Tiaprid Pmcs

Leaflet accompanying the packaging: information for the user

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Tiaprid PMCS

100 mg, tablets

Tiapridum

You should carefully read the contents of the leaflet before using 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.
• If you have any further doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. 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 Tiaprid PMCS and what is it used for
• 2. Important information before using Tiaprid PMCS
• 3. How to use Tiaprid PMCS
• 4. Possible side effects
• 5. How to store Tiaprid PMCS
• 6. Contents of the packaging and other information

1. What is Tiaprid PMCS and what is it used for

Tiaprid PMCS contains the active substance tiapride, which belongs to a group of medicines called antipsychotics, atypical neuroleptics. Tiaprid PMCS is a medicine that affects mental functions and has a positive effect on severe forms of involuntary and abnormal movements in patients. Tiaprid PMCS is used to treat behavioral disorders in elderly patients or in cases of chronic alcohol dependence, including the treatment of withdrawal symptoms after sudden cessation of alcohol consumption. The medicine is also used in cases of severe forms of abnormal movements (Huntington's chorea). Tiaprid PMCS can be used in adults and children from 6 years of age.

2. Important information before using Tiaprid PMCS

When not to use Tiaprid PMCS

• if the patient is allergic to tiapride or any of the other ingredients of this medicine (listed in section 6),
• if the patient has a rare adrenal gland disease, called pheochromocytoma, which causes headaches, hot flashes, and periodic increases in blood pressure,
• if the patient is taking a medicine containing levodopa or other dopaminergic medicines at the same time,
• if the patient has a brain tumor that produces prolactin and (or) breast cancer.

Warnings and precautions

Before starting treatment with Tiaprid PMCS, you should discuss it with your doctor: Like other neuroleptic medicines, a malignant neuroleptic syndrome (a complication that can be fatal) may occur, characterized by hyperthermia (increased body temperature above the normal range), muscle stiffness, and autonomic disorders (disorders of the part of the nervous system responsible for controlling internal body functions that are independent of will). Cases have been observed with atypical symptoms, such as lack of muscle stiffness or increased muscle tone, and lower fever. If unexplained hyperthermia occurs, tiapride treatment should be discontinued. Except in special cases, tiapride should not be used to treat patients with Parkinson's disease. Neuroleptic medicines may reduce the seizure threshold. Patients with epilepsy will be closely monitored during tiapride treatment. If the patient has kidney disease, the doctor will adjust the dose of the medicine, due to the possible risk of loss of consciousness due to overdose (see section 3). In elderly patients, the doctor will assess tiapride treatment individually for each patient, in relation to the potential risk (reduced level of consciousness and coma, increased risk of death due to concomitant use of antipsychotic medicines). Prolongation of the QT interval (a time interval measured between the beginning of the Q wave and the end of the T wave in the electrocardiogram): Tiapride may cause prolongation of the QT interval, which increases the risk of heart rhythm disorders. For this reason, before administering the medicine, the doctor will check if there are factors that may increase the risk of heart rhythm disorders, such as:

• Slowing of heart rate (bradycardia) below 55 beats per minute.
• Electrolyte disorders, especially hypokalemia (low potassium levels in the blood).
• Congenital prolongation of the QT interval.
• Concomitant use of medicines that may cause significant slowing of heart rate (<55 beats per minute), electrolyte imbalance, decreased intracardiac conduction, or prolongation of the qt interval.< li>

If the patient has risk factors for stroke, the doctor will closely monitor treatment with Tiaprid PMCS, as special caution is required in this case. Venous thromboembolic disease (a disease characterized by the formation of blood clots in a specific location in the bloodstream, and then moving to the lungs): There have been reports of venous thromboembolic disease, sometimes fatal, associated with the use of antipsychotic medicines. If the patient has or has had blood clots in the veins, the doctor will closely monitor treatment with Tiaprid PMCS, as special caution is required in this case. Tiapride may increase prolactin levels. Therefore, caution is advised. If the patient or a family member has breast cancer, the doctor will closely monitor the patient during tiapride treatment. There have been reports of decreased white blood cell count (leukopenia, neutropenia, agranulocytosis) associated with the use of antipsychotic medicines, including tiapride. If unexplained infection and fever occur, you should immediately contact your doctor, as these may be symptoms of blood disorders.

Children and adolescents

No thorough studies have been conducted on the use of tiapride in children and adolescents (see section 3).

