Amisulpride 400mg Tablets
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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 is and what it is 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 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 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belief despite evidence against it (delusions), inability to think normally, and feeling emotional, disinterested or withdrawn.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. Before you take Amisulpride tablets
Do not take Amisulpride tablets and tell your doctor if you:
• are breastfeeding
• 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 levodopa (used for treating Parkinson’s 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 Parkinson’s Disease
• are elderly (over 65 years of age) 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.
• have or are at risk of having diabetes
• have any risk factors of 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
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
• medicines for irregular heartbeat (eg. quinidine, disopyramide, amiodarone, sotalol)
• antimalarials (e.g. meflquine)
• 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
Contact your doctor before taking Amisulpride tablets if you are pregnant, trying to get pregnant or breastfeeding. If you are a woman of child bearing age discuss using adequate contraception with your doctor whilst taking Amisulpride tablets.
Ask your doctor or pharmacist for advice before taking any medicines.
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
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 intolerance 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, do not chew.
The tablet can be divided into equal halves.
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. If you stop taking the tablets you may develop withdrawal symptoms such as feeling or being sick, difficulty sleeping, involuntary movements (restlessness, muscle spasm, jerky muscles) or the return of old mental health symptoms.
This medicine should be taken for as long as your doctor tells you to, they may reduce your dose slowly to reduce the risk of the effects.
4. Possible side effects
Like all medicines, Amisulpride tablets can sometimes causes unwanted side effects in some people, although not everybody gets them.
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.
• 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.
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:
• Very common (affects more than 1 in 10 users): shakiness in the arms or legs (tremor), stiffness of movement (rigidity), uncontrolled/jerky movements, 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.
• Common (affects less than 1 in 10 users): constipation, feeling sick (nausea), being sick (vomiting), dry mouth , weight gain, 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), muscle spasm in the neck, shoulders and body (dystonia), difficulty in sleeping (insomnia), sleepiness (somnolence), anxiety or agitation, low blood pressure (hypotension).
• Uncommon (affects less than 1 in 100 users): shaking fits (seizures), slow heartbeat (bradycardia), alteration of liver enzymes (seen in blood tests). Slow, difficult and jerky movements mainly of the face and tongue (tardive dyskinesia) may occur after using Amisulpride tablets for a long time, high blood sugar (you may experience thirst, excessive urinating, tiredness, weakness)
• Frequency unknown: ‘torsade de pointes’ (palpitations, dizziness, or fainting), fast or irregular heart beat, heart attack.
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. 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 cartons and blisters after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 contains
The active ingredient is amisulpride. Each tablet contains 400mg of the active ingredient.
The other ingredients in the tablet are lactose monohydrate, methylcellulose, sodium starch glycollate type A, magnesium stearate and microcrystalline cellulose.
The film coating contains methacrylate polymers, titanium dioxide (E171), talc, magnesium stearate and macrogol 6000.
What Amisulpride tablets looks like and contents of the pack
The 400mg tablets are white to off-white, ovoidal-shaped, biconvex, film-coated 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.
*Only the marketed pack size will appear on the final leaflet
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK.