Amisulpride 200mg Tablets
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Amisulpride 50 mg Tablets Amisulpride 100 mg Tablets Amisulpride 200 mg Tablets Amisulpride 400 mg Film Coated Tablets (Amisulpride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again
• If you have any further questions, please 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 Amisulpride is and what it is used for
2. What you need to know before you take Amisulpride
3. How to take Amisulpride
4. Possible side effects
5. How to store Amisulpride
6. Contents of the pack and other information.
1. What Amisulpride is and what it is used for
Amisulpride belongs to a group of medicines called antipsychotics. Amisulpride may be used to treat schizophrenia. Schizophrenia can make you feel, see or hear things which do not exist, have strange and frightening thoughts, change how you act, and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed. Amisulpride works by improving disturbed thoughts, feelings and behaviour.
If you are not sure why you are taking this medicine, check with your doctor.
2. What you need to know before you take Amisulpride
Do not take Amisulpride if you
• are allergic (hypersensitive) to amisulpride or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• are under 18 years old
• are being treated for breast cancer or a prolactin dependent tumour (such as a pituitary gland tumour)
• are pregnant or breastfeeding
• suffer from high blood pressure caused by a tumour near the kidney (phaeochromocytoma).
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amisulpride if:
• you have kidney problems
• you have Parkinson’s disease
• you know you suffer from a slow beating heart, abnormal heartbeat or low potassium (salt) levels in your blood
• if you have heart disease
• if you or one of your family has an abnormal heartbeat
• your doctor has told you that you are at risk of having a stroke
• you have epilepsy, as your doctor may want to monitor you more often.
• 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
• you are diabetic or have been told that you have an increased risk of having diabetes
• you are elderly. This is because elderly people are more likely to get low blood pressure or feel sleepy. A small increase in the number of deaths of elderly people with dementia has been reported for patients taking antipsychotics compared to those not receiving antipsychotics.
• if you have a low white blood count (agranulocytosis) .This means you may get infections more easily than usual
• if you have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem (leucopenia).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amisulpride.
Blood tests
Taking Amisulpride may affect the results of some blood tests. These include tests to measure the hormone ‘prolactin’ and liver tests. If you are going to have a blood test, it is important to tell your doctor you are taking Amisulpride
Other medicines and Amisulpride
Do not take Amisulpride and tell your doctor if you are already taking any of the following medicines:
• medicine to treat an irregular heartbeat eg. quinidine, disopyramide, procainamide, amiodarone, sotalol, bepridil
• thioridazine, to treat mental illness
• medicine to treat infection eg. erythromycin (by injection), pentamidine, sparfloxacin, halofantrine
• cisapride
• sultopride
• vincamine (by injection)
• levodopa (a medicine to treat Parkinson’s disease)
• bromocriptine or ropinirole (medicines used to treat Parkinson’s disease).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or the following:
• other anti-psychotic medicines used for mental problems
• medicine to treat a heart condition or lower blood pressure e.g. beta-blockers (examples include atenolol), diltiazem, verapamil, digoxin, guanfacine
• medicines which can affect your heart rhythm e.g. some antihistamines
• diuretics (‘water’ tablets) e.g. furosemide
• laxatives e.g. senna
• steroids such as prednisolone
• tetracosactide
• amphotericin B (by injection), to treat infection
• other medicine to treat mental illness eg. pimozide, haloperidol, lithium
• antidepressants e.g. imipramine
• strong painkillers such as tramadol and indometacin
• medicines for severe pain called opiates such as morphine or pethidine
• medicines which help you sleep e.g. barbiturates, benzodiazepines
• antihistamines such as promethazine which make you sleepy
• clonidine used for migraines, flushing or high blood pressure
• mefloquine used to treat malaria
Tell your doctor if you are going to have surgery and will need a general anaesthetic.
Amisulpride with food, drink and alcohol
Drinking alcohol whilst taking Amisulpride may make you drowsy.
Pregnancy and breast-feeding
It is important to use a reliable method of contraception while taking this medicine.
Do not take Amisulpride if you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby or planning to breast feed.
The following symptoms may occur in newborn babies of mothers that have used Amisulpride 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.
Driving and using machines
Do not drive or operate machinery if you feel less alert, drowsy or sleepy whilst taking Amisulpride Tablets.
