ITALPRID 100 mg Таблетки

Содержание инструкции

1. ITALPRID 100 mg tablets
   1. What is ITALPRID and what is it 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

ITALPRID 100 mg tablets

Tiapride hydrochloride

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is ITALPRID and what is it used for

ITALPRID contains the active ingredient tiapride hydrochloride, belonging to a group of medicines
called antipsychotics that work by blocking the action of certain molecules (neurotransmitters)
present in the brain, thus helping to control involuntary movements.
This medicine is indicated for the treatment of:

• involuntary muscle contractions that generate movements (involuntary movements, choreic in particular);
• excessive movements (hyperkinetic conditions of a functional type);
• headache (headache syndromes of various etiologies);
• behavioral disorders with agitation and anxiety (anxiety disorders);
• behavioral disorders due to alcohol withdrawal (acute and chronic alcohol syndromes);
• behavioral disorders in the elderly;
• stomach and intestinal disorders (alteration of gastro-intestinal motility and gastro-intestinal dyskinesias).

2. What you need to know before taking ITALPRID

Do not take ITALPRID

• if you are allergic to tiapride hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have a disorder called “prolactin-dependent tumor” (e.g. prolactinoma of the pituitary gland);
• if you have breast cancer;
• if you have a tumor (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.
Pay particular attention before taking Italprid:

• if you are taking other medicines belonging to the class of neuroleptics. As with other medicines that act on the Central Nervous System (neuroleptics), a set of disorders called Neuroleptic Malignant Syndrome, a potentially life-threatening complication, may occur, characterized by increased body temperature (hyperthermia), muscle rigidity, significant decrease in movements (akinesia), vegetative disorders such as irregularity of the pulse (perceptible heartbeat) and blood pressure, sweating, tachycardia (increased heart rate), arrhythmia (alteration of the heartbeat), changes in consciousness, which can progress to stupor and coma. Cases with atypical features such as loss of muscle rigidity or increased muscle tone (hypertonia) and low fever may occur;
• if you are taking the medicine at high doses in case of treatment of alcoholism, particular caution must be observed;
• if you have Parkinson's disease. In this case, Italprid should only be used in exceptional cases;
• if you suffer from epilepsy. During treatment with Italprid, you may be subject to convulsive attacks and increased frequency; your doctor will need to keep you under strict control;
• if you suffer from a kidney function disorder (renal insufficiency), your doctor will reduce the dose because the use of Italprid could cause you 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 blood circulation disorders (cardiovascular and hemodynamic conditions), especially if you suffer from low blood pressure (hypotension); If you are taking Italprid, you may experience cases of decreased blood volume (hypovolemia) or sudden drops in blood pressure when you stand up or exert yourself (orthostatic hypotension).
• Italprid can induce a heart disorder called "prolongation of the QT interval" which increases the risk of heart rhythm disorders (severe ventricular arrhythmia, such as torsade de pointes; see “Possible side effects”). Before taking Italprid, your doctor will check the condition of your heart to specifically check if you have other heart or blood circulation (cardiovascular) diseases, if other family members have a heart rhythm disorder with “prolongation of the QT interval”, if there are factors that could increase the risk of heart rhythm disorders, such as:
• if you suffer from a disorder that causes a decrease in heartbeats (bradycardia, with less than 55 beats per minute);
• if you suffer from an imbalance of certain substances contained in the blood (electrolytes), in particular a decrease in potassium in the blood (hypokalemia);
• if you have congenital heart rhythm alterations (congenital prolongation of the QT interval).
• if you have ongoing treatments with medicines that produce:
• decreased heartbeats (bradycardia);
• imbalance of certain substances contained in the blood (electrolytes);
• alterations in heart function (decreased intracardiac conduction or prolongation of the QT interval; see “Other medicines and Italprid”).
• if you are elderly, because the use of Italprid could cause a drop in blood pressure (hypotension), a decrease in consciousness and coma.
• During therapy with Italprid, a disease that causes a severe decrease in white blood cells in the blood (severe neutropenia) may occur. In this case, your doctor will suspend the use of Italprid until your white blood cells return to normal values.

With the use of medicines of the same class as Italprid (antipsychotics), decreases in some types of blood cells (leukopenia, neutropenia and agranulocytosis) have been reported. Talk to your doctor or pharmacist if unexplained infections or fever may indicate an alteration of blood composition (hematological dyscrasia - see “Possible side effects”), which requires immediate blood investigation.

