Masultab

Leaflet included in the packaging: information for the user

Masultab, 50 mg, tablets

Masultab, 100 mg, tablets

Masultab, 200 mg, tablets

Masultab, 400 mg, tablets

Active substance: Amisulpridum
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. 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 undesirable effects, including any undesirable effects not mentioned in this leaflet, they should tell their 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 undesirable effects
• 5. How to store Masultab
• 6. Contents of the packaging and other information

1. What is Masultab and what is it used for

Amisulpride, the active substance of Masultab, is used in the treatment of various forms of schizophrenia.
Masultab is indicated for the treatment of acute and chronic schizophrenia 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 the patient is allergic to amisulpride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has certain tumors dependent on prolactin: pituitary tumor (prolactinoma) or breast cancer;
• if the patient has an adrenal gland tumor (pheochromocytoma);
• if the patient is breastfeeding (see "Pregnancy and breastfeeding");
• if the patient is being treated with levodopa, bromocriptine, or ropinirole (active substances used in Parkinson's disease) (see also "Masultab and other medicines");
• if the patient is taking medicines used to treat heart rhythm disorders (e.g., amiodarone, sotalol, quinidine, disopyramide, bepridil);
• if the patient is taking medicines:
• that slow down the movement of the digestive tract (cisapride)
• used in depression (sulpiride)
• sedatives (thioridazine)
• narcotic substitutes (methadone)
• intravenous antibiotics (erythromycin)
• certain antibiotics (sparfloxacin)
• that improve blood circulation (vincamine)
• against protozoal infections (halofantrine, pentamidine)
• against fungal infections (imidazole)
• in children and adolescents under 14 years of age, Masultab should not be used.

Warnings and precautions

You should exercise particular caution when taking Masultab in case of additional health conditions. Before starting treatment with Masultab, you should consult a doctor.
If the patient has any of the following diseases, the doctor will carefully 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 the patient has acute alcohol poisoning, sleeping pills, or drugs that affect mental functions.
In such a case, before starting Masultab, the doctor will treat the poisoning.
Elderly patients (over 65 years old)
In the case of elderly patients, the doctor will carefully adjust the dose of Masultab to minimize the risk of low blood pressure or fatigue.
If during treatment, the following disorders occur
If during treatment, the following disorders occur, the doctor will stop the treatment with Masultab and immediately inform the doctor. The doctor will check if the patient has a very rare "malignant neuroleptic syndrome" (English: malignant neuroleptic syndrome - MNS), which can lead to death, and will start appropriate treatment.
If there are rhythm disorders or changes in laboratory measurements of heart rhythm (EKG).
Before starting Masultab, the doctor will check:

• if the patient has heart disease and coronary artery disease
• if there have been specific changes in the EKG recording in the patient's family (so-called long QT syndrome)
• if the patient is taking sleeping pills, sedatives, or antipsychotic drugs (so-called neuroleptics), as they should be avoided when taking Masultab.

If there is a risk of stroke
If the patient has a risk of stroke, the doctor will recommend taking Masultab with caution and will monitor the treatment accordingly.
If there is a risk of breast cancer
If the patient has a risk of breast cancer, the doctor will recommend taking Masultab with caution and will monitor the treatment accordingly.
If the patient has diabetes
It has been observed that the level of sugar in the blood increases during treatment with medicines such as Masultab. If the patient has diabetes or risk factors for diabetes, the doctor will monitor the blood sugar level at the start of Masultab treatment.
In case of seizures
If the patient has or has had epilepsy in the past, they should inform the doctor, as Masultab may cause such symptoms. If necessary, the doctor will closely monitor the use of Masultab.
If the patient has kidney disease
In the case of impaired kidney function, the doctor will reduce the dose of Masultab accordingly.
If the patient or a family member has had blood clots in the past
The use of antipsychotic drugs is associated with the occurrence of blood clots. The doctor will determine before starting treatment and during treatment if there are any risk factors for the development of venous thrombosis 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, the doctor will recommend gradual, gradual discontinuation of Masultab.
If during treatment, unexplained infections or fever occur
In such cases, the doctor will order a blood test.
If during treatment, a decrease in vision and persistent headache occur
Drugs such as Masultab may increase the level of prolactin (one of the hormones). During Masultab treatment, cases of benign pituitary tumors (prolactinoma) have been observed (see "What are the possible undesirable effects?"). In case of decreased vision and headaches that may be symptoms of a pituitary tumor, the 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

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

The following medicines must not be taken at the same time as 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 (intravenous) (certain antibiotics)
• halofantrine, pentamidine (in the treatment of protozoal infections)
• imidazole (in the treatment of fungal infections)
• cisapride (a medicine used in gastrointestinal disorders)
• bepridil (in the treatment of heart pain)
• methadone (pharmacological replacement therapy)
• vincamine administered intravenously (a medicine that stimulates blood circulation).

