Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole
500 milligram(s)
Pessary
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Marketed
1983-03-14
BCH22024 PACKAGE LEAFLET: INFORMATION FOR THE USER CANESTEN® 500MG PESSARY clotrimazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • 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. • You must contact a doctor if your symptoms worsen or do not improve in 7 days. WHAT IS IN THIS LEAFLET 1. What is Canesten 500mg Pessary and what is it used for 2. What you need to know before you use Canesten 500mg Pessary 3. How to use Canesten 500mg Pessary 4. Possible side effects 5. How to store Canesten 500mg Pessary 6. Contents of the pack and other information 1. WHAT IS CANESTEN® 500MG PESSARY AND WHAT IS IT USED FOR Canesten 500mg Pessary is a single application for the treatment of vaginal thrush. It is inserted into the vagina for treatment at the site of infection. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH. The active substance in Canesten 500mg Pessary is clotrimazole. Clotrimazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as vaginal thrush. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN® 500MG PESSARY DO NOT USE CANESTEN® 500MG PESSARY: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients of Canesten 500mg Pessary (listed in section 6). • During your period as it may be less effective. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before using CANESTEN® 500MG PESSARY You are unsure whether you have thrush or this is the first time you have had these symptoms. • You have had more than two infections of thrush in the last six months. • You Прочитајте комплетан документ
Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten 500 mg Pessary 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 500mg Clotrimazole. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Pessary. White, convex pessary marked ‘Bayer’ on one side and ‘MU’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten Pessaries are recommended for the treatment of candidal vaginitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten Pessary should be inserted intravaginally, as high as possible, using the applicator supplied. Adults and children of 12 years of age and over: Insert one pessary daily, preferably at night before going to bed. If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor. The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause. Patient should seek medical advice if symptoms return within 2 months. If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given, in addition to the intravaginal treatment (combination treatment). Canesten pessaries need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the pessary might crumble out of the vagina. Pieces of undissolved pessary may be noticed by women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible into the vagina at bedtime. Children under 12 years of age: As this product is administered with a vaginal applicator, paediatric usage is not recommended. To insert the pessary: 1. Pull out plunger until it stops. Place the pessary into the applicator. 2. Carefully insert the applicator containing the pessary as deeply as is comfortable into the vagina. (This is best done with the patient lying on her back with th Прочитајте комплетан документ