Ripedon 4mg 60 tablets

Risperidone 1mg film-coated tablets Risperidone 2mg film-coated tablets Risperidone 3mg film-coated tablets Risperidone 4mg film-coated tablets Risperidone Patient Information Leaflet Before taking this medicine, read this leaflet carefully as it contains important information for you. · 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. · If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Risperidone is and what it is used for 2. What you need to know before you take Risperidone 3. How to take Risperidone 4. Possible side effects 5. How to store Risperidone 6. Contents of the pack and other information 1. What Risperidone is and what it is used for Risperidone belongs to a group of medicines called antipsychotics. Risperidone is used to treat: · Schizophrenia, a disorder where you may see, hear or feel things that are not there, believe things that are not true or be unusually suspicious or confused. · Mania, where you may feel very excited, agitated, energetic, enthusiastic/bold or overactive. Mania occurs in a condition called bipolar disorder. · Short-term treatment (up to 6 weeks) of persistent aggression in patients with dementia due to Alzheimer’s disease, who are harming themselves or others. Alternative (non-drug) treatments should have been tried first. · Short-term treatment (up to 6 weeks) of persistent aggression in intellectually disabled children (at least 5 years old) and adolescents with conduct disorder. 2. What you need to know before you take Risperidone Do not take Risperidone: · If you are allergic to risperidone or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist before taking Risperidone. Warnings and precautions Talk to your doctor or pharmacist before taking Risperidone: · If you have heart problems. For example, irregular heart rhythm, or if you are prone to low blood pressure or are taking medicines that lower blood pressure. Risperidone can lower blood pressure. Your dose may need to be adjusted. · If you know you have risk factors for stroke, such as high blood pressure, cardiovascular disease or problems with blood vessels in the brain. · If you or anyone in your family has a history of blood clots, as medicines like this have been associated with formation of blood clots. · If you have Parkinson’s disease or dementia. · If you have diabetes. · If you have epilepsy. · If you are a man and have ever had a prolonged or painful erection. If you experience this while taking Risperidone, contact your doctor immediately. · If you have problems controlling your body temperature or overheating. · If you have kidney problems. · If you have liver problems. · If you have unusually high levels of the hormone prolactin in your blood, or if you have a tumour that may be prolactin-dependent. · If you have a history of low white blood cell count. Tell your doctor immediately if you develop: · Involuntary rhythmic movements of the tongue, mouth or face. It may be necessary to stop Risperidone. · Fever, muscle stiffness, sweating or a decrease in consciousness (a disorder called neuroleptic malignant syndrome). Emergency treatment may be needed. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Risperidone. Because a reduction in white blood cells has been seen very rarely (including those that help you fight bacterial infection) in patients taking risperidone, your doctor may check your white blood cell count during your treatment with Risperidone. Risperidone may cause weight gain. Significant weight gain can negatively affect your health. Your doctor should check your weight regularly. Because the development of diabetes or worsening of pre-existing diabetes has been observed during risperidone treatment, your doctor should check for signs of high blood sugar. In patients with pre-existing diabetes, blood glucose levels should be checked regularly. Risperidone often increases the level of the hormone prolactin. This can cause side effects such as menstrual irregularities or fertility problems in women, and breast enlargement in men (see Possible side effects). If such side effects occur, it is recommended to check prolactin levels in the blood. During cataract surgery, the pupil (the black circle in the middle of the eye) may not get larger as needed. Also, during surgery, the iris (the coloured part of the eye) may become floppy and may cause damage to the eye. If you are going to have eye surgery, tell the eye doctor that you are taking this medicine. Elderly patients with dementia Elderly patients with dementia have an increased risk of stroke. You should not take risperidone if you have dementia caused by stroke. See your doctor frequently when being treated with risperidone. If you, or your caregiver, notice a sudden change in your mental state, or sudden weakness or numbness of the face, arms or legs, especially on one side, or speech disorder, even for a short period, immediate medical attention