Tiapridal

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

TIAPRIDAL

100 mg, tablets

Tiapridum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Tiapridal and what is it used for
• 2. Important information before using Tiapridal
• 3. How to use Tiapridal
• 4. Possible side effects
• 5. How to store Tiapridal
• 6. Contents of the pack and other information

1. What is Tiapridal and what is it used for

Tiapridal is available in the form of tablets 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 in cases of psychomotor agitation and aggressive behavior 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 tumor that depends on prolactin levels, such as a prolactinoma, a prolactin-dependent breast tumor,
• 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

In case of the following during treatment: hyperthermia (overheating), muscle stiffness, you should immediately contact your doctor (it may be a sign of malignant neuroleptic syndrome, life-threatening).
At the beginning of treatment, the doctor may order an ECG and blood electrolyte tests (especially potassium levels). The use of tiapride may cause changes in the ECG and increase the risk of severe ventricular arrhythmias, such as torsades de pointes. This risk is higher when bradycardia (heart rate below 55 beats per minute) occurs, potassium levels decrease, and in cases of congenital or acquired QT interval prolongation in the ECG (during concomitant use of medications that cause QT interval prolongation). Therefore, you should inform your doctor about all recently used medications.
In patients with Parkinson's disease, the medicine can only be used if it is absolutely necessary.
Tiapride is excreted from the body by the kidneys, and in patients with renal failure, the dose of the medicine will be reduced by the doctor depending on the assessment of kidney function (creatinine clearance).
In case of liver failure, dose reduction is not necessary.
Tiapride should be used with caution in patients with stroke risk factors and in patients with venous thromboembolism risk factors.
Elderly patients with psychosis associated with dementia who are 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 count, 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, you should avoid drinking alcohol and taking medications containing alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using 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 used Tiapridal during the last three months of pregnancy, her child may experience hyperactivity, increased muscle tone, tremors, drowsiness, breathing difficulties, or feeding disorders.
If any of these symptoms occur in the child, you should contact a doctor.
Breastfeeding
Tiapridal should not be used during breastfeeding. If a patient is using Tiapridal, she should discuss alternative breastfeeding options with her doctor.
Fertility
Tiapridal may lead to amenorrhea or anovulation and may decrease fertility in humans.

Driving and using machines

Tiapridal may cause excessive sedation, which may affect the ability to drive vehicles and operate precision instruments during treatment.

Tiapridal and other medicines

You should tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan 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 ECG is not recommended. These medications include:

• medications that cause bradycardia (heart rate below 55 beats per minute): diltiazem and verapamil, clonidine, guanfacine, digitalis glycosides;
• medications that decrease potassium levels: diuretics, laxatives, amphotericin B administered intravenously, glucocorticoids, tetracosactide;
• class Ia antiarrhythmic medications, such as quinidine, disopyramide;
• class III antiarrhythmic medications, 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 anxiolytic medications, clonidine, and its derivatives.

3. How to use Tiapridal

The medicine should be used as recommended by the doctor. In case of doubts, you should contact the doctor again.
Usually, 200 mg is used per day for a period of 1 to 2 months.
The maximum dose is 300 mg/day.
Treatment starts with a dose of 50 mg twice a day, and then the dose is increased over the next 2-3 days to 100 mg three times a day.
If you feel that the effect of Tiapridal is too strong or too weak, you should consult a doctor.

Using a higher dose of Tiapridal than recommended

There is little 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 are: 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, it should always be considered that the patient may also be poisoned with other medications.
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 to maintain basic life functions and close monitoring of heart function until the patient's condition improves.
In case of using a higher dose of Tiapridal than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Tiapridal

In case of missing a dose, you should take it as soon as possible, unless it is close to the time of taking the next dose. You should not take two doses of the medicine at the same time or at short intervals. In case of doubts, you should consult a doctor.

4. Possible side effects

Like all medicines, Tiapridal can cause side effects.
Frequent (in 1 to 10 out of 100 patients):

• dizziness, headaches;
• symptoms like those of Parkinson's disease: tremors, increased muscle tone, hypokinesia (reduced mobility), and drooling. 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), erectile dysfunction, and orgasm disorders, which may occur infrequently.

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

• early dyskinesia, dystonia (spasm, spastic torticollis, oculogyric crises), and akathisia (excessive psychomotor activity, restlessness, anxiety). These symptoms usually disappear after administration of anti-Parkinson's disease medications (e.g., biperiden);
• weight gain;
• disorientation, hallucinations;
• loss of consciousness, 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 to treat mental disorders (neuroleptics). In case of such movement disorders, you should immediately inform your doctor, 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 blood vessels to the lungs, causing chest pain and breathing difficulties], sometimes resulting in death; In case of any of the above symptoms, you should immediately consult a doctor (see section 2 Important information before using Tiapridal);
• aspiration pneumonia caused by food particles or vomit entering the lungs;
• breathing difficulties, such as shortness of breath, difficulty breathing, shallow breathing, 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tiapridal

There are no special recommendations for storage.
The medicine should be stored out of sight and reach of children.
You should not use this medicine 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 the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the pack and other information

What Tiapridal contains

The active substance of the medicine is 100 mg tiapride (in the form of 111.1 mg tiapride hydrochloride).
The medicine also contains the following excipients: mannitol (E 421), microcrystalline cellulose, povidone, colloidal silicon dioxide, magnesium stearate.

What Tiapridal looks like and contents of the pack

The pack contains 20 tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Sanofi România 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 by:

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 authorization number in Romania, the country of export: 7570/2015/01

Parallel import authorization number: 204/22 Date of approval of the leaflet: 11.05.2022

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