AMISULPRIDE 200MG TABLETS
Active substance: AMISULPRIDE
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Logo actavis Amisulpride 50mg, 100mg, and 200mg Tablets
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. 2. 3. 4. 5. 6. What Amisulpride is and what it is used for Before you take Amisulpride tablets How to take Amisulpride tablets Possible side effects How to store Amisulpride tablets Further information
1. What Amisulpride is and what it is used for
Amisulpride tablets belong to a group of medicines called benzamide antipsychotics. These work by improving thoughts, feelings and/or behaviour when these are disturbed in certain medical conditions. Amisulpride tablets may be used in the treatment of acute (severe or sudden) and chronic (ongoing or long-term) schizophrenia, a condition where certain symptoms become very noticeable. These include feeling, hearing or seeing things that arent really there (hallucinations), having a strong false belief despite evidence against it (delusions), inability to think normally, and feeling emotional, disinterested or withdrawn.
2. Before you take Amisulpride tablets
Do not take Amisulpride tablets and tell your doctor if you:
are pregnant, planning to become pregnant or breastfeeding. Women of childbearing age should not take Amisulpride tablets without using adequate contraception have ever had an allergic reaction to amisulpride or any of the ingredients in the tablet. (An allergic reaction may include a rash, itching or difficulty breathing) (see section 6) have a tumour that depends on prolactin (a hormone produced by the pituitary gland) or breast cancer have phaeochromocytoma (a tumour of the adrenal gland causing high blood pressure) are giving to a child under the age of 15 years of age are taking the following other medicines: medicines to treat irregular heart rhythms (such as quinidine, procainamide, disopyramide or amiodarone), beta blockers (such as sotalol) or calcium channel blockers (such as bepridil) cisapride (for stomach disorders), sultopride or thioridazine (other antipsychotic medicines for schizophrenia), halofantrine (to treat malaria), pentamidine or sparfloxacin (antibiotics), injections into the veins of erythromycin (antibiotic) or vincamine (improves blood flow around the brain). are taking levodopa (used for treating Parkinsons Disease).
Take special care with Amisulpride tablets and tell your doctor if you:
have kidney disease have epilepsy or a history of epileptic fits (collapse followed by violent jerking and shaking). Your doctor will regularly check your epilepsy whilst you are taking Amisulpride tablets
are already taking tranquillisers such as pimozide or haloperidol (neuroleptics) have a very high body temperature (hyperthermia), this may lead to Neuroleptic Malignant syndrome (symptoms include rigid muscles, fast breathing, high body temperature, reduced consciousness and restlessness) have Parkinsons Disease are elderly have slow or irregular heart rate have low potassium levels in the blood (seen in blood tests). have heart or blood vessel disease or anyone in your family has had problems with their heart rhythm. or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. Especially any of the following: medicines to lower blood pressure such as calcium-channel blockers (diltiazem, verapamil), beta-blockers (e.g. atenolol), clonidine (and its derivatives) or guanfacine digoxin (for irregular heartbeat) medicines which lower potassium levels in the blood including certain diuretics (water tablets e.g. furosemide), laxatives (e.g. senna), intravenous amphotericin (an antibiotic), glucocorticoids (e.g. dexamethasone) or tetracosactides (e.g. tetracosactrin for pain associated with damaged tissues and inflammation) antidepressants such as imipramine lithium (for moderating mood and treating mania) medicines which reduce activity of the nervous system including strong painkillers (e.g. morphine, codeine), anaesthetics (e.g. lidocaine), antihistamines that cause drowsiness (e.g. chlorphenamine for hayfever, rashes or insect bites), barbiturates (e.g. phenobarbital for epilepsy), benzodiazepines (e.g. diazepam for anxiety) and other medicines which reduce anxiety (e.g. buspirone)
Taking Amisulpride tablets with alcohol
You are advised NOT to drink alcohol with this medicine as Amisulpride tablets may enhance the adverse effects of alcohol. Discuss this with your doctor if you have any questions.
