast-feeding. Short-term treatment (up to 6 weeks) of long-term Your doctor will decide if you can take it. aggression in people with Alzheimers dementia, who The following symptoms may occur in newborn babies, harm themselves or others. Alternative (non-drug) of mothers that have used Risperidone in the last treatments should have been used previously trimester (last three months of their pregnancy): shaking, Short-term treatment (up to 6 weeks) of long-term, muscle stiffness and/or weakness, sleepiness, agitation, aggression in intellectually disabled children (at least breathing problems, and difficulty in feeding. If your 5 years of age) and adolescents with conduct disorder. baby develops any of these symptoms you may need to contact your doctor. BEFORE YOU TAKE RISPERIDONE Ask your doctor or pharmacist for advice before taking any medicine. Do NOT take Risperidone: If you are allergic (hypersensitive) to Risperidone or any Driving and using machines Dizziness, tiredness, and vision problems may occur of the other ingredients of this medicine (see section 6 during treatment with Risperidone. Do not drive or use Further information). any tools or machines without talking to your doctor first. If you are not sure if the above applies to you, talk to your Important information about some of the ingredients of doctor or pharmacist before using Risperidone. Risperidone Take special care with Risperidone: If you have been told by your doctor that you have Check with your doctor or pharmacist before taking intolerance to some sugars, contact your doctor before Risperidone if you: taking this medicine. have a heart problem. Examples include an irregular heart rhythm or if you are prone to low blood pressure HOW TO TAKE RISPERIDONE or if you are using medicines for your blood pressure. Risperidone may cause low blood pressure. Your dose How much to take may need to be adjusted For the treatment of schizophrenia know of any factors which would favour you having a Adults stroke, such as high blood pressure, cardiovascular The usual starting dose is 2 mg per day, this may be disorder or blood vessel problems in the brain increased to 4 mg per day on the second day have Parkinsons disease or dementia Your dose may then be adjusted by your doctor are diabetic depending on how you respond to the treatment have epilepsy are a man and you have ever had a prolonged or painful Most people feel better with daily doses of 4 mg to 6 mg erection. If you experience this while taking Risperidone, This total daily dose can be divided into either one or two doses a day. Your doctor will tell you which is the contact your doctor straight away best for you. have problems controlling your body temperature or overheating Elderly people have kidney problems Your starting dose will normally be 0.5 mg twice a day have liver problems Your dose may then be gradually increased by your have an abnormally high level of the hormone prolactin doctor to 1 mg to 2 mg twice a day in your blood or if you have a tumour, which is possibly Your doctor will tell you which is the best for you. dependent on prolactin Children and adolescents have or someone else in your family has a history of Children and adolescents under 18 years old should not blood clots, as medicines like these have been associated be treated with Risperidone for schizophrenia. with formation of blood clots. For the treatment of mania Tell your doctor immediately if you experience Adults involuntary rhythmic movements of the tongue, mouth Your starting dose will usually be 2 mg once a day and face. Withdrawal of Risperidone may be needed Your dose may then be gradually adjusted by your fever, severe muscle stiffness, sweating or a lowered doctor depending on how you respond to the treatment level of consciousness (a disorder called neuroleptic Most people feel better with doses of 1 mg to 6 mg once malignant syndrome). Immediate medical treatment a day. may be needed. Elderly people If you are not sure if any of the above applies to you, talk Your starting dose will usually be 0.5 mg twice a day to your doctor or pharmacist before using Risperidone. Your dose may then be gradually adjusted by your Risperidone may cause you to gain weight. doctor to 1 mg to 2 mg twice a day depending on how much you respond to the treatment. Elderly people with dementia In elderly patients with dementia, there is an increased risk Children and adolescents of stroke.You should not take Risperidone if you have Children and adolescents under 18 years old should not dementia caused by stroke. be treated with Risperidone for bipolar mania. During treatment with Risperidone you should frequently For the treatment of long-standing aggression in people see your doctor. with Alzheimers dementia Medical treatment should be sought straight away if you Adults (including elderly people) or your care-giver notice a sudden change in your mental Your starting dose will normally be 0.25 mg twice a day state or sudden weakness or numbness of your face, arms Your dose may then be gradually adjusted by your or legs, especially on one side, or slurred speech, even for doctor depending on how you respond to the treatment a short period of time. These may be signs of a stroke. Most people feel better with 0.5 mg twice a day. Some Children and adolescents patients may need 1 mg twice a day Before treatment is started in conduct disorder, other Treatment duration in patients with Alzheimers causes of aggressive behaviour should have been ruled out. dementia should be not more than 6 weeks. If during treatment with Risperidone tiredness occurs, a For the treatment of conduct disorder in children and change in the time of administration might improve adolescents attention difficulties. The dose will depend on your childs weight: Taking other medicines For children who weigh less than 50 kg Please tell your doctor or pharmacist if you are taking or have The starting dose will normally be 0.25 mg once a day recently taken any other medicines, including medicines The dose may be increased every other day in steps of obtained without a prescription and herbal medicines. 0.25 mg per day The usual maintenance dose is 0.25 mg to 0.75 mg once It is especially important to talk to your doctor or a day. pharmacist if you are taking any of the following: Medicines that work on your brain such as to help you For children who weigh 50 kg or more calm down (benzodiazepines) or some medicines for pain The starting dose will normally be 0.5 mg once a day (opiates), medicines for allergy (some antihistamines), as The dose may be increased every other day in steps of Risperidone may increase the sedative effect of all of these 0.5 mg per day Medicines that may change the electrical activity of your The usual maintenance dose is 0.5 mg to 1.5 mg once a heart, such as medicines for malaria, heart rhythm day. problems (such as quinidine), allergies (anti-histamines), Treatment duration in patients with conduct disorder some antidepressants or other medicines for mental should be not more than 6 weeks. problems Medicines that cause a slow heart beat Children under 5 years old should not be treated with Medicines that cause low blood potassium (e.g. certain Risperidone for conduct disorder. diuretics) People with kidney or liver problems Medicines to treat elevated blood pressure. Risperidone Regardless of the disease to be treated, all starting doses

