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Grafiche Pradslla    Cadice Pradatta: 3SE03BB9 vers. OOE

ETICHETTIFICIO E CARTOTECNICA

Cllente Rivapharm	Parmacode: EES	F.toAperto 130x400		F.to Chluso I30XE40		Stampa B Stampa Bflf		□	Bozza n. 1 17/0E/E015		Tlmbro E Flrma per APPROVAZIO\E
					Nero	Dl C □ c £			tu c □ c	01 c a c
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SI prega dl cantrollare TEST!. MISURE, CHOICE PROOOTTO e PHARMACODE

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amisulpride 50 mg tablets Amisulpride 100 mg tablets Amisulpride 200 mg tablets Amisulpride 400 mg film-coated tablets

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

The name of your medicine is Amisulpride 50 mg tablets, Amisulpride 100 mg tablets, Amisulpride 200 mg tablets or Amisulpride 400 mg film-coated tablets (called Amisulpride tablets throughout this leaflet).

The active ingredient in this medicine is amisulpride. This belongs to a group of medicines called ‘anti-psychotics’. It is used to treat an illness called 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. It is used to treat schizophrenia when it starts and also over the long term.

2.    BEFORE YOU TAKE AMISULPRIDE TABLETS

Do not take Amisulpride tablets and tell your doctor if:

•    You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Amisulpride (listed in Section 6)

Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    You are pregnant, might become pregnant or are breast-feeding (see ‘Pregnancy and breast-feeding’ section)

•    You have breast cancer or something called ‘a prolactin dependent tumour’

•    You have a tumour on the adrenal gland (called phaeochromocytoma)

•    You are taking levodopa, a medicine to treat Parkinson’s disease (see ‘Taking other medicines’ section)

•    The patient is under 18 years of age.

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.

Take special care with Amisulpride tablets

Check with your doctor or pharmacist before taking your medicine if:

•    You have kidney problems

•    You have Parkinson’s disease

•    You have ever had fits (epileptic seizures)

•    You have an unusual heart rate (rhythm)

•    You have heart disease or family history of heart problems

•    Your doctor has told you that you might have a stroke

•    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

•    You are diabetic or have been told you have an increased risk of having diabetes

•    You have a slow heart beat (less than 55 beats per minute)

•    You have been told you have a low amount of potassium in your blood.

•    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.

•    You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual.

•    You have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called “leucopenia”

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amisulpride.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Amisulpride can affect the way some other medicines work. Also some medicines can affect the way Amisulpride works.

In particular, do not take this medicine, and tell your doctor if you are taking any of the following medicines:

•    Levodopa, a medicine to treat Parkinson’s disease

Tell your doctor if you are taking any of the following medicines:

•    Medicines used to control your heart beat such as quinidine, disopyramide, amiodar one, sotalol and bepridil

•    Medicines for depression or to calm emotional and mental illness such as pimozide, haloperidol, imipramine, thioridazine, lithium and sultopride

•    Medicines for severe pain called opiates such as morphine, pethidine or methadone

•    Medicines for high blood pressure and

migraine such as clonidine, diltiazem and verapamil, guanfacine and digitalis

•    Clonidine used for migraines, flushing or high blood pressure

•    Mefloquine used for treating malaria

•    Medicines which help you sleep such as barbiturates and benzodiazepines

•    Pain-killers such as tramadol and indometacin

•    Anaesthetics

•    Antihistamines such as promethazine which make you sleepy.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amisulpride.

Taking Amisulpride tablets with food and drink

•    Swallow Amisulpride tablets with plenty of water before a meal

•    Do not drink alcohol while you are taking Amisulpride. This is because it can affect the way 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

You may feel less alert, drowsy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Amisulpride tablets

Amisulpride tablets contain lactose, a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking this medicinal product.

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.

Taking this medicine

•    Take this medicine by mouth

•    Swallow the tablets whole or halved with a drink of water. Do not chew your tablets

•    Take before a meal

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

•    If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How much to take

The amount of Amisulpride you take will depend on your illness. Follow your doctor’s instructions carefully.