Pregnancy and breastfeeding
Do not take Amisulpride tablets if you are pregnant, trying to get pregnant or breastfeeding. If you are a woman of child bearing age do not take Amisulpride tablets unless you are also using adequate contraception. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Amisulpride tablets may slow your reactions. Make sure you are not affected before you drive or operate machinery.
Sugar intolerance
This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients who are lactose intolerant should not take this medicine. If you see another doctor or go into hospital let them know what medicines you are taking.
3. How to take Amisulpride tablets
Always take Amisulpride tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:
Adult and children over 15 years old Your dose will be adjusted to suit you. It will range from 50mg to 1200mg a day. If you are on a dose of 300mg or less this is to be taken as a single dose at the same time each day. Doses over 300mg should be divided into two, with half taken in the morning and half in the evening, at the same times each day. Elderly To be used with caution as elderly patients are at risk of low blood pressure or sedation. Children under 15 years old Must NOT take Amisulpride tablets. Kidney impairment A lower dose will be given depending on your kidney function. Swallow these tablets with water.
If you take more Amisulpride tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose may include drowsiness, sedation, coma, drop in blood pressure or extrapyramidal effects (abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity)
If you forget to take Amisulpride tablets
If you forget to take a dose, take one as soon as you remember. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Amisulpride tablets
Do NOT stop taking Amisulpride tablets just because you feel better. This medicine should be taken for as long as your doctor tells you to.
4. Possible side effects
Like all medicines, Amisulpride tablets can sometimes cause unwanted side effects in some people, although not everybody gets them. 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. Stop taking Amisulpride tablets and contact your doctor or the nearest hospital casualty department immediately if either of the following very rare effects happen: a condition involving a fever (feeling hot) with muscle stiffness, panting, sweating and reduced consciousness called Neuroleptic Malignant Syndrome. allergic reactions which include feeling faint or fainting, swelling of face, lips, throat or tongue, difficulty breathing or rash. Symptoms are not always easy to identify as to whether they are side effects of the medicine or part of the underlying medical condition. Tell your doctor if any of the following effects occur: Common (affects less than 1 in 10 users): difficulty in sleeping (insomnia), anxiety or agitation. Uncommon (affects less than 1 in 100 users): sleepiness (somnolence), constipation, feeling sick (nausea), being sick (vomiting) or dry mouth. Very rare (affects less than 1 in 10,000 users): Shaking fits (seizures), torsade de pointes (palpitations, dizziness, or fainting), alteration of liver enzymes (seen in blood tests). Other possible side effects: weight gain
muscle spasm in the neck, shoulders and body (dystonia), shakiness in the arms or legs (tremor), stiffness of movement (rigidity), slowed movements (hypokinesia), drooling (hypersalivation) and restlessness (akathisia)- all of these symptoms tend to be mild and can be partly or fully treated without need to stop taking Amisulpride tablets. slow, difficult and jerky movements mainly of the face and tongue (tardive dyskinesia) may occur after using Amisulpride tablets for a long time. low blood pressure (hypotension) and slow heartbeat (bradycardia) have been reported occasionally. Fast or irregular heart beat, heart attack. over production of breast milk (galactorrhoea), enlarged breasts in men (gynaecomastia), breast pain, missed menstrual periods (amenorrhoea), reduced sexual potency (impotence) and sexual performance (orgasmic dysfunction) may occur. These effects gradually disappear after stopping Amisulpride tablets. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Please do not be worried. Most people taking this medicine will not experience any problems.
5. How to store Amisulpride tablets
Keep out of the reach and sight of children. Do not use Amisulpride tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special storage precautions. 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 Amisulpride tablets contain
The active ingredient is amisulpride. Each tablet contains either 50mg, 100mg or 200mg of the active ingredient. The other ingredients are maize starch, lactose monohydrate, methylcellulose, colloidal anhydrous silica and magnesium stearate.