is required. These could be signs of a stroke. Children and adolescents Before starting treatment for conduct disorder, other causes of aggressive behaviour should be ruled out. If fatigue develops during risperidone treatment, changing the time of day you take the medicine may improve concentration. Your or your child’s body weight should be checked before starting treatment and monitored regularly during treatment. A small and inconclusive study has noted height growth in children taking risperidone, but it is unknown whether this event is caused by the given medicine or other reasons. Other medicines and Risperidone Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is particularly important to tell your doctor or pharmacist if you are taking: · Medicines that act on the brain, such as sedatives (benzodiazepines) or some painkillers (opioids), anti-allergy medicines (some antihistamines), as risperidone may increase the sedative effect of all these medicines. · Medicines that can change the electrical activity of the heart, such as anti-malarials, medicines for heart rhythm problems (like quinidine), anti-allergy medicines (antihistamines), some antidepressants or other medicines for mental problems. · Medicines that cause slow heart rate. · Medicines that cause low potassium levels in the blood (e.g. some diuretics). · Medicines that lower blood pressure. Risperidone can lower blood pressure. · Medicines for Parkinson’s disease (e.g. levodopa). · Diuretics (water tablets) used for heart problems or swelling of body parts caused by fluid build-up (such as furosemide or hydrochlorothiazide). Taking Risperidone alone or with furosemide may increase the risk of stroke or death in elderly patients with dementia. · Medicines that increase the activity of the central nervous system (psychostimulants, such as methylphenidate). The following medicines can reduce the effect of risperidone: · Rifampicin (a medicine for some infections) · Carbamazepine, phenytoin (medicines for epilepsy) · Phenobarbital When starting or stopping treatment with such medicines, the dose of risperidone may need to be adjusted. The following medicines may increase the effect of risperidone: · Quinidine (used for some types of heart disease). · Antidepressants such as paroxetine, fluoxetine, tricyclic antidepressants. · Medicines known as beta-blockers (for treating high blood pressure). · Phenothiazines (e.g. used to treat psychosis or as sedatives). · Cimetidine, ranitidine (medicines that block stomach acid). · Itraconazole and ketoconazole (medicines for fungal infections). · Some medicines for HIV/AIDS such as ritonavir. · Verapamil, a medicine used to treat high blood pressure and/or heart rhythm disorders. · Sertraline and fluvoxamine, medicines used to treat depression and other psychiatric disorders. If you start or stop taking such medicines, the dose of risperidone may need to be adjusted. The use of paliperidone with this medicine is not recommended, as the combination of the two medicines may lead to increased side effects. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Risperidone. Risperidone with food and alcohol The medicine can be taken with or without food. Alcohol should not be consumed while using Risperidone. Pregnancy, breast-feeding and fertility · If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take it. · The following symptoms may develop in newborns of mothers who took Risperidone in the last trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby develops any of these symptoms, contact your doctor. · Risperidone can increase the level of a hormone called prolactin, which may affect fertility (see Possible side effects). Driving and using machines Dizziness, tiredness and vision problems may occur when taking Risperidone. Do not drive or use machines without consulting your doctor. Risperidone contains lactose (milk sugar) Risperidone contains 76mg of lactose monohydrate per tablet. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Risperidone Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. How much to take For schizophrenia Adults The recommended starting dose is 2mg per day, which can be increased to 4mg per day from the second day. Your dose may be further adjusted by your doctor depending on your response to treatment. Most patients feel better taking 4-6mg per day. The total daily dose can be divided into one or two doses per day. Your doctor will advise you on what is best for you. Elderly patients Your starting dose will usually be 0.5mg twice a day. Your dose may be gradually increased by your doctor to 1-2mg twice a day. Your doctor will advise you on what is best for you. Use in children and adolescents Risperidone is not used to treat schizophrenia in children and adolescents under 18 years of age. For mania Adults Your starting dose is 2mg once a day. Your doctor may gradually increase your dose depending on your response to