Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
Tiaprid PMCS (Tiapride PMCS)
100 mg, tablets
Tiapridum
Tiaprid PMCS and Tiapride PMCS are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Tiaprid PMCS is and what it is used for
What you need to know before taking Tiaprid PMCS
How to take Tiaprid PMCS
Possible side effects
How to store Tiaprid PMCS
Contents of the pack and other information

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

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

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 disorder called phaeochromocytoma, causing headaches, hot flushes and episodes of high blood pressure,
if the patient is taking a medicine containing levodopa or other dopaminergic drugs,
if the patient has a prolactin-producing brain tumour and/or breast cancer.

Warnings and precautions
Before starting treatment with Tiaprid PMCS, please discuss this with your doctor.
As with other neuroleptic medicines, neuroleptic malignant syndrome (a complication that may be fatal) may occur, characterised by hyperthermia (increased internal body temperature above the normal range), muscle rigidity and autonomic dysfunction (disturbance of the part of the nervous system responsible for controlling internal body functions independently of will).
Cases with atypical symptoms, such as absence of muscle rigidity or increased muscle tone and lower-grade fever, have been observed. If unexplained increase in body temperature (hyperthermia) occurs, treatment with tiapride should be discontinued.
Except in special cases, tiapride should not be used to treat patients with Parkinson's disease.
Neuroleptic medicines may lower the seizure threshold. Patients with epilepsy will be closely monitored during treatment with tiapride.
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 individually assess tiapride treatment with regard to potential risks (reduced level of consciousness and coma, increased risk of death due to concomitant use of antipsychotic medicines).

QT interval prolongation (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 QT interval prolongation, which increases the risk of cardiac arrhythmias. Therefore, before administering the medicine, the doctor will check whether risk factors for cardiac arrhythmias are present, such as:

Slow heart rate (bradycardia) below 55 beats per minute.
Electrolyte disturbances, especially hypokalaemia (low potassium levels in the blood).
Congenital QT interval prolongation.
Concomitant use of medicines that may cause marked slowing of heart rate (<55 beats/min), electrolyte imbalance, impaired intracardiac conduction or QT interval prolongation.

If the patient has risk factors for stroke, the doctor will closely monitor treatment with Tiaprid PMCS, as particular caution is required in such cases.
Venous thromboembolic disease (a condition characterised by formation of blood clots at a specific site in the bloodstream, followed by their migration to the lungs): Cases of venous thromboembolic disease, sometimes fatal, have been reported in association with the use of antipsychotic medicines.
If the patient has or has previously had blood clots in the veins, the doctor will closely monitor treatment with Tiaprid PMCS, as particular caution is required in such cases.
Tiapride may increase the level of the hormone prolactin. Therefore, caution is advised. If the patient or any family member has had breast cancer, the doctor will closely monitor the patient during treatment with tiapride.
Decreased white blood cell count (leukopenia, neutropenia, agranulocytosis) has been reported in association with the use of antipsychotic medicines, including tiapride. If unexplained infection or fever occurs, contact your doctor immediately, as these may be symptoms of blood disorders.

Children and adolescents
Adequate studies on the use of tiapride in children and adolescents have not been conducted (see section 3).

Tiaprid PMCS and other medicines
Tiaprid PMCS and other medicines taken simultaneously may interact with each other. Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Dopaminergic agonists (medicines with effects similar to dopamine, a naturally occurring substance important in the nervous system) and Tiaprid PMCS counteract each other's effects; therefore, they should not be used together. Patients with Parkinson's disease should receive the lowest effective dose of levodopa and tiapride.
Medicines affecting the central nervous system, such as painkillers, antitussives, hypnotics, sedatives, medicines used to treat depression or psychosis, antiemetics, antihistamines, centrally-acting antihypertensives, and other medicines (baclofen, thalidomide, pizotifen, clonidine) may enhance the effects of tiapride, leading to reduced alertness and increased drowsiness.
Alcohol also enhances the overall effect of Tiaprid PMCS, particularly increasing sedation and marked drowsiness. Therefore, alcohol consumption should be avoided during treatment with this medicine.

