País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
PROCHLORPERAZINE MESILATE
Sanofi-Aventis Ireland Limited T/A SANOFI
N05AB; N05AB04
PROCHLORPERAZINE MESILATE
12.5 milligram(s)/millilitre
Solution for injection
Product subject to prescription which may be renewed (B)
Phenothiazines with piperazine structure; prochlorperazine
Marketed
1977-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER STEMETIL® 12.5 MG/ML SOLUTION FOR INJECTION -1 ML AMPOULE _Prochlorperazine Mesilate _ _ _ IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 4035600 FOR HELP READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START HAVING 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell 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 Stemetil Injection is and what it is used for 2. What you need to know before you take Stemetil Injection 3. How Stemetil Injection is given 4. Possible side effects 5. How to store Stemetil Injection 6. Contents of the pack and other information 1. WHAT STEMETIL INJECTION IS AND WHAT IT IS USED FOR Stemetil Injection contains a medicine called prochlorperazine mesilate. This belongs to a group of medicines called ‘phenothiazine antipsychotics’. It works by blocking the effects of a chemical in the brain. Stemetil Injection can be used to: • Treat balance problems or dizziness (vertigo). This includes problems of the inner ear such as ‘Meniere’s Syndrome’ • Stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines • Treat schizophrenia • Treat over-active behaviour or thoughts (mania) • Treat anxiety in the short-term, when used in addition to other medicines 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STEMETIL INJECTION DO NOT HAVE THIS MEDICINE AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to prochlorperazine mesilate, other phenothiazine medicines such as chlorpromazine or any of the other ingredients of Leer el documento completo
Health Products Regulatory Authority 02 November 2023 CRN00CXNS Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stemetil 12.5 mg/ml solution for injection - 1 ml Ampoule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of solution contains 12.5 mg of Prochlorperazine Mesilate. Excipients: Also includes anhydrous sodium sulfite (E221) 1.0 mg per 1ml; sodium metabisulphite (E223) 0.75 mg per 1ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for Injection. A clear, bright solution, almost colourless or not more than very pale yellow, contained in a printed ring coded ampoule. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stemetil injections are recommended in the management of acute vertigo such as is associated with Meniere’s syndrome, nausea and vomiting, migraine and anxiety states. The course of treatment should not normally exceed 2 weeks duration. In the management of phobias, schizophrenia, acute mania, and similar psychotic reactions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intramuscular _Recommended Dosage:_ _ _ Adults: For the management of migrane or nausea and vomiting: - The usual total daily dosage is 12.5 mg followed by oral dosage 6 hours later if required. In schizophrenia and other psychotic disorders: The usual total daily dosage is 25-75mg in divided doses. Elderly: Stemetil should be used cautiously in the elderly owing to their susceptibility to drugs acting centrally on the nervous system. There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use therefore a lower initial dosage is recommended. If required, dosage adjustment is recommended in this population (see section 4.4). Care should also be taken not to confuse the adverse effects of Stemetil, e.g. orthostatic hypotension, with effects due to the underlying disorder. Children: Not recommended for use in children. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to prochlorperazine or other Phenoth Leer el documento completo