Tiapridal

Patient Information Leaflet

Caution! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Tiapridal, 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 doubts, consult your doctor or pharmacist.
• 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 not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of Contents:

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

1. What Tiapridal is and what it is used for

Tiapridal is available as tablets and contains tiapride as the active substance.
Tiapride is an atypical neuroleptic agent with anxiolytic and calming properties. Additionally, it has a beneficial effect on the level of alertness in elderly patients.
Tiapridal is indicated for the short-term treatment of agitation and aggression in elderly patients.

2. Important information before using Tiapridal

When not to use Tiapridal:

• 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 tumour whose growth is dependent on prolactin levels, e.g. a prolactin-secreting pituitary adenoma (prolactinoma), prolactin-dependent breast cancer,
• if the patient has a chromaffin tumour (phaeochromocytoma),
• if the patient is concurrently taking levodopa (see section: Tiapridal with other medicines).

Warnings and precautions
You should contact your doctor immediately:

• if fever and/or muscle rigidity occur during treatment with Tiapridal, especially if taken together with other medicines acting on mental health.
• if the patient has or has had problems with alcohol (see section: Tiapridal, food, drink and alcohol).

At the beginning of treatment, your doctor may prescribe an ECG and blood tests to measure electrolyte levels (particularly potassium). Tiapride may cause changes in the ECG and increase the risk of severe ventricular arrhythmias such as torsade de pointes. This risk is higher if bradycardia (heart rate below 55 beats per minute), low blood potassium levels, or congenital or acquired QT interval prolongation on ECG are present (especially when used together with other medicines that prolong the QT interval). Therefore, inform your doctor about all medicines recently taken.
Tiapride may be used in patients with Parkinson's disease only if absolutely necessary.
Tiapride is eliminated from the body via the kidneys. In patients with renal impairment, the dose will be reduced by the doctor depending on kidney function assessment (creatinine clearance).
Dose reduction is not necessary in case of liver impairment.
Tiapride should be used with caution in patients with risk factors for stroke, as well as in patients with risk factors for venous thromboembolic disease.
Elderly patients with psychosis associated with dementia treated with antipsychotic medicines are at increased risk of death.
Tiapride may lower the seizure threshold; patients with epilepsy should be under medical supervision during treatment with this medicine.
In elderly patients, tiapride, like other neuroleptics, should be used with particular caution due to the risk of disturbances in consciousness and coma.

Children and adolescents
There is insufficient data on the use of tiapride in children.
Cases of leukopenia, neutropenia and agranulocytosis have been observed after administration of antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be signs of blood disorders; immediate blood tests are required.

Tiapridal, food, drink and alcohol
The medicine should be taken just before a meal.
During treatment with tiapride, consumption of alcohol and use of medicines containing alcohol should be avoided.
Drinking alcohol while taking Tiapridal may also cause electrolyte imbalance (disturbance in blood mineral balance) and may lead to QT interval prolongation (cardiac rhythm/frequency disturbances) (see "Warnings and precautions").

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
The use of Tiapridal is not recommended in pregnant women or in women of childbearing potential who are not using effective contraception.
If Tiapridal was used during the last three months of pregnancy, the newborn may experience symptoms such as hyperexcitability, increased muscle tone, tremor, somnolence, breathing difficulties or feeding problems. If any of these symptoms occur in the newborn, contact a doctor.

Breastfeeding
Tiapridal should not be used if the patient is breastfeeding. If the patient is taking Tiapridal, she should discuss with her doctor the best alternative feeding method.

Effect on fertility
Tiapridal may cause amenorrhoea or anovulation and may reduce fertility in humans.

Driving and operating machinery
Tiapridal may cause excessive sedation, which may affect the ability to drive or operate machinery during treatment.

Tiapridal with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of tiapride and levodopa is contraindicated.
Concomitant use of tiapride and medicines that may cause torsades de pointes (severe cardiac arrhythmias) or QT interval prolongation on ECG is not recommended. These include:

• medicines causing bradycardia (heart rate below 55 beats per minute): diltiazem and verapamil, clonidine, guanfacine, cardiac glycosides (digitalis glycosides);
• medicines reducing potassium levels: diuretics, laxatives, intravenous amphotericin B, glucocorticoids, tetracosactide;
• class Ia antiarrhythmics such as quinidine, disopyramide;
• class III antiarrhythmics such as amiodarone, sotalol;
• other medicines such as pimozide, sultopride, haloperidol, thioridazine, methadone, imipramine-derivative antidepressants, lithium, bepridil, cisapride (a prokinetic agent), intravenous erythromycin, intravenous vinpocetine (used in cerebral circulation disorders), halofantrine, pentamidine, sparfloxacin.

Your doctor should consider the possibility of concomitant use of tiapride with medicines that depress the central nervous system, such as: morphine derivatives (analgesics and antitussives); most antihistamines (H\ receptor antagonists), barbiturates, benzodiazepines and other anxiolytics, clonidine and its derivatives.

3. How to use Tiapridal

The dosage may vary and should be adjusted individually for each patient.
This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The initial dose is 100 mg per day. If necessary, the dose may be gradually increased up to a
maximum of 300 mg per day.
The duration of treatment should not exceed 28 days.
If you feel that the effect of Tiapridal is too strong or too weak, consult your doctor.

