Patient leaflet - Amisulpride 100 mg tablets
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- becoming withdrawn and subdued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
taking
levodopa: a medicine to treat Parkinson’s disease
-
Warnings and Precautions
Talk to your doctor or pharmacist before taking Amisulpride if:
you are developing fever, faster breathing, excessive sweating, reduced consciousness or stiff muscles which are symptoms of a severe – potentially fatal – disorder called “neuroleptic malignant syndrome”. Stop immediately taking Amisulpride and contact your doctor.
See also section 4, first paragraph
you have 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.
you have kidney function disorder
See section “3 How to take Amisulpride”
you have 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.
you are over 65 years old
Elderly people are more likely to get low blood pressure or feel sleepy during therapy with Amisulpride. 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 Parkinson’s disease
- you have a low number of white blood cells, so called agranulocytosis. This means that you may get infections more easily than usual. A medical specialist, haematologist, should be consulted if this occurs.
- you have frequent unexplained infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem (leucopenia, neutropenia) and might require the consultation of a doctor specialized in haematology.
- you have 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”
- you have had a stroke previously or are at risk of stroke
- 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 or someone else in your family has a history of breast cancer. A strict medical follow up is needed during treatment with Amisulpride.
- you have high levels of prolactin. This can lead to swelling of breasts and unexpected production of breast milk in men and women and to no monthly or irregular periods in women. You must stop taking Amisulpride if this is confirmed by your doctor after a blood test.
Severe liver problems have been reported with Amisulpride. Talk to your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellow discoloration of the eyes or skin.
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
- clozapine used to treat schizophrenia
- 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
Amisulpride is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
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 should not breast-feed during therapy with Amisulpride. Talk to your doctor about the best way to feed your baby if you are taking Amisulpride.
Fertility
Treatment with Amisulpiride 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. It may also cause blurred vision.
Amisulpride contains lactose and sodium
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 this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet/film-coated tablet, that is to say essentially ‘sodium-free’.
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 Amisulpride 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.
Amisulpride tablets can be divided into equal doses.
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.
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:
Uncommon: may affect up to 1 in 100 people
- fits
more infections than usual
This could be because of a decrease in the number of white blood cells called “leukopenia” or “neutropenia”.
Rare: may affect up to 1 in 1,000 people
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 or unusual 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
severe allergic reaction called angioedema, involving:
- difficulty breathing
- low blood pressure
- swelling in the mouth, throat or face
- skin rash
- itching
more infections than usual
This could be because of a blood disorder called “agranulocytosis”.
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
- 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
- blurred vision
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
- high levels of fat (triglycerides) or cholesterol in the blood
- slowing of the heart beat
- increased values of specific liver enzymes in the blood
- feeling confused
- nasal congestion
- accidential inhalation of food with risk of lung infection (pneumonia)
- increase in blood pressure
- difficulty passing urine
- a condition called “osteoporosis”. This is when your bones are more likely to break.
- liver tissue damage
- allergic reaction
Rare: may affect up to 1 in 1,000 people
- noncancerous benign tumour (such as prolactinoma)
feeling unwell, confused or weak, feeling sick (nausea), loss of appetite, feeling irritable.
This could be an illness called “syndrome of inappropriate antidiuretic hormone secretion (SIADH)”
- tired, weak, confused, have muscles that ache, are still or do not work well. This may be due to low sodium levels in your blood
- swelling of the skin associated with pain, redness and itching
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
- restless legs syndrome: uncomfortable feeling in your legs temporarily relieved by movement and symptoms getting worse at the end of the day
- increased sensitivity of your skin to sun and ultraviolet light
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 Yellow Card Scheme: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Amisulpride
Keep this medicine out of the sight and reach of children.
Do not use this medicine 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.
This medicine 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 of amisulpride.
Amisulpride 100 mg tablets:
Each tablet contains 100 mg of amisulpride.
Amisulpride 200 mg tablets:
Each tablet contains 200 mg of amisulpride.
Amisulpride 400 mg film-coated tablets:
Each film-coated tablet contains 400 mg of amisulpride.
50 mg, 100 mg, 200 mg tablets:
The other ingredients are lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, sodium starch glycolate (type A).
400 mg film-coated tablets:
The other ingredients are lactose monohydrate, magnesium stearate, methylcellulose, microcrystalline cellulose, sodium starch glycolate (type A), macrogol 6000, magnesium stearate, methacrylate copolymer (Eudragit E 100), talc, titanium dioxide (E 171).
What Amisulpride looks like and contents of the pack
50 mg tablets:
White, round, 6 mm in diameter, with a score line, and rounded on the upper and lower side.
100 mg tablets:
White, round, flat, 8 mm in diameter, with a score line.
200 mg tablets:
White, round, flat, 11 mm in diameter, with a score line.
400 mg film-coated tablets:
White to off white, capsule shaped, 18 mm in length and 8 mm in width, with a score line on one side.
The tablets/ film-coated tablets are packed in PVC/aluminium blisters and inserted in a carton.
Pack sizes:
10, 12, 14, 20, 21, 30, 42, 50, 60, 98, 100, 150, 198, 200 (bundled package 2x100) tablets/ film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Maxis 1 Western Road
Bracknell
United Kingdom
RG12 1RF
Manufacturer
Lek Pharmaceuticals D.D. Ljubljana, ljub or
Lek S.A., Warsaw, Poland
or
Salutas Pharma GmbH, Barleben, Germany