Amisan

Leaflet accompanying the packaging: information for the user

Amisan, 400 mg, coated tablets

Amisulpride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amisan and what is it used for
• 2. Important information before taking Amisan
• 3. How to take Amisan
• 4. Possible side effects
• 5. How to store Amisan
• 6. Contents of the packaging and other information

1. What is Amisan and what is it used for

Amisan affects the functioning of nerve cells that function through dopamine.
This substance is important for regulating the activity of the nervous system, which is disturbed in many
mental illnesses, such as schizophrenia. Amisan, as a medicine, acts on dopamine, especially in those
parts of the brain that are directly related to mental illnesses. Amisan does not affect other substances that regulate brain function, which is particularly beneficial due to the low frequency of side effects.
Amisan is used to treat both acute and chronic schizophrenia. The medicine effectively alleviates positive symptoms (delusions, hallucinations, thought disorders, anxiety, mistrust, etc.),
and negative symptoms that predominate (emotional flattening, anxiety, social and emotional withdrawal, feelings of guilt, etc.). Amisan also has a very positive effect on secondary
negative symptoms and mood disorders, such as depression, which may occur in schizophrenia with positive symptoms.
The medicine is intended for use in adults.

2. Important information before taking Amisan

When not to take Amisan

• If you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• If you have a specific type of cancer that causes disturbances in the secretion of the prolactin hormone (e.g. pituitary adenoma or breast cancer);
• If you have an adrenal gland tumor, known as a pheochromocytoma;
• If you are taking levodopa for the treatment of Parkinson's disease;
• In children before puberty;

Warnings and precautions

Before starting to take Amisan, you should discuss it with your doctor:
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In case of taking higher doses of Amisan than recommended for the treatment of schizophrenia, in rare cases, a so-called malignant neuroleptic syndrome may occur, characterized by unexplained increased body temperature, muscle stiffness and autonomic nervous system disorders, which can sometimes lead to death.
In such a case, you should immediately contact your doctor and stop taking the medicine;
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If during treatment, the patient experiences muscle stiffness or muscle breakdown associated with muscle breakdown (rhabdomyolysis), rapid breathing, sweating, and disturbances of consciousness (drowsiness/drowsiness) and fever of unknown cause: you should immediately stop taking the medicine and urgently contact your doctor, as these may be symptoms of a rare disease syndrome, called malignant neuroleptic syndrome, which can lead to death (see section 4);
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Taking Amisan in patients with Parkinson's disease must be justified by existing, important reasons, as the symptoms of the disease may worsen;
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If you have slow heart rate or if you are taking medicines that can cause a slowing of the heart rate, your doctor will regularly monitor your condition;
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If you have been diagnosed with heart disease or blood vessel disease, your doctor will regularly monitor your condition;
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Caution should be exercised when treating elderly patients with severe mental illness associated with dementia;
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You should tell your doctor if you or anyone in your family has ever had blood clots (blockage of blood vessels, embolism), as the use of similar medicines is associated with the formation of blood clots in blood vessels;
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In patients with diabetes or risk factors for diabetes, starting treatment with Amisan, the doctor should regularly monitor the patient's blood sugar levels;
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In patients with epilepsy, Amisan may increase the frequency of seizures;
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In elderly patients, a decrease in blood pressure and excessive sedation may occur;
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In case of discontinuation of Amisan treatment, the medicine should be discontinued gradually. Abrupt discontinuation of the medicine may cause withdrawal symptoms (e.g. involuntary movements);
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During treatment with Amisan, the number of certain white blood cells may decrease, which may manifest as infection or fever of unknown cause;
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If you or anyone in your family has had breast cancer, your doctor should monitor you more closely;
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During treatment with Amisan, a benign brain tumor (pituitary adenoma) and associated vision disorders and headaches may occur. In such a case, the doctor will perform a head examination.
Severe liver function disorders have been reported in association with amisulpride. You should immediately contact your doctor if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin.

Amisan and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You must not take Amisan with the following medicines:

• Levodopa, used in the treatment of Parkinson's disease;
• Medicines called dopamine receptor agonists (e.g. ropinirole, bromocriptine).

