Package Insert: Information for the User

Tiaprizal 100 mg Tablets

Tiaprida

Tiaprizal belongs to a group of medications known as antipsychotics.

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

Do not take Tiaprizal

• if you are allergic to tiapride or any of the other ingredients of this medicine (listed in section 6),
• if you have concomitant prolactin-dependent tumours (a hormone that stimulates milk production in the mammary glands), for example, pituitary prolactinomas and 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 starting to take Tiaprizal:

• if you have bradycardia (slowing of the heart rate), low levels of potassium in the blood, prolongation of the QT interval (may induce ventricular arrhythmias/alteration of heart rate) or are being treated with a medicine that favours any of these circumstances (see “Use of Tiaprizal with other medicines”),
• if you develop an unknown fever, the treatment with Tiaprizal should be discontinued as it could be the neuroleptic malignant syndrome, a potentially fatal complication characterised by high body temperature, muscle rigidity and alteration of the nervous system (see “Possible side effects”). Cases with atypical characteristics such as lack of muscle rigidity or hypertension and lower fever have been observed,
• if you develop fever and/or muscle rigidity during treatment with Tiaprizal and particularly if you are already taking any other medicine for mental health treatment,
• if you have or have had problems with alcohol (see Taking Tiaprizal with food, drinks and alcohol),
• if you have Parkinson's disease, do not use this medicine except in exceptional cases,
• if you have risk factors for a stroke (vascular disease that affects the arteries of the brain or that reach the brain),
• in elderly patients with dementia-related psychosis, who are being treated with antipsychotics (since they have a higher risk of death),
• in patients with risk factors for venous thromboembolism (obstruction of a blood vessel by a blood clot) (see “Possible side effects”),
• if you have or have had epilepsy, since the group of medicines to which Tiaprizal belongs may favour the appearance of epileptic seizures,
• if you have renal insufficiency (alteration of kidney function), since the dose of Tiaprizal should be reduced,
• if the medicine is administered to elderly patients, since tiapride may present a risk of decreased level of consciousness and coma in these patients, so it should be used with caution,
• if the medicine is to be administered to children, since tiapride has not been thoroughly investigated in this group of patients,
• if you have a history or family history of breast cancer, you should be monitored by your doctor during treatment with tiapride. Tiapride may increase prolactin levels (a hormone that stimulates milk production in the mammary glands),
• if you have leucopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of a type of white blood cell, neutrophils) and agranulocytosis (decrease in a type of white blood cell, granulocytes), as well as unknown fever, inform your doctor, as it could be a blood disorder (see “Possible side effects”).

Consult your doctor or pharmacist if such symptoms appear.

Use of Tiaprizal with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may have to use any other medicine.

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

Combinations that are contraindicated:

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

Combinations that are not recommended:

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

• Levodopa(medicine for the treatment of Parkinson's disease).

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

• Methadone(medicine that calms pain).

• Medicines that may induce alterations in heart rhythm (torsades de pointes):

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

-Some neuroleptics such as pimozide, sulpiride, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, haloperidol, droperidol, flupentixol, zuclopenthixol (medicines for the treatment of psychiatric diseases such as psychosis, schizophrenia, anxiety, etc.).

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

• Other medicines:
• bepridil (medicine for angina pectoris),
• cisapride (medicine for gastrointestinal motility disorders),
• erythromycin intravenously, spiramycin intravenously, moxifloxacin (antibiotics),
• vincamine intravenously (medicine that improves cerebral blood circulation),
• mizolastine (medicine for allergy treatment),
• difemanil (medicine for spasms of the digestive apparatus).

Combinations that require caution:

• Medicines that induce bradycardia (slowing of the heart rate)(in particular antiarrhythmic agents class Ia, beta-blockers, some antiarrhythmic agents class II, some calcium antagonists, cardiac glycosides, pilocarpine, cholinesterase inhibitors).

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

• Agents that decrease potassium levels(diuretics that decrease potassium levels, laxatives, anfotericin B intravenously, glucocorticoids, cosyntropin).

Medicines whose simultaneous administration should be taken into account:

• Anti-hypertensive medicines(medicines for treating high blood pressure): all.

• Medicines that depress the central nervous system

Narcotics (analgesics, cough medicines, opioid substitution therapy); barbiturates (used to produce sedation); benzodiazepines (used for their sedative effect, for the treatment of anxiety, insomnia, epilepsy, etc.); other non-benzodiazepine anxiolytics; hypnotics; neuroleptics; sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine); H1 antihistamines with sedative effects; central-acting anti-hypertensive medicines; other medicines: baclofen, thalidomide, pizotifen.

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

• Nitrate derivatives and related compounds(substances that contain nitrates in their composition: for example, nitrate derivatives used in the treatment of angina pectoris, heart failure, etc.).

Be aware that these instructions may also apply to medicines that have been used before or may be used afterwards.

Taking Tiaprizal with food, drinks and alcohol

Since alcohol may potentiate the sedative effect of tiapride, it is not recommended to consume alcoholic beverages or other medicines that contain alcohol in their composition while taking this medicine. The consumption of alcohol while taking Tiaprizal may also cause an electrolyte imbalance (imbalance of minerals in the blood) and may cause a prolongation of the QT interval (alteration of heart rhythm/frequency) (see Warnings and precautions).

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 problems, eating disorders. If your baby develops any of these symptoms, consult your doctor.

Tiapride used in the final stages of pregnancy may theoretically, and particularly at high doses:

- manifest as tachycardia, hyperexcitability, abdominal distension, delayed meconium elimination,

- sedation.