RISPERIDONE 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg and 6 mg FILM-COATED TABLETS

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and following doses of Risperidone should be halved. Dose increases should be slower in these patients. Risperidone should be used with caution in this patient group. How to take Risperidone Always take Risperidone exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will tell you how much medicine to take and for how long. This will depend on your condition and varies from person to person. The amount of medicine you should take is explained under the How much to take sub-heading below. Risperidone film-coated tablets You should swallow your tablet with a drink of water If you take more Risperidone than you should See a doctor right away. Take the medicine pack with you. In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems standing and walking, feel dizzy due to low blood pressure, or have abnormal heart beats or fits. If you forget to take Risperidone If you forget to take a dose, take it as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue as usual. If you miss two or more doses, contact your doctor Do not take a double dose (two doses at the same time) to make up for a forgotten dose. If you stop taking Risperidone You should not stop taking this medicine unless told to do so by your doctor. Your symptoms may return. If your doctor decides to stop this medicine, your dose may be decreased gradually over a few days. If you have any further questions on the use of this product, ask your doctor or pharmacist.

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POSSIBLE SIDE EFFECTS

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Like all medicines, Risperidone can cause side effects, although not everybody gets them. Very common: affects more than 1 user in 10 Common: affects 1 to 10 users in 100 Uncommon: affects 1 to 10 users in 1,000 Rare: affects 1 to 10 users in 10,000 Very rare: affects less than 1 user in 10,000 Not known: frequency cannot be estimated from the available data. The following side effects may happen: Very Common (affects more than 1 user in 10): Parkinsonism. This is a medical term that includes many symptoms. Each individual symptom may occur less frequently than in 1 in 10 people. Parkinsonism includes: increase in saliva secretion or watery mouth, musculoskeletal stiffness, drooling, jerks when bending the limbs, slow, reduced or impaired body movements, no expression on the face, muscle tightness, stiff neck, muscle stiffness, small, shuffling, hurried steps and lack of normal arm movements when walking, persistent blinking in response to tapping of the forehead (an abnormal reflex) Headache, difficulty falling or staying asleep. Common (affects 1 to 10 users in 100): Drowsiness, fatigue, restlessness, inability to sit still, irritability, anxiety, sleepiness, dizziness, poor attention, feeling exhausted, sleep disorder Vomiting, diarrhoea, constipation, nausea, increased appetite, abdominal pain or discomfort, sore throat, dry mouth Weight increased, increase in body temperature, decreased appetite Difficulty breathing, lung infection (pneumonia), flu, infection of the breathing passages, blurred vision, nose congestion, nose bleeding, cough Urinary tract infection, bed wetting Muscle spasm, involuntary movements of face or arms and legs, joint pain, back pain, swelling of arms and legs, pain in arms and legs Rash, skin redness Fast beating heart, chest pain Blood prolactin hormone level increased. Uncommon (affects 1 to 10 users in 1000): Excessive drinking of water, stool incontinence, thirsty, very hard faeces, hoarseness or voice disorder Lung infection caused by inhaling of food into the breathing passages, bladder infection, pink eye, sinus infection, viral infection, ear infection, tonsil infection, infection under the skin, eye infection, stomach infection, eye discharge, yeast infection of nails Abnormal electrical conduction of the heart, drop in blood pressure after standing, low blood pressure, feeling dizzy after changing body position, abnormal electric activity tracing of the heart (ECG), abnormal heart rhythm, awareness of heart beating, heart rate increased or decreased Urinary incontinence, pain when passing urine, frequent passing of urine Confused, disturbance in attention, low level of consciousness, excessive sleep, nervousness, elated mood (mania), lack of energy and interest Blood sugar increased, liver enzymes increased, white blood cell count decreased, low haemoglobin or red blood cell count (anaemia), increase in eosinophils (special white blood cells), blood creatinine phosphokinase increased, decrease in platelets (blood cells that help you stop bleeding) Muscle weakness, muscle pain, ear pain, neck pain, joint swelling, abnormal posture, joint stiffness, musculoskeletal chest pain, chest discomfort Skin lesion, skin disorder, dry skin, intense itching of skin, acne, hair loss, skin inflammation caused by mites, skin discoloration, thickening of skin, flushing, reduced skin sensitivity to pain or touch, inflammation of oily skin No menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, breast discharge, enlargement of breast in men, decreased sexual drive, irregular menstruation, vaginal discharge Fainting, gait disturbance, sluggishness, decreased appetite resulting in malnutrition and low body weight, feeling out of sorts, balance disorder, allergy, oedema, speech disorder, chills, abnormal coordination Painful oversensitivity to light, increased blood flow to the eye, eye swelling, dry eye, increase in tears Breathing passage disorder, lung congestion, crackly lung noise, congestion of breathing passages, trouble speaking, difficulty swallowing, cough with sputum, coarse/whistling sound during breathing, flu-like illness, sinus congestion Unresponsive to stimuli, loss of consciousness, sudden

