Țară: Malta
Limbă: engleză
Sursă: Malta Medicines Authority
CLOTRIMAZOLE
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
G01AF02
CLOTRIMAZOLE 20 mg/g CLOTRIMAZOLE 500 mg
VAGINAL CREAM VAGINAL TABLET
CLOTRIMAZOLE 20 mg/g CLOTRIMAZOLE 500 mg
OTC
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
Authorised
2006-03-02
BCH22024 PACKAGE LEAFLET: INFORMATION FOR THE USER CANESTEN® COMBI PESSARY & CREAM 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 Combi and what is it used for 2. What you need to know before you use Canesten Combi 3. How to use Canesten Combi 4. Possible side effects 5. How to store Canesten Combi 6. Contents of the pack and other information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR Canesten Combi Pessary & Cream 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 Combi Pessary & 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. 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® COMBI DO NOT USE CANESTEN® COMBI PESSARY & CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol or benzyl alcohol, of Canesten Combi Pessary & Cream (listed in section 6). • During your period as it may be less effective. WARNINGS AND PRECAUTIONS: Talk to your Citiți documentul complet
BCH22024 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Canesten Combi Pessary & Cream. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The pessary contains clotrimazole 500 mg 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 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary and vaginal cream. White, convex pessary marked "Bayer" on one side and "MU" on the other side. A white oil-in-water type cream. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications The pessary 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 The pessary should be inserted intravaginally, as high as possible, using the applicator provided. Adults and children of 12 years of age and older: Insert one pessary, 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 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 BCH22024 2 women who experience vaginal dryness. To help prevent this it is important that the pessary is inserted as high as possible into the vagina at bedtime. To insert the pessary: 1. Pull out plunger until it stops. Place the pessary into the applicator. 2. Carefully insert the applicator containing the pessary as deeply as is co Citiți documentul complet