Special caution should be exercised when taking Amisan at the same time as the following medicines:

• Medicines containing substances that affect the central nervous system (painkillers, some antihistamines, sleeping pills, sedatives, anxiolytics, clonidine used in the treatment of high blood pressure and its derivatives);
• Medicines that lower blood pressure;
• Medicines that affect heart function (e.g. anti-arrhythmic drugs of class IA and class III, e.g. amiodarone, sotalol);
• Certain antihistamines;
• Certain other medicines used in the treatment of mental illnesses (antipsychotics);
• Certain antimalarial drugs.

Taking Amisan with food, drink, and alcohol

You must not drink alcohol while taking Amisan, as the medicine may enhance the effect of alcohol on the central nervous system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy
Taking Amisan is not recommended during pregnancy or in women of childbearing age who are not using effective contraception.
In newborns whose mothers took Amisan during pregnancy, the following symptoms may occur: involuntary trembling of the body (tremors), increased muscle tone, drowsiness, agitation, difficulty breathing, and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.
Breastfeeding
You must not breastfeed while taking Amisan. You should discuss with your doctor the best way to feed your child if you are taking Amisan.

Driving and operating machines

Amisan may adversely affect activities that require attention and coordination of movements (driving vehicles and operating machines). These activities can only be performed after consulting a doctor.

Amisan contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
Amisan contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Amisan

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
Amisan can be taken in a dose of up to 400 mg once a day. Higher doses should be taken in two divided doses. The exact dosage and duration of treatment will be determined by your doctor.
The usual dose is 400-800 mg per day. Your doctor may increase the dose to 1200 mg per day. A higher dose is not recommended.
Doses should be individualized according to the patient's response, and maintenance treatment should be carried out with the smallest effective dose.
In conditions associated with apathy and a tendency to social withdrawal, the recommended dose is from 50 mg to 300 mg per day. Doses should be individualized.
Elderly patients
In elderly patients, the medicine should be taken with special caution, due to the possible risk of decreased blood pressure or excessive sedation.
In patients with impaired renal function, the doctor may reduce the dose of the medicine.
Use in children and adolescents
Amisan is not recommended for use in children from puberty to 18 years of age. This medicine should not be used in children before puberty, as its safety in this age group has not been established.
Patients with impaired renal function
The doctor will reduce the dose of the medicine depending on the severity of the renal impairment.
Patients with impaired liver function
No dose adjustment is necessary in these patients.

Method of administration

The tablets should be taken without chewing, with a large amount of water.

Duration of treatment

Treatment is usually long-term.

Taking a higher dose of Amisan than recommended

Experiences with overdose are limited. Reports have been made of an intensification of the medicine's effects, including drowsiness and excessive sedation, disturbances of consciousness, decreased blood pressure, involuntary movements, and coma. In case of overdose or accidental ingestion of the medicine by a child, you should immediately contact your doctor for close monitoring of vital functions.

Missing a dose of Amisan

If you miss a dose of the medicine, you should take it as soon as possible. However, if it is almost time for the next dose, you should skip the missed dose. You should not take a double dose to make up for the missed dose. You should continue taking the medicine at the usual times.

Stopping Amisan treatment

Your doctor will decide how long you should take Amisan. You should not stop taking the tablets just because you feel better.
Stopping Amisan treatment may cause the disease to worsen or recur. You should not abruptly stop taking Amisan, unless your doctor decides otherwise. Abrupt discontinuation of the medicine may cause withdrawal symptoms, such as nausea or vomiting, insomnia, sweating, extreme anxiety, muscle stiffness, abnormal body movements, or recurrence of the disease.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

You should seek medical help immediately if you experience the following side effects:

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions, such as skin rashes, itching, or swelling, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue;
• Seizure (epileptic fit);

Rare(may affect up to 1 in 1,000 people)

• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties;

Unknown(frequency cannot be estimated from the available data)

• High fever, sweating, muscle stiffness, rapid heartbeat, rapid breathing, confusion, drowsiness, or agitation. These may be symptoms of a serious but rare side effect called malignant neuroleptic syndrome;
• Abnormal heart function, rapid heartbeat, or chest pain, which can lead to a heart attack or life-threatening heart disease.

