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 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 someone else, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of 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 as tablets and contains tiapride as the active substance.
Tiapride is an atypical neuroleptic agent with anxiolytic and calming properties. It also 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 depends on prolactin levels, e.g. a prolactinoma or prolactin-dependent breast cancer,
• if the patient has a chromaffin tumour (phaeochromocytoma),
• if the patient is taking levodopa at the same time (see section: Tiapridal with other medicines).

Warnings and precautions
Contact your doctor immediately:
˗ if fever and/or muscle rigidity occur during treatment with Tiapridal,
especially if other medicines affecting mental health are being taken concomitantly;
˗ if the patient has or has had problems with alcohol (see section: Tiapridal with food, drink and
alcohol).
At the beginning of treatment, the doctor may request 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 greater if bradycardia (a
slowing of heart rate below 55 beats per minute), low blood potassium levels, or congenital or
acquired QT interval prolongation on ECG are present (especially when other drugs that prolong the
QT interval are taken concomitantly). Therefore, inform your doctor about all medicines recently
taken.
Tiapridal may be used in patients with Parkinson's disease only if strictly necessary.
Tiapride is eliminated from the body via the kidneys. In patients with renal impairment, the doctor
will reduce the dose depending on kidney function (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 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
abnormal blood counts; immediate blood tests are required.

Tiapridal with food, drink and alcohol
The medicine should be taken just before meals.
Alcohol consumption and use of medicinal products containing alcohol should be avoided during
treatment with tiapride.
Drinking alcohol while taking Tiapridal may also cause electrolyte imbalance (disturbance in blood
mineral balance) and may lead to QT interval prolongation (disturbances in heart rhythm/rate) (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
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 took Tiapridal during the last three months of pregnancy, the newborn may experience
hyperexcitability, increased muscle tone, tremors, drowsiness, breathing difficulties or feeding
problems. If any of these symptoms occur in the newborn, contact a doctor.

Breastfeeding
Tiapridal should not be used while 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, including
medicines not requiring a prescription, as well as any medicines planned for future use.

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 (slowing of 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 antiarrhythmic medicines such as quinidine, disopyramide;
˗ class III antiarrhythmic medicines such as amiodarone, sotalol;
˗ other medicines such as pimozide, sultopride, haloperidol, thioridazine, methadone,
tricyclic antidepressants, lithium, bepridil, cisapride (a gastrointestinal motility stimulant),
intravenous erythromycin, intravenous vinpocetine (a medicine used in cerebral circulation
disorders), halofantrine, pentamidine, sparfloxacin.

The doctor should consider the possibility of concomitant use of tiapride with medicines that depress
the central nervous system, i.e.: 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 individually for each patient.
This medicine should always be used according to the doctor's instructions. If in 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, 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 occurs.
If a higher than recommended dose of the medicine has been taken, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Tiapridal
If a dose is missed, 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. If in doubt, consult your doctor.

4. Possible adverse effects

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

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

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

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

• 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 antiparkinsonian 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 nodular/irregular rash);
• amenorrhoea, orgasmic disorders.

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

• acute dyskinesia. This symptom usually resolves after administration of antiparkinsonian drugs;
• decreased number of white blood cells (leucopenia, neutropenia, and agranulocytosis);
• decreased sodium levels in the 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 medicines 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. Antiparkinsonian drugs should not be used. In this case, antiparkinsonian 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 cardiac 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 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 concomitantly with other centrally acting depressant medicines;
• 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 effects have been reported:
Frequency unknown (frequency cannot be estimated from available data):

• withdrawal symptoms in newborns;
• falls.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Tiapridal

Keep this medicine out of the 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.
No special storage instructions apply.
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 components are: mannitol, microcrystalline cellulose, povidone,
  colloidal anhydrous silica, magnesium stearate.

What Tiapridal looks like and contents of the pack
Tiapridal tablets are round, smooth, white to almost white, with bevelled edges, marked with a cross on one side and an embossed code "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 Romania, country of export:
neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Straße 23
40764 Langenfeld, Germany

Manufacturer:
Delpharm Dijon
6, boulevard de l’Europe
21800 Quetigny
France

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 Number in Romania, country of export: 7570/2015/01
Parallel Import Licence Number: 326/17