Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Trifluoperazine
Mercury Pharmaceuticals Ltd
N05AB; N05AB06
Trifluoperazine
5 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Phenothiazines with piperazine structure; trifluoperazine
Not marketed
1977-04-01
PATIENT INFORMATION LEAFLET STELAZINE ® 1MG AND 5MG FILM-COATED TABLETS TRIFLUOPERAZINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. The product is known by the name above but will be referred to as Stelazine Tablets throughout the rest of this leaflet. IN THIS LEAFLET: 1. What Stelazine Tablets are and what they are used for 2. Before you take Stelazine Tablets 3. How to take Stelazine Tablets 4. Possible side effects 5. How to store Stelazine Tablets 6. Further information 1. WHAT STELAZINE TABLETS ARE AND WHAT THEY ARE USED FOR Stelazine Tablets contain the active ingredient trifluoperazine hydrochloride, which belongs to a class of drugs called phenothiazine tranquilisers. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain. • At a low dose, Stelazine Tablets are used to manage anxiety and depression. It is used in this way for short periods of time • Stelazine tablets may also be used to treat nausea (feeling sick) and vomiting (being sick) • At high doses, Stelazine Tablets are used to treat and prevent relapses of schizophrenia (a serious mental illness) and related conditions. 2. BEFORE YOU TAKE STELAZINE TABLETS DO NOT TAKE STELAZINE TABLETS IF: • You know that you are allergic to trifluoperazine hydrochloride or any of the other ingredients of Stelazine Tablets (see section 6 of this leaflet) • You are suffering from liver problems, blood disorders, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles • You have previously had to stop taking other medicin Read the complete document
Health Products Regulatory Authority 27 February 2019 CRN008X3J Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stelazine 5mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains trifluoperazine hydrochloride equivalent to 5 mg of trifluoperazine. Excipients: Each tablet contains 17mg sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Blue aqueous coated tablets having "FW241" embossed on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Low dosage: ‘Stelazine’ is indicated as an adjunct in the short-term management of anxiety states. It is also indicated in the symptomatic treatment of nausea and vomiting. High dosage: Treatment of symptoms and prevention of relapse in schizophrenia and in other psychoses, especially of the paranoid type, but not in depressive psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral Administration: Adults: Low Dosage Requirements 2-4 mg a day, given in divided doses, according to the severity of the patient’s condition. If necessary, dosage may be increased to 6 mg a day, but above this level extrapyramidal symptoms are more likely to occur in some patients. High Dosage Requirements Adults: The recommended starting dose for physically fit adults is 5 mg twice a day; after a week this may be increased to 15 mg a day. If necessary, further increases of 5 mg may be made at three-day intervals, but not more often up to a maximum of 30 mg per day. When satisfactory control has been achieved, dosage should be reduced gradually until an effective maintenance level has been established. As with all major tranquillisers clinical improvement may not be evident for several weeks after starting treatment, and there may also be delay before recurrence of symptoms after stopping treatment. Gradual withdrawal from high-dosage treatment is advisable. Children: Aged 6 to 12 years: Low Dosage Requirements The usual total daily dosage is 1 to 4 mg in divided doses Health Pr Read the complete document