Tiaprizal 100 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tiaprizal 100 mg tablets

Tiapride

Package leaflet contents:

1. What Tiaprizal is and what it is used for
2. What you need to know before taking Tiaprizal
3. How to take Tiaprizal
4. Possible side effects
5. Storage of Tiaprizal
6. Contents of the pack and other information

1. What Tiaprizal is and what it is used for

Tiaprizal belongs to a group of medicines called antipsychotics.

This medicine is indicated for the treatment of involuntary movements or behavioural disorders in adults (caused, for example, by certain diseases, age, or alcohol consumption).

2. What you need to know before taking Tiaprizal

Do not take Tiaprizal

• if you are allergic to tiapride or to any of the other ingredients of this medicine (listed in section 6),
• if you have concomitant prolactin-dependent tumours (hormone that stimulates milk production in mammary glands), for example, pituitary prolactinomas or breast cancer,
• if you have phaeochromocytoma (a tumour of the adrenal gland),
• if you are being treated with levodopa or other dopaminergic medicines (see "Use of Tiaprizal with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before taking Tiaprizal:

• if you have bradycardia (slowing of the heart rate), low blood potassium levels, QT interval prolongation (which may lead to ventricular arrhythmias/heart rhythm disturbances), or are taking any medicine that may promote any of these conditions (see "Use of Tiaprizal with other medicines"),
• if you develop fever of unknown origin, treatment with Tiaprizal should be discontinued as this may indicate neuroleptic malignant syndrome, a potentially life-threatening condition characterised by high body temperature, muscle rigidity, and nervous system disturbances (see "Possible side effects"). Cases with atypical features such as absence of muscle rigidity or hypertonia and lower fever have been observed,
• if you develop fever and/or muscle rigidity during treatment with Tiaprizal, particularly if you are already taking any other medicine for mental health disorders,
• if you have or have had problems with alcohol (see Taking Tiaprizal with food, drinks and alcohol),
• if you have Parkinson's disease, you should not use this medicine except in exceptional cases,
• if you have risk factors for stroke (vascular disease affecting arteries to or within the brain),
• in elderly patients with psychosis associated with dementia who are being treated with antipsychotics (as they have an increased risk of death),
• in patients with risk factors for venous thromboembolism (blockage of a blood vessel by a blood clot) (see "Possible side effects"),
• if you have or have had epilepsy, as the class of medicines to which Tiaprizal belongs may increase the risk of epileptic seizures,
• if you have renal impairment (impaired kidney function), as the dose of Tiaprizal should be reduced,
• if the medicine is to be administered to elderly patients, as tiapride may pose a risk of decreased level of consciousness and coma in these patients and should therefore be used with caution,
• if the medicine is to be administered to children, as tiapride has not been thoroughly studied in this patient group,
• if you have personal or family history of breast cancer, you should be monitored by your doctor during treatment with tiapride. Tiapride may increase levels of prolactin (hormone that stimulates milk production in mammary glands),
• if you have leucopenia (reduced number of white blood cells), neutropenia (reduced number of a type of white blood cells, neutrophils), and agranulocytosis (reduced number of a type of white blood cells, granulocytes), as well as infections or fever of unknown origin, inform your doctor, as this may indicate a blood dyscrasia (blood disorder) (see "Possible side effects").

Consult your doctor or pharmacist if any of these symptoms occur.

Use of Tiaprizal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, inform your doctor if you are taking any of the following medicines:

Combinations that are contraindicated:

Except in patients with Parkinson's disease, simultaneous administration of dopaminergic agonists (cabergoline, quinagolide) with neuroleptics should be avoided.

Combinations not recommended:

• Alcohol (see "Taking Tiaprizal with food, drinks and alcohol").

• Levodopa (a medicine used to treat Parkinson's disease).

• Dopaminergic agonists other than levodopa (amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline) in patients with Parkinson's disease.

• Methadone (a pain-relieving medicine).

• Medicines that may cause disturbances in heart rhythm (torsades de pointes):

• Antiarrhythmic agents such as quinidine, disopyramide, hydroquinidine, amiodarone, sotalol, dofetilide and ibutilide.

• Some neuroleptics such as pimozide, sultopride, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, haloperidol, droperidol, flufenazine, pipamperone, flupentixol, zuclopenthixol (medicines used to treat psychiatric disorders such as psychosis, schizophrenia, anxiety, etc.).

• Some antiparasitic medicines such as halofantrine, lumefantrine and pentamidine.

  • Other medicines:
  • bepridil (a medicine for angina pectoris),
  • cisapride (a medicine for gastrointestinal motility disorders),
  • intravenous erythromycin, intravenous spiramycin, moxifloxacin (antibiotics),
  • intravenous vincamine (a medicine that improves cerebral blood circulation),
  • mizolastine (a medicine for treating allergy),
  • difemethiazole (a medicine for treating digestive tract spasms).

