Italprid

Package leaflet: Information for the patient

ITALPRID 100 mg tablets

Tiapride hydrochloride
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ITALPRID is and what it is used for

ITALPRID contains the active substance tiapride hydrochloride, which belongs to a group of medicines called antipsychotics that work by blocking the action of certain brain chemicals (neurotransmitters), thereby helping to control involuntary movements.
This medicine is indicated for the treatment of:

• involuntary muscle contractions causing movements (involuntary movements, choreic movements in particular);
• excessive movements (hyperkinetic syndromes of functional origin);
• headaches (cephalic syndromes of various etiologies);
• behavioural disorders associated with agitation and anxiety (anxiety disorders);
• behavioural disturbances related to alcohol withdrawal (acute and chronic alcohol syndromes);
• behavioural disturbances in the elderly;
• stomach and intestinal disorders (gastrointestinal motility disorders and gastrointestinal dyskinesias).

2. What you need to know before taking ITALPRID

Do not take ITALPRID

• if you are allergic to tiapride hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
• if you have a condition called "prolactin-dependent tumour" (e.g. prolactinoma of the pituitary gland);
• if you have breast cancer;
• if you have a tumour (confirmed or suspected) of the gland located above the kidneys (pheochromocytoma);
• if you are taking levodopa or other medicines used to treat Parkinson's disease (see "Other medicines and Italprid").

Warnings and precautions
Talk to your doctor or pharmacist before taking ITALPRID.
Take particular care before taking Italprid:

• if you are taking other medicines belonging to the class of neuroleptics. As with other medicines acting on the Central Nervous System (neuroleptics), a group of disorders called Neuroleptic Malignant Syndrome may occur, a potentially life-threatening complication characterized by increased body temperature (hyperthermia), muscle rigidity, marked reduction in movement (akinesia), autonomic disturbances such as irregular pulse (palpitations) and blood pressure changes, sweating, tachycardia (increased heart rate), arrhythmia (irregular heartbeat), altered mental status, which may progress to stupor and coma. Cases with atypical features may also occur, such as loss of muscle rigidity or increased muscle tone (hypertonia) and low-grade fever;
• if you are taking the medicine at high doses for the treatment of alcoholism, particular caution is required;
• if you have Parkinson's disease. In this case, Italprid should be used only in exceptional circumstances;
• if you suffer from epilepsy. During treatment with Italprid, you may experience seizures that could increase in frequency; your doctor should monitor you closely;
• if you have impaired kidney function (renal insufficiency), your doctor will reduce the dose because the use of Italprid could lead to loss of consciousness (coma) due to overdose (see "How to take Italprid" and "If you take more Italprid than you should");
• if you suffer from severe heart or circulatory disorders (cardiovascular and haemodynamic conditions), especially if you have low blood pressure (hypotension). If you are taking Italprid, you may experience episodes of reduced blood volume (hypovolemia) or sudden drops in blood pressure when standing up or exerting yourself (orthostatic hypotension);
• Italprid may cause a heart disorder called "QT interval prolongation", which increases the risk of heart rhythm disturbances (serious ventricular arrhythmias such as torsades de pointes; see "Possible side effects"). Before taking Italprid, your doctor will check your heart condition, particularly to determine whether you have other heart or circulatory diseases (cardiovascular), whether other family members have a heart rhythm disorder with "QT interval prolongation", or whether risk factors that could increase the likelihood of rhythm disturbances are present, such as:
• if you have a condition causing a reduced heart rate (bradycardia, less than 55 beats per minute);
• if you have an imbalance of certain substances in the blood (electrolytes), particularly low potassium levels in the blood (hypokalaemia);
• if you have congenital abnormalities in heart rhythm (congenital QT interval prolongation);
• if you are undergoing treatment with medicines that cause:
• reduced heart rate (bradycardia);
• imbalance of certain substances in the blood (electrolytes);
• disturbances in heart function (decreased intracardiac conduction or QT interval prolongation; see "Other medicines and Italprid");
• if you are elderly, because the use of Italprid may cause low blood pressure (hypotension), reduced consciousness, and coma.

During treatment with Italprid, a disease causing a severe decrease in white blood cells (severe neutropenia) may occur. In such a case, your doctor will discontinue Italprid until your white blood cell count returns to normal levels.

With the use of medicines of the same class as Italprid (antipsychotics), decreases in certain types of blood cells (leucopenia, neutropenia, and agranulocytosis) have been reported. Talk to your doctor or pharmacist if unexplained infections or fever occur, as these may indicate a blood disorder (haematological dyscrasia - see "Possible side effects"), requiring immediate blood testing.

Stroke
Italprid should be used with caution in patients with risk factors for stroke (cerebrovascular events) or disorders of cerebral blood circulation, as an increased risk of such events has been observed.

Elderly patients with dementia
In elderly patients with dementia, the risk of death is increased, and in most cases appears to be due to heart and circulatory problems (e.g. heart failure, where the heart's function is insufficient to ensure adequate blood supply to the body), sudden death, or infections (e.g. pneumonia).

