Amisulpride holsten

Package leaflet: Information for the patient

Amisulpryd Holsten, 200 mg, tablets
Amisulpride
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 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Amisulpryd Holsten is and what it is used for

The active substance in this medicine is amisulpride. Amisulpride belongs to a group of medicines called neuroleptics. Amisulpryd Holsten is indicated for the treatment of schizophrenia.
Schizophrenia may cause patients to feel, see or hear things that are not real, experience strange and disturbing thoughts, changes in behaviour, and social withdrawal. Patients may also experience tension, anxiety or depression. Amisulpride improves disturbances in thinking, feeling or behaviour. Amisulpryd Holsten is used in the treatment of both newly developed and chronic schizophrenia.

2. Important information before using Amisulpryd Holsten

When must Amisulpryd Holsten not be used:

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• if the patient is breastfeeding (see section "Pregnancy and breastfeeding").
• if the patient has breast cancer or tumours whose growth is dependent on prolactin levels.
• if the patient has a phaeochromocytoma (a tumour of the adrenal gland).
• if the patient is taking other medicines that may affect heart function, such as antiarrhythmics (see section "Other medicines").
• if the patient is taking levodopa, a medicine used in the treatment of Parkinson's disease (see section "Other medicines").
• in children under 18 years of age.

If any of the situations described above apply, this medicine must not be taken.
If in doubt, consult a doctor or pharmacist before using Amisulpryd Holsten.

Warnings and precautions

Before taking Amisulpryd Holsten, discuss with your doctor or pharmacist if:

• the patient has kidney disease
• the patient has Parkinson's disease
• the patient has ever had seizures (epileptic fits)
• the patient has abnormal heart function (heart rhythm)
• there is a family history of heart disease or heart disorders
• the patient has been informed by a doctor about a risk of stroke
• the patient has diabetes or has been told they are at increased risk of developing diabetes
• the patient is elderly. Elderly patients are more likely to experience low blood pressure or drowsiness. A small increased risk of death in elderly patients with dementia who are treated with antipsychotic medicines has been reported (compared to patients not treated with these medicines)
• the patient has a slow heart rate (less than 55 beats per minute)
• the patient has low blood potassium levels
• the patient or someone in their family has had blood clots, as medicines such as amisulpride may increase the risk of blood clots
• the patient has a low white blood cell count (agranulocytosis). This may lead to more frequent infections than usual.
• the patient frequently experiences infections with fever, chills, sore throat or mouth ulcers. These may be symptoms of a blood disorder called leukopenia.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using Amisulpryd Holsten.

Amisulpryd Holsten and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take. This includes medicines available without a prescription, including herbal medicines. Amisulpride may affect the action of certain medicines, and certain medicines may affect the action of amisulpride.

In particular, do not take amisulpride and inform your doctor if the patient is taking the following medicines:

• levodopa, a medicine used in the treatment of Parkinson's disease.
• medicines known as "dopamine agonists", such as ropinirole and bromocriptine.

Tell your doctor if the patient is taking any of the following medicines:

• medicines used to control heart function, such as quinidine, disopyramide, amiodarone and sotalol
• other antipsychotic medicines used in the treatment of mental illnesses
• medicines used for severe pain, known as opioids, such as morphine, pethidine or methadone
• medicines used for high blood pressure and heart conditions, such as diltiazem and verapamil, guanfacine and cardiac glycosides
• clonidine, used in the treatment of migraines, facial flushing or high blood pressure
• mefloquine, used to treat malaria
• sleeping medicines, such as barbiturates and benzodiazepines
• painkillers, such as tramadol and indometacin
• anaesthetics
• antihistamines, such as promethazine, which cause drowsiness.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before using Amisulpryd Holsten.

Amisulpryd Holsten with food, drink and alcohol

• Amisulpryd Holsten tablets should be taken before meals, with a large amount of water.
• Do not consume alcohol while taking Amisulpryd Holsten, as alcohol may affect the action of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Do not use Amisulpryd Holsten if the patient is breastfeeding or planning to breastfeed.
Use of this medicine during pregnancy is not recommended unless the benefit to the mother clearly outweighs the potential risk.
Before starting treatment, women of childbearing age should discuss effective contraceptive methods in detail with their doctor.
Newborns whose mothers have taken amisulpride during the third trimester (last three months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties and feeding problems. If any of these symptoms occur in the baby, contact a doctor immediately.

Driving and using machines

Amisulpryd Holsten may cause reduced alertness, dizziness or drowsiness. If any of these symptoms occur, do not drive or operate any machinery or equipment.

Amisulpryd Holsten tablets contain lactose monohydrate.
If the patient has been previously diagnosed with an intolerance to certain sugars by a doctor, they should consult their doctor before taking this medicine.

Amisulpryd Holsten tablets contain sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amisulpryd Holsten

This medicine should always be taken exactly as directed by the physician. In case of doubts, consult
your doctor or pharmacist.
Administration of the medicine

• The medicine should be taken orally.
• Tablets should be swallowed whole or divided, with water. Do not chew the tablets.
• This medicine should be taken before meals.
• If you feel that the effect of the medicine is too strong or too weak, consult your doctor. Do not change the dosage on your own.
• If your doctor has informed you about intolerance to certain sugars, you should contact your doctor before taking this medicine.

