Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole
2 percent weight/weight
Vaginal cream
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Marketed
1981-03-02
BCH22024 PATIENT LEAFLET: INFORMATION FOR THE USER CANESTEN THRUSH CREAM 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 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 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 Thrush Cream and what is it used for 2. What you need to know before you use Canesten Thrush Cream 3. How to use Canesten Thrush Cream 4. Possible side effects 5. How to store Canesten Thrush Cream 6. Contents of the pack and other information 1. WHAT IS CANESTEN® THRUSH CREAM AND WHAT IS IT USED FOR Canesten Thrush Cream relieves irritation of the vulva (vulvitis) which is caused by vaginal thrush (candidiasis). Although this cream provides relief from the external irritation caused by vaginal thrush, it cannot treat any internal (vaginal) cause of the infection. Ask your doctor or pharmacist to recommend a treatment for this. Canesten Thrush Cream 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 this cream to prevent reinfection, even if they have no symptoms of thrush. The active substance in Canesten Thrush Cream 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® THRUSH CREAM DO NOT USE C Soma hati kamili
Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Thrush Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 20mg Clotrimazole (2% 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 Vaginal Cream A white oil-in-water type cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten Thrush 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 Canesten Thrush Cream should be applied to the vulva and surrounding area. It can also be applied to the sexual partner's penis to prevent re-infection. Adults and children of 12 years of age and older: The cream should be applied thinly two or three times daily and rubbed in gently. Treatment should be continued until symptoms of the infection disappear. 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. Patients should seek medical advice if symptoms return within 2 months. 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. Children under 12 years of age: There is no clinical experience in the use of Canesten Thrush Cream in children. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Health Products Regulatory Authority 05 December 2022 CRN00D655 Page 2 of 5 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medical advice should be sought if this is the first time the pat Soma hati kamili