What Amisulpride tablets look like and contents of the pack
The tablets are white to off-white, round tablets with a break line. Amisulpride tablets are available in pack sizes of *. * 10, 20, 28, 30, 50, 56, 60, 84, 90, 100 or 150 tablets. (only the marketed pack size will appear on the final leaflet)
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in February 2010
Logo actavis
Actavis, Barnstaple, EX32 8NS, UK
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. 2. 3. 4. 5. 6. What Amisulpride is and what it is used for Before you take Amisulpride tablets How to take Amisulpride tablets Possible side effects How to store Amisulpride tablets Further information
1. What Amisulpride is and what it is used for
Amisulpride tablets belong to a group of medicines called benzamide antipsychotics. These work by improving thoughts, feelings and/or behaviour when these are disturbed in certain medical conditions. Amisulpride tablets may be used in the treatment of acute (severe or sudden) and chronic (ongoing or long-term) schizophrenia, a condition where certain symptoms become very noticeable. These include feeling, hearing or seeing things that arent really there (hallucinations), having a strong false belief despite evidence against it (delusions), inability to think normally, and feeling emotional, disinterested or withdrawn.
2. Before you take Amisulpride tablets
Do not take Amisulpride tablets and tell your doctor if you:
are pregnant, planning to become pregnant or breastfeeding. Women of childbearing age should not take Amisulpride tablets without using adequate contraception have ever had an allergic reaction to amisulpride or any of the ingredients in the tablet. (An allergic reaction may include a rash, itching or difficulty breathing) (see section 6) have a tumour that depends on prolactin (a hormone produced by the pituitary gland) or breast cancer have phaeochromocytoma (a tumour of the adrenal gland causing high blood pressure) are giving to a child under the age of 15 years of age are taking the following other medicines: medicines to treat irregular heart rhythms (such as quinidine, procainamide, disopyramide or amiodarone), beta blockers (such as sotalol) or calcium channel blockers (such as bepridil) cisapride (for stomach disorders), sultopride or thioridazine (other antipsychotic medicines for schizophrenia), halofantrine (to treat malaria), pentamidine or sparfloxacin (antibiotics), injections into the veins of erythromycin (antibiotic) or vincamine (improves blood flow around the brain). are taking levodopa (used for treating Parkinsons Disease).
Take special care with Amisulpride tablets and tell your doctor if you:
have kidney disease have epilepsy or a history of epileptic fits (collapse followed by violent jerking and shaking). Your doctor will regularly check your epilepsy whilst you are taking Amisulpride tablets
are already taking tranquillisers such as pimozide or haloperidol (neuroleptics) have a very high body temperature (hyperthermia), this may lead to Neuroleptic Malignant syndrome (symptoms include rigid muscles, fast breathing, high body temperature, reduced consciousness and restlessness) have Parkinsons Disease are elderly have slow or irregular heart rate have low potassium levels in the blood (seen in blood tests). have heart or blood vessel disease or anyone in your family has had problems with their heart rhythm. or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. Especially any of the following: medicines to lower blood pressure such as calcium-channel blockers (diltiazem, verapamil), beta-blockers (e.g. atenolol), clonidine (and its derivatives) or guanfacine digoxin (for irregular heartbeat) medicines which lower potassium levels in the blood including certain diuretics (water tablets e.g. furosemide), laxatives (e.g. senna), intravenous amphotericin (an antibiotic), glucocorticoids (e.g. dexamethasone) or tetracosactides (e.g. tetracosactrin for pain associated with damaged tissues and inflammation) antidepressants such as imipramine lithium (for moderating mood and treating mania) medicines which reduce activity of the nervous system including strong painkillers (e.g. morphine, codeine), anaesthetics (e.g. lidocaine), antihistamines that cause drowsiness (e.g. chlorphenamine for hayfever, rashes or insect bites), barbiturates (e.g. phenobarbital for epilepsy), benzodiazepines (e.g. diazepam for anxiety) and other medicines which reduce anxiety (e.g. buspirone)
Taking Amisulpride tablets with alcohol
You are advised NOT to drink alcohol with this medicine as Amisulpride tablets may enhance the adverse effects of alcohol. Discuss this with your doctor if you have any questions.
Pregnancy and breastfeeding
Do not take Amisulpride tablets if you are pregnant, trying to get pregnant or breastfeeding. If you are a woman of child bearing age do not take Amisulpride tablets unless you are also using adequate contraception. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Amisulpride tablets may slow your reactions. Make sure you are not affected before you drive or operate machinery.