Use of a higher than recommended dose of Tiapridal
There is limited data on tiapride overdose. Fatal cases have been reported following tiapride overdose, mainly in combination with other antipsychotic drugs. The most commonly observed symptoms of overdose include: dizziness, excessive sedation, coma, hypotension, and extrapyramidal symptoms (muscle rigidity, reduced facial expression, motor retardation, motor restlessness, involuntary muscle contractions, and involuntary movements).
In cases of severe overdose, poisoning with other drugs should always be considered.
Tiapride is only minimally eliminated from the body by hemodialysis. Therefore, hemodialysis is not recommended for removal of the drug from the body.
There is no specific antidote for tiapride. Treatment therefore consists of supportive measures to maintain vital functions and close monitoring of cardiac function until improvement occurs.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Tiapridal
If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. Do not take two doses at the same time or within a short interval. In case of doubt, consult your doctor.

4. Possible adverse effects

Like all medicines, Tiapridal may cause adverse effects, although not everyone experiences them.

Common (in 1 to 10 out of 100 patients):

• dizziness, headache;
• Parkinsonism-like symptoms: tremor, increased muscle tone, hypokinesia (reduced mobility), and drooling. These symptoms usually resolve after administration of anti-parkinsonism drugs (e.g. biperiden);
• drowsiness, insomnia, agitation, reduced responsiveness to stimuli (apathy);
• weakness, fatigue;
• hyperprolactinaemia (increased blood prolactin levels). This symptom resolves after discontinuation of the drug. Hyperprolactinaemia may cause other disturbances such as breast swelling and pain, galactorrhoea, menstrual disorders in women (painful menstruation, absence of menstruation), gynaecomastia (breast enlargement in men), orgasmic disorders, erectile dysfunction in men.

Uncommon (in 1 to 10 out of 1,000 patients):

• early dyskinesia, dystonia (spasm, spasmodic torticollis, oculogyric crisis (involuntary deviation of the eyes and head to one side), trismus) and akathisia (excessive psychomotor activity, restlessness, anxiety). These symptoms usually resolve after administration of anti-parkinsonism drugs (e.g. biperiden);
• weight gain;
• disorientation, hallucinations;
• fainting, seizures;
• hypotension, usually upon standing;
• deep vein thrombosis;
• constipation;
• rash (including erythematous rash or papular/irregular rash);
• amenorrhoea, orgasmic disorders.

Rare (in 1 to 10 out of 10,000 patients):

• acute dyskinesia. This symptom usually resolves after administration of anti-parkinsonism drugs;
• decreased number of white blood cells (leukopenia, neutropenia, and agranulocytosis);
• decreased sodium levels in blood (hyponatraemia), a condition known as "syndrome of inappropriate antidiuretic hormone secretion" (SIADH);
• tardive dyskinesia (characterized by rhythmic, involuntary movements primarily of the tongue and/or facial muscles) after prolonged use of the drug for more than 3 months, as with all other drugs used in the treatment of psychiatric disorders (neuroleptics). If such movement disorders occur, the physician should be informed immediately so appropriate measures can be taken. Anti-parkinsonism drugs should not be used. In this case, administration of anti-parkinsonism drugs is ineffective and may even worsen symptoms;
• neuroleptic malignant syndrome (see also section 2 "Warnings and precautions"), which is a potentially life-threatening complication;
• loss of consciousness;
• QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may lead to ventricular fibrillation or circulatory arrest and sudden death (see also section 2 "Warnings and precautions");
• pulmonary embolism [blood clots in veins, especially in the legs (with leg swelling, pain, and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties], sometimes resulting in death;
  If any of the above symptoms are observed, medical advice must be sought immediately (see section 2 "Important information before using Tiapridal");
• aspiration pneumonia caused by food particles or vomit entering the lungs;
• respiratory disorders, e.g. shortness of breath, difficulty breathing, shallow breathing, particularly when used with other centrally nervous system depressant drugs;
• intestinal obstruction;
• increased liver enzyme activity;
• urticaria;
• increased creatine kinase activity in blood, muscle weakness and/or muscle pain;
• breast swelling and pain, galactorrhoea, gynaecomastia, erectile dysfunction.

Additionally, the following adverse reactions have been reported:
Frequency unknown (frequency cannot be estimated from available data):

• withdrawal symptoms in newborns;
• falls.

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

5. How to store Tiapridal

Keep the medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Tiapridal contains

• The active substance is 100 mg of tiapride (as 111.10 mg tiapride hydrochloride).
• The other ingredients are: mannitol, microcrystalline cellulose, povidone, colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and contents of the pack
Tiapridal tablets are round, white to ivory-coloured, with a cross on one side and an embossed "T100" on the other side.
The pack contains 20 or 50 tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Neuraxpharm Bohemia s.r.o.
náměstí Republiky 1078/1
110 00 Prague 1 – New Town
Czech Republic

Manufacturer:
Delpharm Dijon
6 boulevard de l’Europe
21800 Quetigny, France
Famar Healthcare Services Madrid, S.A.U.
Avda. de Leganés, n°62
28923 Alcorcón, Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in the Czech Republic, the country of export: 68/171/85-C
Parallel Import Licence Number: 282/25