Contraindicated combinations
Combinations with the following medicines, which may cause serious cardiac arrhythmias (torsades de pointes) or QT interval prolongation (the time interval in the electrocardiographic recording):

Medicines causing slow heart rate (bradycardia), such as beta-blockers, calcium channel blockers causing bradycardia (e.g. diltiazem and verapamil), clonidine, guanfacine, cardiac glycosides (digoxin), pilocarpine, cholinesterase inhibitors, some class II antiarrhythmic medicines. Medicines causing electrolyte imbalance, especially hypokalaemia (low potassium levels in the blood): diuretics causing hypokalaemia (medicines increasing urine production and excretion and reducing blood potassium levels, necessitating potassium supplementation via potassium-containing medicines or diet), laxatives with stimulant action (loosening stools), intravenous amphotericin B, glucocorticosteroids, tetracosactide, cosyntropin. The doctor will correct hypokalaemia (low potassium levels in the blood).
Class IA antiarrhythmic medicines (medicines used to treat cardiac arrhythmias), such as quinidine, hydroquinidine, disopyramide.
Class III antiarrhythmic medicines, such as amiodarone, sotalol, dofetilide, ibutilide.
Certain antiparasitic medicines, such as halofantrine, lumefantrine, pentamidine, certain neuroleptics (medicines used to treat psychosis), such as pimozide, sultopride, haloperidol, thioridazine, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, droperidol, flufenazine, pipamperone, flupenthixol, zuclopenthixol.
Other medicines such as methadone, imipramine, antidepressants, lithium, bepridil, cisapride, intravenous erythromycin, intravenous vincamine, sparfloxacin, difemethicon, mizolastine, spiramycin difemethicon, moxifloxacin.

The effect of medicines used to lower high blood pressure and medicines used to treat coronary artery disease may be enhanced when taken together with Tiaprid PMCS, which may lead to a significant drop in blood pressure, manifesting as dizziness or fainting upon rapid standing.

Tiaprid PMCS with food, drink and alcohol
Tiaprid PMCS may be taken with or without food.
Alcoholic beverages should not be consumed during treatment with Tiaprid PMCS.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Caution is advised when using this medicine during pregnancy.

Pregnancy
Use of Tiaprid PMCS during pregnancy is not recommended, nor is it recommended for women who may become pregnant and are not using effective contraception.
Use of Tiaprid PMCS during the last three months of pregnancy may cause symptoms in the newborn such as restlessness, muscle stiffness, tremors, drowsiness, breathing difficulties and feeding problems. If any of these symptoms occur in the newborn, contact your doctor.

Breastfeeding
Breastfeeding should not be performed during treatment with Tiaprid PMCS. If the patient is taking Tiaprid PMCS, she should consult her doctor to discuss the best way to feed her baby.

Fertility
Tiaprid PMCS may cause absence of menstruation or lack of ovulation and reduced fertility.

Driving and operating machinery
Tiaprid PMCS may impair the ability to drive and operate machinery, as it may cause sedation, even when taken as directed (see section 4).
Tiaprid PMCS contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Tiaprid PMCS

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
The dosage is determined individually by the doctor for each patient.
Adults
Treatment of behavioural disturbances 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 should be initiated at a dose of 50 mg (i.e. ½ tablet) twice daily, then increased over the next 2–3 days to 100 mg (i.e. 1 tablet) three times daily. 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 for treating 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 form of choreatic movements in Huntington's disease: the dose is individually adjusted within a wide range from 300 mg to 1200 mg (3–12 tablets).
Elderly patients
Since elderly patients are highly sensitive to tiapride, the dosage prescribed by the physician must be strictly observed.
Use in children and adolescents aged 6 years and older
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 of 30–60 mL/min, to 50% of the usual dose in patients with creatinine clearance of 10–30 mL/min, and to 25% of the usual dose in patients with creatinine clearance below 10 mL/min.
Hepatic impairment
The drug is minimally metabolized; therefore, dose reduction is not necessary.
Use of a higher than recommended dose of Tiaprid PMCS
If more tablets than recommended are taken, the following symptoms may occur: drowsiness and sedation, coma, decreased arterial blood pressure, facial and neck muscle spasms, uncontrolled protrusion of the tongue, prolonged spasms of masticatory muscles, and limb muscle rigidity. Tremor and muscle stiffness of the limbs may also occur.
Cases of death following tiapride overdose have been reported, mainly in combination with other drugs affecting the central nervous system. In case of overdose or accidental ingestion by a child, contact a doctor or the nearest hospital emergency department 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 the patient has missed more than one dose, inform the doctor.
Stopping Tiaprid PMCS
Do not discontinue treatment without consulting your doctor. Symptoms of the disease may return or worsen.
Information for physicians
Appropriate supportive measures and close monitoring of vital functions are recommended.
Cardiac function should be monitored until the patient's condition stabilizes (risk of QT interval prolongation and subsequent ventricular arrhythmias).
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Common (may occur in up to 1 in 10 people):

