Masultab

Package Leaflet: Information for the User

Masultab, 50 mg, tablets

Masultab, 100 mg, tablets

Masultab, 200 mg, tablets

Masultab, 400 mg, tablets

Active substance: Amisulpridum
Read this leaflet carefully before taking the medicine, as it contains important information for you.

• 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. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Masultab and what is it used for

Amisulpride, the active substance of Masultab, is used to treat various forms of schizophrenia.
Masultab is indicated for the treatment of acute and chronic schizophrenic disorders with:

• positive symptoms of schizophrenia, especially with paranoid-hallucinatory syndrome (such as delusions, hallucinations, thought disorders),
• negative symptoms of schizophrenia (such as decreased drive, affective flattening, emotional withdrawal).

2. Important information before taking Masultab

When not to take Masultab:

• if you are allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• if you have certain prolactin-dependent tumors: pituitary gland tumor (prolactinoma) or breast cancer;
• if you have an adrenal gland tumor (pheochromocytoma);
• if you are breastfeeding (see also "Pregnancy and breastfeeding");
• if you are being treated with levodopa, bromocriptine, or ropinirole (substances used in Parkinson's disease) (see also "Masultab and other medicines");
• if you are taking medicines used to treat heart rhythm disorders (e.g., amiodarone, sotalol, quinidine, disopyramide, bepridil);
• if you are taking medicines that:
• enhance gastrointestinal motility (cisapride)
• are used in depression (sulpiride)
• are sedatives (thioridazine)
• are substitutes for narcotics (methadone)
• are antibiotics given intravenously (erythromycin)
• are certain antibiotics (sparfloxacin)
• improve blood circulation (vincamine)
• are used to treat protozoal infections (halofantrine, pentamidine)
• are used to treat fungal infections (imidazole)
• Children and adolescents under 14 years of age should not take Masultab.

Warnings and precautions

You should be particularly cautious when taking Masultab if you have any additional health conditions.
Before starting treatment with Masultab, you should consult your doctor.
If you have any of the following diseases, your doctor will closely monitor the use of Masultab and adjust the dosage individually:

• heart disease or blood vessel disease
• bone marrow damage
• severe kidney and liver disorders
• Parkinson's disease

If you have acute alcohol poisoning, sedatives, or drugs that affect mental functions.
In such cases, before starting Masultab, your doctor will treat the poisoning.
Elderly patients (over 65 years old)
In the case of elderly patients, the doctor will adjust the dose of Masultab with caution to minimize the risk of low blood pressure or fatigue.
If you experience any of the following symptoms during treatment
If you experience any of the following symptoms during treatment, such as high fever, muscle stiffness, circulation disorders, and consciousness disorders or muscle weakness associated with muscle pain (rhabdomyolysis) and increased creatine phosphokinase (CPK) enzyme levels in the blood, you should stop taking Masultab and immediately inform your doctor. The doctor will check if you have a very rare "malignant neuroleptic syndrome" (MNS), which can lead to death, and will start appropriate treatment.
If you experience heart rhythm disorders or changes in laboratory measurements of heart rhythm (ECG).
Before starting Masultab, your doctor will check:

• if you have heart disease and coronary artery disease
• if there have been specific changes in the ECG recording in your family (so-called long QT syndrome)
• if you are taking sedatives, tranquilizers, or antipsychotic drugs (so-called neuroleptics), as they should be avoided when taking Masultab.

