Tiapridal

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging 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, 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. This medicine may harm others, even if their symptoms are the same.
• If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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. In addition, it has a beneficial effect on the level of alertness in elderly patients.
Tiapridal is used in the treatment of psychomotor agitation and aggressive behaviour in elderly patients with dementia.

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-producing pituitary adenoma (prolactinoma), 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

Should hyperthermia (elevated body temperature) or muscle rigidity occur during treatment, contact a doctor immediately (these may be symptoms of neuroleptic malignant syndrome, a life-threatening condition).
At the beginning of treatment, the doctor may recommend performing an ECG and measuring blood electrolytes (especially 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 (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 the doctor about all medicines 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 according to kidney function assessment (creatinine clearance).
Dose reduction is not necessary in case of liver insufficiency.
Tiapride should be used cautiously 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 the use of antipsychotic medicines, including Tiapridal. Unexplained infections or fever may be signs of blood dyscrasia; immediate blood tests are required.

Tiapridal with food, drink, and alcohol
The medicine should be taken just before a meal.
Alcohol consumption and use of medicinal products containing alcohol should be avoided during treatment with tiapride.

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 a doctor or pharmacist before using this medicine.

Pregnancy
The 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 symptoms such as hyperexcitability, increased muscle tone, tremor, 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 cause amenorrhoea or anovulation and may reduce fertility in humans.

Driving and using machines
Tiapridal may cause excessive sedation, which may affect the ability to drive motor vehicles or operate precision machinery during treatment.

Tiapridal with other medicines
Inform the doctor about all medicines the patient is currently taking or has 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, 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 vincamine (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, such as: morphine derivatives (analgesics and antitussives); most antihistamines (H\1 receptor antagonists); barbiturates; benzodiazepines and other anxiolytics; clonidine and its derivatives.

3. How to use Tiapridal

The medicine should be used as directed by the physician. If in doubt, consult your doctor again.
The usual dose is 200 mg per day for a period of 1 to 2 months.
The maximum dose is 300 mg/day.
Treatment should be initiated at a dose of 50 mg twice daily, then increased over the next 2–3 days to 100 mg three times daily.
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, 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 elimination of 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 used, seek immediate medical advice from a doctor or pharmacist.

Missed dose of Tiapridal
If a dose is missed, take it 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 reactions

Like any medicine, Tiapridal may cause adverse reactions.

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

• dizziness, headache;
• Parkinsonism-like symptoms: tremor, increased muscle tone, hypokinesia (reduced mobility), and hypersalivation. These symptoms usually resolve after administration of anti-parkinsonian drugs (e.g. biperiden);
• drowsiness, insomnia, agitation, reduced sensitivity to stimuli (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, galactorrhea, menstrual disorders in women (painful menstruation, amenorrhea), gynaecomastia (breast enlargement in men), orgasmic disorders, erectile dysfunction in men, which may occur less commonly.

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;
• loss of consciousness, seizures;
• hypotension, usually upon standing;
• deep vein thrombosis;
• constipation;
• rash (including erythematous rash or nodular/irregular rash);
• amenorrhea, orgasmic disorders.

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

• acute dyskinesia. This symptom usually resolves after administration of anti-parkinsonian drugs;
• decrease in white blood cell count (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 medications 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-parkinsonian drugs should not be used. In this case, administration of anti-parkinsonian 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 cardiac arrest and sudden death (see also section 2 Warnings and precautions);
• pulmonary embolism [blood clots in veins, particularly 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 these 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. dyspnoea, 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, galactorrhea, gynaecomastia, erectile dysfunction.

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

• withdrawal symptoms in newborns;
• falls.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Tiapridal

No special storage instructions are required.
The medicine should be stored in a place 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 month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. 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 111.1 mg tiapride hydrochloride).
The other ingredients are: mannitol (E 421), microcrystalline cellulose, povidone,
colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and contents of the pack
The pack contains 20 tablets.
For more detailed information, please contact the responsible entity or the parallel importer.

Marketing Authorisation Holder in Romania, the country of export:
Sanofi Romănia S.R.L.
Str. Gara Herăstrău, nr 4
Clădirea B
Etajele 8-9, Sector 2
Bucharest
Romania

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

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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation Number in Romania, the country of export: 7570/2015/01
Parallel Import Licence Number: 204/22