PACKAGE LEAFLET: INFORMATION FOR THE USER
Amisulpride 50mg, 100mg, 200mg & 400mg 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. What Amisulpride Tablets are and what they are used for
2. Before you take Amisulpride Tablets
3. How to take Amisulpride Tablets
4. Possible side effects
5. How to store Amisulpride Tablets
6. Further information
1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Amisulpride belongs to a group of medicines called antipsychotics.
The tablets are used in the treatment of acute and chronic schizophrenia. This condition causes symptoms such as becoming withdrawn, sensing, seeing or hearing things which do not exist, mistaken beliefs or unfounded suspicions. Sometimes people with these symptoms may also feel tense, anxious or depressed.
2. BEFORE YOU TAKE AMISULPRIDE TABLETS
Do not take Amisulpride Tablets:
- If you are sensitive or allergic to amisulpride or any other ingredients in this product (symptoms such as a rash, lumpy skin rash (hives), fever or difficulty breathing)
- If you are pregnant, might become pregnant or are breast-feeding (see Pregnancy and breast-feeding section)
- If you are breast-feeding
- If you have a prolactin dependent tumour or breast cancer
- If you have phaeochromocytoma (a tumour on the adrenal gland)
- If you are under 15 year of age
- If you are taking antiarrhythmic drugs for controlling the heart rhythm such as quinidine, disopyramide, procainamide, amiodarone, sotalol
- If you are taking bepridil (calcium channel blockers used for chest pain)
- If you are taking cisapride for gastrointestinal problems
- If you are taking sultopride used in schizophrenia
- If you are taking thioridazine used for schizophrenia and psychosis
- If you are taking IV erythromycin and sparfloxacin used in infections
- If you are taking IV vincamine used to improve blood flow in the brain
- If you are taking halofantrine used to treat malaria
- If you are taking pentamidine used in chest infections
- If you are taking levodopa used in Parkinson's Disease
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Amisulpride Tablets.
Take special care with Amisulpride Tablets:
Please tell your doctor before you start to take your tablets:
- If you suffer from kidney disease
- If you have a history of epilepsy or seizures (fits)
- If you suffer from Parkinson's disease
- If you have a slow or unusual heart rate
- If you have low potassium levels in your blood
- If you have a long QT interval (heart conduction problem)
- 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
- If you have a hear disease or family history of heart problems
- If your doctor have told you that you might have a stroke
- If you are diabetic or have been told you have an increased risk of having diabetes
- If you are elderly. This is because elderly people are more likely to get low blood pressure or feel sleepy
- if you are elderly and suffer form dementia
Contact your doctor immediately if you notice any change in your heart rhythm or develop symptoms like a high fever with fast breathing, sweating, muscle stiffness and reduced consciousness.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amisulpride Tablets.
Taking other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken, any other medicine including those that you have bought without a prescription.
Do not take this medicine and tell your doctor if you are taking any of the following medicines:
- Levodopa to treat Parkinson's disease
Tell your doctor BEFORE starting your medicine if you are taking any of the following:
- Medicines to reduce your heart rate such as quinidine, dysopiramide, amiodarone and sotalol
- medicines for high blood pressure and heart problems such as diltiazem, verapamil, guanfacine or digitalis
- clonidie used for migraines, flushing or for high blood pressure
- other anti-psycotic medicines used for mental problems
- medicines for severe pain called opiates such as morphine and pethidine
- pain-killers such as tramadol and indometacin
- mefloquine, medicine used to treat malaria
- medicines to hlep uyou sleep such as barbiturates and benzodiazepines
- anti-histamines such as promethazine which make you sleepy
- Medicines which lower the blood potassium levels such as some water tablets (diuretics), laxatives, amphotericin, glucocorticoids, tetracosactides
- Neuroleptics such as pimozide, haloperidon; imipramine, antidepressants, lithium
Taking Amisulpride Tablets with food and drink
Do not drink alcohol while you are taking Amisulpride Tablets. This is because it can affect the way how the medicine works.
Pregnancy and breast-feeding:
Do not take this medicine if you are breast-feeding or planning to breast-feed
The following symptoms may occur in newborn babies, of mothers that have used Amisulpride 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.
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant.
Driving and using machines:
Amisulpride Tablets may affect your reaction time and cause tiredness. Do not drive or use machinery unless you are sure how you react to your medicine.
Important information about some of the ingredients of Amisulpride Tablets
These tablets contain lactose. If you have been told that you have an intolerance to some sugars then contact your doctor before taking these tablets.
3. HOW TO TAKE AMISULPRIDE TABLETS
Always take your tablets exactly how your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets whole with a glass of water.