If there is a risk of stroke
If you are at risk of stroke, your doctor will recommend taking Masultab with caution and will closely monitor the treatment.
If there is a risk of breast cancer
If you are at risk of breast cancer, your doctor will recommend taking Masultab with caution and will closely monitor the treatment.
If you have diabetes
Increased blood sugar levels have been observed during treatment with medicines like Masultab. If you have diabetes or risk factors for developing diabetes, your doctor will monitor your blood sugar levels when starting Masultab.
In case of seizures
If you have had seizures or have a history of seizures, you should inform your doctor, as Masultab may cause such symptoms. If necessary, your doctor will closely monitor the use of Masultab.
If you have kidney disease
In the case of impaired kidney function, your doctor may reduce the dose of Masultab.
If you or a family member have had blood clots in the past
The use of antipsychotic drugs is associated with the occurrence of blood clots. Your doctor will determine before starting treatment and during treatment if there are any risk factors for developing blood clots and will take preventive measures.
In case of sudden discontinuation of treatment
Sudden discontinuation of high doses may cause withdrawal symptoms, such as nausea, vomiting, and drowsiness. Therefore, your doctor will recommend gradual, gradual discontinuation of Masultab.
If you experience unexplained infections or fever during treatment
In such cases, your doctor will order a blood test.
If you experience decreased vision and persistent headache during treatment
Drugs like Masultab may increase prolactin levels (one of the hormones). During treatment with Masultab, cases of benign pituitary tumors (prolactinoma) have been observed (see "Possible side effects"). If you experience decreased vision and headaches that may be symptoms of a pituitary tumor, your doctor will order appropriate tests.
Liver damage
Masultab may cause serious liver damage. You should contact your doctor immediately if you experience fatigue, loss of appetite, nausea, vomiting, abdominal pain, or yellowing of the eyes or skin.

Masultab and other medicines

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

The following medicines must not be taken with Masultab:

• medicines that can cause significant heart rhythm disorders (e.g., with the active substance quinidine, disopyramide, amiodarone, sotalol)
• Medicinal products containing the following active substances:
• levodopa, bromocriptine, ropinirole (in the treatment of Parkinson's disease)
• thioridazine, sulpiride (in the treatment of mental illnesses)
• sparfloxacin, erythromycin (given intravenously) (certain antibiotics)
• halofantrine, pentamidine (in the treatment of protozoal infections)
• imidazole (in the treatment of fungal infections)
• cisapride (a drug used in gastrointestinal disorders)
• bepridil (in the treatment of heart pain)
• methadone (pharmacological substitution therapy)
• vincamine given intravenously (a drug that stimulates blood circulation).

Your doctor will closely monitor the use of Masultab when taking the following medicines:

• depressant drugs, as strong drowsiness and drowsiness may occur, e.g., anesthetics, certain painkillers, certain antihistamines (used in allergic diseases or motion sickness), sedatives, tranquilizers, and antipsychotics, certain blood pressure lowering drugs (active substance: clonidine and related substances)
• if you need antibiotics for bacterial infections, your doctor will closely monitor the treatment for the first few weeks
• drugs that slow down heart rate (such as diltiazem and verapamil, clonidine, guanfacine, digitalis glycosides)
• drugs that can cause potassium deficiency in the blood (diuretics, laxatives, active substances such as amphotericin (given intravenously), glucocorticoids, tetracosactide)
• drugs used in the treatment of mental disorders (active substances such as pimozide, haloperidol, tricyclic antidepressants, lithium)
• the use of Masultab with the active substance clozapine may increase the level of Masultab in the blood
• certain antimalarial drugs (e.g., with the active substance mefloquine).

Masultab and alcohol

Masultab may enhance the effects of alcohol on the nervous system. Therefore, you should avoid drinking alcohol while taking Masultab.

Pregnancy and breastfeeding

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
Masultab is not recommended during pregnancy and in women of childbearing age who do not use effective contraception.
If you have taken Masultab in the last three months of pregnancy, your baby may experience the following symptoms: restlessness, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding difficulties. If your baby experiences any of these symptoms, you should contact your doctor.
Masultab passes into the placenta.
Breastfeeding
You should not breastfeed while taking Masultab. You should discuss with your doctor the best way to feed your baby while taking Masultab.

Driving and using machines

Masultab may cause drowsiness and impaired vision, even when taken as recommended, and may affect your reaction time to the extent that it impairs your ability to actively participate in traffic or operate machinery (see section 4 "Possible side effects"). This applies even more when combined with alcohol and medicinal products with a depressant effect on the nervous system.