Venous thromboembolism (VTE)
Cases of venous blood clot formation, a circulatory disorder known as venous thromboembolism (VTE), have been reported with antipsychotic medicines. Since patients treated with antipsychotics often have risk factors for VTE, your doctor will identify all possible risk factors for VTE before and during treatment with Italprid and take preventive measures.

Breast cancer
Italprid may increase a hormone acting on the breast (prolactin). If you or a family member has had breast cancer during treatment with Italprid, your doctor will monitor you closely.

Other medicines and Italprid
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicine.

Do not take this medicine if you are taking:

• medicines acting on the nervous system such as sedatives or tranquilizers (neuroleptics);
• levodopa, a medicine used to treat Parkinson's disease, or other medicines used to treat Parkinson's disease such as cabergoline, quinagolide, because Italprid may counteract their effect.

Use caution, avoid use, and consult your doctor if you are taking:

• medicines used to treat heart rhythm disorders, e.g. quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, bepridil, diltiazem, verapamil, guanfacine, clonidine (used to treat high blood pressure), digitalis (to improve the heart's pumping strength), pilocarpine (to treat dry mouth and dry eyes), cholinesterase inhibitors;
• diuretics (medicines that reduce blood pressure), stimulant laxatives, intravenous amphotericin B (used to treat fungal infections), glucocorticoids (anti-inflammatory agents), tetracosactide (used to treat severe epilepsy);
• certain medicines for mental disorders (neuroleptics) (e.g. sultopride, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, pimozide, haloperidol, droperidol, flufenazine, pipamperone, flupentixol, zuclopentixol, thioridazine);
• certain antiparasitic medicines (e.g. halofantrine, lumefantrine, pentamidine);
• antibiotic medicines (medicines used to treat bacterial infections) such as intravenous erythromycin, intravenous spiramycin, moxifloxacin, sparfloxacin, cisapride (for gastrointestinal disorders), difemanil (for muscle spasms), mizolastine (for allergies), intravenous vincamine (to increase cerebral blood flow), imipramine and other antidepressants, lithium (used to treat psychotic disorders);
• methadone (for severe pain or opioid dependence);
• nitrates and related compounds (used to dilate blood vessels);
• medicines used to treat Parkinson's disease such as amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, and selegiline, because Italprid may counteract their effect.

Exercise particular caution and consult your doctor if you are taking:

• medicines used to treat heart rhythm disorders, e.g. esmolol, sotalol, bisoprolol, carvedilol, metoprolol, nebivolol;
• morphine derivatives (analgesics, antitussives, and opioid therapy), antihistamines (medicines used for allergies), barbiturates (medicines for epilepsy), benzodiazepines (medicines used for anxiety and insomnia), antidepressants (amitriptyline, doxepine, mianserin, mirtazapine, trimipramine), anaesthetics, analgesics (painkillers), and other medicines such as baclofen (a muscle relaxant), thalidomide (an antitumour agent), pizotifen (used for headaches).

Italprid and alcohol
Alcohol increases the sedative effect of Italprid. Avoid consuming alcoholic beverages and medicines containing alcohol while taking this medicine.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Italprid is not recommended during pregnancy and in women of childbearing potential who are not using an effective method of contraception. Do not take Italprid during pregnancy unless specifically instructed by your doctor, who may decide to continue treatment throughout pregnancy under close medical supervision.

Medicines of the same class as Italprid (neuroleptics) may cause maternal low blood pressure (hypotension). Italprid crosses the placenta. If Italprid is taken during pregnancy, the newborn may experience adverse effects and should be closely monitored by a doctor.

If you use Italprid during the last three months of pregnancy, your newborn may experience:

• increased heart rate (tachycardia);
• exaggerated response to psychological or emotional stimuli (hyperexcitability);
• abdominal swelling (abdominal distension);
• delayed first bowel movement (meconium);
• excessive calmness (sedation);
• agitation, hypertonia and hypotonia (increased and decreased muscle tone), tremor, drowsiness, respiratory distress (breathing problems), feeding difficulties. Contact your doctor if your baby shows any of these symptoms.

Breastfeeding
You must not breastfeed while taking Italprid. Ask your doctor for advice on the best way to feed your baby while taking Italprid.

Fertility
Italprid may cause absence of menstruation and lack of ovulation and may reduce human fertility (see "Possible side effects").

Driving and using machines
Even when used as directed by your doctor, Italprid may cause excessive calmness (sedation), so your ability to drive vehicles or operate machinery may be impaired (see "Possible side effects").

3. How to take ITALPRID

Take this medicine exactly as your doctor or pharmacist has told you.
If you are in any doubt, consult your doctor or pharmacist.
Your doctor will determine the dose and route of administration according to your condition.

Treatment of acute and chronic alcohol syndromes
The recommended dose is 1 - 2 tablets per day.

Treatment of behavioural disorders in the elderly and chronic agitation states
The recommended dose is 1 - 2 tablets per day.

Treatment of abnormal movements
The recommended dose is 3 - 6 tablets depending on the severity of symptoms.