Stroke
Italprid should be used with caution in patients with risk factors for stroke (cerebrovascular accidents), for disorders of blood circulation in the brain, because an increased risk of these disorders occurring has been observed.

Elderly patients with a syndrome leading to a progressive reduction in mental functions

(dementia)
In elderly patients with dementia, the risk of death increases and, in most cases, appears to be due to heart and blood circulation problems (e.g. heart failure, the functionality of your heart is insufficient to ensure an adequate supply of blood to the body), sudden death or caused by infections (e.g. pneumonia).

Disease of the circulatory system called Venous Thromboembolism – VTE
Cases of blood clot formation in the veins, a disease of the circulatory system called venous thromboembolism (VTE), have been reported with antipsychotic medicines. Since patients treated with antipsychotics often have risk factors for this disease (VTE), the doctor will identify all possible risk factors for VTE, before and during treatment with Italprid and will take preventive measures.

Breast cancer
Italprid can increase a hormone that acts on the breast (prolactin). If you or a family member have had breast cancer during therapy with Italprid, your doctor will keep you under control.

Other medicines and ITALPRID
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take the medicine if you are taking:

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

Be cautious, avoid, talk to your doctor if you are taking:

• medicines used to treat heart rhythm disorders, for example quinidine, hydroquinidine, disopyramide, amiodarone, dofetilide, ibutilide, bepridil, diltiazem, verapamil and guanfacine, clonidine (used to treat high blood pressure), digitalis (to improve the pumping force of the heart), pilocarpine (to treat dry mouth and eyes), cholinesterase inhibitors;
• diuretics (medicines that reduce blood pressure), stimulant laxatives, amphotericin B administered by injection (for the treatment of fungal infections), glucocorticoids (anti-inflammatory drugs), tetracosactides (to treat severe epilepsy);
• some medicines for the treatment of mental disorders (neuroleptics) (e.g. sultopride, pipothiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, pimozide, haloperidol, droperidol, flufenazine, pipamperone, flupentixol, zuclopentixol, thioridazine);
• some medicines for the treatment of parasitic infections (e.g. alofantrine, lumefantrine, pentamidine);
• antibiotic medicines (medicines used to treat infections caused by bacteria) such as erythromycin, administered by injection, spiramycin administered by injection, moxifloxacin and sparfloxacin, cisapride (for the treatment of gastric disorders), difemanil (for the treatment of muscle contractions caused by spasm), mizolastine (for the treatment of allergies), vincamine administered by injection (to increase blood flow to the brain), imipramine and other drugs for the treatment of depression, lithium (used to treat psychotic disorders);
• methadone (for the treatment of severe pain or to counteract drug addiction);
• nitrate derivatives 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.

Be particularly careful and talk to your doctor if you are taking:

• medicines used to treat heart rhythm disorders, for example 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 therapy), antidepressants (amitriptyline, doxepin, mianserine, mirtazapine, trimipramine), anesthetics, analgesics (pain relievers), other medicines such as baclofen (a muscle relaxant), thalidomide (an antitumor drug), pizotifen (used for headaches).

Italprid with alcohol
Alcohol increases the sedative effect of Italprid. Avoid taking alcoholic beverages and medicines containing alcohol at the same time.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Italprid is not recommended during pregnancy and in women of childbearing potential who are not using effective contraception. Do not take Italprid if you are pregnant, unless expressly indicated by your doctor who, if necessary, may continue therapy during the entire pregnancy and under the direct control of the doctor.
Medicines of the same class as Italprid (neuroleptics) can cause a decrease in maternal blood pressure (hypotension). Italprid crosses the placenta. If Italprid is taken during pregnancy, the newborn may experience side effects and must be adequately monitored by the doctor.
If you use Italprid during the last three months of pregnancy, your newborn may suffer from:

• increased heart rate (tachycardia);
• exaggerated reaction to psychic or emotional stimuli (hyperexcitability);
• swelling of the abdomen (abdominal distension);
• delay in the first bowel movement (meconium);
• excessive calm (sedation);
• agitation, hypertonia and hypotonia (increased and decreased muscle tone), tremor, drowsiness, respiratory distress (breathing problems), feeding disorders. Contact your doctor if your baby presents any of these symptoms.

