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
Please read all of this leaflet carefully before taking this medicine, because 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 personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Masultab is and what it is 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 Masultab is and what it is used for

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

• positive symptoms of schizophrenic-type psychosis, especially paranoid-hallucinatory syndrome (such as delusions, hallucinations, thought disorders),
• negative symptoms of schizophrenic-type psychosis (such as reduced drive, affective blunting, emotional withdrawal).

2. Important information before using 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 prolactin-dependent tumours: pituitary tumour (pituitary prolactinoma) or breast cancer;
• if the patient has an adrenal gland tumour (pheochromocytoma);
• if the patient is breastfeeding (see below "Pregnancy and breastfeeding")
• if the patient is currently being treated with levodopa, bromocriptine or ropinirole (active substances used in Parkinson's disease) (see also "Masultab and other medicines")
• if the patient is currently taking medicines used to treat heart rhythm disorders (e.g. amiodarone, sotalol, quinidine, disopyramide, bepridil);
• if the patient is currently taking any of the following medicines:
• drugs that increase gastrointestinal motility (cisapride)
• medicines used in depression (sultopride)
• sedatives (thioridazine)
• opioid substitutes (methadone)
• antibiotics administered intravenously (erythromycin)
• certain antibiotics (sparfloxacin)
• medicines improving blood circulation (vinpocetine)
• medicines against protozoal infections (halofantrine, pentamidine)
• antifungal medicines (imidazole)
• Masultab must not be used in children and adolescents under 14 years of age.

Warnings and precautions
Special caution is required when taking Masultab if any additional medical conditions are present. Before starting treatment with Masultab, consult your doctor.
If the patient has any of the following diseases, the doctor will closely monitor the use of
Masultab and individually adjust the dosage:

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

If the patient has acute alcohol intoxication, sedative drugs or medicines affecting mental functions.
In such cases, the doctor will treat the intoxication before starting Masultab therapy.
Elderly patients (over 65 years of age)
In elderly patients, the doctor will carefully adjust the dose of Masultab to minimize the risk of low blood pressure or fatigue.
If the following disorders occur during treatment
If during treatment the following symptoms occur: sudden high fever, muscle rigidity, circulatory disturbances and disturbances of consciousness, or muscle weakness associated with muscle pain (rhabdomyolysis) and increased blood levels of the muscle enzyme creatine phosphokinase (CPK), treatment with Masultab must be discontinued and the doctor must be informed immediately. The doctor will check whether the patient has a very rare "neuroleptic malignant syndrome" (NMS), which may be fatal, and will initiate appropriate treatment.
If there are heart rhythm disorders or changes in laboratory heart rhythm measurements (ECG).
Before starting Masultab, the doctor will check:

• whether the patient has heart or coronary artery disease
• whether there is a family history of specific ECG abnormalities (so-called long QT syndrome)
• whether the patient is taking sleeping pills, sedatives or antipsychotics (neuroleptics), as these should not be used concomitantly with Masultab.

If there is a risk of stroke
If the patient is at risk of stroke, the doctor will recommend using Masultab with caution and will appropriately monitor the course of treatment.
If there is a risk of breast cancer
If the patient is at risk of breast cancer, the doctor will recommend using Masultab with caution and will appropriately monitor the course of treatment.
If the patient has diabetes
Increased blood sugar levels have been observed during treatment with medicines such as Masultab. If the patient has diabetes or risk factors for developing diabetes, the doctor will monitor blood glucose levels at the beginning of Masultab treatment.
In case of seizure disorders
If the patient has epilepsy or a history of seizures, the doctor should be informed, as Masultab may provoke such symptoms. If necessary, the doctor will closely monitor the use of Masultab.
If the patient has kidney disease
In case of impaired kidney function, the doctor will appropriately reduce the dose of the medicine.
If the patient or a family member has a history of blood clots
The use of antipsychotic medicines is associated with the occurrence of blood clots. The doctor will assess, before and during treatment, whether there are any risk factors for developing blood vessel disorders and will take preventive measures.
In case of sudden discontinuation of treatment
Sudden discontinuation of high-dose treatment may cause withdrawal symptoms such as nausea, vomiting and drowsiness. Therefore, the doctor will recommend gradually tapering off Masultab slowly.
If unexplained infections or fever occur during treatment
In such cases, the doctor will order blood tests.
If reduced visual field and persistent headache occur during treatment
Medicines such as Masultab may increase prolactin levels (one of the hormones). Cases of benign pituitary tumours (prolactinomas) have been observed during treatment with Masultab (see "What are the possible side effects?"). If worsening of visual field or headaches occur, which may be symptoms of a pituitary tumour, the doctor will order appropriate tests.
Liver damage
Masultab may cause serious liver function disturbances. Contact your doctor immediately if fatigue, loss of appetite, nausea, vomiting, abdominal pain or yellowing of the eyes or skin (jaundice) occur.
Masultab and other medicines
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 used concomitantly with Masultab:

• medicines that may cause significant disturbances in heart rhythm (e.g. containing the active substances quinidine, disopyramide, amiodarone, sotalol)
• Medicinal products containing the following active substances:
  • levodopa, bromocriptine, ropinirole (used in Parkinson's disease)
  • thioridazine, sultopride (used in psychiatric disorders)
  • sparfloxacin, erythromycin (administered intravenously) (certain antibiotics)
  • halofantrine, pentamidine (used in parasitic infections)
  • imidazole (used in fungal infections)
  • cisapride (a medicine used for gastrointestinal disorders)
  • bepridil (used for chest pain)
  • methadone (pharmacological substitution therapy)
  • intravenous vinpocetine (a medicine stimulating blood circulation).

The doctor will appropriately monitor the use of Masultab when the following medicines are used concomitantly:

• medicines with depressant effects on the central nervous system, as they may cause pronounced fatigue and drowsiness, e.g. anaesthetics, certain painkillers, certain antihistamines (used in allergic diseases or motion sickness), sleeping pills, sedatives and antipsychotics, certain antihypertensive medicines (active substance: clonidine and related substances)
• if the patient requires antibacterial treatment, the doctor will carefully monitor the treatment for the first few weeks
• medicines that slow heart rate (such as: diltiazem and verapamil, clonidine, guanfacine, cardiac glycosides)
• medicines that may cause low potassium levels in the blood (diuretics, laxatives, active substances such as: amphotericin (administered intravenously), glucocorticoids, tetracosactide)
• medicines used in the treatment of psychiatric disorders (active substances such as: pimozide, haloperidol, tricyclic antidepressants, lithium)
• concomitant use of Masultab with clozapine may lead to increased blood levels of Masultab
• certain antimalarial medicines (e.g. containing the active substance mefloquine).

Masultab and alcohol
Masultab may enhance the effect of alcohol on the nervous system. Therefore, alcohol consumption should be avoided during treatment with Masultab.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.
Pregnancy
Masultab is not recommended during pregnancy and in women of childbearing potential who are not using effective contraception.
If a patient has taken Masultab during the last three months of pregnancy, the newborn may experience the following symptoms: restlessness, increased muscle tone, tremors, drowsiness, breathing difficulties or feeding problems. If any of these symptoms occur in the newborn, contact a doctor immediately.
Masultab crosses the placental barrier.
Breastfeeding
Breastfeeding must not be performed during treatment with Masultab. Discuss with your doctor the best way to feed the baby while taking Masultab.
Driving and operating machinery
Masultab may cause drowsiness and blurred vision, even when taken as directed, and may impair reaction ability to such an extent that it affects the ability to actively participate in road traffic or operate machinery (see section 4. "Possible side effects"). This effect is particularly pronounced when combined with alcohol or other medicinal products with central nervous system depressant effects.
Masultab contains lactose and sodium
Masultab contains monohydrate lactose, a type of sugar. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Masultab

This medicine should always be taken as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Tablets may be divided into equal doses.
The following tablet strengths are available for individual dosing: 50 mg, 100 mg, 200 mg, 400 mg.
Unless otherwise prescribed by the doctor, the recommended doses are as follows:
Negative symptoms of psychosis or inhibitory symptoms
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 up to 1200 mg per day.
Adolescents aged 14 to 18 years
There is limited data on the efficacy and safety of Masultab in adolescents aged 14 to 18 years; therefore,
its use cannot be recommended.
If there is an absolute medical indication, dosing should be as in adults.
Elderly patients (65 years and older)
In elderly patients, the physician will use Masultab cautiously due to the risk of hypotension and
depressive effects.
Use in patients with renal impairment
If the patient has reduced 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 renal function is even lower, the doctor will adjust the dose individually.
Use in patients with hepatic impairment
Dose reduction is usually not required.
Instructions for taking the medicine
Oral administration.
The daily dose of Masultab up to 400 mg may be taken as a single dose.
For daily doses exceeding 400 mg, the doctor will recommend taking the medicine in two
separate doses.
Tablets should be swallowed whole, without chewing, with sufficient 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.
Taking more than the recommended dose of Masultab
Symptoms of overdose may include drowsiness, stupor, hypotension, tremor, and muscle rigidity.
If more than the recommended dose of Masultab has been taken, seek immediate medical advice from a
doctor or go to the nearest hospital. Bring the medicine packaging with you so the doctor knows which
medicine the patient has taken.
Information for physicians on management in case of overdose is provided at the end of this leaflet.
Missed dose of Masultab
Do not take a double dose to make up for a missed dose. Continue treatment as usual.
Stopping Masultab treatment
If Masultab treatment is stopped prematurely, the original symptoms may recur. Therefore, treatment
should only be interrupted or discontinued after consultation with the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
The following adverse reactions have been observed in controlled clinical trials and in
spontaneous reports. It should be noted that in some cases it is difficult to distinguish
adverse reactions from symptoms of the underlying disease.