Sugar intolerance
This medicine contains lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine. Patients who are lactose intolerant should not take this medicine. If you see another doctor or go into hospital let them know what medicines you are taking.
3. How to take Amisulpride tablets
Always take Amisulpride tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is:
Adult and children over 15 years old Your dose will be adjusted to suit you. It will range from 50mg to 1200mg a day. If you are on a dose of 300mg or less this is to be taken as a single dose at the same time each day. Doses over 300mg should be divided into two, with half taken in the morning and half in the evening, at the same times each day. Elderly To be used with caution as elderly patients are at risk of low blood pressure or sedation. Children under 15 years old Must NOT take Amisulpride tablets. Kidney impairment A lower dose will be given depending on your kidney function. Swallow these tablets with water.
If you take more Amisulpride tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose may include drowsiness, sedation, coma, drop in blood pressure or extrapyramidal effects (abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity)
If you forget to take Amisulpride tablets
If you forget to take a dose, take one as soon as you remember. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Amisulpride tablets
Do NOT stop taking Amisulpride tablets just because you feel better. This medicine should be taken for as long as your doctor tells you to.
4. Possible side effects
Like all medicines, Amisulpride tablets can sometimes cause unwanted side effects in some people, although not everybody gets them. 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. Stop taking Amisulpride tablets and contact your doctor or the nearest hospital casualty department immediately if either of the following very rare effects happen: a condition involving a fever (feeling hot) with muscle stiffness, panting, sweating and reduced consciousness called Neuroleptic Malignant Syndrome. allergic reactions which include feeling faint or fainting, swelling of face, lips, throat or tongue, difficulty breathing or rash. Symptoms are not always easy to identify as to whether they are side effects of the medicine or part of the underlying medical condition. Tell your doctor if any of the following effects occur: Common (affects less than 1 in 10 users): difficulty in sleeping (insomnia), anxiety or agitation. Uncommon (affects less than 1 in 100 users): sleepiness (somnolence), constipation, feeling sick (nausea), being sick (vomiting) or dry mouth. Very rare (affects less than 1 in 10,000 users): Shaking fits (seizures), torsade de pointes (palpitations, dizziness, or fainting), alteration of liver enzymes (seen in blood tests). Other possible side effects: weight gain
muscle spasm in the neck, shoulders and body (dystonia), shakiness in the arms or legs (tremor), stiffness of movement (rigidity), slowed movements (hypokinesia), drooling (hypersalivation) and restlessness (akathisia)- all of these symptoms tend to be mild and can be partly or fully treated without need to stop taking Amisulpride tablets. slow, difficult and jerky movements mainly of the face and tongue (tardive dyskinesia) may occur after using Amisulpride tablets for a long time. low blood pressure (hypotension) and slow heartbeat (bradycardia) have been reported occasionally. Fast or irregular heart beat, heart attack. over production of breast milk (galactorrhoea), enlarged breasts in men (gynaecomastia), breast pain, missed menstrual periods (amenorrhoea), reduced sexual potency (impotence) and sexual performance (orgasmic dysfunction) may occur. These effects gradually disappear after stopping Amisulpride tablets. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Please do not be worried. Most people taking this medicine will not experience any problems.
5. How to store Amisulpride tablets
Keep out of the reach and sight of children. Do not use Amisulpride tablets after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special storage precautions. 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 Amisulpride tablets contain
The active ingredient is amisulpride. Each tablet contains either 50mg, 100mg or 200mg of the active ingredient. The other ingredients are maize starch, lactose monohydrate, methylcellulose, colloidal anhydrous silica and magnesium stearate.
What Amisulpride tablets look like and contents of the pack
The tablets are white to off-white, round tablets with a break line. Amisulpride tablets are available in pack sizes of *. * 10, 20, 28, 30, 50, 56, 60, 84, 90, 100 or 150 tablets. (only the marketed pack size will appear on the final leaflet)
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in February 2010
Logo actavis
Actavis, Barnstaple, EX32 8NS, UK
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
