Patient leaflet - AMISULPRIDE 50 MG TABLETS
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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, ask your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
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1. What Amisulpride Tablets are and what they are used for
2. What you need to know before you take Amisulpride Tablets
3. How to take Amisulpride Tablets
4. Possible side effects
5. How to store Amisulpride Tablets
6. Contents of the pack and other information
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1. What Amisulpride Tablets are and what they are used for Amisulpride tablets contain the active substance amisulpride which 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 aren’t really there (hallucinations), having a strong false belief despite evidence against it (delusions), inability to think normally, and feeling emotional, disinterested or withdrawn.
2. what you need to know before you take amisulpride tablets
Do not take Amisulpride tablets if you:
- are breastfeeding
- are allergic to amisulpride or any of the other ingredients of this medicine (listed in 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 who has not reached puberty
- are taking levodopa (used for treating Parkinson’s Disease).
- 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 diabetes or risk factors for developing diabetes
- have Parkinson’s Disease
- are elderly and/or have dementia
- 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.
- your doctor has told you might have a stroke
- 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 or someone else in your family has a history of breast cancer
Other medicines and Amisulpride Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including:
- medicines to lower blood pressure such as calcium-channel blockers (diltiazem, verapamil), betablockers (e.g. atenolol), clonidine (and its derivatives) or guanfacine
- digoxin (for irregular heartbeat)
- 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)
- dopamine agonists (e.g. ropinerole or bromocriptine)
- clozapine (for schizophrenia) and other medicines for mental illness
- medicines to control your heart beat such as quinidine, disopyramide, amiodarone and sotalol
- mefloquine (for malaria)
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
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.
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.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Amisulpride tablets may make you feel sleepy, slow your reactions or blur your vision. Make sure you are not affected before you drive or operate machinery.
Amisulpride tablets contain 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 this medicine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults and children who have reached puberty
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 who have not reached puberty
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 a double dose to make up a forgotten dose.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. If you stop taking the tablets you may experience withdrawal effects such as feeling or being sick, involuntary movements including restlessness or spasms and difficulty sleeping.
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 unwanted side effects, 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 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.
- fast or irregular heart rate, dizziness, or fainting, which may cause the heart to stop and sudden death (QT interval prolongation or ‘torsade de pointes’)
- increase in infections with fever, severe chills, sore throat or mouth ulcers caused by low number of white blood cells (leukopenia, neutropenia or agranulocytosis)
- noncancerous benign tumour (prolactinoma) causing visual disturbances and headache
5. how to store amisulpride tablets
Keep this medicine out of the sight and reach 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.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help 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 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
Accord, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in December 2018