País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Fosfomycin
Lexon Pharmaceuticals (Ireland) Limited
J01XX; J01XX01
Fosfomycin
Granules for oral solution
Other antibacterials; fosfomycin
2022-06-24
MONURIL 3 G GRANULES FOR ORAL SOLUTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. * If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: What Monuril is and what it is used for What you need to know before you take Monuril How to take Monuril Possible side effects How to store Monuril Contents of the pack and other information WHAT MONURIL IS AND WHAT IT IS USED FOR Monuril contains the active substance fosfomycin (as fosfomycin trometamol). It is an antibiotic that works by killing bacteria which can cause infections. Monuril is used to treat uncomplicated infection of the bladder in women and female adolescents. Monuril is used as antibiotic prophylaxis for transrectal prostate biopsy in adult man. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MONURIL DO NOT TAKE MONURIL IF YOU: - are allergic to fosfomycin or any of the other ingredients of this medicine (listed in section 6) WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Monuril if you suffer from one of the following disorders: - persistent infections of the bladder, - previously had diarrhoea after taking any other antibiotics. Conditions you need to look out for Monuril can cause serious side effects. These include allergic reactions and an inflammation of the large intestine. You must look out for certain symptoms while you are taking this medicine, to reduce the risk of any problems. See “Serious side effects” in Section 4. CHILDREN AND ADOLESCENTS Do not give this medicine to children less than 12 years of age, as its safety and efficacy have not been established i Llegiu el document complet
Health Products Regulatory Authority 24 June 2022 CRN00CVYH Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Monuril 3 g granules for oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each single-dose sachet contains 3 g of fosfomycin (as fosfomycin trometamol). Excipient(s) with known effect: sucrose and sulphites For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Product imported from Spain_ _ _ Granules for oral solution. White granular powder with a characteristic odour of mandarin flavour. 4 CLINICAL PARTICULARS As per PA1441/002/002 5 PHARMACOLOGICAL PROPERTIES As per PA1441/002/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Mandarin flavour (contains sucrose and sulphites (E 220 and E 222)) Orange flavour (contains corn starch and sulphites (E 220 and E 222)) Saccharin (E 954) Sucrose 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the sachet and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE No special precautions for storage. 6.5 NATURE AND CONTENTS OF CONTAINER Sachets are supplied in cardboard outer containing 1 sachet. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT Health Products Regulatory Authority 24 June 2022 CRN00CVYH Page 2 of 2 The dose must be dissolved in a glass of water and administered soon after dissolving. Any unused product or waste material should be disposed of in accordance with local requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3, Harcourt Centre, Harcourt Road, Dublin 2, Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/044/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 th June 2022 10 DATE OF REVISION OF THE TEXT Llegiu el document complet