Amisulprid Holsten

Leaflet attached to the packaging: patient information

Amisulpryd Holsten, 200 mg, tablets
Amisulpryd

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amisulpryd Holsten and what is it 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 packaging and other information

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

The active substance of the medicine is amisulpride. Amisulpride belongs to a group of medicines called antipsychotics. Amisulpryd Holsten is indicated for the treatment of schizophrenia.
Schizophrenia can cause patients to feel, see, or hear things that are not there, experience strange and disturbing thoughts, changes in behavior, and alienation. Patients may also experience tension, anxiety, or depression. Amisulpride improves thought, feeling, or behavioral disorders. Amisulpryd Holsten is used to treat both starting and chronic schizophrenia.

2. Important information before taking Amisulpryd Holsten

When not to take Amisulpryd Holsten:

• in children under 18 years of age.

If any of the above situations apply to the patient, they should not take this medicine.
In case of doubts, consult your doctor or pharmacist before taking Amisulpryd Holsten.

Warnings and precautions

Before starting to take Amisulpryd Holsten, discuss it with your doctor or pharmacist if:

• the patient has kidney disease
• the patient has Parkinson's disease
• the patient has had seizures (seizure attacks) before
• the patient has abnormal heart function (heart rhythm)
• there is a history of heart disease or heart disorders in the patient's family
• the doctor has informed the patient of the risk of stroke
• the patient has diabetes or is informed that they have an increased risk of diabetes
• the patient is elderly. Elderly patients are more prone to low blood pressure or drowsiness. There have been reports of a slight increase in the risk of death in elderly patients with dementia who took antipsychotic medicines (compared to patients who were not treated with them)
• the patient has a slow heart rate (less than 55 beats per minute)
• the patient has low potassium levels in the blood
• the patient or someone in their family has had blood clots, as the use of medicines like amisulpride is associated with the formation of blood clots
• the patient has a low white blood cell count (agranulocytosis). This leads to more frequent infections than usual.
• the patient often has infections with fever, chills, sore throat, or mouth ulcers. These may be symptoms of a blood disorder called leukopenia.

In case of doubts whether the above situations apply to the patient, consult your doctor or pharmacist before taking Amisulpryd Holsten.

Amisulpryd Holsten and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take, including those available without a prescription, including herbal medicines. Amisulpride may affect the action of some medicines, and some 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 to treat Parkinson's disease.
• medicines called "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 to treat mental illnesses
• medicines used for severe pain, called opioids, such as morphine, pethidine, or methadone
• medicines used for high blood pressure and heart disease, such as diltiazem and verapamil, guanfacine, and digitalis glycosides
• clonidine used to treat migraines, facial flushing, or high blood pressure
• mefloquine used to treat malaria
• sleeping pills, such as barbiturates and benzodiazepines
• painkillers, such as tramadol and indomethacin
• anesthetics
• antihistamines, such as promethazine, which cause drowsiness.

In case of doubts whether the above situations apply to the patient, consult your doctor or pharmacist before taking Amisulpryd Holsten.

Amisulpryd Holsten with food, drink, and alcohol

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Do not take Amisulpryd Holsten if the patient is breastfeeding or plans to breastfeed.
It is not recommended to take this medicine during pregnancy, unless the benefit to the mother justifies the risk.
Before starting treatment, women of childbearing age should discuss effective contraception methods with their doctor.
In newborns whose mothers took amisulpride in the third trimester (last three months of pregnancy), the following symptoms may occur: trembling, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the child experiences any of these symptoms, consult a doctor.

Driving and operating machines

Amisulpryd Holsten may cause reduced alertness, dizziness, or drowsiness. If these symptoms occur, do not drive vehicles or operate any devices or machines.

Amisulpryd Holsten tablets contain lactose monohydrate.

If the doctor has previously determined that the patient has intolerance to some sugars, the patient 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, which means the medicine is considered "sodium-free".

3. How to take Amisulpryd Holsten

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

How to take the medicine

• The medicine should be taken orally.
• Tablets should be swallowed whole or divided, with water. Tablets should not be chewed.
• The medicine should be taken before a meal.
• If the patient feels that the action of the medicine is too strong or too weak, they should consult their doctor. Do not change the dosage yourself.
• If the doctor has informed the patient that they have intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Recommended dose

The dose depends on the severity of the disease. Follow the doctor's instructions carefully.
Adults
The usual dose is between 50 mg and 800 mg per day.
The doctor may start treatment with a lower dose if necessary.
If necessary, the doctor may prescribe a dose of up to 1200 mg per day.
Doses less than 300 mg per day can be taken once a day, as a single dose. The medicine should be taken at the same time every day.
Doses greater than 300 mg per day should be taken in two divided doses, half in the morning and half in the evening.
There are medicines from other pharmaceutical companies that contain amisulpride in smaller doses (such as 50 mg tablets).
Elderly patients
The safety of use in this group has been studied in a limited number of people. The doctor will carefully monitor the patient's condition due to the increased risk of low blood pressure or drowsiness caused by the medicine.
Patients with kidney function disorders
The doctor may reduce the dose.