Lactation

You should not breastfeed during treatment with Tiaprizal. If you are taking Tiaprizal, consult your doctor to find out the best way to feed your baby.

Fertility

Tiaprizal may cause amenorrhea (absence of menstruation) or anovulation and may decrease fertility.

Driving and operating machinery

Tiapride may cause symptoms such as drowsiness, dizziness or visual disturbances, and may decrease your reaction time. These effects, as well as the underlying disease, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose to be administered must be adjusted for each patient.

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

The administration route of Tiaprizal 100 mg tablets is oral.

The dose to be administered is different depending on the disease you suffer from:

Short-term treatment of agitation and aggression states in alcoholic patients:

The recommended dose is 300 to 400 mg/day, that is, 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, that is, 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, that is, 1 to 1.5 tablets/day, with a maximum of 300 mg/day (that is, 3 tablets/day).

Older adults:The initial dose is 100 mg/day. The dose can be increased progressively to a maximum of 300 mg/day, if necessary.

Renal insufficiency:

In patientswith kidney function impairment, the dose must be reduced according to your doctor's instructions.

Liver insufficiency:

In patients with liver function impairment, no dose reduction is necessary.

If you estimate that the action 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, decreased movement, hypersalivation, etc.). Cases of death have been reported, mainly when Tiaprizal is combined with other psychotropic agents (medications used to treat central nervous system diseases).

There is no specific antidote for tiapride. Since tiapride is dialyzed moderately, hemodialysis should not be used to eliminate the medication.

In case of overdose, supportive measures should be initiated, recommending close monitoring of vital functions and cardiac function control (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 Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Tiaprizal

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Side effects have been grouped according to their frequency in accordance with 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, milk production and secretion by the breasts and increased gland size (galactorrhea and ginecomastia), menstrual cycle disorders in women (dysmenorrhea, amenorrhea), and may cause abnormal orgasm/impotence in men on rare occasions
• Dizziness/dizziness, headache
• Parkinsonism and related symptoms: tremor, increased muscle tone, slowed movement, and increased salivation. These symptoms are generally reversible with the administration of an anticholinergic (e.g. biperideno)
• Drowsiness/drowsiness, insomnia, agitation, indifference
• Weakness/asthenia (sensation of weakness)/fatigue.

Uncommon (may affect up to 1 in 100 patients))

• Early discinesia, uncontrolled movements (muscle spasm, torticollis, alteration of eye movement, inability to keep still). These symptoms are generally reversible with the administration of an anticholinergic (e.g. biperideno)
• Confusion, hallucinations
• Convulsions, syncope
• Decreased blood pressure (hypotension), usually when standing up (orthostatic hypotension)
• Deep vein thrombosis
• Constipation
• Rash (including erythematous or nodular/irregular rash)
• Milk production by the breasts
• Absence of menstruation (amenorrhea)
• Abnormal orgasm
• Weight gain.

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

• Loss of consciousness
• Leucopenia (decreased white blood cell count), neutropenia (decreased neutrophil count) and agranulocytosis (decreased granulocyte count) (see "Warnings and precautions")
• Decreased sodium levels in the blood (hyponatremia), a condition known as "inadequate secretion of antidiuretic hormone syndrome (SIHAD")
• Acute discinesia (alteration of movement). These symptoms are generally reversible with the administration of antiparkinsonian medication (for the treatment of Parkinson's disease)
• After prolonged periods of treatment (over 3 months), tardive discinesia has been reported, as with all medications for psychiatric disorders (neuroleptics), characterized by involuntary, rhythmic movements, mainly of the tongue and/or face. If these movements occur, consult a doctor and they will decide what measures to take. Administration of antiparkinsonian medication (for the treatment of Parkinson's disease) should not be used as an antidote as it is ineffective or may even worsen the symptoms
• Like all neuroleptics, tiaprida can 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 starting to take Tiaprizal")
• Prolongation of the QT interval, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia (accelerated heart rate), which could result in ventricular fibrillation or cardiac arrest and sudden death (see also section 2 "Warnings and precautions" and "Use of Tiaprizal with other medications")
• Thromboembolism in the veins, mainly in the legs (with inflammation, pain, and redness in the legs) that can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing, if you notice these symptoms, consult a doctor immediately (see section 2 "What you need to know before starting to take Tiaprizal") sometimes pulmonary embolism can cause death
• Pneumonia caused by aspiration of food or liquid particles into the lungs, altered breathing (respiratory depression)
• Intestinal obstruction (including a type of obstruction called ileus)
• Increased liver enzymes
• Rash (urticaria)
• Elevation of creatine phosphokinase levels in the blood, muscle weakness and/or muscle pain (rhabdomyolysis)
• Chest growth and pain
• Milk production by the breasts (galactorrhea)
• Enlargement of breast tissue in men (ginecomastia)
• Impotence (erectile dysfunction).

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

- Sudden withdrawal syndrome in newborns (see "Pregnancy, lactation, and fertility")

- Falls, especially in elderly patients.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Tiaprizal 100 mg tablets

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

Appearance of the product and content of the packaging

White, round, flat-edged tablets with a cross on one face and "T100" engraved on the other face.

The tablet can be divided into equal doses.

Each package contains 20 or 24 tablets.

Other presentations:

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

Holder of the marketing authorization and responsible for manufacturing

Responsible for manufacturing:

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

Last review date of this leaflet: September 2023

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