Amisan

Package Leaflet: Information for the User

Amisan, 50 mg, tablets

Amisan, 200 mg, tablets

Amisulpride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. Do 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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Amisan and what is it used for

Amisan affects the functioning of nerve cells that work 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, distrust, etc.),
and negative symptoms (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 the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• If the patient has a specific type of cancer that causes disturbances in the secretion of the prolactin hormone (e.g., pituitary adenoma or breast cancer);
• If the patient has an adrenal gland tumor, known as a pheochromocytoma;
• If the patient is taking levodopa for the treatment of Parkinson's disease;
• In children before puberty;

Warnings and precautions

Before starting treatment with Amisan, 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 contact your doctor immediately and stop taking the medicine;
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If during treatment, the patient experiences muscle stiffness or muscle breakdown associated with muscle decay (rhabdomyolysis), rapid breathing, sweating, and disturbances of consciousness (drowsiness/sleepiness) 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 the patient has slow heart rate or is taking medicines that can cause a slowing of the heart rate, the doctor will regularly monitor the patient's condition;
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If the patient has heart disease or blood vessel disease, the doctor will regularly monitor the patient's 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 any of your family members have ever had blood clots (blocked 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 the patient or any of their family members have had breast cancer, the doctor should closely monitor the patient;
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During treatment with Amisan, a benign brain tumor 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 contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, yellowing of the eyes or skin.

Amisan and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Do 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 with 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

Do 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, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Taking Amisan is not recommended during pregnancy or in women of childbearing age 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, contact your doctor.
Breastfeeding
Do not breastfeed while taking Amisan. Discuss with your doctor the best way to feed your baby if you are taking Amisan.

Driving and using machines

Amisan may adversely affect activities that require attention and coordination of movements (driving vehicles and operating machines). Such 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.

3. How to take Amisan

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Amisan can be taken once a day at a dose of up to 400 mg. 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. Do not take more than the recommended dose.
Doses should be adjusted individually 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 adjusted individually.
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. Do not use this medicine in children before puberty, as the safety of its use in this age group has not been established yet.
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

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 by a child, contact your doctor immediately for close monitoring of vital functions.

Missing a dose of Amisan

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

Stopping treatment with Amisan

Your doctor will decide how long you should take Amisan. Do not stop taking the tablets because you feel better.
Stopping treatment with Amisan may cause the disease to worsen or return. Do 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, unusual body movements, or a relapse of the disease.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Seek medical attention 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 sedated;
• 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;
• Swelling or congestion of the nasal mucosa;
• Accidental inhalation of food or stomach contents into the airways with a risk of aspiration pneumonia (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;
• Decreased sodium levels in the blood;
• A syndrome of symptoms called inappropriate antidiuretic hormone secretion (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 (a 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, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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

Keep the medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the blister or carton after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Amisan contains

The active substance of the medicine is amisulpride.
Each Amisan 50 mg tablet contains 50 mg of amisulpride.
Each Amisan 200 mg tablet contains 200 mg of amisulpride.
The other ingredients are: maize starch, cornstarch, lactose monohydrate, methylcellulose 400 cP, silica colloidal anhydrous, magnesium stearate.

What Amisan looks like and contents of the pack

Amisan 50 mg: White or almost white, round tablets with a dividing line on one side, 7.0 mm in diameter. The tablet can be divided into equal doses.
Amisan 200 mg: White or almost white, round tablets with a dividing line on one side, 12.5 mm in diameter. The tablet can be divided into equal doses.

Packaging

PVC/Aluminum blisters in a cardboard box.
50 mg: 12 tablets (1 blister of 12 tablets) and 60 tablets (5 blisters of 12 tablets).
200 mg: 30 tablets (3 blisters of 10 tablets), 60 tablets (6 blisters of 10 tablets), and 150 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 on this medicine, please contact the local representative of the marketing authorization holder:
PRO.MED.PL Sp. z o.o.
[email protected]

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