Tiaprid PMCS and other medicines

Tiaprid and other medicines used at the same time may affect each other's action. 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. Dopaminergic agonists (medicines with an action similar to dopamine, a natural substance that plays an important role in the nervous system) and Tiaprid PMCS cancel each other's action, so they should not be used at the same time. Patients with Parkinson's disease should take the smallest effective dose of levodopa and tiapride. Medicines that affect the central nervous system, such as painkillers, antitussives, sedatives, antidepressants, anti-emetics, antihistamines, antihypertensives that act centrally, and other medicines (baclofen, thalidomide, pizotifen, clonidine) may enhance the action of tiapride, causing decreased alertness and increased drowsiness. Alcohol also enhances the overall action of Tiaprid PMCS, causing increased sedation and significant drowsiness. Therefore, you should avoid drinking alcohol while taking this medicine. Contraindicated combinations: Combinations with the following medicines that may cause serious heart rhythm disorders (torsade de pointes) or prolongation of the QT interval:

• Medicines that cause slowing of heart rate (bradycardia), such as beta blockers, calcium channel blockers that cause bradycardia, such as diltiazem and verapamil, clonidine, guanfacine, cardiac glycosides (digoxin), pilocarpine, cholinesterase inhibitors, and some anti-arrhythmic medicines of class II.
• Medicines that cause electrolyte disorders, especially hypokalemia (low potassium levels in the blood): diuretics that cause hypokalemia (medicines that increase urine production and decrease potassium levels in the blood, which requires the administration of potassium supplements or potassium-rich foods), laxatives that accelerate intestinal peristalsis (loosening the stool), amphotericin B administered intravenously, glucocorticoids, tetracosactide, and cosyntropin. The doctor will correct hypokalemia (low potassium levels in the blood).
• Anti-arrhythmic medicines of class IA (medicines used to treat heart rhythm disorders), such as quinidine, hydroquinidine, and disopyramide.
• Anti-arrhythmic medicines of class III, such as amiodarone, sotalol, dofetilide, and ibutilide.
• Certain anti-parasitic medicines, such as halofantrine, lumefantrine, pentamidine, and some neuroleptics (medicines used to treat psychoses), such as pimozide, sulpiride, haloperidol, thioridazine, pipamperone, flupentixol, and zuclopenthixol.
• Other medicines, such as methadone, imipramine, antidepressants, bepridil, cisapride, erythromycin administered intravenously, vincamine administered intravenously, sparfloxacin, difemanil, mizolastine, spiramycin, difemanil, and moxifloxacin.

The action of medicines that lower high blood pressure and medicines used to treat coronary heart disease may be enhanced when used with Tiaprid, which can lead to significant lowering of blood pressure, resulting in dizziness and loss of consciousness when standing up quickly.

Tiaprid PMCS with food, drink, and alcohol

Tiaprid PMCS can be used with or without food. You should not consume alcoholic beverages while taking Tiaprid PMCS.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Caution is advised when using this medicine during pregnancy. Pregnancy: Tiaprid PMCS should not be used during pregnancy or in women who may become pregnant and are not using effective contraception. Using Tiaprid PMCS during the last three months of pregnancy may cause the baby to experience symptoms such as restlessness, muscle tension, tremors, drowsiness, breathing difficulties, and feeding difficulties. If the baby experiences any of these symptoms, you should contact your doctor. Breastfeeding: You should not breastfeed while taking Tiaprid PMCS. If you are taking Tiaprid PMCS, you should contact your doctor to discuss the best way to feed your baby. Fertility: Tiaprid PMCS may cause absence of menstruation or ovulation and decreased fertility.

Driving and using machines

Tiaprid PMCS may impair your ability to drive and use machines, as it can cause sedation, even when used as recommended (see section 4). Tiaprid PMCS contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Tiaprid PMCS

This medicine should always be used as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The dose is determined by your doctor, individually for each patient. Adults: Treatment of behavioral disorders in elderly patients with dementia: the usual dose is 200-400 mg (2-4 tablets) per day, administered in two or three divided doses. Treatment starts with a dose of 50 mg (i.e., ½ tablet) twice a day, and then increased over the next 2-3 days to 100 mg (i.e., 1 tablet) three times a day. The average dose is 300 mg/day (i.e., 3 tablets per day); the maximum recommended dose is 400 mg/day (i.e., 4 tablets per day). The usual dose used to treat symptoms during chronic alcohol dependence is 300 mg to 400 mg (3-4 tablets) per day, administered in three divided doses, for 1-2 months. Severe forms of abnormal movements in Huntington's disease: the dose is determined individually within a wide range of dosing from 300 mg to 1200 mg (3-12 tablets). Elderly patients: Since elderly patients are very sensitive to the action of tiapride, the dose determined by the doctor should be followed carefully. Use in children and adolescents from 6 years of age: The usual dose is 100-150 mg per day, up to a maximum of 300 mg per day. In each case, the doctor will determine the appropriate dose, the number of tablets to be taken per day, and the duration of treatment. Renal impairment: The dose should be reduced to 75% of the usual dose in patients with creatinine clearance 30-60 ml/min, to 50% of the usual dose in patients with creatinine clearance 10-30 ml/min, and to 25% of the usual dose in patients with creatinine clearance below 10 ml/min. Hepatic impairment: The medicine is metabolized to a small extent in the liver, so dose reduction is not necessary.

Using a higher dose of Tiaprid PMCS than recommended

If you take more tablets than recommended, the following concerns may arise: drowsiness and sedation, coma, decreased blood pressure, facial and neck muscle spasms, uncontrolled tongue protrusion, prolonged muscle spasms, and stiffness of limb muscles. Tremors and stiffness of limb muscles may also occur. There have been reports of deaths due to tiapride overdose, mainly in combination with other medicines that affect the central nervous system. In case of overdose or accidental ingestion by a child, you should immediately contact your doctor or the emergency department of the nearest hospital.

