Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ZUCLOPENTHIXOL DIHYDROCHLORIDE
Lundbeck Limited
N05AF05
ZUCLOPENTHIXOL DIHYDROCHLORIDE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
zuclopenthixol
Marketed
1982-11-01
• Medicines known as neuromuscular blocking agents (e.g. suxamethonium) as concomitant treatment with Clopixol may prolong the effect of neuromuscular blocking agents • Adrenergic medicines (e.g. atenolol) as concomitant treatment with Clopixol may reduce the effect of adrenergic medicines) The following medicines should not be taken with Clopixol: • Medicines for heart rhythm problems such as medicines used to treat irregular heartbeats (e.g. quinidine, amiodarone, sotalol, dofetilide), certain antibiotics (erythromycin, gatifloxacin, moxifloxacin), certain antihistamines (e.g. astemizole, terfenadine), and other medicines such as cisapride and lithium • Other antipsychotic medicines (e.g. thioridazine) Clopixol with food, drink and alcohol Clopixol can be taken with or without food. Clopixol may increase the sedative effects of alcohol making you more drowsy. It is recommended not to drink alcohol during treatment with Clopixol. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Pregnancy If you are pregnant or think you might be pregnant, tell your doctor. Clopixol should not be used during pregnancy, unless clearly necessary. The following symptoms may occur in newborn babies of mothers that have used Clopixol in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor. Breast-feeding If you are breast-feeding, ask your doctor for advice. You should not use Clopixol when breast-feeding, as small amounts of the medicine can pass into the breast milk. Fertility Animal studies have shown that Clopixol affects fertility. Please ask your doctor for advice. Driving and using machines There is a risk of feeling drowsy and dizzy when using Clopixol, especially in the beginning Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clopixol 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg zuclopenthixol (as 11.82 mg zuclopenthixol dihydrochloride). Excipients with known effect Each tablet contains 21.6 mg lactose monohydrate and 0.72 mg hydrogenated castor oil. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Round, biconvex, light red-brown, film-coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of psychoses, especially schizophrenia, particularly in patients who are agitated or aggressive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The usual dose is 20-30 mg/day, increasing as necessary to a maximum of 150 mg/day, in divided doses. The usual maintenance dose in chronic schizophrenia is 20-50 mg/day in divided doses. Lower doses may be appropriate depending on individual patient response. _Older people_ Older people should receive dosages in the lower end of the dosage range. _Children_ Clopixol is not recommended for use in children due to lack of clinical experience. _Reduced renal function_ Clopixol can be given in usual doses to patients with reduced renal function. _Reduced hepatic function_ Dose reduction (relative to the degree of hepatic impairment) should be considered. If possible, where assay facilities exist dosage should be adjusted according to serum levels. Method of administration The tablets are swallowed with water 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Circulatory collapse H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Прочитайте повний документ