Amisulprid Holsten

Leaflet attached to the packaging: patient information

Amisulpryd Holsten, 400 mg, coated 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:

• if the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• if the patient is breastfeeding (see "Pregnancy and breastfeeding").
• if the patient has breast cancer or tumors whose growth is dependent on prolactin levels.
• if the patient has a pheochromocytoma.
• if the patient is taking other medicines that may affect heart function, such as anti-arrhythmic drugs (see "Taking other medicines").
• if the patient is taking levodopa, a medicine used to treat Parkinson's disease (see "Taking other medicines").
• 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, the patient should consult their doctor or pharmacist before taking Amisulpryd Holsten.

Warnings and precautions

Before starting to take Amisulpryd Holsten, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney problems
• the patient has Parkinson's disease
• the patient has had seizures (epileptic fits) in the past
• the patient has abnormal heart function (heart rhythm)
• there is a history of heart disease or cardiac 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 experiencing low blood pressure or drowsiness. There have been reports of a small 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 can lead to more frequent infections than usual.
• the patient often experiences 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, before taking Amisulpryd Holsten, they should consult their doctor or pharmacist.

Amisulpryd Holsten and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan 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, amisulpride should not be taken, and the doctor should be informed 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.

The patient should tell their doctor if they are 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 medicines, 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, before taking Amisulpryd Holsten, they should consult their doctor or pharmacist.

Amisulpryd Holsten with food, drink, and alcohol

• Amisulpryd Holsten tablets should be swallowed before a meal, with a large amount of water.
• Alcohol should not be consumed 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.
Amisulpryd Holsten should not be taken if the patient is breastfeeding or plans to breastfeed.
This medicine should not be taken during pregnancy, unless the benefit to the mother justifies the risk.
Before starting treatment, women of childbearing age should discuss effective contraceptive 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, the doctor should be contacted.

Driving and operating machines

Amisulpryd Holsten may cause reduced alertness, dizziness, or drowsiness. If these symptoms occur, the patient should 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 contact their doctor before taking this medicine.

Amisulpryd Holsten tablets contain sodium.

The medicine contains less than 1 mmol (23 mg) of sodium per coated 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, the patient should consult their doctor or pharmacist.

Administration

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

Recommended dose

The dose depends on the severity of the disease. The patient should follow their doctor's instructions exactly.
Adults
Typically, the 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.
Other pharmaceutical companies' medicines containing amisulpride in smaller doses (such as 50 mg tablets) are available.
Elderly patients
The safety of use in this group has been studied in a limited number of patients. The doctor will carefully monitor the patient's condition due to the increased risk of low blood pressure or drowsiness caused by the medicine.

Use in children and adolescents

The efficacy and safety of amisulpride in the age group from adolescence to 18 years have not been established. There is limited data on the use of amisulpride in adolescents with schizophrenia.
Therefore, do notuse this medicine in children and adolescents, as its safety in this age group has not been established.

Taking more than the recommended dose of Amisulpryd Holsten

In case of taking a larger dose than recommended, the patient should immediately consult their doctor or go to the emergency department of the nearest hospital. The patient should take the medicine packaging with them, 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

In case of missing a dose, the patient should take it as soon as possible. However, if it is almost time for the next dose, the patient should skip the missed dose.
The patient should not take a double dose to make up for the missed dose.

Stopping Amisulpryd Holsten

The patient should continue taking Amisulpryd Holsten until their doctor advises them to stop. Even if the patient feels better, they should 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. Abruptly stopping treatment 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, the patient should consult their 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, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking Amisulpryd Holsten and immediately contact their doctor or go to the emergency department of the nearest hospital if:

• the patient has a high fever, excessive sweating, muscle stiffness, rapid heart rate, rapid breathing, and disorientation, dizziness, or agitation. These may be symptoms of a severe but rare neuroleptic malignant syndrome;
• the patient has abnormal heart function, rapid heart rate, 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 include itching, pain, and redness of the leg). These clots can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If such symptoms are observed, the patient should immediately contact their doctor;
• the patient experiences more frequent infections than usual. This may be due to blood disorders (agranulocytosis) or a decrease in white blood cell count (neutropenia).

Uncommon: may affect up to 1 in 100 people

• Allergic reaction. Symptoms may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• Seizures (epileptic fits).

The patient should immediately inform their doctor if they experience any of the following side effects:

Very common: may affect more than 1 in 10 people

• Trembling, increased muscle tension, or spasm, 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 amisulpride dose 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 achieving 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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:
Al. Jerozolimskie 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

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not take Amisulpryd Holsten after the expiry date stated on the carton and blister after the expiry date (EXP). The batch number is stated after the "Lot" abbreviation. The expiry date refers to the last day of the month stated.
Do not take this medicine if the patient notices any signs of tablet discoloration.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 coated tablet contains 400 mg of amisulpride.
• The other ingredients are: lactose monohydrate, methylcellulose, sodium carboxymethylcellulose type A, microcrystalline cellulose, magnesium stearate, butyl methacrylate copolymer, titanium dioxide (E171), talc, magnesium stearate, macrogol 6000.

What Amisulpryd Holsten looks like and contents of the pack

White or almost white, oblong, coated tablet with a dividing line on one side.
The medicine is available in packs containing 30, 60, and 90 coated 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. In case of any further questions or doubts, the patient should consult their 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