Missing a dose of Tiaprid PMCS

You should take the tablet as soon as you remember. Do not take a double dose to make up for the missed dose. If you forget to take more than one dose, you should tell your doctor.

Stopping treatment with Tiaprid PMCS

You should not stop treatment with Tiaprid PMCS without consulting your doctor. The symptoms of the disease may return or worsen. Information for doctors: Appropriate supportive measures and close monitoring of vital functions are recommended. Monitoring of heart function is recommended until the patient's condition stabilizes (risk of QT interval prolongation and subsequent ventricular arrhythmias). If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tiaprid PMCS can cause side effects, although not everybody gets them. Frequent(may affect up to 1 in 10 people):

• Hyperprolactinemia, which may lead to other disorders in some cases. Less frequently, breast pain, breast enlargement (gynecomastia), menstrual disorders, or absence of menstruation in women, and orgasm disorders or impotence in men may occur.
• Drowsiness, insomnia, agitation, indifference.
• Dizziness/vertigo, headache.
• Symptoms similar to those of Parkinson's disease (tremors, increased muscle tone, limited mobility, and increased salivation). These symptoms are usually reversible after administration of an anticholinergic medicine (e.g., Biperiden).
• Fatigue, feeling of exhaustion.

Uncommon(may affect up to 1 in 100 people):

• Dystonia [muscle spasms, neck muscle contractions, involuntary eye movements (oculogyric crisis), muscle spasms of the jaw (trismus), akathisia (motor restlessness)]. These symptoms are usually reversible after administration of an anticholinergic medicine (e.g., Biperiden).
• Disorientation, hallucinations.
• Fainting (short-term loss of consciousness), seizures.
• Decreased blood pressure, usually orthostatic, deep vein thrombosis.
• Constipation.
• Rash (including redness, urticaria, or patchy rash).
• Absence of menstruation, orgasm disorders.
• Weight gain.

Rare(may affect up to 1 in 1000 people):

• Loss of consciousness.
• Decreased white blood cell count (leukopenia, neutropenia, agranulocytosis).
• Decreased sodium levels in the blood (hyponatremia), syndrome of inappropriate antidiuretic hormone secretion.
• Early dyskinesia (tongue or esophagus spasms, tics). These symptoms are usually reversible after administration of an anticholinergic medicine (e.g., Biperiden).
• Similarly to other antipsychotic medicines (neuroleptics), cases of late dyskinesia have been reported after long-term administration (more than three months), characterized by rhythmic involuntary movements, mainly of the tongue and (or) facial muscles. You should immediately inform your doctor if such movements occur; the doctor will decide on the necessary measures. Antiparkinsonian medicines should not be administered as an antidote, as they are ineffective or may worsen the symptoms.
• Similarly to other neuroleptic medicines, a malignant neuroleptic syndrome (which can be fatal) may occur (see "Important information before using Tiaprid PMCS").
• There have also been reports of heart conduction disorders (QT interval prolongation) and severe, ventricular arrhythmias (such as torsade de pointes, exacerbation of ventricular tachycardia), as well as atrial fibrillation, cardiac arrest, and sudden death (see "Warnings and precautions" and "Tiaprid PMCS and other medicines").
• Venous thromboembolism, particularly in the legs (with swelling, pain, and redness); the clot can move through the bloodstream to the lungs, causing chest pain and shortness of breath. If you experience any of these symptoms, you should immediately seek medical attention (see "Important information before using Tiaprid PMCS"). In some cases, pulmonary embolism can be fatal.
• Certain forms of pneumonia caused by accidental inhalation of food or liquids into the lungs (aspiration pneumonia), respiratory depression (respiratory depression).
• Bowel obstruction, intestinal obstruction.
• Increased liver enzyme activity.
• Rash (urticaria).
• Increased creatine phosphokinase (CPK) activity, muscle breakdown (rhabdomyolysis).

Unknown(based on available data):

• Withdrawal syndrome in newborns (see "Pregnancy, breastfeeding, and fertility").
• Falls, especially in elderly patients.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tiaprid PMCS

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from light and moisture. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. 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 Tiaprid PMCS contains

• The active substance of the medicine is tiapride. Each tablet contains 100 mg of tiapride in the form of 111.1 mg of tiapride hydrochloride.
• The other ingredients of the medicine are: mannitol, microcrystalline cellulose granules, povidone 25, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, and magnesium stearate.

What Tiaprid PMCS looks like and contents of the packaging

Tiaprid PMCS tablets are almost white, round, with a cross-shaped break line on one side, and a diameter of 9.5 mm. The tablet can be divided into four equal doses. The medicine is supplied in blister packs containing 20 and 50 tablets. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Manufacturer:

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Parallel importer:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź, SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów

Marketing authorization number in the Czech Republic, the country of export: 68/106/11-C

Parallel import authorization number: 213/23

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

Slovak Republic: Tiaprid PMCS 100 mg, Lithuania: Tiapride PMCS 100 mg tablets, Poland: Tiaprid PMCS, Romania: Tiapridă PMCS 100 mg tablets

Date of leaflet approval: 28.09.2023

[Information about the trademark]