Recommended dose
The dose depends on the severity of the disease. Always follow your doctor's instructions precisely.
Adults
The usual dose ranges from 50 mg to 800 mg per day.
Your doctor may start treatment with a lower dose if necessary.
If required, your doctor may prescribe a dose of up to 1200 mg per day.
Doses lower than 300 mg per day may be taken once daily as single doses. The medicine should be taken at the same time each day.
Doses higher than 300 mg per day should be taken in two divided doses, half in the morning and half in the evening.
Other pharmaceutical companies offer medicines containing amisulpride in lower strengths (e.g. 50 mg tablets).
Elderly patients
Safety in this patient group has been studied in a limited number of individuals. Your doctor will carefully monitor your condition due to an increased risk of low blood pressure or drowsiness caused by the medicine.
Patients with impaired kidney function
Your doctor may reduce the dose.
Use in children and adolescents
The efficacy and safety of amisulpride have not been established in patients from puberty up to 18 years of age. There is limited data on the use of amisulpride in adolescents with schizophrenia.
Therefore, this medicine should not be used in children and adolescents, as its safety has not been established in this age group.
Overdose of Amisulpryd Holsten
If you take more than the recommended dose, contact your doctor immediately or go to the nearest hospital emergency department. Bring the medicine packaging with you so the doctor knows what you have taken. The following symptoms may occur: restlessness, tremor, muscle stiffness, low blood pressure, dizziness or drowsiness, which may lead to loss of consciousness.
Missed dose of Amisulpryd Holsten
If you miss a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Amisulpryd Holsten
Continue taking Amisulpryd Holsten for as long as your doctor recommends. Even if you feel better, do not stop taking the medicine. Stopping treatment may lead to worsening or recurrence of the illness. Do not discontinue Amisulpryd Holsten abruptly unless otherwise instructed by your doctor. Sudden discontinuation may cause withdrawal symptoms such as:

• nausea, vomiting
• excessive sweating
• difficulty sleeping or intense restlessness
• muscle stiffness or uncontrolled body movements
• return of the initial illness symptoms.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Blood tests
Treatment with Amisulpryd Holsten may affect the results of certain blood tests. This includes tests measuring the level of a hormone called prolactin and tests assessing liver function. If you are scheduled for blood tests, inform your doctor that you are taking Amisulpryd Holsten.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Amisulprid Holsten may cause adverse reactions, although not everyone experiences them.

The use of Amisulprid Holsten must be discontinued and immediate contact with a doctor must be made or the patient should go to the nearest hospital emergency department if:

• the patient has high fever, excessive sweating, muscle stiffness, rapid heartbeat, fast breathing, and confusion, dizziness, or agitation. These may be symptoms of a severe but rare condition called neuroleptic malignant syndrome;
• the patient has abnormal heart function, rapid heartbeat, or chest pain, which may indicate a heart attack or life-threatening heart disorders;
• the patient develops blood clots in the veins, especially in the legs (symptoms include itching, pain, and redness in the leg). These clots may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If such symptoms occur, contact a doctor immediately;
• the patient experiences infections more frequently than usual. This may result from blood disorders (agranulocytosis) or reduced white blood cell count (neutropenia).

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity reactions. The following symptoms may occur: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Seizures (epileptic fits).

Please inform your doctor immediately if any of the following adverse reactions occur:

Very common: may affect more than 1 in 10 people

• Tremor, increased muscle tension or spasms, slow body movements, increased salivation, excessive restlessness.

Common: may affect up to 1 in 10 people

• Uncontrolled body movements, mainly in hands and legs. Drowsiness.

(These symptoms may be alleviated if the doctor reduces the dose of amisulpride or prescribes an additional medicine.)

Uncommon: may affect up to 1 in 100 people

• Uncontrolled body movements, especially in the face or tongue.

Other adverse reactions:

Common: may affect up to 1 in 10 people

• Difficulty falling asleep (insomnia), anxiety, agitation.
• Dizziness, drowsiness.
• Constipation, nausea or vomiting, dryness of the oral mucosa.
• Weight gain.
• Galactorrhea in women and men, breast pain.
• Amenorrhea (cessation of menstruation).
• Gynecomastia in men.
• Difficulty achieving or maintaining erection, ejaculation disorders.
• Dizziness (possibly due to low blood pressure).

Uncommon: may affect up to 1 in 100 people

• Slowed heart rate.
• Excessively high blood sugar levels (hyperglycaemia).
• Changes (increase) in liver enzyme activity.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 provide more information on the safety of the medicine.

5. How to store Amisulpryd Holsten

Keep this medicine out of the sight and reach of children.
There are no special storage requirements for this medicine.
Do not use Amisulpryd Holsten after the expiry date stated on the carton and
blister after EXP. The batch number is indicated after the abbreviation "Lot". The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice any signs of discoloration of the tablets.
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 pack and other information

What Amisulpryd Holsten contains

• The active substance is amisulpride. Each tablet contains 200 mg of amisulpride.
• The other ingredients are: monohydrate lactose, methylcellulose, sodium carboxymethyl starch type A, microcrystalline cellulose, magnesium stearate.

What Amisulpryd Holsten looks like and contents of the pack

White, round, flat tablet with a division line on one side and an embossment "A200" on the other side.
The medicine is available in packs containing 30, 60, 90, 100 or 150 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

The package leaflet does not contain all information about this medicine. If you have any further questions or uncertainties, please consult your doctor or pharmacist.

This medicinal product is authorised for marketing in the European Economic Area member countries under the following names:
Poland: Amisulpryd Holsten