Amisan

Patient Information Leaflet

Amisan, 400 mg, film-coated tablets
Amisulpridum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Amisan is and what it is used for
2. What you need to know 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 Amisan is and what it is used for

Amisan affects nerve cells that function via dopamine.
This substance plays an important role in regulating nervous system activity, which is disturbed in many
psychiatric disorders, such as schizophrenia. Amisan acts specifically on dopamine, particularly in those
areas of the brain directly involved in psychiatric disorders. Amisan does not affect other substances regulating brain function, which is particularly beneficial due to the low incidence of adverse effects.
Amisan is used in the treatment of both acute and chronic schizophrenia. The medicine effectively
alleviates positive symptoms (delusions, hallucinations, thought disorders, anxiety, mistrust, etc.)
and negative symptoms (emotional blunting, anxiety, social and emotional withdrawal, feelings of guilt, etc.).
Amisan also has a highly beneficial effect on secondary negative symptoms and mood disturbances,
such as depression, which may occur in schizophrenia with positive symptoms.
This medicine is intended for use in adults.

2. Important information before using Amisan

When not to use Amisan

• If the patient is allergic to amisulpride or to any of the other ingredients of this medicine (listed in section 6);
• If the patient has a specific type of cancer causing disorders in prolactin hormone secretion (e.g. pituitary adenoma or breast cancer);
• If the patient has an adrenal gland tumour, known as phaeochromocytoma;
• 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 the following with your doctor:
­ When taking higher doses of Amisan than recommended for the treatment of schizophrenia,
a rare condition called neuroleptic malignant syndrome may occur, characterised by unexplained
fever, muscle rigidity and disturbances of the autonomic nervous system, which may sometimes
lead to death. In such a case, contact your doctor immediately and discontinue the medicine;
­ If during treatment the patient develops muscle rigidity or muscle weakness associated
with muscle breakdown (rhabdomyolysis), rapid breathing, sweating, altered consciousness
(drowsiness/sleepiness) and unexplained fever: treatment must be stopped immediately and
urgent medical advice sought, as these may be symptoms of a rare condition called neuroleptic
malignant syndrome, which may be fatal (see section 4);
­ Treatment with Amisan in patients with Parkinson's disease must be justified by significant
clinical reasons, as symptoms of the disease may worsen;
­ If the patient has a slow heart rate or is taking medicines which may slow heart rate, the doctor
will monitor the patient regularly;
­ If the patient has been diagnosed with heart or vascular disease, the doctor will monitor
the patient regularly;
­ Caution should be exercised when treating elderly patients with severe psychiatric disorders
associated with dementia;
­ Inform the doctor if the patient or anyone in their family has ever had blood clots (vessel blockage,
thromboembolism), as use of similar medicines has been associated with formation of blood clots
in blood vessels;
­ In patients with diabetes or risk factors for diabetes, starting treatment with Amisan requires
regular monitoring of blood glucose levels by the doctor;
­ In patients with epilepsy, Amisan may increase the frequency of seizures;
­ In elderly patients, a drop in blood pressure and excessive sedation may occur;
­ When stopping treatment with Amisan, the medicine should be discontinued gradually.
Abrupt discontinuation may cause withdrawal symptoms (e.g. involuntary movements);
­ During treatment with Amisan, the number of certain white blood cells may decrease, which
may present as infection or unexplained fever;
­ If the patient or anyone in their family has had breast cancer, the doctor should monitor
the patient more closely;
­ During treatment with Amisan, a benign pituitary gland tumour may develop, associated with
visual field disturbances and headaches. In such a case, the doctor will perform a head examination.
Severe liver function disorders associated with the use of amisulpride have been reported. Contact
your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal
pain, or yellowing of the eyes or skin (jaundice).

Amisan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines they plan to take.
Do not take Amisan with the following medicines:

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

Exercise particular caution when taking Amisan together with the following medicines:

• Medicines containing substances that affect the central nervous system (painkillers, certain antihistamines, sleeping pills, sedatives, anxiolytics, clonidine used to treat high blood pressure and its derivatives);
• Medicines that lower blood pressure;
• Medicines affecting heart function (e.g. antiarrhythmics of class IA and class III, such as amiodarone, sotalol);
• Certain antihistamines;
• Certain other medicines used to treat psychiatric disorders (antipsychotics);
• Certain antimalarial medicines.

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 the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of Amisan is not recommended during pregnancy or in women of childbearing potential
who are not using effective contraception.
Newborn babies whose mothers took Amisan during the last trimester (last three months)
of pregnancy may experience the following symptoms: involuntary trembling (tremor), increased
muscle tone, drowsiness, agitation, breathing difficulties and feeding problems. If such symptoms
are observed in your baby, contact your doctor immediately.
Breastfeeding
Breastfeeding should not be undertaken while taking Amisan. Discuss with your doctor the best
way to feed your baby if you are taking Amisan.

Driving and operating machinery
Amisan may adversely affect functions requiring attention and motor coordination (such as
driving and operating machinery). These activities should only be performed after consultation
with your doctor.

