Tiapridal

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Tiapridal

100 mg, tablets
Tiapridum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Tiapridal and what is it used for
• 2. Important information before taking Tiapridal
• 3. How to take Tiapridal
• 4. Possible side effects
• 5. How to store Tiapridal
• 6. Package contents and other information

1. What is Tiapridal and what is it used for

Tiapridal is available in tablet form and contains tiapride as the active substance.
Tiapride is an atypical neuroleptic with anxiolytic and sedative effects. Additionally, 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 taking Tiapridal

When not to take Tiapridal:

• if the patient is allergic to tiapride or any other component of this medicine (listed in section 6),
• if the patient has a tumor that depends on prolactin levels, such as a prolactinoma, prolactin-dependent breast cancer,
• if the patient has a pheochromocytoma,
• if the patient is taking levodopa at the same time (see section: Tiapridal and other medicines).

Warnings and precautions

A doctor should be contacted immediately:

• in case of fever and (or) muscle stiffness during treatment with Tiapridal, especially if taken in combination with other psychiatric medications.
• if the patient has or has had problems with alcohol (see section: Tiapridal with food, drink, and alcohol).

At the start of treatment, the doctor may order an EKG and blood electrolyte tests (especially potassium levels). Taking tiapride may cause changes in the EKG and increase the risk of severe ventricular arrhythmias, such as torsades de pointes. This risk is higher when there is also bradycardia (heart rate below 55 beats per minute), decreased potassium levels in the blood, and in cases of congenital or acquired QT interval prolongation in the EKG (during concomitant use of medications that cause QT interval prolongation). Therefore, the doctor should be informed about all recently taken medications.
In patients with Parkinson's disease, the medicine can only be used when absolutely necessary.
Tiapride is excreted from the body by the kidneys, and in patients with renal insufficiency, the dose of the medicine will be reduced by the doctor depending on the assessment of kidney function (creatinine clearance).
In case of liver insufficiency, dose reduction is not necessary.
Tiapride should be used with caution in patients with risk factors for stroke, as well as in patients with risk factors for venous thromboembolism.
Elderly patients with psychosis associated with dementia, treated with antipsychotic medications, 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 special caution due to the risk of consciousness disorders 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 the use of antipsychotic medications, including Tiapridal. Unexplained infections or fever may be a sign of abnormal blood counts, and blood tests should be performed immediately.

Tiapridal with food, drink, and alcohol

The medicine should be taken directly before a meal.
During treatment with tiapride, alcohol consumption and the use of medications containing alcohol should be avoided.
Consuming alcohol while taking Tiapridal may also cause electrolyte imbalance (mineral imbalance in the blood) and may cause QT interval prolongation (heart rhythm disorders) (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Pregnancy
The use of Tiapridal is not recommended in pregnant women and women of childbearing age who do not use effective contraception.
If a patient took Tiapridal during the last three months of pregnancy, their child may experience hyperactivity, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding problems. If any of these symptoms occur in the child, a doctor should be consulted.
Breastfeeding
Tiapridal should not be used during breastfeeding. If a patient is taking Tiapridal, they should discuss alternative feeding methods with their doctor.
Fertility
Tiapridal may lead to amenorrhea or anovulation and may reduce fertility in humans.

Driving and using machines

Tiapridal may cause excessive sedation, which may affect the ability to drive vehicles and operate machines while taking the medicine.

Tiapridal and other medicines

The doctor should be informed about all medicines currently being taken or recently taken by the patient, as well as any medicines the patient plans to take.
Concomitant use of tiapride and levodopa is contraindicated.
Concomitant use of tiapride and medications that may cause torsades de pointes(severe heart rhythm disorders) or QT interval prolongation in the EKG is not recommended. These medications include:

• medications causing bradycardia (heart rate below 55 beats per minute): diltiazem and verapamil, clonidine, guanfacine, digitalis glycosides,
• medications reducing potassium levels: diuretics, laxatives, amphotericin B administered intravenously, glucocorticoids, tetracosactides,
• antiarrhythmic medications of class Ia, such as quinidine, disopyramide,
• antiarrhythmic medications of class III, such as amiodarone, sotalol,
• other medications, such as pimozide, sulpiride, haloperidol, thioridazine, methadone, imipramine-derived antidepressants, lithium, bepridil, cisapride (a medication that stimulates gastrointestinal motility), intravenous erythromycin, intravenous vincamine (a medication used in cerebral circulation disorders), halofantrine, pentamidine, sparfloxacin.

The doctor should consider the possibility of concomitant use of tiapride and medications that suppress the central nervous system, such as morphine derivatives (painkillers and antitussives); most antihistamines (H receptor antagonists); barbiturates, benzodiazepines, and other anxiolytics; clonidine and its derivatives.

3. How to take Tiapridal

The dosage may vary and should be adjusted for each patient.
This medicine should always be taken as directed by the doctor. In case of doubts, the doctor should be consulted.
The initial dose is 100 mg per day. If necessary, the dose can be gradually increased to a maximum of 300 mg per day.
The duration of treatment should not exceed 28 days.
If the patient feels that the effect of Tiapridal is too strong or too weak, they should consult their doctor.

