Document: document 6 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amisulpride 50mg, 100mg, 200mg and 400mg Tablets

(Amisulpride)

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT AMISULPRIDE TABLETS ARE AND WHAT THEY ARE USED FOR

Amisulpride belongs to a group of medicines called antipsychotics which help to control the symptoms of a mental illness called schizophrenia.

Amisulpride Tablets can be used at the start of and for the long term treatment of schizophrenia. Symptoms include:

-delusions (having strange or unusual thoughts)

-    hallucinations (seeing or hearing things that are not there)

-being suspicious or aggressive for no apparent reason

(these symptoms are known as "positive symptoms")

-    becoming withdrawn and subdued (known as "negative symptoms").

2. BEFORE YOU TAKE AMISULPRIDE TABLETS Do not take Amisulpride Tablets:

•    if you are allergic (hypersensitive) to amisulpride

•    if you are allergic to any of the other ingredients of Amisulpride Tablets (see section 6 - Further information)

•    if you are breast-feeding

•    if you have breast cancer or a tumour of the pituitary gland

•    if you have a tumour on the adrenal gland (known as phaeochromocytoma)

•    if you are under 18 years of age

•    if you have severe kidney disease

•    if you are taking levodopa (for Parkinson's disease), medicines to treat heart rhythm disorders, or medicines that may cause an abnormal heart rhythm when used at the same time as amisulpride.

See the section "Taking other medicines" below.

Check with your doctor before taking any other medicine.

Take special care with Amisulpride Tablets:

You should tell your doctor if any of the following apply to you:

•    if you have mild or moderate kidney disease, as your doctor will need to adjust your dose accordingly

•    if you have epilepsy, as amisulpride may increase the chances of a seizure. Your doctor will need to monitor you closely

•    if you have Parkinson's disease, as amisulpride can make this condition worse

•    if you are over 65 years of age, amisulpride could cause sedation (drowsiness) or a drop in blood pressure, and is therefore not generally recommended for this age group as there is only limited experience.

•    if you have or have had heart disease, a slow heartbeat (less than 55 beats per minute) or you are taking other medicines that can cause these side effects

•    if you have a long QT interval or a history of this in your family (this is a measure of the way your heart is working and can be detected by a doctor using an electrocardiogram)

•    if you have electrolyte imbalance, especially low blood potassium or magnesium levels, or you are taking other medicines that cause these side effects

•    if you take any other medicines that could affect your heart's function: check with your doctor before taking any other medicine. See also under headings "Do not take Amisulpride Tablets" and "Taking other medicines"

•    if you develop fever, faster breathing, excessive sweating, reduced consciousness or stiff muscles (see also section 4). Stop taking amisulpride and seek medical attention immediately.

•    if you are at risk for a stroke or transient ischaemic attack (temporary reduction of blood flow to the brain)

•    if you have diabetes, or you know you are at risk of developing diabetes. You should check your sugar levels regularly as they may increase during treatment with amisulpride (hyperglycaemia).

•    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.

Taking other medicines

Check with your doctor before taking any other medicine.

You must not take Amisulpride Tablets if you are taking any of the following types of medicine:

•    medicines to treat heart rhythm problems (such as quinidine, disopyramide, procainamide, amiodarone, soltalol, mexiletine, flecainide and propaphenone)

•    levodopa (a treatment for Parkinson's disease)

•    cisapride (used to treat stomach problems)

•    bepridil (used to treat angina/chest pain and changes in heart rhythm)

•    sultopride and thioridazine (for schizophrenia)

•    methadone (for pain and drug abuse)

•    halofantrine (to prevent malaria)

•    pentamidine (to treat infections in HIV patients)

•    sparfloxacin and erythromycin by injection (antibiotics)

•    medicines for fungal infections, such as clotrimazole

•    vincamine by injection (used for various brain disorders)

•    Amisulpride is not recommended at the same time as the following medicines : medicines used to treat high blood pressure, that could slow your heart rate down, such as beta-blockers, diltiazem, verapamil, clonidine, guanfacine or digitalis glycosides

•    medicines which can cause low potassium levels including diuretics ("water tablets"), some laxatives, amphotericin B (by injection), glucocorticoids (used for conditions such as asthma or rheumatoid arthritis) and tetracosactide (may be used in clinical investigations)

•    pimozide or haloperidol (used to treat schizophrenia)

•    imipramine or lithium (used to treat depression)

•    some antihistamines such as astemizole and terfenadine (for allergies).

The effect of amisulpride on the following medicines could be increased if they are used at the same time, so that your doctor may need to adjust your dose of amisulpride or the other medicine:

•    medicines to lower your blood pressure (eg. clonidine)

•    anaesthetics

•    narcotics used to relieve severe pain

•    antihistamines (for allergies) which cause drowsiness

•    barbiturates (for epilepsy)

•    medicines for the treatment of anxiety including benzodiazepine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Amisulpride Tablets with food and drink

It is recommended that you do not drink alcohol whilst you are taking this medicine.

Pregnancy and breast-feeding

Pregnancy

The safety of amisulpride during pregnancy has not been established. You should not take amisulpride unless your doctor tells you to.

Breast-feeding

You must not breast-feed whilst taking amisulpride.

Ask your doctor or pharmacist for advice before taking any medicine.

