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AMISULPRIDE 400MG TABLETS

Active substance(s): AMISULPRIDE

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Amisulpride 400mg Film-coated Tablets
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 this
leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Amisulpride tablets are and what they are used for
What you need to know before you take Amisulpride tablets
How to take Amisulpride tablets
Possible side effects
How to store Amisulpride tablets
Contents of the pack and other information

1. What Amisulpride tablets are and what they are used for
Amisulpride tablets contain the active substance amisulpride which belongs 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emotional, disinterested or withdrawn.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 under the age of 15 years of age
are taking levodopa (used for treating Parkinson’s Disease).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Amisulpride tablets 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

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
• medicines to lower blood pressure
• medicines for irregular heartbeat (e.g. 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)

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.
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.

Amisulpride tablets contain lactoseIf 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 this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended 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.
Use in 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 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. 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.
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 causes unwanted side effects, 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 (may affect more than 1 in 10 people): 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 (may affect up to 1 in 10 people): 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 (may affect up to 1 in 100 people): 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)
Not known (frequency cannot be estimated from the available data): ‘torsade de pointes’ (palpitations, dizziness, or fainting),
fast or irregular heart beat, heart attack.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme, Website: 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 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 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.
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 contains
The active substance 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.

This leaflet was last revised in December 2015

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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