Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Clotrimazole; Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole; Clotrimazole
2 percent weight/weight
Vaginal cream
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Not marketed
2006-07-28
BCH22054 PACKAGE LEAFLET – INFORMATION FOR THE USER CANESTEN CREAM COMBI INTERNAL AND EXTERNAL CREAMS CLOTRIMAZOLE 10% W/W AND CLOTRIMAZOLE 2% W/W 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 you pharmacist has told you. This medicine is available without prescription. However, you still need to use CANESTEN® CREAM COMBI carefully to get the best results from it. • 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 talk to a doctor if you do not feel better or if you feel worse after seven days. WHAT IS IN THIS LEAFLET 1. What is CANESTEN® CREAM COMBI and what is it used for 2. What you need to know before you use CANESTEN® CREAM COMBI 3. How to use CANESTEN® CREAM COMBI 4. Possible side effects 5. How to store CANESTEN® CREAM COMBI 6. Contents of the pack and other information 1. WHAT IS CANESTEN® CREAM COMBI AND WHAT IS IT USED FOR This product is a complete treatment for vaginal thrush because it treats both the internal cause and external symptoms. It contains: • an intravaginal cream in a pre-filled applicator, containing 500mg (10% w/w) Clotrimazole as the active ingredient, for treatment at the site of infection. • a tube of soothing cream, containing 2% w/w Clotrimazole, to start relieving the external itch immediately. Canesten Cream Combi is used to treat adults and children aged 12 years and over. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING 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 the external cream as well, even if they have no symptoms of thrush. If you are unsure w সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 10 July 2023 CRN00DC2T Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Cream Combi Internal & External Creams 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Canesten Combi 10 % Internal Cream contains Clotrimazole 100 mg/g Canesten Combi 2% External Cream contains Clotrimazole 20 mg/g Excipients with known effect: The 10% cream contains Cetostearyl alcohol 35mg in each gram of cream and Benzyl alcohol 10mg in each gram of cream The 2% cream also contains Cetostearyl alcohol 100mg in each gram of cream and Benzyl alcohol 20mg in each gram of cream For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal Cream. Canesten 10 % Internal Cream contains a soft, white cream in a prefilled applicator Canesten 2% External Cream contains white oil in water type cream 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The internal cream is recommended for the treatment of candidal vaginitis. The external cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis. It can also be used for treatment of the sexual partner’s penis to prevent re-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children of 12 years of age and older: Canesten Internal Cream should be administered intravaginally using the applicator supplied. The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, 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. _ _ Canesten External Cream should be applied thinly to the vulva and surrounding area, two or three times daily and rubbed in gently. If the cream is being used for treatment of the sexual pa সম্পূর্ণ নথি পড়ুন