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, as it contains
important information for you.

• 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 you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Tiapridal is and what it is used for
2. What you need to know 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 effects.
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 prolactin-secreting pituitary adenoma (prolactinoma), 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 when taken together with other medicines acting on mental health,
• if the patient has or has had alcohol problems (see section: "Tiapridal with food, drink and alcohol").

At the beginning of treatment, your doctor may recommend an ECG and blood tests to measure electrolyte levels (particularly potassium). Use of 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 (heart rate below 55 beats per minute), low blood potassium levels, or congenital or acquired QT interval prolongation on ECG are present, especially when tiapride is used together with other medicines that prolong the QT interval. Therefore, inform your doctor about all medicines you have recently taken.
Tiapride may 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 renal function assessment (creatinine clearance).
Dosage reduction 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 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 following administration of antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be signs of blood disorders; immediate blood testing is required.

Tiapridal with food, drink and alcohol
The medicine should be taken just before meals.
Alcohol consumption and use of medicines 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
Use of Tiapridal is not recommended in pregnant women or in women of childbearing potential who are not using effective contraception.
If the patient has taken 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 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 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 you are currently taking or have recently taken, as well as any medicines you plan 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 antiarrhythmic medicines such as quinidine, disopyramide,
• class III antiarrhythmic medicines such as amiodarone, sotalol,
• other medicines such as pimozide, sultopride, 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 (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. Cases of death following 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, concomitant 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, it should be taken as soon as possible, except when 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 experiences them.

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

• dizziness, headache;
• Parkinson-like symptoms: tremor, increased muscle tone, hypokinesia (reduced mobility), and drooling. These symptoms usually resolve after administration of anti-Parkinson drugs (e.g. biperiden);
• drowsiness, insomnia, agitation, 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;
• 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 use of the drug for more than 3 months, as seen 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, 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 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 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, pharmacist, or nurse. Adverse effects can also be reported directly to the Department of Monitoring of 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 effects helps provide more information on the safety of the medicine.

5. How to store Tiapridal

Store below 30°C.
Keep the medicine out of the 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 what to do with 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 of tiapride hydrochloride).
The other ingredients are:
mannitol, microcrystalline cellulose, povidone, colloidal anhydrous silica, magnesium stearate.

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

For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, country of export:
Neuraxpharm Bohemia s.r.o.
náměstí Republiky 1078/1
110 00 Prague 1 - New Town
Czech Republic

Manufacturer:
Delpharm Dijon
6 boulevard de l’Europe
21800 Quetigny, France
Famar Healthcare Services Madrid, S.A.U.
Av. de Leganés, 62
28923 Alcorcón, Spain

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

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Marketing authorisation number in the Czech Republic, country of export: 68/171/85-C
Parallel import authorisation number: 249/25