Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Clotrimazole
Bayer Limited
G01AF; G01AF02
Clotrimazole
10 percent weight/weight
Vaginal cream
Product not subject to medical prescription
Imidazole derivatives; clotrimazole
Not marketed
1986-05-19
BCH22054 PATIENT LEAFLET – INFORMATION FOR THE USER CANESTEN INTERNAL CREAM CLOTRIMAZOLE 10% 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 doctor, pharmacist or nurse have told you. This medicine is available without prescription. However, you still need to use Canesten Internal Cream 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 Internal Cream and what is it used for 2. What you need to know before you use Canesten Internal Cream 3. How to use Canesten Internal Cream 4. Possible side effects 5. How to store Canesten Internal Cream 6. Contents of the pack and other information 1. WHAT IS CANESTEN® INTERNAL CREAM AND WHAT IS IT USED FOR? Canesten Internal Cream is a single application, full course treatment for vaginal thrush. It is a soothing intravaginal cream in a prefilled applicator for treatment at the site of infection. 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. The active substance in Canesten Internal 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® INTERNAL CREAM DO NOT USE CANESTEN® INTERNAL CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients including cetostearyl alcohol or benzyl alcohol, of Caneste Preberite celoten dokument
Health Products Regulatory Authority 10 July 2023 CRN00DC2T Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Internal Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 100mg clotrimazole equivalent to clotrimazole 10% w/w Excipients with known effect: Cetostearyl alcohol 35mg in each gram of cream Benzyl alcohol 10mg in each gram of cream For the full list of excipients, see Section 6.1_._ 3 PHARMACEUTICAL FORM Vaginal cream. A soft, white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten Internal Cream is recommended for the treatment of candidal vaginitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Canesten Internal Cream should be administered intravaginally using the applicator supplied. Adults and children of 12 years of age and older: 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. 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). _ _ CHILDREN UNDER 12 YEARS OF AGE: As the product is used with an applicator, paediatric usage is not recommended. Instructions for use: 1. Remove applicator from package.Insert plunger into applicator. 2. Remove cap by turning. 3. Introduce applicator as deeply as possible into the vagina (this is best done with the patient lying on her back with the knees bent up) and empty its contents into the vagina by pushing the plunger. 4. Remove the applicator and dispose of it. 4.3 CONTRAINDICATIONS Health Products Regulatory Authority 10 July 2023 CRN00DC2T Page 2 of 6 Hyperse Preberite celoten dokument