Hyperprolactinaemia, which in some cases may lead to other disorders. Less frequently, breast pain, breast enlargement (gynaecomastia), menstrual disorders or amenorrhoea in women, and orgasmic disorders or impotence in men may occur.
Drowsiness, insomnia, restlessness, emotional indifference.
Dizziness/vertigo, headache.
Parkinsonism-like symptoms (tremor, increased muscle tension, reduced motor activity, and increased salivation). These symptoms are usually reversible with administration of an anticholinergic drug (e.g. Biperiden).
Fatigue, feeling of exhaustion.

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

Dystonia [muscle spasms, neck muscle spasms, involuntary eye movements (nystagmus), jaw muscle spasms (trismus), akathisia (motor restlessness)]. These symptoms are usually reversible with administration of an anticholinergic drug (e.g. Biperiden).
Disorientation, hallucinations.
Fainting (short-term loss of consciousness), seizures.
Decreased blood pressure, usually orthostatic, deep vein thrombosis.
Constipation.
Skin rash (including redness, urticaria, or maculopapular rash).
Amenorrhoea, orgasmic disorders.
Weight gain.

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

Loss of consciousness.
Decreased white blood cell count (leukopenia, neutropenia, agranulocytosis).
Decreased potassium levels in blood (hypokalaemia), syndrome of inappropriate antidiuretic hormone secretion (SIADH).
Early dyskinesia (tongue or oesophageal spasms, tics). These symptoms are usually reversible with administration of an anticholinergic drug (e.g. Biperiden).
As with other antipsychotics (neuroleptics), cases of tardive dyskinesia have been reported after long-term use (more than three months), characterised by rhythmic involuntary movements, primarily of the tongue and/or facial muscles. If such movements occur, inform your doctor immediately; the doctor will decide on the necessary steps. Do not administer anti-Parkinson drugs as antidotes, as they are ineffective or may worsen symptoms.
As with all other neuroleptic drugs, neuroleptic malignant syndrome (NMS) may occur, which may lead to death (see section "Important information before using Tiaprid PMCS").
Cardiac conduction disorders (QT interval prolongation) and severe ventricular arrhythmias (such as torsades de pointes, worsening of ventricular tachycardia), as well as ventricular fibrillation, cardiac arrest, and sudden death have also been reported (see section "Warnings and precautions" and "Tiaprid PMCS and other medicines").
Venous thrombosis, particularly in the legs (with swelling, pain, and redness); the clot may travel through the bloodstream to the lungs, causing chest pain and shortness of breath. If any of the above symptoms occur, seek immediate medical help (see section "Important information before using Tiaprid PMCS"). In some cases, pulmonary embolism may be fatal.
Certain forms of pneumonia caused by accidental aspiration of food or liquid into the lungs (aspiration pneumonia), respiratory disturbances (respiratory depression).
Intestinal obstruction, bowel obstruction.
Increased liver enzyme activity.
Skin rash (urticaria).
Increased creatine phosphokinase (CPK) activity, breakdown of skeletal muscle (rhabdomyolysis).

Frequency unknown (based on available data):

Withdrawal syndrome in newborns (see "Pregnancy, breastfeeding and fertility").
Falls, particularly in elderly people.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Tiaprid PMCS

Keep this medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Tiaprid PMCS contains

The active substance is tiapride (in the form of tiapride hydrochloride). Each tablet contains 111.1 mg of tiapride hydrochloride, equivalent to 100 mg of tiapride.
Other components of the medicine are: mannitol, granulated microcrystalline cellulose, povidone 25, sodium carboxymethyl starch (type A), colloidal anhydrous silica, and magnesium stearate.

What Tiaprid PMCS looks like and contents of the pack
Tiaprid PMCS tablets are almost white, round, with a cross dividing one side, and have 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, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Lithuania, the exporting country:
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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing Authorisation Number in Lithuania, the exporting country: LT/1/12/3019/001
Parallel Import Authorisation Number: 390/22
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Slovakia Tiaprid PMCS 100 mg
Lithuania Tiapride PMCS 100 mg tabletės
Poland Tiaprid PMCS
Romania Tiapridă PMCS 100 mg comprimate