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 can make you feel drowsy and may affect your ability to react quickly.

Make sure you are not affected before you drive or operate machinery.

Important information about some of the ingredients of Amisulpride Tablets

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking these tablets.

| 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.

Adults

•    If you suffer from positive symptoms, the usual dose is between 400mg to 800mg a day, and will be adjusted individually by your doctor depending on the nature and severity of your illness and your kidney function.

The maximum daily dose is 1200mg.

•    If you suffer from both positive and negative symptoms, your doctor will adjust your dose individually so that there is adequate control of the positive symptoms. To maintain treatment your doctor will use the lowest possible dose that is effective for you.

•    If you suffer from negative symptoms the usual dose is between 50mg and 300mg amisulpride daily. This will be adjusted individually by your doctor depending on the nature and severity of your illness and your kidney function

Patients over 65 years

Amisulpride can cause sedation (drowsiness) or a fall in blood pressure in these patients, and is not generally recommended as there is only limited experience in this age group.

Children and adolescents under 18 years

Amisulpride must not be taken by patients of this age group.

Patients with kidney problems

Ifyou suffer from kidney problems, your doctor will normally prescribe a lower dose. This may be reduced to half or a third of the normal dose depending on how well your kidneys are working.

Patients with impaired liver function

No changes to the normal dose should be necessary.

Method of administration

If you are taking up to 300mg of amisulpride a day, this can be taken as a single dose preferably at the same time each day. Larger doses should usually be divided, with part of the dose given in the morning and the other part later in the day. Your doctor will tell you how and when to take your medicine. Swallow the tablets with a glass of water without chewing them. You can take them during or between meals.

Your doctor will tell you how many tablets you should take and how long you should continue to take them.

If you take more Amisulpride Tablets than you should, you may feel drowsy, shaky, dizzy and faint (low blood pressure) or fall into a coma. You should contact your doctor immediately or go to the nearest hospital casualty department. Remember to take the pack and any remaining tablets with you. If you forget to take Amisulpride Tablets

Take the missed dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose but simply take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amisulpride Tablets

Your doctor will decide how long you should take Amisulpride Tablets for.

Do not stop taking your tablets just because you feel better as it is likely that your original problems will come back.

If your doctor advises that you can stop taking these tablets, you should do so gradually, especially if you have been taking a high dose. If you suddenly stop taking the tablets, you may feel and be sick, feel shaky and have trouble sleeping.

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.

If you notice either of the following you should stop taking the tablets and contact your doctor immediately:

•    You have a rash, itching, blistering or other effects on the skin, eyes, mouth or genitals

•    You get a high temperature, stiff/rigid muscles, a feeling of instability when you try to move, fast heart rate and/or breathing or an increase in sweating (symptoms of a condition called Neuroleptic Malignant Syndrome).

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.

The following side effects have also been reported:

Very common: affects more than 1 user in 10

•    Trembling

•    Pronounced muscle stiffness or spasm

•    Slowness of movement

Common: affects 1 to 10 users in 100

•    Weight gain

•    Abnormal movements such as tics or spasms in the muscles of the neck, eyes or jaw which will be reduced if your doctor prescribes you an additional medicine

•    Drowsiness

•    Dizziness

•    Constipation, nausea, vomiting, dry mouth

•    Low blood pressure (causing dizziness)

Uncommon: affects 1 to 10 users in 1,000

•    Slow heart beat

•    Uncontrollable movements, mainly of the face or tongue (usually after long-term treatment), convulsions (fits)

Not known: frequency cannot be estimated from the available data

• Abnormal heart rhythms, which may be life-threatening and lead to cardiac arrest and sudden death.

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.

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 blister and carton after

EXP:. The expiry date refers to the last day of that month.

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 active substance is amisulpride. Each tablet contains 50 mg, 100mg, 200mg or 400mg of amisulpride.

•    The other ingredients in the 50mg, 100mg and 200mg tablets are maize starch, lactose monohydrate, methylcellulose 400 cP, silica colloidal anhydrous and magnesium stearate.

•    The other ingredients in the 400mg tablets are lactose monohydrate, methylcellulose 400 cP, sodium starch glycollate, magnesium stearate and microcrystalline cellulose. The film-coating for the 400mg tablets contains basic butylated methylacrylate copolymer (Eudragit E100), titanium dioxide (E-171), magnesium stearate, talc and macrogol 6000.

What Amisulpride Tablets look like and contents of the pack:

•    The 50mg tablets are white to off white round tablets with a score line and are embossed AM50

•    The    100mg tablets    are white to    off white    round tablets with a score line and are embossed AM100

•    The    200mg tablets    are white to    off white    round tablets with a score line and are embossed AM200

•    The    400mg tablets    are white to    off white    oval shaped film-coated tablets with a score line and are

embossed with AM400.

Amisulpride 50mg and 200mg tablets are available in blisters containing 50, 60 or 100 tablets. Amisulpride 100mg and 400mg tablets are available in blisters containing 20, 50, 60 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Herts, SG1 4SZ, U K.

Manufacturer:

Arrow Pharm (Malta) Ltd, HF62 Hal Far Industrial Estate, Hal Far BBG 3000, Malta.

This leaflet was last approved in: November 2011.