Tiaprid Pmcs

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tiaprid PMCS

100 mg, tablets

Tiapridum

Before taking the medicine, you should carefully read the contents of the leaflet, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any further doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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. Package contents and other information

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

Tiaprid PMCS contains tiapride as the active substance, 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

• 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 with atypical symptoms, such as lack of muscle stiffness or increased muscle tone, and lower fever have been observed. In case of unexplained increased body temperature, hyperthermia, 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 decrease 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 assess the treatment with tiapride individually for each patient, in relation to the potential risk (decreased 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 electrocardiographic recording of the heart cycle):
Tiapride may cause QT interval prolongation, 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 QT interval prolongation.
• Concomitant use of medicines that may cause significant slowing of heart rate (<55 beats per minute), electrolyte imbalance, decreased intracardiac conduction, or qt interval prolongation.< li>

If the patient has risk factors for stroke, the doctor will closely monitor the 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, in association with the use of antipsychotic medicines. If the patient has or has had blood clots in the veins, the doctor will closely monitor the treatment with Tiaprid PMCS, as special caution is required in this case.
Tiapride may increase prolactin levels. Therefore, caution should be exercised. If the patient or a family member has breast cancer, the doctor will closely monitor the patient during treatment with tiapride.
There have been reports of decreased white blood cell count (leukopenia, neutropenia, agranulocytosis) in association with the use of antipsychotic medicines, including tiapride. In case of unexplained infection and fever, 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).

• 3).

Tiaprid PMCS and other medicines

Tiaprid PMCS and other medicines taken at the same time may affect each other's action.
You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 taken 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 (torsades de pointes) or QT interval prolongation:

• 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, digitalis glycosides (digoxin), pilocarpine, cholinesterase inhibitors, 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-containing medicines or potassium-rich foods), laxatives that accelerate intestinal peristalsis (loosening the stool), amphotericin B administered intravenously, glucocorticosteroids, tetracosactide, 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, disopyramide.
• Anti-arrhythmic medicines of class III, such as amiodarone, sotalol, dofetilide, ibutilide.
• Some anti-parasitic medicines, such as halofantrine, lumefantrine, pentamidine, some 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, lithium, 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 heart disease may be increased when taken with Tiaprid PMCS, which may lead to a significant decrease in blood pressure, manifested by 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 baby, you should consult your doctor or pharmacist before taking this medicine.
Cautions should be exercised when taking 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, 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 menstrual disorders or ovulation disorders, as well as decreased fertility.

Driving and using machines

Tiaprid PMCS may impair your ability to drive and use machines, as it may cause sedation, even when taken 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 prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.
The dose is determined by the 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 for the treatment of symptoms during chronic alcohol dependence is 300-400 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 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.
Liver function disorders
The medicine is metabolized to a small extent, so dose reduction is not necessary.

Taking a higher dose of Tiaprid PMCS than recommended

In case of taking a larger number of tablets, the following concerns may occur: drowsiness and sedation, coma, decreased blood pressure, facial and neck muscle spasms, uncontrolled tongue protrusion, prolonged muscle spasms, and muscle stiffness in the limbs.
It may also cause tremors and muscle stiffness in the limbs. 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 of the medicine by a child, you should immediately contact a 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. You should not take a double dose to make up for the missed dose. If you have missed more than one dose, you should tell your doctor.

Stopping treatment with Tiaprid PMCS

You should 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.
It is recommended to monitor heart function until the patient's condition stabilizes (risk of QT interval prolongation and subsequent ventricular arrhythmias).
In case of any further doubts related to the use of the 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.
Common(may affect up to 1 in 10 people):

• Hyperprolactinemia, which may lead to other disorders in some cases. Less often, it may cause breast pain, breast enlargement (gynecomastia), menstrual disorders, or amenorrhea in women, and orgasm disorders or impotence in men.
• Drowsiness, insomnia, agitation, indifference.
• Dizziness/vertigo, headache.
• Symptoms like those of Parkinson's disease (tremors, increased muscle tone, limited motor activity, 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, muscle contractions of the neck, 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.
• Skin rash (including redness, urticaria, or patchy rash).
• Amenorrhea, 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).
• Similarly to other antipsychotic medicines (neuroleptics), there have been reports of late dyskinesia 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.
• Similarly to all other neuroleptic medicines, a malignant neuroleptic syndrome (which may be fatal) may occur (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 torsades 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 thrombosis, particularly of the legs (with swelling, pain, and redness); the clot may 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 section "Important information before taking Tiaprid PMCS"). In some cases, pulmonary embolism may be fatal.
• Certain forms of pneumonia caused by accidental inhalation of food or liquid into the lungs (aspiration pneumonia), respiratory disorders (respiratory depression).
• Bowel obstruction, intestinal obstruction.
• Increased liver enzyme activity.
• Skin rash (urticaria).
• Increased creatine phosphokinase activity (CPK), skeletal 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 the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 gather more information on the safety of the 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.
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 used. This will help protect the environment.

6. Package contents and other information

What Tiaprid PMCS contains

• The active substance of the medicine is tiapride. 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 K 25, sodium carboxymethylcellulose (type A), anhydrous colloidal silica, and magnesium stearate.

What Tiaprid PMCS looks like and what the package contains

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 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 68/106/11-C

Parallel import authorization number: 149/22

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: 05.04.2022
[Information about the trademark]