Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Trifluoperazine
Amdipharm Limited
N05AB; N05AB06
Trifluoperazine
1 mg/5ml
Syrup
Phenothiazines with piperazine structure; trifluoperazine
Not marketed
1997-04-01
• Swelling, discolouration or pain in your leg, arm or in your chest, or breathing problems, which may be caused by a blood clot. • If you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this medicine. If you stop taking this medicine regularly, you may suddenly feel sick, be sick, sweat and have difficulty in sleeping. Do not stop taking this medicine without the advice of your doctor. Some patients may experience weakness, drowsiness, dizziness, restlessness, difficulty in sleeping, dry mouth, blurred vision, muscle weakness, loss of appetite, faintness on standing up, skin rashes (including increased sensitivity to the sun), weight gain, water retention causing swelling or confusion. These are dependent on the dose that you are taking, and tend to disappear when you have finished taking the medicine. Your doctor should check your progress regularly to make sure no unwanted effects are developing. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie. E-mail: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE STELAZINE SYRUP Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label after “Exp”. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original package. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines Preberite celoten dokument
Health Products Regulatory Authority 05 April 2019 CRN008RTX Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stelazine 1mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of syrup contains 1 mg of trifluoperazine as trifluoperazine hydrochloride. Excipients: Each 5ml of syrup contains 0.01mg sunset yellow (E110) and 1.76ml sorbitol liquid (E420). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup A clear, yellow, solution with a peach aroma. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of anxiety states, and psychoses, and as an anti-emetic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ORAL ADMINISTRATION: LOW DOSAGE REQUIREMENTS Adults: The usual total daily dosage is 2 to 6mg in divided doses. Children: Aged 6 to 12 years: The usual total daily dosage is 1 to 4mg in divided doses. HIGH DOSAGE REQUIREMENTS Adults: The usual total daily dosage is 5 to 25mg in divided doses. Children: Aged 6 to 12 years: The usual total daily dosage is 5mg in divided doses. The Elderly: Reduce the starting dose in elderly or frail patients by at least half. Health Products Regulatory Authority 05 April 2019 CRN008RTX Page 2 of 6 4.3 CONTRAINDICATIONS Do not use ‘Stelazine’ in patients with coma particularly if associated with other central nervous system depressants. Do not use ‘Stelazine’ in patients with existing blood dyscrasias, or known liver damage, or in those hypersensitive to trifluoperazine, related compounds, or any of the excipients. Patients with uncontrolled cardiac decompensation should not be given ‘Stelazine’. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE ‘Stelazine’ should be discontinued at the first sign of clinical symptoms of tardive dyskinesia and Neuroleptic Malignant Syndrome. Patients on long-term phenothiazine therapy require regular and careful surveillance with particular attention to tardive dyskinesia and possible eye changes, blood dyscrasias, liver dysfunction, and myocardial conduction defect Preberite celoten dokument