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Amisulpride 400mg Tablets

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Assessed against UK PIL dated June 2008


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By Khilod at 2:39 pm, Mar 17, 2010


MOCK-UP

Solian® 400mg Tablets Amisulpride 400mg Tablets

(amisulpride)

Your medicine is known by one of the above names, but will be referred to as Solian throughout this:

_Patient Information Leaflet_

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, please 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 Solian is and what it is used for

2)    Before you take Solian

3)    How to take Solian

4)    Possible side effects

5)    How to store Solian

6)    Further information

1)    What Solian is and what it is used for

Solian contains a medicine called 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.

Solian 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 Solian

Do not take this medicine and tell your doctor if:

•    You are allergic (hypersensitive) to amisulpride or any of the other ingredients of Solian (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 other medicines which could change your heart rate such as medicines which are used to control your heart beat (see ‘Taking other medicines' section)

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

•    The patient is under 15 years old

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 Solian.

Taking special care with Solian

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

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

•    You are elderly. This is because elderly people would be more likely to get low blood pressure or feel sleepy

•    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    or someone else in your    family    has    a    history    of    blood    clots,    as

medicines like these have been associated with formation of blood clots.

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

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 Solian can affect the way some other medicines work. Also some medicines can affect the way Solian works.

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

•    Medicines used to control your heart beat such as quinidine, disopyramide, procainamide, amiodarone and sotalol

•    Medicines which may lower potassium levels. This includes water tablets such as bendrofluazide or hydrochlorothiazide, some laxatives, glucocorticoids (used to treat severe asthma and other inflammatory disorders), tetracosactides and amphotericin (used to treat fungal infections)

•    Levodopa, a medicine to treat Parkinson's disease

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

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

•    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

•    Medicines which help you sleep such as barbiturates and benzodiazepines

•    Pain-killers such as tramadol and indometacin

•    Anaesthetics

•    Antibiotics such as erythromycin (given by injection) or sparfloxacin

•    Antihistamines such as promethazine which make you sleepy

•    Pentamidine used for pneumonia

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

Taking Solian with food and drink

•    Swallow Solian tablets with plenty of water before a meal

•    Do not drink alcohol while you are taking Solian. 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

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 Solian

Solian contains 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 Solian

Always take Solian 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 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

How much to take

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

Adults

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

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

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

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

•    Doses above 300mg 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 15 years of age

Solian Solution should not be given to children under 15 years of age If you take more Solian 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, feeling drowsy or sleepy which could lead to a loss of consciousness.

If you forget to take Solian

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 Solian

Keep taking Solian until your doctor tells you to stop. Do not stop taking Solian just because you feel better. If you stop, your illness may get worse or come back. Unless your doctor tells you otherwise, Solian 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 Solian 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 Solian.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4) Possible side effects

Like all medicines, Solian can cause side effects, although not everybody gets them.

Stop taking Solian 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

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.

Uncommon (affects less than 1 in 100 people)

• You have an allergic reaction. The signs may include: a 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 Solian or prescribes an additional medicine)

Uncommon (affects less than 1 in 100 people)

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

•    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.

5)    How to store Solian

•    Keep all medicines out of the reach and sight of children.

•    Do not use after the expiry date printed on the carton, label or blister strip.

•    If your doctor stops your treatment, return any unused tablets to a pharmacist.

•    If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist who will advise you what to do.

•    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 Solian contains

Each tablet contains 400mg of the active ingredient amisulpride.

Each tablet also contains sodium starch glycollate, lactose monohydrate, microcrystalline cellulose, magnesium stearate, hypromellose, polyoxyl 40 stearate and titanium dioxide (E171).

What Solian looks like and contents of the pack

The tablets are white, oblong, film-coated and marked ‘AMI breakline 400' on one side and plain on the other side.

Solian 400mg Tablets are available as blister packs of 30 tablets PL 10383/1492 Solian 400mg Tablets/Amisulpride 400mg Tablets |POM| Who makes and repackages your medicine?

Your medicine is manufactured by Sanofi Winthrop Industrie - 6, Boulevard De L'Europe, Quetigny, France. Procured from within the EU and repackaged by Product Licence Holder: Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex UB8 2RZ.

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.

Leaflet date: 15.03.2010

Solian® is a registered trade mark of sanofi-aventis, Paris, France.

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