Out of date information, search another

Amisulpride 200mg Tablets

Out of date information, search another

Document: document 2 change

Amisulpride 50mg, 100mg, 200mg and 400mg Tablets PL 04416/1278-1281

Package Leaflet Page 1

Package leaflet: Information for the user

Amisulpride 50 mg Tablets Amisulpride 100 mg Tablets Amisulpride 200 mg Tablets Amisulpride 400 mg Film-coated 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 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. What you need to know before you take Amisulpride

3. How to take Amisulpride

4. Possible side effects

5. How to store Amisulpride

6. Contents of the pack and other information

1. What Amisulpride is and what it is used for

Amisulpride contains the active substance amisulpride. It belongs to a group of medicines called antipsychotics.

Amisulpride is used to treat schizophrenia, when it starts and also over the long term. Symptoms of this illness include:

• so called positive symptoms:-hallucinations, such as feeling, seeing or hearing things which do not exist

- strange and/or frightening thoughts

- changes in your behaviour, which can be agressive

• so called negative symptoms:

- becoming withdrawn and subdued

2. What you need to know before you take Amisulpride

Do not take Amisulpride

if you are/have

• allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6).

• breast cancer or something called “prolactin-dependent tumour”

• a tumour on the adrenal gland

• a child before the onset of puberty

• breast-feeding

• taking levodopa: a medicine to treat Parkinson’s disease Warnings and precautions

Talk to your doctor or pharmacist before taking Amisulpride if you are/have

• developing fever, faster breathing, excessive sweating, reduced consciousness or stiff muscles

Other medicines and Amisulpride

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The following medicines must not be used with Amisulpride:

• levodopa: a medicine to treat Parkinson’s disease

• medicines called “dopamine agonists” such as bromocriptine and ropinirole

The following medicines can particularly influence or be influenced by Amisulpride:

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

• other antipsychotic medicines used for mental problems

• medicines to treat severe pain called opiates such as morphine or pethidine

• medicines to treat high blood pressure and heart problems such as diltiazem, verapamil, guanfacine and digitalis

• clonidine used for migraines, flushing or high blood pressure

• medicines to treat malaria, such as mefloquine

• medicines which help you sleep, calm or relax muscles, such as barbiturates and benzodiazepines

• pain-killers such as tramadol and indometacin

• narcotics and anaesthetics

• certain antihistamines used to treat allergies, such as promethazine, astemizole and terfenadine, which make you sleepy

Amisulpride with food, drink and alcohol

Do not drink alcohol during treatment as it can affect the way Amisulpride works. Pregnancy, breast-feeding and fertility

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.

• Pregnancy

Do not take Amisulpride if you are pregnant unless your doctor has told you to.

The following symptoms may occur in newborn babies, of mothers who 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.

• Breast-feeding

You must not take Amisulpride when breast-feeding.

• Fertility

Treatment with Amisulpride may decrease your fertility.

Driving and using machines

Only drive or operate machines if your doctor has approved it.

This will depend upon how this therapy affects you, because Amisulpride may impair your mental alertness and make you feel drowsy or sleepy.

Amisulpride contains lactose

Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Amisulpride.

3. How to take Amisulpride

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

The recommended dose is:

Adults (and adolescents after the onset of puberty, if treatment is absolutely required)

If you suffer from positive symptoms, the usual dose is between 400 mg and 800 mg amisulpride daily, and will be adjusted individually by your doctor depending on the nature and severity of your illness. The maximum daily dose is 1,200 mg.

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 50 mg and 300 mg amisulpride daily, and will be adjusted individually by your doctor depending on the nature and severity of your illness.

Older people

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.

Patients with impaired liver function

No changes to the usual daily dose are necessary.

Patients with impaired kidney function

Your doctor may need to treat you with a lower dose.

Use in children and adolescents

Amisulpride

• must not be given to children before the onset of puberty (see section 2 “Do not take Amisulpride”).

• is not recommended for children and adolescents after the onset of puberty up to the age of 18 years.

Method of administration

• Take this medicine by mouth.

• Swallow the tablets with a glass of water.

• You can take them during or between meals.

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

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

If you take more Amisulpride than you should

Contact your doctor or a hospital at once. Always take the tablets/film-coated tablets (400mg only), leaflet and/or carton with you so the doctor will know what you have taken. Immediate medical care is necessary if the following signs occur: drowsiness, sedation, loss of consciousness, unusual body movements, rigid muscles and low blood pressure.

If you forget to take Amisulpride

Continue treatment by taking your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amisulpride

Do not stop taking Amisulpride unless advised by your doctor, as this may harm the success of therapy.

Stopping treatment suddenly may cause withdrawal symptoms such as nausea, vomiting, sleeplessness, rigid muscels, unusual body movements and recurrence of the symptoms of your illness.

To avoid such symptoms, it is important to reduce the dose gradually according to your doctor’s instructions.

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 cause side effects, although not everybody gets them.