The usual oral dose for:
Adults and children 15 years and above is a range from 50mg up to 800mg daily, usually up to 300mg daily is given in a single dose. A higher dose is usually given in divided doses. This will depend on the nature of your illness. Your doctor may give you a maximum of 1200mg a day.
Elderly is to be used with caution due to the risk of low blood pressure or sedation. Follow the doctor's instructions.
Patients with kidney problems Your doctor may need to give you a lower dose.
These tablets are not recommended for children under the age of 15 years of age.
If you take more Amisulpride Tablets than you should
It is important to take your medicine exactly as your doctor have prescribed. If you or someone else swallows several of these tablets all together, contact your doctor or hospital emergency department immediately. Always take any tablets and the container with you as this will allow easier identification of the tablets.
If you forget to take Amisulpride Tablets
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, do not take double the dose, just carry on as before.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Amisulpride Tablets
Keep taking Amisulpride Tablets until doctor tells you to stop.
Do not stop taking Amisulpride Tablets if you feel better. It is important to keep taking your tablets unless your doctor tells you to stop.
Unless your doctor tells you otherwise, Amisulpride tablets should not be stopped suddenly. Stopping treatment suddenly may cause withdrawal effects such as:
- feeling or being sick
- difficulty sleeping or feeling restless
- muscle stiffness or unusual body movements
- your original condition may come back.
Taking Amisulpride Tablets may affect the results of some blood tests. If you are going to have a blood test it is important to tell your doctor you are taking Amisulpride Tablets.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Amisulpride Tablets can cause side effects, although not everybody gets them.
Stop taking Amisulpride Tablets and see a doctor or go to a hospital straight away if:
- you have a n allergic reaction. The signs may include an itchy, lumpy rush, swallowing or breathing difficulties, swelling of the lips, face, throat or tongue
- If you have 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 have a high temperature, sweating, stiff muscles, fast heart beat, fast breathing and feel confused, drowsy or agitated. These could be the symptoms of a serious but rare side effect called 'neuroleptic malignant syndrome'
- you have unusual heart rate, very fast heart rate or chest pain which could result in a heart attack or life-threatening heart disorder
- you have fit (seizure)
Tell your doctor as soon as possible if you have any of the following side effects:
Very common (affects more than 1 in 10 people)
- trembling, muscle stiffness or spasm. slow movement, producing more saliva than usual or feeling restless
Common (affects less than 1 in 10 people)
- Movements that you cannot control, mainly of the arms and legs
Uncommon (affects less than 1 in 100 people)
- movements that you cannot control, mainly of the face and tongue
Other symptoms include:
Common (affects less than 1 in 10 people)
- Difficulty sleeping (insomnia) or feeling anxious or agitated
- feeling drowsy or sleepy
- constipation, feeling or being sick, dry mouth
- putting on weight
- unusual production of breast milk in women and men, breast pain
- menstural period stops
- breast enlargement in men
- difficulty in getting or maintaining an erection, or in ejaculation
- feeling dizzy
Uncommon(affects less than 1 in 100 people
- slowing of the heart beat
- high blood sugar
If any of the side effects become serious or you notice any side effects not listed in this leaflet contact your doctor or pharmacist.
6. FURTHER INFORMATION
What Amisulpride Tablets contain:
The active ingredient is amisulpride.
Each 50mg tablet contains 50mg of amisulpride.
Each 100mg tablet contains 100mg of amisulpride.
Each 200mg tablet contains 200mg of amisulpride.
Each 400mg tablet contains 400mg of amisulpride.
The other substances for Amisulpride 50mg, 100mg & 200mg Tablets are maize starch, lactose monohydrate, methylcellulose 400cps, colloidal anhydrous silica and magnesium stearate.
The other substances in Amisulpride 400mg Tablets are lactose monohydrate, sodium starch glycollate, magnesium stearate, microcrystalline cellulose,methylcellulose 400cps,basic butylated methacrylate copolymer, titanium dioxide (E171), talc and macrogol 6000.
What Amisulpride Tablets look like and contents of the pack
Amisulpride 50mg, 100mg & 200mg Tablets
White to off-white, round, scored, uncoated tablets with 50, MAM100 and MAM200 marked on one side respectively.
Amisulpride 400mg Tablets
White to off-white, ovoidal shaped, biconvex, scored, film coated tablets marked MAM400 on one side.
Amisulpride 50mg, 100mg, 200mg & 400mg Tablets are available in blister packs of 60 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Odyssey Business Park
West End Road
Odyssey Business Park
West End Road
APL Swift Services (Malta) Ltd.
HF26, Hal Far Industrial Estate
Hal Far,Birzebbugia BBG 3000