Package leaflet: information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Tiapridal
100 mg, tablets
Tiapridum
Please read this 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 adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Tiapridal is and what it is used for
Important information before using Tiapridal
How to use Tiapridal
Possible side effects
How to store Tiapridal
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.
Tiapridal is an atypical neuroleptic medicine 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-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 2: 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 alcohol-related problems (see section 2: Tiapridal, food, drink and alcohol).

At the beginning of treatment, your doctor may recommend an ECG and blood tests to measure electrolyte levels (especially potassium). 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 (heart rate below 55 beats per minute), low blood potassium levels, or congenital or acquired QT interval prolongation on ECG are present, particularly when used concomitantly with 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 strictly 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 renal function assessment (creatinine clearance).
Dosage adjustment is not required in patients with hepatic 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 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 confusion 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 following the use of antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be signs of blood abnormalities and immediate blood tests are necessary.

Tiapridal, food, drink and alcohol
This medicine should be taken just before a meal.
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 (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 baby, 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 potential 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, somnolence, breathing difficulties or feeding problems. If any of these symptoms occur in the newborn, contact a doctor immediately.

Breastfeeding
Tiapridal should not be used during 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 impair 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 planned for 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 (heart rate below 55 beats per minute): diltiazem and verapamil, clonidine, guanfacine, 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, tricyclic antidepressants (imipramine derivatives), 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 (H₁ 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. 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 activity until improvement in health status
is achieved.
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, it should be taken as soon as possible, except when it is almost time for the next
dose. Do not take a double dose or two doses in close succession. If in doubt, consult your doctor.

4. Possible adverse effects

Like all medicines, Tiapridal may cause adverse effects, although not everybody 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-Parkinson drugs (e.g. bipridine);
drowsiness, insomnia, agitation, reduced responsiveness (apathy);
weakness, fatigue;
hyperprolactinaemia (increased prolactin levels in the blood). This effect resolves after discontinuation of the medicine. Hyperprolactinaemia may cause other disturbances such as breast swelling and tenderness, galactorrhoea, menstrual disorders in women (painful menstruation, absence of menstruation), gynaecomastia (breast enlargement in men), orgasm disorders, and erectile dysfunction in men.

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

early dyskinesia, dystonia (muscle spasms, spasmodic torticollis, oculogyric crises (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. bipridine);
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;
decreased number of white blood cells (leukopenia, 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 use of the medicine for more than 3 months, as seen with all other medicines 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-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, difficulty breathing, shallow breathing, particularly when used with other centrally nervous system depressant medicines;
intestinal obstruction;
increased liver enzyme activity;
urticaria;
increased creatine kinase activity in the 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 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 the medicine.

5. How to store Tiapridal

Store below 30°C.
Keep the medicine in a place inaccessible and out of sight 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.
Medicines must not be disposed of via the sewage system or in 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 (in the form of 111.10 mg tiapride hydrochloride).
The other ingredients (excipients) are: mannitol, microcrystalline cellulose, povidone, precipitated 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 mark "T100" on the other side.
The pack contains 20 tablets.
For further information, please contact the Marketing Authorisation Holder 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 – Nové Město
Czech Republic
Manufacturer:
Delpharm Dijon
Quétigny
France
Famar Healthcare Services Madrid S. A. U.
Alcorón
Spain
Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation number in the Czech Republic, the country of export: 68/171/85-C
Parallel Import Licence number: 225/19