Amisulpride tablets contain lactose, a type of sugar.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Amisulpride
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The dose of Amisulpride your doctor gives you will depend on the type of symptoms you are having. Patients can suffer from a mixture of ‘positive symptoms’ (eg. hallucinations, delusions, thought disorder) and negative symptoms (eg. depression, lethargy, poor speech).
Adults
The usual dose is between 400 mg and 800 mg of Amisulpride a day, divided into two doses. Your doctor may increase this dose to help improve your symptoms, up to 1200 mg of Amisulpride in some cases.
If you are mostly suffering from ‘negative symptoms’ your doctor will give you a lower dose of between 50 mg and 300 mg of Amisulpride a day, taken as a single dose. He/she will adjust your dose to best treat the symptoms.
Older people
Elderly patients are more sensitive to the effects of Amisulpride and will be given lower doses.
Patients with kidney disease will be given lower or less frequent doses depending on the severity of the disease.
Children under 18 years of age
Amisulpride should not be given to children under 18 years of age.
If you take more Amisulpride than you should
If you take more Amisulpride than you should, contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you.
Symptoms of overdose include feeling restless or shaky, rigid muscles, low blood pressure, feeling drowsy or sleepy which could lead to a loss of consciousness.
If you forget to take Amisulpride
If you forget to take Amisulpride take the next dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amisulpride
Do not stop taking your Amisulpride without speaking to your doctor first as you may suffer unpleasant side effects such as the symptoms of your condition returning, feeling or being sick, sweating, difficulty sleeping or feeling very restless, muscle stiffness and uncontrollable muscle movements. If you need to stop taking Amisulpride your doctor will reduce the dose slowly.
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.
Stop taking Amisulpride and see a doctor or go to a hospital straight away if you notice any of the following side effects:
• You have an unusual heart rate, very fast heart rate or chest pain which could result in a heart attack or life-threatening heart disorder
• You have a high temperature, sweating, stiff muscles, fast heartbeat, 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 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. You get more infections than usual. This could be because of a blood disorder (agranulocytosis), a decrease in the number, or lack, of white blood cells (neutropenia, leucopenia)
• You have an allergic reaction. The signs may include: an itchy, lumpy rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• You have a fit (seizure)
Tell your doctor as soon as possible if you have any of the following side effects:
Very Common (may affect more than 1 in 10 people)
• Trembling, muscle stiffness or spasm, slow movement, producing more saliva than usual or feeling restless.
Common (may affect up to 1 in 10 people)
• Movements that you cannot control, mainly of the head, neck, jaw or eyes (These symptoms can be reduced if your doctor lowers your dose of Amisulpride or prescribes an additional medicine)
Uncommon (may affect up to 1 in 100 people)
• Movements that you cannot control, mainly of the face or tongue (this is more likely in patients on long term treatment)
Other side effects include:
Common (may affect up to 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
• Menstrual period stops
• Breast enlargement in men
• Difficulty in getting or maintaining an erection, or in ejaculating
• Feeling dizzy (which can be due to low blood pressure)
• Difficulty achieving an orgasm
Uncommon (may affect up to 1 in 100 people)
• Slowing of the heart beat
• High blood sugar (hyperglycaemia)
• Increase in liver enzymes
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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amisulpride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Amisulpride tablets contain
The active substance is amisulpride. Each tablet contains either 50mg, 100mg, 200mg or 400mg of amisulpride.
The other ingredients for the 50mg, 100mg and 200mg tablets are: maize starch, lactose monohydrate, methylcellulose, colloidal silica hydrated and magnesium stearate.
The other ingredients for the 400mg tablets are: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hypromellose (E464) and magnesium stearate. The 400mg tablet film-coating includes: titanium dioxide (E171), hypromellose and macrogol.
What Amisulpride tablets look like and contents of the pack
Your medicine comes as a tablet. The 400mg tablets are film coated.
The 50mg tablet (marked ‘AS 50’ on one side), the 100mg tablet (marked ‘AS 100’ on one side) and the 200mg tablet (marked ‘AS 200’ on one side) are all white and round. The 400mg tablet is white and capsule-shaped with “AS 400” on one side.
Amisulpride 50mg & 100mg Tablets and Amisulpride 400mg Film Coated Tablets are available in blisters packs of 30, 60 and 150 tablets. Amisulpride 200mg Tablets are available in blisters packs of 60 and 150 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.