treatment. Most patients feel well taking 1-6mg per day. Elderly patients Your starting dose will usually be 0.5mg twice a day. Your doctor may gradually increase your dose to 1-2mg twice a day depending on your response to treatment. Use in children and adolescents Risperidone is not used to treat bipolar mania in children and adolescents under 18 years of age. For persistent aggression in patients with Alzheimer’s dementia Adults (including the elderly) Your starting dose will usually be 0.25mg twice a day. (As it is not possible to achieve such a starting dose with a 1mg Risperidone film-coated tablet, your doctor will prescribe another medicinal product containing risperidone for this purpose). Your dose may be gradually adjusted by your doctor depending on your response to treatment. Most patients feel well taking 0.5mg twice a day. Some patients may need 1mg twice a day. The duration of treatment in patients with Alzheimer’s dementia should not exceed 6 weeks. For persistent aggression in conduct disorder in children and adolescents The dose will depend on your child’s weight: Use in children and adolescents weighing less than 50 kg The usual starting dose is 0.25mg once a day. (As it is not possible to achieve the starting dose with a 1mg Risperidone film-coated tablet, your doctor will prescribe another medicinal product containing risperidone for this purpose). The dose can be increased stepwise every following day by 0.25mg per day. The recommended maintenance dose is 0.25mg - 0.75mg once a day. Use in children and adolescents weighing more than 50 kg · The usual starting dose is 0.5mg once a day. · The dose can be increased stepwise every following day by 0.5mg per day. · The recommended maintenance dose is 0.5mg - 1.5mg once a day. The duration of treatment for conduct disorder should not exceed 6 weeks. Children under 5 years of age with conduct disorder cannot be treated with Risperidone. Patients with kidney or liver problems Regardless of the disease, all starting and subsequent doses of risperidone should be divided. In such patients, the dose should be increased slowly. In this group of patients, risperidone should be taken with caution. How to take Risperidone Always take this medicine according to your doctor’s instructions. If you are unsure, ask your doctor. Your doctor will advise you on the dose and duration of treatment. This will depend on your condition and will vary individually. The amount of medicine you should take is explained in the sub-heading “How much to take”. The tablet should be swallowed with water. If you take more Risperidone than you should Contact your doctor immediately. Take the medicine packaging with you. Overdose may cause drowsiness or tiredness, or impaired body movement, problems standing or walking, dizziness due to low blood pressure, or heart rhythm disturbances or seizures. If you forget to take Risperidone If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the forgotten dose and continue with your regular schedule. If you miss two or more doses, contact your doctor. Do not take a double dose to make up for a forgotten dose. If you stop taking Risperidone Do not stop taking this medicine without your doctor’s advice. Your symptoms may return. If your doctor decides to stop the medicine, the dose should be gradually reduced over several days. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Contact your doctor immediately if: · Blood clots form in your veins, especially in your legs (symptoms include: swelling, pain and redness in your leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately. · You have dementia and experience a sudden change in your mental state or sudden weakness or numbness of the face, arms or legs, especially on one side, or speech disorder, even for a short period. These could be signs of a stroke. · You have fever, muscle stiffness, sweating or a decrease in consciousness (a disorder called neuroleptic malignant syndrome). Emergency medical treatment may be needed. · You are a man and have a prolonged or painful erection. This is called priapism. Emergency medical treatment may be needed. · You experience involuntary rhythmic movements of the tongue, mouth or face (tardive dyskinesia). It may be necessary to stop Risperidone. · You have a severe allergic reaction, characterized by fever, swelling of the mouth, face, tongue or lips, shortness of breath, itching, skin rash or a sharp drop in blood pressure. The following side effects may occur: Very common (may affect more than 1 in 10 people): · Parkinsonism. This is a medical term that covers many symptoms. An individual symptom may occur less frequently. Parkinsonism includes: increased secretion of saliva or a “watery” mouth, stiffness of skeletal muscles, drooling, tremor when limbs are bent, slow, reduced or impaired body movements, lack of facial expression, muscle rigidity, stiff neck, moving with small, shuffling, hurried