TIAPRIDAL

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Tiapridal
100 mg, tablets
Tiapridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

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

Contents of the leaflet:

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 in the form of tablets and contains tiapride as the active substance.
Tiapride is an atypical neuroleptic agent with anxiolytic and calming effects. In addition, it has a beneficial effect on the level of alertness in elderly patients.
Tiapridal is used 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-producing pituitary tumour (prolactinoma), prolactin-dependent breast cancer,
• if the patient has a chromaffin tumour (phaeochromocytoma),
• if the patient is 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 request an ECG and blood electrolyte tests
(especially potassium levels). Tiapride may cause changes in the ECG and increase the risk of
severe ventricular arrhythmias, such as torsade de pointes. This risk is higher when bradycardia
(slow 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 concomitantly with drugs that
prolong the QT interval). Therefore, inform your doctor about all medicines recently taken.
Tiapride should 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).
Dosage reduction is not necessary in case of liver dysfunction.
Tiapride should be used cautiously in patients with risk factors for stroke, as well as in patients
with risk factors for venous thromboembolic disease.
Elderly patients with dementia-related psychosis treated with antipsychotic medicines are at an
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 leucopenia, neutropenia and agranulocytosis have been observed after administration of
antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be symptoms of
abnormal blood composition; prompt blood tests are required.
Tiapridal, food, drink and alcohol
The medicine should be taken immediately 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 (heart 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 have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of Tiapridal is not recommended in pregnant women or in women of childbearing age who are
not using effective contraception.
If the patient took Tiapridal during the last three months of pregnancy, the newborn may experience
hyperexcitability, increased muscle tone, tremor, drowsiness, 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 absence of menstruation or ovulation 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 heart rhythm
disturbances) 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,
• 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, sulpiride, haloperidol, thioridazine, methadone, imipramine derivative antidepressants, lithium, bepridil, cisapride (a prokinetic agent), intravenous erythromycin, intravenous vinpocetine (a medicine 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\1 receptor antagonists), barbiturates, benzodiazepines and other anxiolytics,
clonidine and its derivatives.

3. How to use Tiapridal

Dosage may vary and should be adjusted individually for each patient.
This medicine should always be used according to the doctor's instructions. 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, somnolence, coma, hypotension, and extrapyramidal
symptoms (muscle rigidity, reduced facial expression, bradykinesia, motor restlessness, involuntary
muscle contractions, and involuntary movements).
In cases of severe overdose, concomitant poisoning with other drugs should always be considered.
Tiapride is only minimally eliminated from the body by hemodialysis. Therefore, hemodialysis is not
recommended for removing 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 you miss a dose, take it 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 reactions

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

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

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

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

• early dyskinesia, dystonia (muscle spasms, spasmodic torticollis, oculogyric crisis (involuntary upward deviation of eyes and head), trismus);
• akathisia (excessive psychomotor activity, restlessness, anxiety). These symptoms usually resolve after administration of anti-Parkinson drugs (e.g. biperiden);
• weight gain;
• disorientation, hallucinations;
• fainting, seizures;
• low blood pressure, usually upon standing;
• deep vein thrombosis;
• constipation;
• skin rash (including erythematous rash or papular/irregular rash);
• amenorrhoea, orgasm disorders.

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

• acute dyskinesia. This symptom usually resolves after administration of anti-Parkinson drugs;
• decrease in white blood cell count (leucopenia, 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, a doctor should be informed immediately, who will decide on necessary actions. Anti-Parkinson drugs should not be used. In this case, administration of anti-Parkinson 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 occur, medical advice should 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, breathing difficulties, shallow breathing, particularly when used with other centrally acting depressant drugs;
• intestinal obstruction;
• increased liver enzyme activity;
• urticaria;
• increased creatine kinase activity in blood, muscle weakness and/or muscle pain;
• breast swelling and tenderness, galactorrhoea, gynaecomastia, erectile dysfunction.

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

• withdrawal symptoms in newborns;
• falls.

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 181C
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 improve the safety information available for this medicine.

5. How to store Tiapridal

Do not store above 25°C.
Keep the medicine out of 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.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack 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 hydrated silica, magnesium stearate.

What Tiapridal looks like and contents of the pack
Tiapridal tablets are round, white to ivory in colour, with a cross-score on one side and the imprint "T100" on the other side.
The pack contains 20 or 50 tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Hungary, country of export:
sanofi-aventis Zrt.
1138 Budapest
Váci út 133. E épület 3. emelet
Hungary

Manufacturer:
Delpharm Dijon
6, boulevard de L’europe
21800 Quetigny
France
FAMAR Healthcare Services Madrid, S.A.U.
Avda. de Leganés nº62
28923 Alcorcón
Spain

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

Relabelled and/or repackaged by:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation numbers in Hungary, country of export: OGYI-T-1117/01
OGYI-T-1117/02
Parallel Import Authorisation number: 132/14