Amisulpride 100mg Tablets
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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. Before you take Amisulpride
3. How to take Amisulpride
4. Possible side effects
5. How to store Amisulpride
6. Further information
1. WHAT AMISULPRIDE IS AND WHAT IT IS USED FOR
Amisulpride 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 disorder 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- becoming withdrawn and subdued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. BEFORE YOU TAKE AMISULPRIDE
Do not take Amisulpride
if you are/have
• allergic (hypersensitive) to amisulpride or any of the other ingredients as listed under “6 Further Information”.
• breast cancer or something called “prolactin-dependent tumour”
• a tumour on the adrenal gland
• under 15 years old
• breast-feeding
• taking any of the following medicines:
- levodopa: a medicine to treat Parkinson’s disease
- medicines which may cause severe heart beat disorders - See below under “Taking other medicines”, first bullet point
Take special care with Amisulpride
Inform your doctor or pharmacist if you are/have
• developing fever, faster breathing, excessive sweating, reduced consciousness or stiff muscles
See also chapter 4, first paragraph
• high blood sugar levels - diabetes mellitus - or are at risk of developing it
If you do, your doctor may check your blood sugar levels while you are taking Amisulpride.
• kidney function disorder
See chapter “3 How to take Amisulpride”
• ever suffered from fits
If you have epilepsy you may experience more frequent fits during treatment with Amisulpride.Your doctor will need to monitor you more closely.
• over 65 years old
Elderly people are more likely to get low blood pressure and feel sleepy during therapy with Amisulpride.
• Parkinson’s disease
• any involuntary or abnormal movements especially of the tongue, mouth and face while taking this medicine
• heart disease or a family history of heart problems, such as heart failure or irregular heart beat, especially an abnormality known as “prolonged QT-interval”
• heart beat below 55 beats per minute
• electrolyte imbalance, especially a low amount of potassium in your blood
• had a stroke previously or are at risk 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
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
The following medicines can particularly influence or be influenced by Amisulpride:
• medicines which may cause severe heart beat disorders must not be used with Amisulpride. These include:
- medicines to treat irregular heart beats, such as quinidine, disopyramide, procainamide, flecainide, propafenone, amiodarone, sotalol and bepridil
- medicines to treat bacterial infections such as erythromycin given by injection, sparfloxacin and pentamidine
- medicines to treat fungal infections with active substance names ending with “azole”
- medicines to treat malaria, such as halofantrine
- cisapride: a medicine to treat stomach and/or bowel problems
- thioridazine: a medicine to treat mental disorders
- vincamine given by injection: a medicine to increase the blood flow through the brain
- methadone, a medicine to treat severe pain or to counter addiction
- sultopride, a medicine to treat mental disorders
- levodopa: a medicine to treat Parkinson’s disease
• medicines which can lower your heart beat such as:
- medicines to treat high blood pressure, heart disease or other illnesses, so called beta-blockers, with active substance names ending with “olol”
- diltiazem, verapamil, guanfacine: medicines to treat high blood pressure and heart disorders
- clonidine: a medicine to treat high blood pressure and high eye pressure
- digitalis: a medicine to improve the pumping strength of the heart
• medicines which may lower potassium levels in your blood such as:
- water tablets, such as hydrochlorothiazide or bendrofluazide
- some laxatives
- glucocorticoids: medicines used to treat severe asthma and other inflammatory disorders and to prevent organ transplant rejection
- tetracosactide: a medicine used for diagnostic purposes and to treat a severe form of epilepsy
- amphotericin B given by injection: a medicine to treat fungal infections
- other medicines to treat mental or anxiety disorders belonging to the same group of medicines as Amisulpride does, such as pimozide and haloperidol
- medicines to treat depression, such as imipramine and lithium
• medicines which affect the brain or spinal cord, such as:
- narcotics and anaesthetics
- pain killers
- certain antihistamines: medicines to treat allergies, such as astemizole and terfenadine
- barbiturates and benzodiazepines: medicines which calm, induce sleep or relax muscles
- medicines to regulate your blood pressure Taking Amisulpride with food and drink
Do not drink alcohol during treatment as it can affect the way Amisulpride works.
Pregnancy and breast-feeding
• Pregnancy
Do not take Amisulpride if you are pregnant unless your doctor has told you to.
Inform your doctor immediately if you are pregnant or think you may be.
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.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Important information about some of the ingredients of Amisulpride
Amisulpride contains lactose. 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 Amisulpride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many Amisulpride tablets/film-coated tablets you should take and how long you should continue to take them.
Adults (and adolescents from 15 years of age, 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.
Children and adolescents
Efficacy and safety of amisulpride in children and adolescents under 18 years of age have not been established. If absolutely required treatment of adolescents from 15 to 18 years of age must be initiated and performed by a physician experienced in treating schizophrenia in this age group; children and adolescents under 15 years of age must not take Amisulpride (see section 2 “Do not take Amisulpride”).
Patients with impaired kidney function
Your doctor will treat you with a lower dose, half or a third of the usual daily dose, depending on the impairment grade of your kidney.
Patients with impaired liver function
No changes to the usual daily dose are necessary.
Method of administration
• 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 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 and contact your doctor immediately or go to the nearest hospital if you notice any of the following:
• combination of fever, faster breathing, sweating, muscle stiffness and reduced consciousness
All of these could be symptoms of a severe 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.
• severe allergic reaction, involving:
- difficulty breathing
- low blood pressure
- swelling in the mouth, throat or face
- skin rash
- itching
• fits
Reported side effects listed according to the frequencies are:
Very common, occurs in more than 1 per 10 users
• 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, occurs in 1 to 10 per 100 users
• 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.
• low blood pressure
• weight gain
Uncommon, occurs in 1 to 10 per 1,000 users
• movement disorders including uncontrollable tongue, mouth and facial movements This may occur during or after a prolonged course of treatment:
• fits
• high blood sugar
• slowing of the heart beat
• increased values of specific liver enzymes in the blood
• allergic reaction
Very rare, occurs in less than 1 per 10,000 users
• 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.
Frequency unknown, according to the available data
• so called “neuroleptic malignant syndrome”, see also first paragraph in this chapter
• heart arrest, specific heart rhythm disorders, sudden unexplained death
• 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.
• in elderly 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
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
Keep out of the reach and sight 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.
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 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