Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Clotrimazole; Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole; Clotrimazole
100mg/1 percent weight/weight
Cream + pessary
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Not marketed
1977-04-01
BCH22024 PACKAGE LEAFLET: INFORMATION FOR THE USER CANESTEN® DUOPAK 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 Duopak and what is it used for? 2. What you need to know b efore you use Canesten Duopak 3. How to use Canesten Duopak 4. Possible side effects 5. How to store Canesten Duopak 6. Contents of the pack and other information 1. WHAT IS CANESTEN ® DUOPAK AND WHAT IS IT USED FOR? Canesten Duopak is a complete treatment for vaginal thrush because it treats both the internal cause and external symptoms. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH. The active substance in Canesten Duopak 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. Some women suffer from recurrent attacks of thrush. To reduce the frequency of these attacks, the sexual partner’s penis can be treated with this cream to prevent reinfection, even if they have no symptoms of thrush. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE CANESTEN ® DUOPAK DO NOT USE CANESTEN ® DUOPAK: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Canesten Duopak (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 ® DUOPAK IF: You a Aqra d-dokument sħiħ
Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Duopak 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains Clotrimazole 100mg. Each gram of cream contains 10mg clotrimazole (equivalent to 1% w/w). Excipients with known effect: Cetostearyl alcohol 100mg in each gram of cream Benzyl alcohol 20mg in each gram of cream For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Pessaries and cream White biconvex, oblong pessaries with the name “Bayer” engraved on one side and the letters “P3” on the other. A white oil-in-water type cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten 100mg pessaries are recommended for the treatment of candidal vaginitis. The cream is recommended for associated vulvitis and treatment of the sexual partner to prevent re-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten 100mg Pessaries should be inserted intravaginally, as high as possible, using the applicator supplied. The cream is for topical application to the vulva and surrounding area. ADULTS AND CHILDREN OF 12 YEARS OF AGE AND OLDER: Insert one pessary daily, preferably at night, before going to bed, for six consecutive days. Alternatively, two pessaries can be inserted for three consecutive days. The cream should be applied two or three times daily. 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. 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 deeply as po Aqra d-dokument sħiħ