Use in children and adolescents

The efficacy and safety of amisulpride in the age group from puberty to 18 years have not been established. There is little data on the use of amisulpride in adolescents with schizophrenia.
Therefore, this medicine should not be used in children and adolescents, as its safety in this age group has not been established yet.

Taking more than the recommended dose of Amisulpryd Holsten

If a larger dose of the medicine is taken than recommended, consult a doctor or go to the emergency department of the nearest hospital immediately. Take the medicine packaging with you so the doctor knows what the patient has taken. The following symptoms may occur: anxiety, trembling, muscle stiffness, low blood pressure, dizziness, or drowsiness, which can lead to loss of consciousness.

Missing a dose of Amisulpryd Holsten

If a dose of the medicine is missed, 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 the missed dose.

Stopping Amisulpryd Holsten

Do not stop taking Amisulpryd Holsten unless your doctor tells you to. Even if the patient feels better, do not stop taking the medicine. If the patient stops treatment, their condition may worsen or recur. Amisulpryd Holsten should not be stopped abruptly, unless the doctor advises otherwise. Stopping the treatment abruptly may cause the patient to experience withdrawal symptoms, such as:

• nausea, vomiting
• excessive sweating
• difficulty sleeping or feeling extremely anxious
• muscle stiffness or uncontrolled body movements
• return of the initial disease state.

In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

Blood tests

Taking Amisulpryd Holsten may affect the results of some blood tests. This includes tests for prolactin levels and liver function parameters. If the patient is going to have blood tests, they should inform their doctor that they are taking Amisulpryd Holsten.
In case of any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop taking Amisulpryd Holsten and contact your doctor or go to the emergency department of the nearest hospital immediately if:

• the patient has a high fever, sweats a lot, has muscle stiffness, rapid heart rate, rapid breathing, and disorientation, dizziness, or agitation. These may be symptoms of a severe but rare malignant neuroleptic 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 has blood clots in the veins, especially in the legs (symptoms are itching, pain, and redness of the leg). These clots can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If such symptoms are observed, consult a doctor immediately;
• the patient gets infections more often than usual. This may be due to blood disorders (agranulocytosis) or a decrease in the number of white blood cells (neutropenia).

Uncommon: may affect up to 1 in 100 people

• Allergic reaction. The symptoms may be: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Seizures (seizure attacks).

Tell your doctor immediately if you experience any of the following side effects:

Very common: may affect more than 1 in 10 people

• Trembling, increased muscle tension, or muscle spasms, slow body movements, increased salivation, excessive anxiety.

Common: may affect up to 1 in 10 people

• Uncontrolled body movements, mainly of the hands and feet. 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 of the face or tongue.

Other side effects:

Common: may affect up to 1 in 10 people

• Difficulty sleeping (insomnia), anxiety, agitation.
• Dizziness, drowsiness.
• Constipation, nausea, or vomiting, dry mouth.
• Weight gain.
• Milk secretion in women and men, breast pain.
• Menstrual disorders.
• Breast enlargement in men.
• Difficulty getting or maintaining an erection, ejaculation disorders.
• Dizziness (may be caused by low blood pressure).

Uncommon: may affect up to 1 in 100 people

• Slow heart rate.
• High blood sugar levels (hyperglycemia).
• Changes (increases) in liver enzyme activity.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Amisulpryd Holsten

Keep the medicine out of sight and reach of children.
There are no special instructions for storing the medicine.
Do not take Amisulpryd Holsten after the expiry date stated on the carton and blister after the "EXP" date. The batch number is stated after the "Lot" abbreviation. The expiry date stated is the last day of the specified month.
Do not take this medicine if you notice any discoloration of the tablets.
Medicines should not be disposed of via wastewater or household waste. 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 Amisulpryd Holsten contains

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

What Amisulpryd Holsten looks like and what the pack contains

White, round, flat tablet with a dividing line on one side and the inscription "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 authorization holder and manufacturer

Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
The leaflet does not contain all the information about the medicine. If you have any further questions or doubts, consult your doctor or pharmacist.

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

Poland:
Amisulpryd Holsten

Date of last revision of the leaflet: 08.2024