Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Clotrimazole; Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole; Clotrimazole
500 mg/2 percent weight/weight
Cream + vaginal capsule, soft
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Marketed
2016-03-24
BCH22013 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 Baca dokumen lengkapnya
Health Products Regulatory Authority 05 December 2022 CRN00CW79 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Combi Soft Vaginal Capsule & Cream 500 mg Soft Vaginal Capsule and 2 % w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The soft vaginal capsule contains 500mg clotrimazole. Each gram of cream contains 20mg clotrimazole (equivalent to 2% w/w). Excipients with known effect: Cetostearyl alcohol 100mg in each gram of cream Benzyl alcohol 20mg in each gram of cream Soya oil. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal capsule, soft and cream. Yellow teardrop-shaped soft capsule. A white oil-in-water type cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The soft vaginal capsule is recommended for the treatment of candidal vaginitis. The cream is recommended for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis. The cream can also be used for treatment of the sexual partner’s penis to prevent re-infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults: One 500mg soft vaginal capsule should be inserted at night, before going to bed. A second treatment may be carried out if necessary. The cream should be applied thinly to the vulva and surrounding area two or three times daily and rubbed in gently. Treatment should be continued until symptoms of the infection disappear. Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Combi. Canesten Combi can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician. If the cream is being used for treatment of the sexual partner's penis it should be applied two or three times daily for up to two weeks. _Paediatric Population_ Not for use in children under 16. Health Products Regulatory Authority 05 December 2022 CR Baca dokumen lengkapnya