Package leaflet: Information for the user Tiaprid PMCS 100 mg tablets tiapride hydrochloride Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Tiaprid PMCS 100 mg is and what it is used for 2. What you need to know before you take Tiaprid PMCS 100 mg 3. How to take Tiaprid PMCS 100 mg 4. Possible side effects 5. How to store Tiaprid PMCS 100 mg 6. Contents of the pack and other information 1. What Tiaprid PMCS 100 mg is and what it is used for Tiaprid PMCS 100 mg contains the active ingredient tiapride hydrochloride, which belongs to a group of medicines called antipsychotics, atypical neuroleptic agents. Tiaprid PMCS 100 mg is a medicinal product which acts on the mental functions and has a positive effect on severe forms of involuntary and abnormal movements of the patient. Tiaprid PMCS 100 mg is used for behaviour disorders in the elderly or chronic alcoholism including withdrawal symptoms if the digestion of alcohol is stopped abruptly. It can also be used for severe forms of abnormal movements (Huntington’s chorea). Tiaprid PMCS 100 mg tablets can be used by adults and children from the age of 6. 2. What you need to know before you take Tiaprid PMCS 100 mg Do not take Tiaprid PMCS 100 mg - if you are allergic to tiapride or any of the other ingredients of this medicine (listed in section 6). - if you suffer from a rare disease of the adrenal gland, so-called pheochromocytoma accompanied by headaches, hot flushes and periodic rise in blood pressure. - if you are concomitantly taking a levodopa-containing medicine or other dopaminergic medicines (see section ’Other medicines and Tiaprid PMCS 100 mg’) if you are administered levodopa for the treatment of Parkinson’s disease (a disease displayed by a strong trembling and muscle rigidity). - if you suffer concomitantly from brain cancer producing the hormone prolactin and/or breast cancer. Warnings and precautions Talk to your doctor before taking Tiaprid PMCS 100 mg: Like with other neuroleptic agents, neuroleptic malignant syndrome (a complication with possible deadly consequences), characterised by hyperthermia (increased internal body heat above the normal range), muscle rigidity and autonomic dysfunction (failure of the part of the nervous system 1/8 responsible for controlling internal bodily functions that are not affected by will) may occur. Cases with unusual symptoms such as lack of muscle rigidity or increased muscle tension and lower fever reduction have been reported. In the event of elevated body temperature of unknown origin, use of tiapride should be discontinued. If the internal body temperature rises above the normal range for unknown origin, administration of tiapride should be discontinued. Other than in exceptional cases, tiapride should not be taken by patients with Parkinson’s disease. Neuroleptic agents may reduce the threshold for epileptic seizures., although this has not been evaluated in tiapride. If you have epilepsy, you will be thoroughly monitored while being treated with tiapride. If you have kidney problems, your physiciandoctor will adjust your dose of tiapride because of a possible risk of unconsciousnesscoma due to overdoseage (see section 3). If you are an older patient, the physician will assess your treatment with tiapride individually with respect to the potential risks (decreased level of consciousness and coma, increased risk of death due to concomitant use of antipsychoticssedative effect, with concurrent use with antipsychotics, and increased risk of death). QT prolongation (in cardiology, the time measured between the beginning of the Q wave and the end of the T wave in the electric cycle of the heart): Tiapride may cause QT prolongation, which increases the risk of cardiac arrhythmia. For this reason before administering the medicine to you, your doctor will monitor factors that may support the occurrence of arrhythmia, such as: - Slowed heart rate (bradycardia), less than 55 beats per minute - Electrolytic imbalance, especially hypokalaemia (low level of potassium in the blood) - Congenital QT prolongation - Concomitant use of medicines that likely cause a clear reduction in heart rate (<55 heart beats/min), electrolytic imbalance, reduced intracardiac conduction or QT prolongation. If you are a patient with stroke risk factors, your doctor will thoroughly monitor your treatment with Tiaprid PMCS 100 mg, because increased caution is necessary in this case. Venous thromboembolism (a condition characterised by the formation