Stop taking Amisulpride and contact your doctor immediately or go to the nearest hospital if you notice any of the following serious side effects:

Not known: frequency cannot be estimated from the available data

• combination of fever, faster breathing, sweating, muscle stiffness and reduced consciousness

All of these could be symptoms of a severe - potentially fatal - disorder called “neuroleptic malignant syndrome”.

• irregular heart beat, very fast heart rate or chest pain

This 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

• more infections than usual

This could be because of a blood disorder called “agranulocytosis” or a decrease in the number of white blood cells called “neutropenia”.

Uncommon: may affect up to 1 in 100 people

• severe allergic reaction, involving:

- difficulty breathing

- low blood pressure

- swelling in the mouth, throat or face

- skin rash

- itching

• fits

Other reported side effects listed according to the frequencies are:

Very common: may affect more than 1 in 10 people

• trembling

• muscle stiffness or spasm

• slow movement

• producing more saliva than usual

• feeling restless

Consult your doctor if this occurs. These symptoms are generally mild and can be reduced by lowering your Amisulpride dose, or by treatment with an additional medicine.

Common: may affect up to 1 in 10 people

• muscle cramps, mainly of the neck, eyes and jaws

Consult your doctor if this occurs. These effects are reversible by adequate treatment with an additional medicine.

• feeling sleepy

• difficulty sleeping

• feeling anxious or agitated

• difficulty having orgasms

• constipation

• nausea and vomiting

• dry mouth

• increased values of a hormone called prolactin in your blood, which can lead to

- unusual production of breast milk in women and men

- menstrual period stopping or irregular menstrual periods

- breast enlargement in men

- breast pain or breast enlargement

- prolactin-dependent tumour

- difficulty in getting or maintaining an erection or in ejaculating These symptoms disappear after ending therapy with Amisulpride.

• feeling dizzy due to low blood pressure

• weight gain

Uncommon: may affect up to 1 in 100 people

• movement disorders including uncontrollable tongue, mouth and facial movements This may occur during or after a prolonged course of treatment:high blood sugar

• slowing of the heart beat

• increased values of specific liver enzymes in the blood Very rare: may affect up to 1 in 10,000 people

• discontinuation symptoms such as

- nausea, vomiting and sleeplessness

- recurrence of the symptoms of your disorder

- involuntary or abnormal movements especially of the tongue, mouth and face These occur when you suddenly stop taking Amisulpride, especially if you have taken high doses of this medicine.

Not known: frequency cannot be estimated from the available data

• in older people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics

• swelling of the skin associated with pain, redness and itching

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme (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

Keep out of the sight and reach of children.

Do not use Amisulpride after the expiry date which is stated on the carton and on the blister. 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 medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Amisulpride contains The active substance is amisulpride.

Amisulpride 50 mg tablets:

Each tablet contains 50 mg amisulpride.

Amisulpride 100 mg tablets:

Each tablet contains 100 mg amisulpride.

Amisulpride 200 mg tablets:

Each tablet contains 200 mg amisulpride.

Amisulpride 400 mg film-coated tablets:

Each film-coated tablet contains 400 mg amisulpride.

The other ingredients are:

Amisulpride 50 mg tablets:

Lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, sodium starch glycolate (type A)

Amisulpride 100 mg tablets:

Lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, sodium starch glycolate (type A)

Amisulpride 200 mg tablets:

Lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, sodium starch glycolate (type A)

Amisulpride 400 mg film-coated tablets:

• Tablet core: Lactosemonohydrate, magnesium stearate, methylcellulose, microcrystalline

cellulose, sodium starch glycolate (type A)

• Tablet coating: Macrogol 6000, magnesium stearate, methacrylate copolymer (Eudragit

E 100), talc, titanium dioxide (E 171)

What Amisulpride looks like and contents of the pack

Amisulpride 50 mg tablets are white, round with 6 mm diameter and rounded on the upper and lower side. They have a score line and can be divided into equal halves.

Amisulpride 100 mg tablets are white, round with 8 mm diameter and flat. They have a score line and can be divided into equal halves.

Amisulpride 200 mg tablets are white, round with 11 mm diameter and flat. They have a score line and can be divided into equal halves.

Amisulpride 400 mg film-coated tablets are white to off white,18 mm long and 8 mm wide. They have a score line and can be divided into equal halves.

Amisulpride 50 mg, 100mg and 200mg tablets are available in blister packs of 10, 12, 14, 20, 21, 30, 42, 50, 60, 98, 100, 150 and 198 tablets.

Amisulpride 400 mg film-coated tablets are available in blister packs of 10, 12, 14, 20, 21, 30, 42, 50, 60, 98, 100, 150 and 198 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Ltd.

Frimley Business Park,

Frimley, Camberley, Surrey,

GU16 7SR.

Manufacturer

Lek Pharmaceuticals D.D. Ljubljana, ljub or

Lek S.A., Warsaw, Poland or

Salutas Pharma GmbH, Barleben, Germany or

Salutas Pharma GmbH (Gerlingen), Gerling, Germany This leaflet was last revised in 02/2015.

PIL.1278-1281.004.2A 11/02/15 V007: Update texts in line with reference

product + National Phase + Post approval

update