Adults

The usual dose is between 50 mg and 800 mg each day.

Your doctor may start you on a lower dose if necessary.

If necessary your doctor can prescribe up to 1200 mg each day.

Doses up to 300 mg each day can be taken as a single dose. Take the dose at the same time each day.

Doses above 300 mg should be taken as half in the morning and half in the evening.

Elderly

Your doctor will need to keep a close check on you as you are more likely to have low blood pressure or sleepiness due to this medicine.

People with kidney problems

Your doctor may need to give you a lower dose.

Children under 18 years of age Amisulpride should not be given to children under 18 years of age.

If you take more Amisulpride tablets than you should

If you take more tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: 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 tablets

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Amisulpride tablets

Keep taking Amisulpride until your doctor tells you to stop. Do not stop taking Amisulpride just because you feel better. If you stop, your illness

may get worse or come back. Unless your doctor tells you otherwise, Amisulpride should not be stopped suddenly. Stopping treatment suddenly may cause withdrawal effects such as:

•    Feeling or being sick

•    Sweating

•    Difficulty sleeping or feeling very restless

•    Muscle stiffness or unusual body movements

•    Your original condition may come back. Blood Tests

Taking Amisulpride may affect the results of some blood tests. These include tests to measure the hormone called ‘prolactin’ and liver tests. If you are going to have a blood test, it is important to tell your doctor you are taking Amisulpride.

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 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 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 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 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.

•    You get more infections than usual. This could be because of a blood disorder (agranulocytosis) or a decrease in the number of white blood cells (neutropenia).

Uncommon (affects less than 1 in 100 people)

•    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 (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.

(These symptoms can be reduced if your doctor lowers your dose of Amisulpride or prescribes an additional medicine).

Uncommon (affects less than 1 in 100 people)

•    Movements that you cannot control, mainly of the face or tongue.

Other side effects 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

•    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).

Uncommon (affects less than 1 in 100 people)

•    Slowing of the heart beat

•    High blood sugar (hyperglycaemia)

Tell your doctor or pharmacist if any of the side effects get serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

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 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 TABLETS

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Amisulpride after the expiry date, which is stated on the carton and blisters after 'EXP'. The expiry date refers to the last day of that month.

Do not use Amisulpride if you notice that the tablets become discoloured.

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 contain

The Amisulpride 50 mg tablets contain 50 mg of the active substance, amisulpride.

The Amisulpride 100 mg tablets contain 100 mg of the active substance, amisulpride.

The Amisulpride 200 mg tablets contain 200 mg of the active substance, amisulpride.

The Amisulpride 400 mg film-coated tablets contain 400 mg of the active substance, amisulpride.

The other ingredients in Amisulpride are: lactose monohydrate, methylcellulose, sodium starch glycolate (Type A), microcrystalline cellulose, magnesium stearate.

Amisulpride 400 mg tablets also contain Eudragit (El00), titanium dioxide (El71), talc, magnesium stearate, Macrogol 6000.

What Amisulpride tablets look like and contents of the pack

Amisulpride 50 mg tablets are white, round, biconvex tablets with a break line on one side and embossed with A50 on the other side. They are available in blister packs of 60 tablets. Amisulpride 100 mg tablets are white, round, flat tablets with break line on one side and embossed with A100 on the other side. They are available in blister packs of 60 tablets. Amisulpride 200 mg tablets are white, round, flat tablets with break line on one side and embossed with A200 on the other side. They are available in blister packs of 60 tablets. Amisulpride 400 mg tablets are white to off white, film-coated, oblong tablets with break line on one side. They are available in blister packs of 60 tablets.

Marketing authorisation holder and manufacturer

Marketing Authorisation Holder

DOUBLE-E PHARMA LTD.

7th Floor, Hume House, Ballsbridge

Dublin 4

Ireland

Manufacturers

Laboratories BTT ZIdeKrafft 67150 Erstein France

Rivopharm UK Limited 30th Floor, 40 Bank Street Canary Wharf London E14 5NR

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in 02/2015