Using a higher dose of Tiapridal than recommended

There is limited data on tiapride overdose. Cases of death have been reported after tiapride overdose, mainly in combination with other antipsychotic medications. The most common symptoms after overdose include: dizziness, excessive sedation, coma, decreased blood pressure, and extrapyramidal symptoms (muscle stiffness, reduced facial expressions, slowed movements, restlessness, involuntary muscle contractions, and involuntary movements).
In case of severe overdose, the possibility of poisoning with other medications should always be considered.
Tiapride is only slightly removed from the body by hemodialysis. Therefore, hemodialysis is not recommended for removing the medicine from the body.
There is no specific antidote for tiapride. Treatment consists of supportive care for basic life functions and close monitoring of heart function until improvement of the patient's condition.
In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.

Missing a dose of Tiapridal

In case of missing a dose, it should be taken as soon as possible, unless it is close to the time for the next dose. Two doses of the medicine should not be taken at the same time or in a short period. In case of doubts, the doctor should be consulted.

4. Possible side effects

Like all medicines, Tiapridal can cause side effects, although not everybody gets them.
Common (in 1 to 10 out of 100 patients):

• dizziness, headaches;
• symptoms like those in Parkinson's disease: tremors, increased muscle tension, hypokinesia (reduced mobility), and salivation. These symptoms usually disappear after administration of anti-Parkinson's disease medications (e.g., biperiden);
• drowsiness, insomnia, agitation, reduced sensitivity to stimuli (apathy);
• weakness, fatigue;
• hyperprolactinemia (increased prolactin levels in the blood). This symptom disappears after withdrawal of the medicine. Hyperprolactinemia can cause other disorders, such as breast swelling and pain, galactorrhea, menstrual disorders in women (painful menstruation, amenorrhea), gynecomastia (breast enlargement in men), orgasm disorders, and erectile dysfunction in men.

Uncommon (in 1 to 10 out of 1000 patients):

• early dyskinesia, dystonia (spasm, spastic torticollis, oculogyric crises), and akathisia (excessive psychomotor activity, anxiety, fear). These symptoms usually disappear after administration of anti-Parkinson's disease medications (e.g., biperiden);
• weight gain;
• disorientation, hallucinations;
• fainting, seizures;
• decreased blood pressure, usually when standing up;
• deep vein thrombosis;
• constipation;
• rash (including redness or papular/pustular rash);
• amenorrhea, orgasm disorders.

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

• acute dyskinesia. This symptom usually disappears after administration of anti-Parkinson's disease medications;
• decreased white blood cell count (leukopenia, neutropenia, and agranulocytosis);
• decreased sodium levels in the blood (hyponatremia), a condition called "syndrome of inappropriate antidiuretic hormone secretion" (SIADH);
• late dyskinesia (characterized by rhythmic, involuntary movements of the tongue and/or facial muscles) after prolonged use of the medicine for more than 3 months, similar to other medications used in the treatment of psychiatric disorders (neuroleptics). In case of such movement disorders, the doctor should be informed immediately, who will decide on the necessary actions. Anti-Parkinson's disease medications should not be used. In this case, the use of anti-Parkinson's disease medications is ineffective and may even worsen the symptoms;
• malignant neuroleptic 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 can lead to ventricular fibrillation or cardiac arrest and sudden death (see also section 2 Warnings and precautions);
• pulmonary embolism [blood clots in the veins, especially in the legs (with swelling, pain, and redness of the legs), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties], sometimes resulting in death; In case of any of the above symptoms, a doctor should be consulted immediately (see section 2 Important information before taking Tiapridal);
• aspiration pneumonia caused by food particles or vomit entering the lungs;
• breathing difficulties, such as shortness of breath, difficulty breathing, shallow breathing, especially when used with other medications that have a depressive effect on the central nervous system;
• intestinal obstruction;
• increased liver enzyme activity;
• hives;
• increased creatine kinase activity in the blood, muscle weakness, and/or muscle pain;
• breast swelling and pain, galactorrhea, gynecomastia, erectile dysfunction.

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

• withdrawal symptoms in newborns;
• falls.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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 side effects can help gather more information on the safety of the medicine.

5. How to store Tiapridal

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Medicines should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Tiapridal contains

The active substance of the medicine is 100 mg tiapride (in the form of 111.10 mg tiapride hydrochloride).
The medicine also contains the following excipients:
mannitol, microcrystalline cellulose, povidone, colloidal silicon dioxide, magnesium stearate.

What Tiapridal looks like and what the package contains

Tiapridal tablets are round, white to ivory, with a cross on one side and the inscription "T100" on the other side.
The package contains 20 or 50 tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Hungary, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Hungarian marketing authorization number: OGYI-T-1117/01
OGYI-T-1117/02

Parallel import authorization number: 132/14

Date of leaflet approval: 19.03.2024

[Information about the trademark]