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Summary of Product Characteristics NL/H/0662/001/MR NL/H/0663/001/MR NL/H/0664/001/MR SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tiaprid XXX 100 mg, tablets 2. QUALITATIVE AND QUANTIATIVE COMPOSITION Each tablet contains 100 mg tiapride (as hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round tablets with beveled edge and a cross on both sides. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For the treatment of neuroleptic-induced tardive dyskinesia, mainly oro-bucco-lingual type. 4.2 Posology and method of administration Adults should take 100-200 mg tiapride three times daily, depending on the severity of the disease and the body weight of the individual . The proposed daily dose for the claimed indication is 300-600 mg tiapride. The effect of treatment may not be apparent until after a period of 4-6 weeks of treatment. Tiaprid XXX tablets should preferably be taken with a little liquid after meals. Tiapride is not intended for treatment in children. Dosage in renal impairment Creatinine clearance: 50-80 ml/min = 75 % of the 10-50 ml/min = 50 % normal less than 10 ml/min = 25 % daily dose 4.3 Contraindications – Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. – Concomitant Prolactin-dependent tumours, e.g. pituitary gland prolactinoma and breast cancer. 1 NL/H/0662/001/MR NL/H/0663/001/MR NL/H/0664/001/MR – Phaeochromocytoma. – Association with levodopa or other dopaminergic medicines (see section 4.5). – Neuroleptic malignant syndrome (see section 4.8). 4.4 Special warnings and precautions for use As with other neuroleptics, Neuroleptic Malignant Syndrome, a potentially fatal complication, which is characterised by hyperthermia, muscle rigidity and autonomic dysfunction may occur. In case of hyperthermia of undiagnosed origin, tiapride should be discontinued. Neuroleptic agents may reduce the seizure threshold in epilepsy, although this has not been evaluated with tiapride. Therefore, patients with a history of epilepsy should be closely monitored during tiapride treatment. In patients with renal impairment the dose has to be reduced, while in patients with severely impaired renal function tiapride should be discontinued on medical advice (see section 4.2). Tiapride should not be used in patients with Parkinson’s disease, with the exception of special circumstances. Because tiapride can have an increased sedative effect in elderly patients, caution should be exercised. New researches indicate that increased prolactine levels may be associated with an increased risk of breast cancer. Notwithstanding, due to a lack of epidemiologic studies, a final conclusion on hyperprolactinemia as an independent risk factor of breast cancer can so far not be drawn. Prolongation of the QT interval Tiapride may induce a prolongation of the QT interval. This effect is known to potentiate the risk of serious ventricular arrhythmias such as torsades de pointes (see section 4.8). Before any administration, and if possible according to the patient’s clinical status, it is recommended to monitor factors which could favour the occurrence of this rhythm disorder, such as for example: - bradycardia less than 55 bpm, - electrolyte imbalance in particular hypokalaemia, - congenital prolongation of the QT interval, - on-going treatment with a medication likely to produce pronounced bradycardia (< 55 bpm), electrolyte imbalance, decreased intracardiac conduction, or prolongation of the QT interval (see section 4.5). Tiapride should be prescribed with caution in patients presenting with risk factors which may predispose to prolongation of the QT interval. Venous thromboembolism Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with tiapride and preventive measures undertaken. Increased Mortality in Elderly people with dementia Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug- treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was 2 NL/H/0662/001/MR NL/H/0663/001/MR NL/H/0664/001/MR about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death in clinical trials with atypical antipsychotics were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Tiapride is not licensed for the treatment of dementia-related behavioural disturbances. Stroke In randomized clinical trials versus placebo performed in a population of elderly patients with dementia and treated with certain atypical antipsychotic drugs, a 3-fold increase of the risk of cerebrovascular events has been observed. The mechanism of such risk increase is not known. An increase in the risk with other antipsychotic drugs or other populations of patients cannot be excluded. Tiapride should be used with caution in patients with stroke risk factors. Children In children, tiapride has not been thoroughly investigated. Therefore, tiapirde is not intended for treatment in children (see section 4.2). 4.5 Interactions with other medicinal products and other forms of interaction Combinations which are contraindicated Dopaminergic agonists, excluding patients with Parkinson’s disease (cabergoline, quinagolide), due to reciprocal antagonism between dopaminergic agonists and neuroleptics. Combinations which are not recommended Medications which can induce torsades de pointes Class Ia (quinidine, hydroquinidine, disopyramide), and class III antiarrhythmic agents (amiodarone, sotalol, dofetilide, ibutilide), certain neuroleptics (sultopride, pipothiazine, sertindole, veralipide, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, pimozide, haloperidol, droperidol, fluphenazine, pipamperone, flupentixol, zuclopentixol), some antiparasitic drugs (halofantrine, lumefrantine, pentamidine), other medications: IV erythromycin, IV spiramycin, moxifloxacin, bepridil, cisapride, diphemanil, mizolastine, IV vincamine. Increased risk of ventricular arrhythmias, especially torsades de pointes. If possible, discontinue the medication that can induce torsades de pointes, except for antiinfective agents. If combination therapy cannot be avoided, check the QT interval before starting treatment and monitor ECG. Alcohol Alcohol may enhance the sedative effect of neuroleptics. The alteration of the vigilance can make dangerous the driving of vehicles and the use of machines. Avoid drinking alcohol and taking medicines containing alcohol. Levodopa Reciprocal antagonism of the effects of levodopa and neuroleptics. Use minimal effective doses of each of both drugs in patients with Parkinson’s disease. Dopaminergic agonists except levodopa 3 NL/H/0662/001/MR NL/H/0663/001/MR NL/H/0664/001/MR Amantadine, apomorphine, bromocriptine, entacapone, lisuride, pergolide, piribedil, pramipexole, ropinirole, selegiline in patients with Parkinson’s disease. Reciprocal antagonism of the effects of the dopaminergic agonist and neuroleptics. The dopaminergic agonist can induce or accentuate psychotic disorders. When neuroleptic therapy cannot be avoided in patients with Parkinson’s disease treated with dopaminergic agonists, these agents must be tapered off and discontinued (sudden withdrawal of dopaminergic agonists can induce neuroleptic malignant syndrome). Methadone Enhanced risk of ventricular arrhythmia, in particular torsades de pointes. Combinations which require precautions for use Bradycardia-inducing agents In particular class Ia antiarrhythmia agents, beta-blockers, some class II antiarrhythmia agents, some calcium antagonists, cardiac glycosides, pilocarpine, cholinesterase-inhibitors: increased risk of ventricular arrhythmias, especially torsades de pointes. Clinical and electrocardiographic monitoring. Beta-blockers in heart failure Bisoprolol, carvedilol, metoprolol, nebivolol. Enhanced risk of ventricular arrhythmia, inparticular torsades de pointes. Clinical monitoring and ECG monitoring are necessary. Potassium-lowering agents Potassium-lowering diuretics, stimulant laxatives, IV amphotericin B, glucocorticoids, cosyntropin. Increased risk of ventricular arrhythmias, especially torsades de pointes. Correct any hypokalaemia before starting treatment with amisulpride and ensure clinical, electrolyte and electrocardiographic monitoring. Its concomitant administration has to be taken into account Antihypertensives (all) Antihypertensive effect and increased risk of orthostatic hypotension (additive effect). Other central nervous system depressants Narcotics (analgesics, antitussives and opioid replacement therapy); barbiturates; benzodiazepines; other non-benzodiazepine anxiolytics; hypnotics;
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