Masultab contains lactose and sodium

Masultab contains lactose monohydrate, a type of sugar. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Masultab

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The tablets can be divided into equal doses.
The following tablet strengths are available: 50 mg, 100 mg, 200 mg, 400 mg
Unless your doctor has prescribed otherwise, the recommended doses are as follows:
Negative symptoms of psychosis or symptoms of inhibition
Adults:
50-300 mg amisulpride per day
Positive symptoms of psychosis
Adults:
400-800 mg amisulpride per day. In individual cases, the maximum dose of amisulpride may be increased to 1200 mg per day.

Adolescents from 14 to 18 years old

There are limited data on the efficacy and safety of Masultab in adolescents from 14 to 18 years old, so it is not recommended to use it in this age group.
If there is an absolute indication, the dosage should be the same as for adults.

Elderly patients (65 years and older)

In elderly patients, the doctor will use Masultab with caution due to the risk of low blood pressure and depressant effects.

Use in patients with renal impairment

If you have reduced kidney function, your doctor may prescribe a lower dose.
Creatinine clearance of 30-60 mL/min: half the dose
Creatinine clearance of 10-30 mL/min: one-third of the dose.
If kidney function is even lower, your doctor will adjust the dose individually.

Use in patients with hepatic impairment

Usually, no dose reduction is necessary

Instructions for taking the medicine

Oral administration.
A daily dose of Masultab up to 400 mg can be taken once a day.
In the case of higher daily doses, your doctor will recommend taking the medicine in two single doses.
The tablets should be swallowed whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water), regardless of meals.
Your doctor will determine the individual dose and duration of treatment depending on your condition.

Overdose of Masultab

Symptoms of overdose may include drowsiness, dizziness, low blood pressure, nausea, and muscle stiffness.
If you have taken more than the recommended dose of Masultab, you should contact your doctor or go to the nearest hospital immediately. You should take the medicine package with you so that the doctor knows what medicine you have taken.
Information for the doctor on how to proceed in case of overdose can be found at the end of this leaflet.

Missed dose of Masultab

You should not take a double dose to make up for a missed dose. You should continue treatment as usual.

Stopping treatment with Masultab

In the case of premature discontinuation of Masultab, the original symptoms may recur. Therefore, treatment should only be discontinued or terminated after consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Masultab can cause side effects, although not everybody gets them.
The following side effects have been observed in controlled clinical trials and spontaneous reports. Note that in some cases, it is difficult to distinguish side effects from symptoms of the underlying disease.
Very common:may affect more than 1 in 10 people

• Nausea, muscle tension, restricted movements, strong excitement, anxiety, movement disorders. (These disorders are mild when Masultab is dosed correctly and usually disappear completely after stopping treatment. The doctor will not stop treatment with Masultab.)

Common:may affect up to 1 in 10 people

• Increased prolactin levels in the blood may lead to temporary absence of menstruation, milk secretion, breast enlargement, breast tension, or erectile dysfunction (symptoms disappear after stopping Masultab).
• Insomnia, anxiety, anxiety, sexual disorders.
• Cervical torsion, eye muscle spasm, jaw spasm (these disorders disappear completely after applying a specific treatment). The doctor will not stop treatment with Masultab.
• Drowsiness, dizziness.
• Impaired vision.
• Low blood pressure.
• Constipation, nausea, vomiting, dry mouth.
• Weight gain

Uncommon:may affect up to 1 in 100 people

• Blood: Decreased total white blood cell count (leukopenia, neutropenia).
• Allergic reactions.
• Disorders of fat metabolism, increased cholesterol levels.
• Increased blood sugar levels (see also "Warnings and precautions").
• Confusion.
• Prolonged treatment may cause involuntary movements of the tongue or face; seizures
• Slow heart rate.
• High blood pressure.
• Stuffy nose, respiratory tract diseases.
• Decreased bone density, bone loss (osteoporosis).
• Urinary retention.
• Increased liver enzyme activity (especially transaminases) in the blood.