Combinations requiring precautions in use:

• Medicines that cause a decrease in heart rate (bradycardia) (particularly class Ia antiarrhythmics, beta-blockers, some class II antiarrhythmics, some calcium antagonists, cardiac glycosides, pilocarpine, cholinesterase inhibitors).

• Beta-blockers used in heart failure (heart problems) (bisoprolol, carvedilol, metoprolol, nebivolol).

• Agents that reduce potassium levels (potassium-depleting diuretics, stimulant laxatives, intravenous amphotericin B, glucocorticoids, cosyntropin).

Medicines whose simultaneous administration should be considered:

• Antihypertensives (medicines to treat high blood pressure): all.

• Central nervous system depressants

Narcotics (analgesics, cough medicines, opioid replacement therapy); barbiturates (medicines used to induce sedation); benzodiazepines (due to their sedative effect, used to treat anxiety, insomnia, epilepsy, etc.); other non-benzodiazepine anxiolytics; hypnotics; neuroleptics; sedative antidepressants (amitriptyline, doxepine, mianserin, mirtazapine, trimipramine); sedative H1 antihistamines; centrally acting antihypertensives; other medicines: baclofen, thalidomide, pizotifen.

• Beta-blockers (except esmolol, sotalol and beta-blockers used in heart failure).

• Nitrates and related compounds (substances containing nitrates, such as nitrate derivatives used to treat symptoms of angina pectoris, heart failure, etc.).

Please note that these instructions may also apply to medicines that have been used previously or may be used in the future.

Taking Tiaprizal with food, drinks and alcohol

As alcohol may enhance the sedative effect of tiapride, consumption of alcoholic beverages or other medicines containing alcohol is not recommended while taking this medicine. Alcohol consumption while taking Tiaprizal may also cause electrolyte imbalance (imbalance of minerals in the blood) and may lead to QT interval prolongation (disturbance in heart rhythm/rate) (see Warnings and precautions).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Tiaprizal is not recommended during pregnancy or in women of childbearing age who are not using effective contraception.

If you take Tiaprizal during the last three months of pregnancy, your baby may experience tremors, increased muscle tone, drowsiness, agitation, breathing difficulties, or feeding problems. If your baby develops any of these symptoms, consult your doctor.

Tiapride used in the late stages of pregnancy may theoretically, particularly at high doses, cause:

• symptoms such as tachycardia, hyperexcitability, abdominal distension, delayed meconium passage,
• sedation.

Breastfeeding

You should not breastfeed while being treated with Tiaprizal. If you are taking Tiaprizal, consult your doctor about the best way to feed your baby.

Fertility

Tiaprizal may cause absence of menstruation or absence of ovulation and may reduce fertility.

Driving and use of machines

Tiapride may cause symptoms such as drowsiness, dizziness or visual disturbances, and may impair reaction ability. These effects, as well as the underlying illness, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.

3. How to take Tiaprizal

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose must be adjusted individually for each patient.

The duration of this treatment is limited. Your doctor will inform you of the duration of your treatment.

The route of administration of Tiaprizal 100 mg tablets is oral.

The dose to be administered varies depending on the condition you have:

Short-term treatment of agitation and aggressiveness in alcoholic patients:

The recommended dose is 300 to 400 mg/day, i.e., 3 to 4 tablets/day, for 1 to 2 months.

Treatment in severe cases of Huntington's chorea:

Initial dose: up to 1,200 mg/day, i.e., 12 tablets/day, divided into at least three doses, with a progressive reduction to the usual maintenance dose according to individual response.

Children:

The usual dose is 100 to 150 mg/day, i.e., 1 tablet to 1 and a half tablets per day, with a maximum of 300 mg/day (i.e., 3 tablets/day).

Elderly patients: The initial dose is 100 mg per day. The dose may be progressively increased up to a maximum of 300 mg per day, if necessary.

Renal impairment:

In patients with impaired kidney function, the dose should be reduced according to your doctor's instructions.

Hepatic impairment:

In patients with impaired liver function, dose reduction is not necessary.

If you think that the effect of Tiaprizal is too strong or too weak, inform your doctor or pharmacist.

If you take more Tiaprizal than you should

If you have taken more Tiaprizal than you should, consult your doctor or pharmacist immediately.

Overdose may cause drowsiness, sedation, coma, decreased blood pressure, and extrapyramidal symptoms (tremor, increased muscle tone, reduced movement, hypersalivation, etc.). Cases of death have been reported, mainly when Tiaprizal is combined with other psychotropic agents (medications used to treat diseases of the central nervous system).

There is no specific antidote for tiapride. Since tiapride is moderately dialyzable, hemodialysis should not be used to remove the drug.

In case of overdose, appropriate supportive measures should be initiated, with close monitoring of vital functions and cardiac function recommended (due to the risk of QT interval prolongation and ventricular arrhythmias), until the patient recovers.