Treatment of cephalalgic syndromes
The recommended dose is 1 - 3 tablets per day.
In more severe cases, the dose may be increased to 4 tablets per day.

Use in the elderly
Your doctor will determine the appropriate dose.

If you take more ITALPRID than you should
An excessive dose of this medicine may cause movement disorders (severe parkinsonism), which may progress to coma.
In case of accidental ingestion or overdose, symptoms such as drowsiness and excessive calmness (sedation), and low blood pressure (hypotension) may occur. Inform your doctor immediately or go to the nearest hospital.

If you forget to take ITALPRID
Do not take a double dose to make up for the forgotten tablet.

If you stop taking ITALPRID
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people)

• increased levels of prolactin in the blood which may cause further disturbances. Therefore, breast pain, breast enlargement, and excessive and persistent milk secretion from the mammary gland (gynecomastia, galactorrhea), menstrual disorders or absence of menstruation (dysmenorrhea, amenorrhea) in women, erectile dysfunction/orgasm disorders may uncommonly occur in men
• feeling of intense tiredness (asthenia)
• fatigue
• dizziness and vertigo
• headache
• symptoms typical of Parkinson's disease: tremor, muscle rigidity, increased muscle tone (hypertonia), movement disorders (hypokinesia), and increased saliva production (hypersalivation). These symptoms are generally reversible after administration of anticholinergic or antiparkinson drugs (e.g., biperiden)
• drowsiness
• sedation
• insomnia
• agitation
• indifference

Uncommon side effects (may affect up to 1 in 100 people)

• weight gain
• a psychomotor syndrome called "akathisia"
• early dyskinesia, dystonia such as muscle spasms, torticollis, abnormal eye movements (oculogyric crisis), jaw muscle contraction (trismus). These symptoms are generally reversible after administration of an anticholinergic or antiparkinson drug (e.g., biperiden)
• absence of menstruation (amenorrhea)
• orgasm disorders
• confusion (mental confusion, disorientation), hallucinations
• syncope, seizures
• low blood pressure, generally when standing
• constipation (stipsis)
• skin redness (including with redness or blisters)
• venous thromboembolism and deep vein thrombosis

Rare side effects (may affect up to 1 in 1000 people)

• severe movement disorders (acute dyskinesia)
• loss of consciousness
• reduction in white blood cell count (leucopenia), reduction in neutrophil count, a type of white blood cell (neutropenia), and reduction in granulocyte count, a type of white blood cell (agranulocytosis)
• decreased sodium levels in the blood (hyponatremia), a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH)
• acute dyskinesia; this symptom is generally reversible with administration of antiparkinson drugs. After prolonged treatment (beyond 3 months), a condition called "tardive dyskinesia" has been reported, as with all medicines used to treat psychiatric disorders (neuroleptics). This is characterized by involuntary rhythmic movements, especially of the tongue and/or facial muscles. If such movement disorders occur, you must inform your doctor immediately, who will decide on the necessary measures. Do not

use antiparkinson drugs as antidotes, as they are ineffective or may worsen
symptoms

• as with all neuroleptics, Neuroleptic Malignant Syndrome may occur, which is a potentially life-threatening complication (see "Warnings and precautions")
• cardiac conduction disorders (prolongation of QT interval) and severe cardiac arrhythmias (such as torsades de pointes, ventricular tachycardia), and even ventricular fibrillation or cardiac arrest and sudden death (see "Warnings and precautions" and "Other medicines and Italprid")
• blood clots in blood vessels, especially in the legs (with swelling, pain, and redness of the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, contact your doctor immediately (see "What you should know before taking Italprid"). Sometimes pulmonary embolism can be fatal
• pneumonia caused by food particles or vomit entering the lungs (aspiration pneumonia)
• reduced ability to breathe, e.g., decreased breathing rate and depth of breathing (respiratory depression), when taking other central nervous system depressant medicines
• intestinal obstruction, ileus
• increased liver enzymes in the blood
• urticaria (allergic reaction)
• increased levels in the blood of a substance produced by the body indicating possible muscle damage (elevated CPK), muscle weakness and/or muscle pain due to muscle breakdown (rhabdomyolysis)
• breast enlargement
• breast pain
• excessive and persistent milk secretion from the mammary gland (galactorrhea)
• gynecomastia
• impotence (erectile dysfunction)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• withdrawal syndrome in the newborn, extrapyramidal disorders (such as rigidity, muscle spasms)
• falls
• depression

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ITALPRID

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 that month.
Store below 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ITALPRID contains

• The active substance is tiapride hydrochloride. One tablet contains 111.2 mg of tiapride hydrochloride, equivalent to 100 mg of tiapride.
• The other components are: mannitol, polyvinylpyrrolidone, microcrystalline cellulose, silica, magnesium stearate.

Description of the appearance of ITALPRID and contents of the pack
Carton containing 20 tablets
Marketing Authorization Holder
Teofarma S.r.l. - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)
Manufacturer
Teofarma S.r.l. - Viale Certosa 8/A - 27100 Pavia.