Breastfeeding
You should not breastfeed while taking Italprid. Ask your doctor what is the best way to breastfeed your baby while taking Italprid.
Fertility
Italprid can lead to absence of the menstrual cycle and lack of ovulation and can decrease human fertility (see “Possible side effects”).
Driving and using machines
Even if used as advised by your doctor, Italprid can cause excessive calm (sedation), so the ability to drive vehicles and use machinery may be impaired (see “Possible side effects”).

3. How to take ITALPRID

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The doctor will establish the dose and the 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 behavioral 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 the 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
The doctor will establish the appropriate dose.

If you take more ITALPRID than you should
An excessive dose of this medicine can cause movement disorders (very severe parkinsonian syndrome), which can lead to coma.
In case of accidental ingestion/intake of an excessive dose of this medicine, disorders such as drowsiness and excessive calmness (sedation), low blood pressure (hypotension) immediately notify your doctor or go to the nearest hospital.

If you forget to take ITALPRID
Do not take a double dose to compensate for the missed tablet

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

4. Possible side effects

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

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

• increased levels of prolactin in the blood which may cause other disorders. Therefore, breast pain, breast enlargement and excessive and continuous milk production from the breast (gynecomastia, galactorrhea), menstrual disorders or absence of menstruation (dysmenorrhea, amenorrhea) in women, erectile dysfunction/orgasm disorders may unusually occur in men
• feeling of intense fatigue (asthenia)
• tiredness
• dizziness and vertigo
• headache
• typical symptoms of Parkinson's disease: tremor, muscle rigidity, increased muscle tone (hypertonia), alterations in movement (hypokinesia) and increased saliva production (hypersalivation). These symptoms are generally reversible after administration of an anticholinergic antiparkinson drugs (for example biperidene)
• sleepiness
• sedation
• insomnia
• agitation
• indifference

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

• weight gain
• psychomotor syndrome called "akathisia"
• early dyskinesia, dystonia such as muscle spasms, torticollis, deviations of the gaze (oculogyric crisis), contraction of the muscles of the jaw (trismus). These symptoms are generally reversible after administration of an anticholinergic, an antiparkinson drug (for example biperidene)
• absence of menstruation (amenorrhea)
• orgasm disorders
• confusion (mental confusion, disorientation), hallucinations
• syncope, seizures
• low blood pressure, generally when standing up
• constipation
• skin redness (including that with redness or blisters)
• venous thromboembolism and deep vein thrombosis.

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

• serious movement disorders (acute dyskinesia)
• loss of consciousness
• reduction in the number of white blood cells (leukopenia), reduction in the number of neutrophils, a type of white blood cells (neutropenia) and reduction in the number of granulocytes, a type of white blood cells (agranulocytosis)
• decrease in sodium in the blood (hyponatremia), a disease called inappropriate secretion of antidiuretic hormone syndrome (SIADH)
• acute dyskinesia, this symptom is generally reversible with the administration of antiparkinson drugs; after a prolonged period of treatment (more than 3 months), a condition called “tardive dyskinesia” has been reported, as with all medicines used to treat psychological disorders (neuroleptic drugs). This is characterized by involuntary rhythmic movements especially of the tongue and/or facial muscles. If these movement disorders occur, you should immediately inform your doctor, who will decide the necessary measures. They must not

be used as an antidote to antiparkinson medicines, because they are ineffective or may worsen the
symptoms

• as with all neuroleptics, Neuroleptic Malignant Syndrome may occur, which is a potentially fatal complication (see “Warnings and precautions”).
• disorders of cardiac conduction (prolongation of the QT interval) and serious 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 can move through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately (see “What you need to know before taking Italprid”). Sometimes pulmonary embolism can be fatal
• pneumonia caused by food particles or vomit entering the lungs (aspiration pneumonia)
• decreased ability to breathe, e.g. decrease in the number of breaths and the depth of breathing (respiratory depression) when taking other medicines, depressants of the Central Nervous System
• intestinal obstruction, ileus
• increased in the blood of liver enzymes
• urticaria (allergic reaction)
• increase in the blood of a substance produced by the body that indicates possible muscle damage (elevated CPK), muscle weakness and/or muscle pain due to muscle destruction (rhabdomyolysis)
• breast enlargement
• breast pain
• excessive and continuous milk production from the mammary gland (galactorrhea)
• gynecomastia
• impotence (erectile dysfunction).

Side effects with unknown frequency (frequency cannot be estimated on the basis of
available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through 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 at a temperature not exceeding 25° C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ITALPRID contains

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

Description of the appearance of ITALPRID and contents of the pack
Pack containing 20 tablets

Marketing Authorisation 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.