of a blood clot at a specific site in the blood circulation and its subsequent “travelling” to the lungs): Cases of venous thromboembolism have been reported in connection with the use of antipsychotics, sometimes deadly. If you have or had blood clots in your veins in the past, your doctor will thoroughly monitor your treatment with Tiaprid PMCS 100 mg, because increased caution is necessary in this case. Tiapride may increase levels of the prolactin hormone. For this reason, caution is necessary. If you or a member of your family has had breast cancer, you will be thoroughly monitored during treatment with tiapride. Lowered white blood cell count (leukopenia, neutropenia, agranulocytosis) has been reported in connection with the use of antipsychotics, including tiapride. In case of Uunexplained infections andor fever, contact your doctor immediately as they may be a symptom of blood composition problems. and require immediate blood tests. Use of tiapride in children and adolescents has not been studied in detail (see section 3). Other medicines and Tiaprid PMCS 100 mg The effects of Tiaprid PMCS 100 mg and effect of other concomitant medicines may influence each other. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 2/8 Dopaminergic agonists (medicines with effects similar to dopamine, natural substance with important function in the nervous system) and Tiaprid PMCS 100 mg cancel out each others’ effects and should not be used together. Patients with Parkinson’s disease take the lowest effective dose of levodopa and tiapride. Medications that act on the central nervous system, such as pain medications, cough suppressants, sleeping medications, medications that calm you down, treat depression or psychosis, prevent vomiting, antihistamines, centrally-acting medications against high blood pressure and other medications (baclofen, thalidomide, pizotifen, clonidine) may increase the effect of tiapride and cause reduced attention and greater sleepiness. Alcohol also increases the effect of tiapride, primarily through an increase in general sedation and significant sleepiness. For this reason, avoid using alcohol while taking the medicinal product. Not recommended combinations: Combinations with the following medicines, which may induce serious heart rate disorders (torsades de pointes) or QT prolongation (interval on an electrocardiogram report): - Medicines causing a reduced heart rate (bradycardia), such as beta blockers, calcium channel blockers that cause bradycardia such as diltiazem and verapamil, clonidine, guanfacine; cardiac glycozides (digoxin), pilocarpine, cholinesterase inhibitors, certain class II anti-arrhythmics. - Medicines that cause electrolyte imbalance, especially hypokalaemia (low level of potassium in the blood): hypokalaemic diuretics (medicines that increase the formation and excretion of urine, reduce the potassium content in the blood, which must be subsequently supplied by other medicines or food), stimulating laxatives (stool loosener), i.v. (intravenous) amphotericin B, glucocorticoids, tetracosactides, cosyntropin. Your doctor will correct hypokalaemia (low level of potassium in the blood). - Class IA anti-arrhythmics (medicines that treat heart rhythm disorders), such as quinidine, hydroquinidine, disopyramide. - Class III anti-arrhythmics, such as amiodarone, sotalol, dofetilide, ibutilide. - Certain antiparasitics, such as halofantrine, lumefantrine, pentamidine. - Certain neuroleptics (medications for treating psychosis), such as pimozide, sultopride, haloperidol, thioridazine, pipotiazine, sertindole, veralipride, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, droperidol, fluphenazine, pipamperone, flupentixol, zuclopenthixol. - Other medications, such as methadone, imipramine antidepressants, lithium, bepridil, cisapride, i.v. erythromycin, i.v. vincamine, sparfloxacin, diphemanil, mizolastine, i.v. spiramycin, moxifloxacin. The efficacy of high blood pressure medications and medications that treat coronary heart disease may be increased while taking Tiaprid PMCS 100 mg and may therefore lead to a large decrease in blood pressure, which manifests as dizziness with loss of consciousness after quickly standing up. Tiaprid PMCS 100 mg with food, drink and alcohol Tiaprid PMCS 100 mg may be taken with or without food. Alcoholic drinks may not be consumed with the treatment of Tiaprid PMCS 100 mg. Pregnancy, and breast-feeding and fertility If you are pregnant or breast-feeding,