Very common: may affect more than 1 in 10 people

• Tremor, muscle tension, limitation of movements, severe agitation, anxiety, movement disorders. (These symptoms are mild when Masultab is properly dosed and usually resolve completely after targeted treatment is completed. The doctor will not discontinue treatment with Masultab).

Common: may affect up to 1 in 10 people

• Increased blood levels of the hormone (prolactin) may lead to temporary absence of menstruation, milk secretion, breast enlargement, chest tightness, or erectile dysfunction (symptoms resolve after discontinuation of Masultab).
• Insomnia, anxiety, restlessness, sexual disturbances.
• Neck spasms, eye muscle spasms, jaw spasms (these symptoms resolve completely with appropriate treatment). The doctor will not discontinue treatment with Masultab.
• 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 (so-called leukopenia, neutropenia).
• Allergic reactions.
• Fat metabolism disorders, increased cholesterol levels.
• Increased blood sugar levels (see also "Warnings and precautions").
• Confusion.
• With long-term treatment, involuntary movements of the tongue or face may occur; seizures.
• Slowed heart rate.
• High blood pressure.
• Nasal congestion, respiratory tract disorders.
• Decreased bone density, bone loss (so-called osteoporosis).
• Urinary retention.
• Increased activity of liver enzymes (especially transaminases) in blood.

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

• Blood: marked decrease in certain white blood cells increases susceptibility to infections, fever.
• Benign pituitary gland tumour (symptoms include reduced visual field and headache) (see "Warnings and precautions").
• Low sodium levels in blood, syndrome of inappropriate antidiuretic hormone secretion (SIADH) (insufficient fluid excretion by kidneys, resulting in inadequately diluted urine).
• "Neuroleptic malignant syndrome" with symptoms such as sudden fever, muscle rigidity, circulatory and consciousness disturbances (see "Warnings and precautions").
• Certain changes in ECG (QT interval); cardiac rhythm disturbances which may lead to ventricular fibrillation or cardiac arrest (potentially fatal) (see "Warnings and precautions").
• Blood clots in veins, especially in legs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties.
• Skin: allergic, painful swelling of skin and subcutaneous tissue, especially in the facial area; urticaria.

Frequency unknown: frequency cannot be estimated from available data

• Restless legs syndrome (unpleasant sensation in legs, temporarily relieved by movement and worsening towards the end of the day).
• Liver cell damage.
• Increased skin sensitivity to sunlight and ultraviolet (UV) radiation.
• Withdrawal symptoms in newborns.
• Falls due to adverse reactions affecting body balance, sometimes leading to fractures.
• Rhabdomyolysis (muscle breakdown associated with muscle pain).
• Increased creatine phosphokinase activity (a blood value indicating muscle damage).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration 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
Adverse reactions can also be reported to the responsible entity.
By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Masultab

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Masultab contains

• The active substance is amisulpride. Each tablet contains 50 mg, 100 mg, 200 mg, or 400 mg of amisulpride.
• Other ingredients are: monohydrate lactose, sodium carboxymethyl starch (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, marked with "MC" on one side.
Masultab 200 mg: white, round, flat tablets with a diameter of 11.5 mm and a score line on one side. The tablet can be divided into equal doses.
Masultab 400 mg: white, biconvex capsule-shaped tablets with a score line on both sides, measuring 19 mm x 10 mm. The tablet can be divided into equal doses.
Masultab 50 mg tablets: PVC/PVDC/Aluminium blisters containing 12, 20, 30, 60, 90 or 100 tablets, in a cardboard carton.
Masultab 100/200/400 mg tablets: PVC/PVDC/Aluminium blisters containing 20, 30, 60, 90 or 100 tablets, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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
Medochemie Ltd,
Agios Athanassios Industrial Area,
Michail Irakleous 2,
Agios Athanassios,
Limassol, 4101,
Cyprus

This medicinal product is authorised in the European Economic Area under the following names:
Austria: Amisu 50/100/200/400 mg-Tabletten
Poland: Masultab
Romania: Masultab 50/100/200/400 mg comprimate
Hungary: Talsian 100/200 mg tabletta

For further information about this medicine, contact the local representative of the Marketing Authorisation Holder:
G.L. PHARMA POLAND Sp. z o.o.
ul. Sienna 75; 00-833 Warsaw, Poland
Tel: +48 022/ 636 52 23; 636 53 02
[email protected]

The following information is intended for healthcare professionals:
Management in case of overdose
In acute overdose, consider the possibility of multiple drug intoxication.
Since amisulpride is only minimally dialyzable, hemodialysis is not suitable for eliminating amisulpride. There is no known specific antidote for amisulpride. In case of overdose, standard supportive measures should therefore be taken: continuous monitoring of vital functions and ECG (risk of QT interval prolongation) until the patient recovers.
If extrapyramidal symptoms occur, anticholinergic drugs should be administered.