מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Fosfomycin
IMED Healthcare Ltd.
J01XX01
Fosfomycin
Granules for oral solution
fosfomycin
2023-10-13
PACKAGE LEAFLET: INFORMATION FOR THE USER MONURIL ® 3 G GRANULES FOR ORAL SOLUTION fosfomycin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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 IN THIS LEAFLET 1. What Monuril is and what it is used for 2. What you need to know before you take Monuril 3. How to take Monuril 4. Possible side effects 5. How to store Monuril 6. Further information 1. 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. 2. 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 diarrhea 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 it קרא את המסמך השלם
Health Products Regulatory Authority 13 October 2023 CRN00DMVC 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) Excipients with known effect: sucrose and sulfites. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Granules for oral solution. _Product imported from Spain:_ 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 flavor (contains sucrose and sulfites (E 220 and E 222)) Orange flavor (contains corn starch and sulfites (E220 and E 222)) Saccharin Sucrose 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of 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 This medicinal product does not require any special storage conditions. Store in the original packaging. 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 13 October 2023 CRN00DMVC 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 IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15, Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/213/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 th October 2023 10 DATE OF REVISION OF THE T קרא את המסמך השלם