Package leaflet: information for the user

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Tiaprid PMCS
100 mg, tablets
Tiapridum
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, pharmacist or nurse.
This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet:

What Tiaprid PMCS is and what it is used for
Important information 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 called
antipsychotics, atypical neuroleptic agents.
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 behavioural 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 headache, hot flushes and episodic high blood pressure,
if the patient is concurrently taking a medicine containing levodopa or other dopaminergic agents,
if the patient has a prolactin-producing brain tumour and (or) breast cancer.

Warnings and precautions
Before starting treatment with Tiaprid PMCS, discuss the following with your doctor:
As with other neuroleptic medicines, neuroleptic malignant syndrome (a potentially fatal complication) may occur, characterised by hyperthermia (elevated internal body temperature above the normal range), muscle rigidity and autonomic disturbances (dysfunction of the part of the nervous system responsible for controlling internal bodily functions independently of will). Cases with atypical symptoms, such as absence of muscle rigidity or increased muscle tension and lower-grade fever, have been observed. If unexplained increase in body temperature (hyperthermia) occurs, treatment with tiapride should be discontinued.
Except in special circumstances, 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 due to the possible risk of loss of consciousness due to overdose (see section 3).
In elderly patients, the doctor will individually assess treatment with tiapride 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).
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, increasing the risk of cardiac arrhythmias. Therefore, before administering the medicine, the doctor will check whether any factors that may increase the risk of cardiac arrhythmias are present, such as:

Slow heart rate (bradycardia) below 55 beats per minute.
Electrolyte imbalances, especially hypokalaemia (low blood potassium levels).
Congenital QT 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 circulation, 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 had blood clots in the veins in the past, 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 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 concomitantly used medicines may interact with each other.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Dopaminergic agonists (medicines with dopamine-like action, a natural substance playing an important role in the nervous system) and Tiaprid PMCS counteract each other's effects; therefore, they should not be used simultaneously. Patients with Parkinson's disease should receive the lowest effective dose of levodopa and tiapride.
Medicines affecting the central nervous system, such as analgesics, antitussives, hypnotics, sedatives, medicines used in the treatment of depression or psychosis, antiemetics, antihistamines, centrally acting antihypertensives, and other medicines (baclofen, thalidomide, pizotifen, clonidine) may enhance the effects of tiapride, causing 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.
Combinations not recommended
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 imbalances, especially hypokalaemia (low blood potassium levels): diuretics causing hypokalaemia (medicines increasing urine production and excretion and decreasing 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 blood potassium levels).
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, some neuroleptics (medicines used in the treatment of psychosis), such as pimozide, sultopride, haloperidol, thioridazine, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, droperidol, flufenazine, pipamperone, flupentixol, zuclopenthixol.
Other medicines such as methadone, imipramine, antidepressants, lithium, bepridil, cisapride, intravenous erythromycin, intravenous vinpocetine, sparfloxacin, difenamid, mizolastine, spiramycin, moxifloxacin.

The effect of antihypertensive medicines and medicines used in the treatment of coronary artery disease may be enhanced when taken concomitantly with Tiaprid, potentially leading to a significant drop in blood pressure, manifesting as dizziness and loss of consciousness 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 should be exercised when using this medicine during pregnancy.
Pregnancy
Use of Tiaprid PMCS is not recommended during pregnancy and in 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, tremor, drowsiness, breathing difficulties and feeding problems. If any of these symptoms occur in the newborn, contact your doctor.
Breastfeeding
Breastfeeding is not recommended 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 used according to recommendations (see section 4).
Tiaprid PMCS contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tiaprid PMCS

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The dose is determined individually by the doctor for each patient.
Adults
Treatment of behavioural 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 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 treatment of 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 form of choreic 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 particularly sensitive to the effects of tiapride, the dosage prescribed by the doctor 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 every 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 blood pressure, facial and neck muscle spasms, uncontrolled protrusion of the tongue, prolonged spasms of the jaw muscles, and limb muscle stiffness.
Tremor and rigidity of the limbs may also occur. Fatal cases have been reported following tiapride overdose, 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 a missed dose. If you have missed more than one dose, inform your doctor.
Stopping Tiaprid PMCS treatment
Do not discontinue treatment without consulting your doctor. Symptoms of the disease may return or worsen.
Information for doctors
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 cardiac arrhythmias).
If you have any further doubts 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 absence of menstruation in women, and orgasmic disorders or impotence in men may occur.
Drowsiness, insomnia, agitation, emotional indifference.
Dizziness/vertigo, headache.
Parkinsonism-like symptoms (tremor, increased muscle rigidity, 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 contractions, involuntary eye movements (nystagmus), jaw muscle spasms (bruxism), akathisia (motor restlessness)]. These symptoms are usually reversible with administration of an anticholinergic drug (e.g. Biperiden).
Disorientation, hallucinations.
Fainting (transient loss of consciousness), seizures.
Decreased blood pressure, usually orthostatic, deep vein thrombosis.
Constipation.
Skin rash (including redness, urticaria or maculopapular rash).
Absence of menstruation, orgasmic disorders.
Weight gain.

Rare (may occur in up to 1 in 1,000 people):

Loss of consciousness.
Decreased white blood cell count (leucopenia, neutropenia, agranulocytosis).
Decreased potassium levels in blood (hypokalaemia), syndrome of inappropriate antidiuretic hormone secretion.
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 (over 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 necessary actions. 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 can be fatal (see section "Important information before taking Tiaprid PMCS").
Cardiac conduction disorders (QT interval prolongation) and severe ventricular arrhythmias (such as torsades de pointes, exacerbation 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 legs (with swelling, pain and redness); the clot may travel through the circulation to the lungs, causing chest pain and breathlessness. If any of these symptoms occur, seek immediate medical help (see section "Important information before taking Tiaprid PMCS"). In some cases, pulmonary embolism may be fatal.
Certain forms of pneumonia caused by accidental aspiration of food or fluid into the lungs (pulmonary aspiration), respiratory disorders (respiratory depression).
Intestinal obstruction, bowel obstruction.
Increased liver enzyme activity.
Skin rash (urticaria).
Increased creatine phosphokinase (CPK) activity, breakdown of skeletal muscle (rhabdomyolysis).

Unknown frequency (based on available data):

Withdrawal syndrome in newborns (see "Pregnancy, breastfeeding and effects on 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, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +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 the medicine.

5. How to store Tiaprid PMCS

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

6. Contents of the package and other information

What Tiaprid PMCS contains

The active substance is tiapride. Each tablet contains 111.1 mg of tiapride hydrochloride, equivalent to 100 mg of tiapride.
The other ingredients are: mannitol, granulated microcrystalline cellulose, povidone K 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 on 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 or 50 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Czech Republic, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorisation number in the Czech Republic, country of export: 68/106/11-C
Parallel import authorisation number: 149/22
This medicinal product is authorised for sale in the European Economic Area under the following names:
Slovak Republic Tiaprid PMCS 100 mg
Lithuania Tiapride PMCS 100 mg tabletės
Poland Tiaprid PMCS
Romania Tiapridă PMCS 100 mg comprimate