steps and restricted normal arm movements when walking, constant blinking of the eyes in response to tapping the forehead (an unusual reflex). · Headache, difficulty falling asleep or staying asleep. · Sedation/drowsiness. Common (may affect up to 1 in 10 people): · Lung infection (pneumonia), respiratory tract infection, flu-like illness, sinusitis, urinary tract infection, ear infection, influenza; · Increased levels of the hormone prolactin in the blood (with or without symptoms). Symptoms of high prolactin levels are uncommon and may include breast enlargement in men, erectile dysfunction or other sexual dysfunction. In women, it may include discomfort in the breasts, discharge from the breasts, absence of menstruation or other menstrual irregularities, or fertility problems; · Weight gain, increased appetite, decreased appetite. · Sleep disturbances, agitation, depression, anxiety, restlessness. · Dystonia: involuntary prolonged muscle contractions. As these movements can involve the whole body (and cause unusual posture), dystonia often affects the facial muscles and causes involuntary movements of the eyes, mouth, tongue or jaw. · Dizziness. · Dyskinesia: including involuntary movements, rhythmic movements and muscle twitching. · Tremor. · Blurred vision, eye infection or red eyes. · Fast heartbeat, high blood pressure, difficulty breathing. · Sore throat, cough, nosebleeds, stuffy nose. · Abdominal pain or discomfort, vomiting, nausea, constipation, diarrhoea, indigestion, dry mouth, toothache. · Rash, redness of the skin. · Muscle spasms, bone or muscle pain, back pain, joint pain. · Urinary incontinence. · Swelling of the body, arms and legs, fever, chest pain, asthenia, fatigue, pain. · Falls. Uncommon (may affect up to 1 in 100 people): · Respiratory tract infection, bladder infection, eye infection, tonsillitis, fungal nail infection, subcutaneous infection, localized infection, viral infection, tick-borne skin inflammation. · Reduction in white blood cells (including those that protect us from bacterial infections), reduction in platelets (blood components that stop bleeding), low haemoglobin or reduced number of red blood cells (anaemia), increase in eosinophils (special white blood cells); · Allergic reaction. · Diabetes mellitus, high blood sugar, excessive water intake. · Weight loss, decreased appetite leading to weight loss and emaciation. · Increased cholesterol in the blood. · Mood changes (mania), confusion, decreased libido, nervousness, nightmares. · Sudden interruption of blood supply to the brain (stroke or "mini-stroke"). · Absence of reaction to stimuli, loss of consciousness, decreased consciousness. · Convulsion, syncope. · Feeling of intense restlessness, balance disorder, coordination disorder, dizziness on changing body position, decreased attention, speech disorder, loss of taste or unusual taste, reduced skin sensitivity to pain or touch, tingling or numbness sensation on the skin. · Painful hypersensitivity to light, dry eyes, increased tearing, increased blood flow to the eyes. · Vertigo, ringing in the ears (tinnitus), ear pain. · Atrial fibrillation, atrioventricular block, impaired heart conduction, prolonged QT interval on electrocardiogram, bradycardia (slow heart rate), disturbance of the heart's electrical activity (ECG), sensation of throbbing or pounding in the chest (palpitations). · Low blood pressure, drop in blood pressure on standing up, hyperaemia. · Lung infection caused by food entering the airways, lung congestion, airway congestion, crackling sound in the lungs, coarse/wheezing sound when breathing, hoarse voice/voice disturbance, impaired airway function. · Faecal incontinence, difficulty passing stools, stomach and intestinal infection, difficulty swallowing, bloating. · Hives, intense itching of the skin, hair loss, skin thickening, eczema, dry skin, skin discolouration, acne, inflammation of oily skin, skin problems, skin lesions. · Increased blood creatine phosphokinase, unusual posture, joint stiffness, joint swelling, muscle weakness, neck pain. · Frequent urination, difficulty urinating or emptying the bladder, pain during urination. · Absence of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorder, spontaneous milk discharge from the breasts, breast enlargement in men, menstrual irregularities, breast pain, breast discomfort, vaginal discharge. · Facial swelling, chills, increased body temperature, thirst, chest discomfort, malaise, irritability, discomfort. · Gait disturbance. · Increased liver enzymes, increased transaminases, increased gamma-glutamyltransferase. · Procedural pain. Rare (may affect up to 1 in 1000 people): · Infection. · Severe reduction in white blood cells, increasing the risk of infections (agranulocytosis). · Anaphylactoid reaction (allergic reaction causing difficulty breathing and shock). · Inappropriate secretion of the hormone that controls the amount of