swelling of lips and eyes along with difficulty breathing, sudden weakness or numbness of the face, arms, or legs, especially on one side, or instances of slurred speech that last for less than 24 hours (these are called mini-strokes or strokes), involuntary movements of face, arms, or legs, ringing in ears, face edema. Rare (affects 1 to 10 users in 10,000): Inability to reach orgasm, menstrual disorder Dandruff Drug allergy, coldness in arms and legs, lip swelling, lip inflammation Glaucoma, reduced visual clarity, eyelid margin crusting, eye rolling Lack of emotion Change in consciousness with increased body temperature and twitching of muscles, edema all over the body, drug withdrawal syndrome, body temperature decreased Fast shallow breathing, trouble breathing during sleep, chronic otitis media Obstruction of intestine Reduced blood flow to the brain Decrease in white blood cells, inappropriate secretion of a hormone that controls urine volume Breakdown of muscle fibers and pain in muscles (rhabdomyolysis), movement disorder Coma due to uncontrolled diabetes Yellowing of the skin and the eyes (jaundice) Inflammation of the pancreas. Very rare (affects less than 1 user in 10,000): Life threatening complications of uncontrolled diabetes. Unknown frequency of occurrence (frequency cannot be estimated from the available data): Severe allergic reaction resulting in difficulty in breathing and shock No granulocytes (a type of white blood cell to help you against infection) Prolonged and painful erection Dangerously excessive intake of water 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 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.

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HOW TO STORE RISPERIDONE

Keep out of the reach and sight of children. Do not use Risperidone after the expiry date which is stated on the outer packaging or bottle. The expiry date refers to the last day of the month. Do not store above 30C for 0.5 mg Do not store above 25C for 1.0 mg This medicinal product does not require any special storage conditions for 2 mg, 3 mg, 4 mg and 6 mg. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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FURTHER INFORMATION

What Risperidone contains: The active ingredient is risperidone. Other ingredients are lactose monohydrate, sodium lauril sulfate, hypromellose (E464), macrogol 6000, macrogol 400, colloidal anhydrous silica, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate (Type A) and magnesium stearate. The tablets contain the following colours: 0.5 mg tablets: iron oxide red (E172), iron oxide yellow (E172) and titanium dioxide (E171) 1 mg tablets: titanium dioxide (E171) 2 mg tablets: iron oxide red (E172), Iron oxide yellow (E172) and titanium dioxide (E171) 3 mg tablets: titanium dioxide (E171) and quinoline yellow aluminium lake (E104) 4 mg tablets: titanium dioxide (E171), quinoline yellow aluminium lake (E104), indigo carmine aluminium lake (E132) and iron oxide yellow (E172) 6 mg tablets: titanium dioxide (E171), iron oxide red (E172) and iron oxide yellow (E172). What Risperidone looks like and the contents of the pack: Risperidone 0.5 mg Film-Coated Tablets are brownish-red, round, slightly arched tablets, with RIS 0.5 and a score line marked on one side and plain on the other side Risperidone 1 mg Film-Coated Tablets are white, round, slightly arched tablets with RIS 1 and a score line marked on one side and plain on the other side Risperidone 2 mg Film-Coated Tablets are tan colour, round, slightly arched tablets with RIS 2 and a score line marked on one side and plain on the other side Risperidone 3 mg Film-Coated Tablets are yellow, round, slightly arched tablets, with RIS 3 and a score line marked on one side and plain on the other side Risperidone 4 mg Film-Coated Tablets are green, round, slightly arched tablets, with RIS 4 and a score line marked on one side and plain on the other side Risperidone 6 mg Film-Coated Tablets are tan colour, round, slightly arched tablets with RIS 6 and a score line marked on one side and plain on the other side The 0.5 mg tablets are available in pack sizes of 10, 20 and 60 film-coated tablets The 1 mg tablets are available in pack sizes of 6, 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets The 2 mg tablets are available in pack sizes of 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets The 3 mg tablets are available in pack sizes of 10, 20, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets The 4 mg tablets are available in pack sizes of 10, 20, 30, 50, 60, 100, 100 (5x20 hospital pack) and 500 film-coated tablets The 6 mg tablets are available in pack sizes of 7, 20, 28, 30, 50, 60, 100 and 100 (5x20 hospital pack) film-coated tablets. Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: November 2011 PL 00289/0652-57 69703-ZA