Amisan contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
Amisan contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered
"sodium-free".

3. How to use Amisan

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Amisan at a dose of up to 400 mg may be taken once daily. 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 up to 1200 mg per day. Doses higher than this are not recommended.
Dosage should be individually adjusted according to the patient's response, and maintenance treatment should be continued with the lowest effective dose.
In conditions associated with apathy and tendency towards social withdrawal, the recommended dose is 50 mg to 300 mg per day. Dosage should be individually adjusted.

Elderly patients
Amisan should be used with particular caution in elderly patients due to possible risk of reduced blood pressure or excessive drowsiness.
In patients with renal impairment, the doctor may reduce the dose of the medicine.

Use in children and adolescents
Amisan is not recommended for use in children and adolescents from puberty up to the age of 18 years. This medicine must not be used in children before puberty, as safety has not yet been established in this age group.

Patients with renal impairment
The doctor will reduce the dose of the medicine depending on the severity of renal impairment.

Patients with hepatic impairment
Dosage adjustment is not 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 more Amisan than recommended
Experience with overdose is limited. Symptoms reported include increased effects of the medicine such as 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.

If you forget to take 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 your usual times.

Stopping Amisan
Your doctor will decide how long you should take Amisan. Do not stop taking the tablets just because you feel better.
Stopping Amisan may cause your condition to worsen or return. Do not stop taking Amisan suddenly unless your doctor tells you to. Abrupt discontinuation may lead to withdrawal symptoms such as nausea or vomiting, insomnia, sweating, extreme anxiety, muscle stiffness, unusual body movements, or recurrence of the illness.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Seek immediate medical help if the patient experiences any of the following
adverse reactions:
Uncommon (may occur in up to 1 in 100 people)

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

Rare (may occur in up to 1 in 1000 people)

• Blood clots in veins, especially in the lower limbs (symptoms include swelling, pain and redness in the limbs), which may travel along blood vessels to the lungs, causing chest pain and difficulty breathing;

Unknown frequency (frequency cannot be estimated from available data)

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

The following adverse reactions have also been reported:
Very common (may occur in more than 1 in 10 people)

• Tremor, muscle stiffness or contractions, slowed movements, increased salivation or inability to stay still. These symptoms usually resolve if the doctor reduces the dose of Amisan or prescribes an additional medicine.

Common (may occur in up to 1 in 10 people)

• Acute dystonia (involuntary muscle contractions). This is reversible with antiparkinsonian medication, without the need to discontinue amisulpride;
• Difficulty falling asleep (insomnia), anxiety, agitation (restless movements), orgasm disorders;
• Feeling sleepy 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 erection or ejaculation disorders;
• Low blood pressure;
• Blurred vision.

Uncommon (may occur in up to 1 in 100 people)

• Decreased number of white blood cells (leukopenia or neutropenia);
• Confusion;
• Uncontrollable movements, mainly of hands, feet, face and tongue;
• Slowed heart rate;
• Increased blood pressure;
• Swelling or congestion of nasal mucosa;
• Accidental aspiration of food or stomach contents into the respiratory tract, with risk of aspiration pneumonia (lung infection) (mainly when used with other medicines belonging to the group of central nervous system depressants and antipsychotic medicines used to treat disorders of thought and perception);
• Osteopenia (reduced bone density) and osteoporosis (thinning of bones);
• Urinary retention in the bladder;
• Increased blood sugar levels (hyperglycaemia);
• Increased levels of fats (triglycerides) and cholesterol in blood;
• Increased liver enzyme activity in blood;
• Liver tissue damage.

Rare (may occur in up to 1 in 1000 people)

• More frequent infections, which may be caused by a blood disorder (agranulocytosis);
• Benign pituitary gland tumour;
• Decreased sodium levels in blood;
• Syndrome of symptoms known as syndrome of inappropriate antidiuretic hormone secretion (characterized by water retention in the body and swelling);
• Oedema, urticaria.
• Changes in ECG recording (heart rhythm disturbances).

Unknown frequency (frequency cannot be estimated from available data)

• In newborns whose mothers used Amisan during pregnancy, withdrawal syndrome may occur.
• Restless legs syndrome (uncomfortable sensation in legs temporarily relieved by movement, symptoms worsening in the evening);
• Increased skin sensitivity to sunlight and ultraviolet radiation.
• Falls due to impaired body balance, which may lead to fractures;
• Rhabdomyolysis (muscle breakdown with accompanying muscle pain);
• Increased creatine phosphokinase activity (a blood test indicating muscle damage).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amisan

Keep this medicine out of sight and reach of children.
No special precautions for storage are required.
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 stated month.
Medicines must 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 package and other information

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

What Amisan looks like and contents of the pack
Amisan 400 mg: White or almost white, oval, biconvex coated tablets with a dividing groove on one side, size 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 Authorisation Holder and Manufacturer
PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
PRO.MED.PL Sp. z o.o.
[email protected]

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