TIAPRID 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Tiaprid PMCS, 100 mg, Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Tiaprid PMCS and what is it used for
4. Important information before taking Tiaprid PMCS
   1. When not to take Tiaprid PMCS
   2. Warnings and precautions
   3. Children and adolescents
   4. Tiaprid PMCS and other medicines
   5. Tiaprid PMCS with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
5. How to take Tiaprid PMCS
   1. Overdose of Tiaprid PMCS
   2. Missed dose of Tiaprid PMCS
   3. Stopping treatment with Tiaprid PMCS
6. Possible side effects
   1. Reporting side effects
7. How to store Tiaprid PMCS
8. Contents of the pack and other information
   1. What Tiaprid PMCS contains
   2. What Tiaprid PMCS looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Tiaprid PMCS, 100 mg, Tablets

(Tiapridum)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. 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.

Table of Contents of the Leaflet:

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

When not to take Tiaprid PMCS

Warnings and precautions

Before starting treatment with Tiaprid PMCS, discuss it with your doctor:
As with 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.
With the exception of special cases, tiapride should not be used to treat patients with Parkinson's disease.
Neuroleptic medicines can lower 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 potential risks (reduced level of consciousness and coma, increased risk of death due to concomitant use of antipsychotic medicines).
Prolongation of the QT interval (in cardiology, the time measured between the beginning of the Q wave and the end of the T wave in the electrical recording of the heart cycle):
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:

• Slow heart rate (bradycardia) below 55 beats per minute.
• Electrolyte disturbances, especially hypokalemia (low potassium levels in the blood).
• Congenital prolongation of the QT interval.
• Concomitant use of medicines that may cause significant slowing of the heart rate (<55 beats per minute), electrolyte disturbances, 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 anyone in the patient's family 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, contact a doctor immediately, 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 concomitantly used medicines may affect each other's action. Tell your doctor or pharmacist about all medicines you are taking now 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 concomitantly. 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, anxiolytics, antidepressants, antiemetics, 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 sedation and significant drowsiness. Therefore, you should avoid drinking alcohol while taking this medicine.
Contraindicated combinations
Combinations with the following medicines, which may cause serious heart rhythm disorders (torsade de pointes) or QT interval prolongation:

• Medicines that cause slow 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, certain antiarrhythmic medicines of class II.
• Medicines that cause electrolyte disturbances, 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-containing medicines or potassium-rich foods), laxatives that accelerate intestinal peristalsis (loosening the stool), amphotericin B administered intravenously, glucocorticoids, tetracosactide. The doctor will correct hypokalemia (low potassium levels in the blood).
• Antiarrhythmic medicines of class IA (medicines used to treat heart rhythm disorders), such as quinidine, hydroquinidine, disopyramide.
• Antiarrhythmic medicines of class III, such as amiodarone, sotalol, dofetilide, ibutilide.
• Certain antiparasitic medicines, such as halofantrine, lumefantrine, pentamidine, certain neuroleptics (medicines used to treat psychoses), such as pimozide, sultopride, haloperidol, thiordazine, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluperazine, cyamemazine, sulpiride, droperidol, fluphenazine, pipamperone, flupentixol, zuclopenthixol.
• Other medicines, such as methadone, imipramine, antidepressants, bepridil, cisapride, erythromycin administered intravenously, vincamine administered intravenously, sparfloxacin, difemanil, mizolastine, spiramycin difemanil, moxifloxacin.

The action of medicines that lower high blood pressure and medicines used to treat coronary artery disease may be increased when taken concomitantly with Tiaprid, which may lead to significant lowering of blood pressure, causing dizziness and loss of consciousness when standing up quickly.

Tiaprid PMCS with food, drink, and alcohol

Tiaprid PMCS can be taken 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, ask your doctor or pharmacist for advice before taking 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 do not use effective contraception.
Taking 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, contact a doctor.
Breastfeeding
You should not breastfeed while taking Tiaprid PMCS. If you are taking Tiaprid PMCS, 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 take Tiaprid PMCS

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The dose will be 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, given in two or three divided doses.
Treatment starts with a dose of 50 mg (i.e., ½ tablet) twice a day, and then the dose is 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, given 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 prescribed dose should be strictly followed.
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.
Kidney failure
The dose should be reduced to 75% of the usual dose in patients with a creatinine clearance of 30-60 ml/min, to 50% of the usual dose in patients with a creatinine clearance of 10-30 ml/min, and to 25% of the usual dose in patients with a creatinine clearance below 10 ml/min.
Liver dysfunction
The medicine is metabolized to a small extent in the liver, so dose reduction is not necessary.

Overdose of Tiaprid PMCS

In case of overdose, 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, contact a doctor or the emergency department of the nearest hospital immediately.

Missed dose of Tiaprid PMCS

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

Stopping treatment with Tiaprid PMCS

Do not stop taking the medicine 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 questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• Hyperprolactinemia, which may lead to other disorders in some cases. Less commonly, 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, torticollis, 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 (transient 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 1,000 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 esophageal spasms, tics). These symptoms are usually reversible after administration of an anticholinergic medicine (e.g., Biperiden).
• Similar 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. You should not take anti-Parkinson's medicines as an antidote, as they are ineffective or may worsen the symptoms.
• Similar to other neuroleptic medicines, a malignant neuroleptic syndrome (NMS) may occur, which can be fatal (see section "Important information before taking Tiaprid PMCS").
• There have also been reports of cardiac 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 section "Warnings and precautions" and "Tiaprid PMCS and other medicines").
• Venous thromboembolism, particularly of 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, seek medical help immediately (see section "Important information before taking Tiaprid PMCS"). In some cases, pulmonary embolism can be fatal.
• Certain forms of pneumonia, caused by accidental inhalation of food or liquid into the lungs (aspiration pneumonia), respiratory depression.
• Bowel obstruction, intestinal obstruction.
• Increased liver enzyme activity.
• Rash (urticaria).
• Increased creatine phosphokinase activity (CPK), 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 not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
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 Tiaprid PMCS

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tiaprid PMCS contains

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

What Tiaprid PMCS looks like and contents of the pack

Tiaprid PMCS tablets are almost white, round, with a cross on one side, 9.5 mm in diameter. The tablet can be divided into four equal doses.
The medicine is available in blister packs containing 20 and 50 tablets.

Marketing authorization holder and manufacturer

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

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 last revision of the leaflet:14.03.2023