Tiapridal

Patient Information Leaflet

Warning! 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 this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• 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 in tablet form 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 suffers from a tumour whose growth depends on prolactin levels, e.g. a pituitary adenoma of the prolactinoma type, or 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 recommend an ECG and blood electrolyte tests
(particularly potassium levels). Tiapride may cause changes in the ECG trace 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 may be used in patients with Parkinson's disease only if strictly necessary.
Tiapride is excreted by the kidneys. In patients with renal impairment, the dose will be reduced by
the doctor depending on renal function assessment (creatinine clearance).
Dose reduction is not necessary in case of liver dysfunction.
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 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 leukopenia, neutropenia and agranulocytosis have been observed following the use of
antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be symptoms of
abnormal blood composition; immediate blood tests are required.

Tiapridal, food, drink and alcohol
The medicine should be taken immediately before meals.
During treatment with tiapride, alcohol consumption 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 have a
child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
The use of Tiapridal is not recommended in pregnant women or in women of childbearing age who
are not using effective contraception.
If the patient has taken Tiapridal during the last three months of pregnancy, the newborn may show
symptoms such as hyperexcitability, increased muscle tone, tremor, drowsiness, breathing disorders
or feeding difficulties. 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 lead to 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
Inform your doctor about all medicines currently or 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;
˗ 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-
derived antidepressants, lithium, bepridil, cisapride (a prokinetic agent), intravenous erythromycin,
intravenous vinpocetine (used in cerebral circulation disorders), halofantrine, pentamidine,
sparfloxacin.

The doctor should consider the possibility of concomitant use of tiapride with central nervous system
depressants, such as morphine derivatives (analgesics and antitussives); most antihistamines
(H1 receptor antagonists), barbiturates, benzodiazepines and other anxiolytics, clonidine and its
derivatives.

3. How to use Tiapridal

The dosage may vary and should be adjusted for each individual 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. Cases of death after tiapride overdose have been reported,
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, bradykinesia, motor restlessness, involuntary muscle
contractions, and involuntary movements).
In cases of severe overdose, poisoning with other drugs should always be considered.
Tiapride is only removed from the body in small amounts 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 in health
status occurs.
If a higher than recommended dose of the medicine has been taken, seek immediate advice from a
doctor or pharmacist.
Missed dose of Tiapridal
If a dose of the medicine is missed, it should be taken as soon as possible, except when it is almost
time for the next dose. Do not take two doses of the medicine at the same time or within a short
interval. In case of doubt, consult your doctor.

4. Possible side effects

Like all medicines, Tiapridal can cause side effects, although not everyone experiences them.

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

• dizziness, headache;
• Parkinsonism-like symptoms: tremor, increased muscle tension, hypokinesia (reduced mobility), and drooling. These symptoms usually resolve after administration of anti-parkinsonian drugs (e.g. biperiden);
• drowsiness, insomnia, agitation, reduced responsiveness (apathy);
• weakness, fatigue;
• hyperprolactinaemia (increased prolactin levels in blood). This symptom resolves after discontinuation of the drug. Hyperprolactinaemia may cause other disturbances such as breast swelling and tenderness, galactorrhoea, menstrual disorders in women (painful menstruation, amenorrhoea), 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); and akathisia (excessive psychomotor activity, restlessness, anxiety). These symptoms usually resolve after administration of anti-parkinsonian drugs (e.g. biperiden);
• weight gain;
• disorientation, hallucinations;
• fainting, seizures;
• low blood pressure, usually upon standing;
• deep vein thrombosis;
• constipation;
• 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-parkinsonian 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 treatment lasting more than 3 months, as observed with all other drugs used in the treatment of psychiatric disorders (antipsychotics). If such movement disorders occur, the physician should be informed immediately so appropriate measures can be taken. Anti-parkinsonian drugs should not be used. In this case, anti-parkinsonian drugs are 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 cardiac 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, immediate medical advice must be sought (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 concomitantly 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 unknown (frequency cannot be estimated from available data):

• withdrawal symptoms in newborns;
• falls.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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 provide more information on the safety of this medicine.

5. How to store Tiapridal

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Store below 25°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 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 anhydrous silica, magnesium stearate.

What the medicine looks like and contents of the pack
Tiapridal tablets are round, smooth, white to almost white, with bevelled edges, marked with a cross dividing the tablet on one side and embossed with the code "T100" on the other side.
The pack contains 20 or 50 tablets.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Hungary, country of export:
Neuraxpharm Hungary Kft.
Szervita tér 8.
1052 Budapest, Hungary

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

Marketing Authorisation numbers in Hungary, country of export: OGYI-T-1117/01
OGYI-T-1117/02

Parallel import authorisation number: 61/23