The doctor will carefully monitor the use of Masultab in case of concurrent use of 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), sleeping pills, sedatives, and antipsychotics, certain blood pressure lowering drugs (active substance: clonidine and related substances)
• if the patient needs antibiotics for bacterial infections, the doctor will carefully monitor the treatment for the first few weeks
• drugs that slow down the 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 (intravenous), 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 lead to an increase in the level of Masultab in the blood
• certain antimalarial drugs (e.g., with the active substance mefloquine).

Masultab with alcohol

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to have a child, you should consult your doctor 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, the baby may experience the following symptoms: restlessness, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding difficulties. If the 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 blurred vision, even if taken as recommended, and may affect reaction time to the extent that it impairs the ability to actively participate in traffic or operate machines (see section 4. "Possible undesirable effects"). This applies to a greater extent to the combination 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 been diagnosed with intolerance to some sugars, you should contact your doctor before taking the 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

This medicine should always be taken as directed by your doctor. In case of doubts, you should consult a doctor or pharmacist.
The tablets can be divided into equal doses.
For individual doses, the following tablet strengths are available: 50 mg, 100 mg, 200 mg, 400 mg
Unless the doctor prescribes otherwise, the recommended doses are as follows:
Negative symptoms of psychosis or symptoms of inhibition
Adults:
50-300 mg of amisulpride per day
Positive symptoms of psychosis
Adults:
400-800 mg of 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 cannot be recommended for use in this age group.
If there is an absolute indication, the dosage should be used as in 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 impaired kidney function

If the patient has impaired kidney function, the doctor may recommend 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, the doctor will adjust the dose individually.

Use in patients with impaired liver function

Usually, no dose reduction is necessary

Instructions for taking the medicine

Oral administration.
The daily dose of Masultab up to 400 mg can be taken once.
In the case of higher daily doses, the 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.
The doctor will determine the individual dose and duration of treatment depending on the patient's condition.

Use of a higher than recommended dose of Masultab

Overdose symptoms may include drowsiness, stupor, low blood pressure, tremors, and stiffness.
In case of taking a higher than recommended dose of Masultab, you should immediately contact a doctor or go to the nearest hospital. You should take the medicine packaging with you so that the doctor knows what medicine you have taken.
Information for the doctor regarding the procedure in case of overdose can be found at the end of this leaflet.

Missing a dose of Masultab

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

Discontinuation of Masultab

In case of premature discontinuation of Masultab, the original symptoms may recur. Therefore, treatment should only be discontinued or completed after consulting a doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible undesirable effects

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

• Tremors, muscle tension, restricted movements, strong excitement, anxiety, movement disorders. (These disorders are mild when Masultab is dosed correctly and usually disappear completely after the end of targeted treatment. The doctor will not discontinue Masultab treatment).

Common:may affect up to 1 in 10 people

• Increased hormone levels (prolactin) in the blood may lead to temporary absence of menstruation, milk secretion, breast enlargement, breast tension, or erectile dysfunction (symptoms disappear after discontinuation of Masultab).
• Insomnia, anxiety, anxiety, sexual disorders.
• Cervical torsion, eye muscle spasm, jaw spasm (these disorders disappear completely after the use of targeted treatment). The doctor will not discontinue Masultab treatment.
• Drowsiness, dizziness.
• Blurred 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.
• During long-term treatment, involuntary movements of the tongue or face may occur; 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 EKG (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; urticaria

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

• Restless legs syndrome (unpleasant sensation in the legs, which improves briefly 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 undesirable effects that affect balance, sometimes leading to fractures
• Rhabdomyolysis (muscle breakdown associated with muscle pain)
• Increased creatine phosphokinase activity (blood value indicating muscle damage)

Reporting undesirable effects

If you experience any undesirable effects, including any undesirable effects not mentioned in this leaflet, you should tell your doctor, pharmacist, or nurse. Undesirable 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
Undesirable effects can also be reported to the marketing authorization holder.
Thanks to the reporting of undesirable effects, more information can be collected on the safety of the medicine.

5. How to store Masultab

The medicine should be stored in a place that is not visible and inaccessible to children.
You should not use the medicine after the expiration date stated on the packaging after EXP. The expiration date refers to the last day of the specified month.
There are no special recommendations for storing the medicine.
Medicines should not be disposed of in the sewage system or household waste containers. You should 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 Masultab contains

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

What Masultab looks like and what the packaging contains

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, bilaterally 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

In order to obtain more detailed information about this medicine, you should contact the 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, the possibility of poisoning with several medicines should be considered.
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, standard precautions should be taken: continuous monitoring of vital functions and EKG (risk of QT interval prolongation) until the patient recovers.
If pronounced extrapyramidal disorders occur, anticholinergic drugs should be administered.