The following side effects have also been reported:
Very common(may affect more than 1 in 10 people)

• Tremors, stiffness, or muscle spasms, slowed movements, increased salivation, or inability to remain still. These symptoms usually disappear if the doctor reduces the dose of Amisan or prescribes an additional medicine.

Common(may affect up to 1 in 10 people)

• Acute dystonia (involuntary muscle spasms). It is reversible after administration of an antiparkinsonian medicine, without the need to discontinue amisulpride;
• Difficulty falling asleep (insomnia), anxiety, agitation (restless movements), orgasm disorders;
• Feeling drowsy or drowsiness;
• Constipation, nausea, vomiting, dry mouth;
• Weight gain;
• Abnormal production and secretion of milk in women and men, breast pain;
• Menstrual disorders, such as absence of menstrual bleeding;
• Breast enlargement in men;
• Difficulty achieving or maintaining an erection or ejaculation disorders;
• Low blood pressure;
• Blurred vision.

Uncommon(may affect up to 1 in 100 people)

• Decreased number of white blood cells (leukopenia or neutropenia);
• Confusion;
• Uncontrollable movements, mainly of the hands, legs, face, and tongue;
• Slowed heart rate;
• Increased blood pressure;
• Nasal congestion or swelling of the nasal mucosa;
• Accidental inhalation of food or stomach contents into the airways with a risk of aspiration pneumonia (lung infection) (mainly in cases of concomitant use with other medicines belonging to the group of medicines called central nervous system depressants and antipsychotics used in the treatment of thought and perception disorders);
• Osteopenia (decreased bone density) and osteoporosis (bone thinning);
• Urinary retention in the bladder;
• Increased blood sugar levels (hyperglycemia);
• Increased levels of fats (triglycerides) and cholesterol in the blood;
• Increased activity of liver enzymes in the blood;
• Liver tissue damage.

Rare(may affect up to 1 in 1,000 people)

• More frequent than usual infections, which may be caused by a blood disorder (agranulocytosis);
• Benign brain tumor (pituitary adenoma);
• Decreased sodium levels in the blood;
• A syndrome of symptoms called inappropriate antidiuretic hormone secretion syndrome (characterized by water retention in the body and swelling);
• Swelling, hives.
• Changes in the ECG recording (heart rhythm disorders).

Unknown(frequency cannot be estimated from the available data)

• In newborns whose mothers took Amisan during pregnancy, a withdrawal syndrome may occur.
• Restless legs syndrome (feeling of discomfort in the legs, temporarily relieved by movement, symptoms worsening at the end of the day);
• Increased sensitivity of the skin to sunlight and ultraviolet radiation.
• Falls, caused by disturbances of balance, which can lead to fractures;
• Rhabdomyolysis (muscle breakdown with accompanying muscle pain);
• Increased activity of creatine phosphokinase (a blood test indicating muscle damage).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amisan

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the blister or carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amisan contains

The active substance of the medicine is amisulpride.
Each Amisan 400 mg coated tablet contains 400 mg of amisulpride.
The other ingredients are: lactose monohydrate, methylcellulose 400 cP, sodium carboxymethylcellulose type A, magnesium stearate, microcrystalline cellulose (core), methacrylic acid copolymer type E, titanium dioxide (E 171), talc, magnesium stearate, macrogol 6000 (tablet coating).

What Amisan looks like and contents of the pack

Amisan, 400 mg: White or almost white, oval, biconvex, coated tablets with a dividing line on one side, measuring 18 x 8 mm. The coated tablets can be divided into equal doses.

Packaging

PVC/Aluminum blisters in a cardboard box.
400 mg: 30 coated tablets (3 blisters of 10 tablets), 60 coated tablets (6 blisters of 10 tablets), and 150 coated tablets (15 blisters of 10 tablets).

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic
To obtain more detailed information about this medicine, you should contact the local representative of the marketing authorization holder:
PRO.MED.PL Sp. z o.o.
biuro@promedcs.com

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:07.09.2024