urine, glucose content in urine. · Sugar content in urine. · Dangerously excessive water intake, low blood sugar, increased triglycerides in the blood. · Lack of emotion, inability to achieve orgasm. · Neuroleptic malignant syndrome (confusion, clouded or lost consciousness, high fever and severe muscle stiffness). · Brain attack (sudden increase in blood flow to the brain, seizures, stroke). · Coma, due to uncontrolled diabetes. · Head tremor (shaking). · Glaucoma, eye movement disorder, crusting on the eyelid margin, involuntary eye movement. · Eye problems during cataract surgery. During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) may develop if you are taking or have taken Risperidone. If you need cataract surgery, tell your eye doctor if you are taking or have taken this medicine. · Change in heart rate (sinus arrhythmia). · Blood clots in the lungs, blood clots in veins. · Rapid, shallow breathing, difficulty breathing during sleep. · Pancreatitis, intestinal obstruction, tongue swelling, lip inflammation. · Allergy to the medicine (skin rash), dandruff. · Breakdown of muscle fibres and pain in the muscles (rhabdomyolysis). · Drug withdrawal syndrome (nausea, vomiting, sweating, insomnia, relapse of psychotic symptoms, illness with involuntary movements). · Drug withdrawal syndrome in infants (tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty feeding). · Priapism (prolonged erection of the male genital organ, which may require surgical treatment). · Delayed menstruation, milk stasis in the breast, breast enlargement, discharge from the breasts. · Reduced body temperature, coldness in hands and feet, rough skin. · Yellowing of the skin and eyes (jaundice). Very rare (may affect up to 1 in 10,000 people): · Life-threatening complications due to uncontrolled diabetes. · Severe allergic reaction causing swelling of the face or throat (angioedema) and difficulty breathing. · Weakening of intestinal muscle movement leading to blockage. The following side effect, observed with paliperidone (a medicine very similar to risperidone), may also occur with risperidone: fast heartbeat on standing up. Additional side effects in children and adolescents In general, the type of side effects in children is similar to those in adults. The following side effects were observed more frequently in children and adolescents (5-17 years) than in adults: drowsiness/sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, abdominal pain, dizziness, cough, fever, tremor, diarrhoea and urinary incontinence. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine. This medicinal product does not require any special storage conditions. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month. Do not throw away medicines down the drain or in household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What Risperidone contains - The active substance is risperidone 1mg, 2mg, 3mg and 4mg in each film-coated tablet. - The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate. Coating: Risperidone 1mg film-coated tablets: Opadry-Y-1-7000 White: hypromellose, titanium dioxide (E171), macrogol 400. Risperidone 2mg film-coated tablets: Opadry Yellow 03B220015: hypromellose, titanium dioxide (E171), macrogol 400, quinoline yellow aluminium lake (E104). Risperidone 3mg film-coated tablet: Opadry Green 03B21372: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminium lake (E132), quinoline yellow aluminium lake (E104). Risperidone 4mg film-coated tablets: Opadry Green 03B21368: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminium lake (E132), quinoline yellow aluminium lake (E104). What Risperidone looks like and contents of the pack Risperidone 1mg film-coated tablets: Elongated, slightly biconvex on both sides, white or almost white, odourless, film-coated tablet, embossed with the stylized inscriptions E and 751 on one side and a dividing line on the other. The fracture surface is white. Risperidone 2mg film-coated tablets: Elongated, slightly biconvex on both sides, yellow, odourless, film-coated tablet, embossed with the stylized inscriptions E and 752 on one side and a dividing line on the other. The fracture surface is white. Risperidone 3mg film-coated tablets: Elongated, slightly biconvex on both sides, light green, odourless, film-coated tablet, embossed with the stylized inscriptions E and 753 on one side and a dividing line on the other. The fracture surface is white. Risperidone 4mg film-coated tablets: Elongated, slightly biconvex on both sides, grass green, odourless, film-coated tablet, embossed with the stylized inscriptions E and 754 on one side and a dividing line on the other. The fracture surface is white. The tablet can be divided into equal doses. 10, 20, or 60 film-coated tablets in PVC/PVDC//Al blisters and cardboard boxes. Not all pack sizes may be marketed. Dispensing category: Pharmaceutical product group II, dispensed with N3 prescription.