Rare:may affect up to 1 in 1,000 people

• Blood: significant decrease in the number of certain white blood cells, increased susceptibility to infections, fever.
• Benign pituitary tumor (symptoms include decreased vision and headache) (see "Warnings and precautions").
• Decreased sodium levels in the blood, syndrome of inadequate ADH secretion (SIADH) (excessive water retention in the body).
• "Malignant neuroleptic syndrome" with symptoms such as sudden fever, muscle stiffness, circulation disorders, and consciousness disorders (see "Warnings and precautions").
• Certain changes in ECG (QT interval prolongation); heart rhythm disorders that can lead to ventricular fibrillation or cardiac arrest (potentially fatal) (see "Warnings and precautions").
• 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.
• Skin: allergic, painful swelling of the skin and subcutaneous tissue, especially on the face; hives

Frequency not known: the frequency of occurrence cannot be determined from the available data

• Restless legs syndrome (unpleasant sensation in the legs, which improves temporarily with movement and worsens at the end of the day)
• Liver cell damage
• Increased skin sensitivity to sunlight and ultraviolet radiation (UV)
• Withdrawal symptoms in newborns
• Falls due to side effects that affect balance, sometimes leading to fractures
• Rhabdomyolysis (muscle breakdown associated with muscle pain)
• Increased creatine phosphokinase (CPK) enzyme activity (a blood value indicating muscle damage)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
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 Masultab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 pack and other information

What Masultab contains

• The active substance of Masultab is amisulpride. Each tablet contains 50 mg, 100 mg, 200 mg, or 400 mg of amisulpride.
• The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose (type A), hypromellose 2910 E5, microcrystalline cellulose PH-101, magnesium stearate.

What Masultab looks like and contents of the pack

Masultab, 50 mg: white, round, flat tablets with a diameter of 7 mm.
Masultab, 100 mg: white, round, flat tablets with a diameter of 9.5 mm with the inscription MC on one side.
Masultab, 200 mg: white, round, flat tablets with a diameter of 11.5 mm with a dividing line on one side. The tablet can be divided into equal doses.
Masultab, 400 mg: white, convex tablets in the shape of a capsule, with a dividing line on both sides, measuring 19 mm x 10 mm. The tablet can be divided into equal doses.
Masultab, 50 mg, tablets: PVC/PE/PVDC/Aluminum or PVC/PVDC/Aluminum blisters, containing 12, 20, 30, 60, 90, or 100 tablets, in a cardboard box.
Masultab, 100/200/400 mg, tablets: PVC/PE/PVDC/Aluminum or PVC/PVDC/Aluminum blisters, containing 20, 30, 60, 90, or 100 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria

Manufacturer

G.L. Pharma GmbH
Schlossplatz 1
8502 Lannach
Austria
Medochemie Limited
Constantinoupoleos 1-10
3011 Limassol
Cyprus

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

Austria: Amisu 50/100/200/400 mg tablets
Poland: Masultab
Romania: Masultab 50/100/200/400 mg tablets
Hungary: Talsian 50/100/200/400 mg tablets

For more information about this medicine, contact your local representative of the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o.
Sienna 75 Street; 00-833 Warsaw, Poland
Tel: +48 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of last revision of the leaflet: 06.06.2024

The following information is intended for healthcare professionals:

Procedure in case of overdose
In case of acute overdose, consider the possibility of poisoning with several medicines.
Since amisulpride can only be dialyzed in small amounts, hemodialysis is not suitable for eliminating amisulpride. There is no specific antidote for amisulpride. In case of overdose, therefore, take standard precautions: continuous monitoring of vital functions and ECG (risk of QT interval prolongation) until the patient recovers.
If severe extrapyramidal disorders occur, administer anticholinergic drugs.