In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Tiaprizal

Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects have been grouped according to their frequency based on the following classification:

• very common: may affect more than 1 in 10 patients,
• common: may affect up to 1 in 10 patients,
• uncommon: may affect up to 1 in 100 patients,
• rare: may affect up to 1 in 1,000 patients,
• very rare: may affect up to 1 in 10,000 patients,
• frequency not known: cannot be estimated from available data.

Common (may affect up to 1 in 10 patients)

• Increased levels of prolactin in the blood, which may cause other disorders such as chest pain, breast enlargement and milk secretion, and enlargement of the glands (galactorrhea and gynecomastia), menstrual cycle disorders in women (dysmenorrhea, amenorrhea), and may rarely cause abnormal orgasm/impotence in men
• Dizziness/vertigo, headache
• Parkinsonism and related symptoms: tremor, increased muscle tone, slowed movement, and increased salivation. These symptoms are usually reversible with administration of an anticholinergic (e.g. biperiden)
• Somnolence/drowsiness, insomnia, agitation, indifference
• Asthenia (feeling of weakness)/fatigue.

Uncommon (may affect up to 1 in 100 patients)

• Early dyskinesia, uncontrolled movements (muscle spasms, torticollis, eye movement disorders, inability to open the mouth), and inability to remain sitting still. These symptoms are usually reversible with administration of an anticholinergic (e.g. biperiden)
• Confusion, hallucinations
• Seizure, syncope
• Decreased blood pressure (hypotension), usually upon standing (orthostatic hypotension)
• Deep vein thrombosis
• Constipation
• Rash (including erythematous or nodular/irregular rash)
• Milk secretion from the breasts
• Absence of menstruation (amenorrhea)
• Abnormal orgasm
• Weight gain.

Rare (may affect up to 1 in 1,000 patients)

• Loss of consciousness
• Leukopenia (reduced number of white blood cells), neutropenia (reduced number of a type of white blood cells, neutrophils), and agranulocytosis (reduction in a type of white blood cells, granulocytes) (see “Warnings and precautions”)
• Decreased sodium levels in the blood (hyponatremia), a condition known as “syndrome of inappropriate antidiuretic hormone secretion (SIADH)”
• Acute dyskinesia (movement disorders). These symptoms are usually reversible with administration of anti-Parkinson medication
• After prolonged periods of treatment (longer than 3 months), tardive dyskinesia has been reported, as with all medications used to treat psychological disorders (neuroleptics). This is characterized by involuntary, rhythmic movements, mainly of the tongue and/or face. If such movements occur, consult your doctor, who will decide on the necessary measures. Anti-Parkinson medication should not be used as an antidote, as it is ineffective and may even worsen symptoms
• As with all neuroleptics, tiapride may cause neuroleptic malignant syndrome, a potentially fatal complication characterized by fever of unknown origin and muscle rigidity (see section 2 “What you need to know before taking Tiaprizal”)
• QT interval prolongation has been reported, along with ventricular arrhythmias such as torsades de pointes, ventricular tachycardia (accelerated heart rate), which could lead to ventricular fibrillation or cardiac arrest and sudden death (see also section 2 “Warnings and precautions” and “Use of Tiaprizal with other medicines”)
• Blood clots in the veins, mainly in the legs (with swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing. If you experience these symptoms, consult your doctor immediately (see section 2 “What you need to know before taking Tiaprizal”). Sometimes pulmonary embolism can be fatal
• Lung inflammation (pneumonia) due to aspiration caused by food particles or liquid entering the lungs, altered breathing (respiratory depression)
• Intestinal obstruction (including a type of obstruction known as ileus)
• Increased liver enzymes
• Rash (urticaria)
• Elevated levels of creatine phosphokinase in the blood, muscle weakness and/or muscle pain (rhabdomyolysis)
• Breast enlargement and pain
• Milk secretion from the breasts (galactorrhea)
• Enlargement of breast glands in men (gynecomastia)
• Impotence (erectile dysfunction).

Frequency not known (cannot be estimated from available data):

• Withdrawal syndrome in newborns (see “Pregnancy, lactation and fertility”)
• Falls, especially in elderly patients.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tiaprizal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their containers to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tiaprizal 100 mg tablets

• The active substance is tiapride. Each tablet contains 100 mg of tiapride base, equivalent to 111.10 mg of tiapride hydrochloride.
• The other components are mannitol (E-421), microcrystalline cellulose, povidone, colloidal hydrated silica, magnesium stearate.

Appearance of the product and contents of the pack

White, round, biconvex tablets, with a cross on one side and engraved "T100" on the other.

The tablet can be divided into equal doses.

Each pack contains 20 or 24 tablets.

Other presentations:

• Tiaprizal 100 mg injectable solution, pack containing 12 ampoules of 2 ml.
• Tiaprizal 12 mg/ml oral drops in solution, pack containing one 60 ml bottle and a dosing syringe.

Marketing Authorization Holder and Manufacturer

Manufacturer:

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 Alcorcón (Madrid)

Spain

or

Delpharm Dijon

6 Boulevard de l’Europe

21800 Quetigny

France

Date of the most recent review of this leaflet: September 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/