Land: Malta
Språk: engelsk
Kilde: Medicines Authority
CLOTRIMAZOLE
Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom
G01AF02
CLOTRIMAZOLE 2 % (W/W)
VAGINAL CREAM VAGINAL SOFT CAPSULE
CLOTRIMAZOLE 2 % (W/W)
OTC
GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
Withdrawn
2013-07-30
Black Pantone 485 U Pantone Cool Gray 11 U Kontur CAN Soft Gel Pessary Combi GB 210 x 297 mm Verlag Book, Book Italic, Bold, Bold Italic; Zapf Dingbats Regular; Bliss Pro Medium 9 pt READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Canesten Thrush Combi Soft Gel Pessary and External 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. • You must contact a doctor if your symptoms worsen or do not improve in 7 days. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET 1. What is Canesten Thrush Combi and what is it used for? 2. Before you use Canesten Thrush Combi 3. How to use Canesten Thrush Combi 4. Possible side effects 5. How to store Canesten Thrush Combi 6. Further information 1. WHAT IS CANESTEN® THRUSH COMBI AND WHAT IS IT USED FOR? Canesten Thrush Combi Soft Gel Pessary and External 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 Thrush Combi 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. BEFORE YOU USE CANESTEN® THRUSH COMBI DO NOT USE CANESTEN® THRUSH COMBI SOFT GEL PESSARY AND EXTERNAL CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Thrush Combi Soft Gel Pessary and External Cream (_see Section 6. _ _Further Information_). • To treat nail and scalp infections. BEFORE USING CANESTEN® THRUSH COMBI SOFT GEL PESSARY AND EXTERNAL CREAM, YOU SHOULD SEE YOUR DOCTOR IF: • You are unsure whether you have thrush or Les hele dokumentet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Canesten Thrush Combi Soft Gel Pessary & External Cream 500mg / 2% w/w vaginal capsule & cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Canesten Thrush Soft Gel Pessary contains Clotrimazole 500mg. Canesten Thrush External Cream contains Clotrimazole 2% w/w. Excipient with known effect: Cream: Cetostearyl alcohol For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal capsule, soft Yellow teardrop-shaped soft capsule Cream White cream 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The soft gel pessary is indicated for the treatment of candidal vaginitis. The cream is indicated for the treatment of candidal vulvitis. It should be used as an adjunct to treatment of candidal vaginitis. These products should only be used if candidal vulvovaginitis (thrush) was previously diagnosed by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults One soft gel pessary should be inserted into the vagina at night. Using the applicator provided, the soft gel pessary should be inserted as high as possible into the vagina. This is best achieved when lying back with legs bent up. Treatment during the menstrual period should be avoided due to the risk of the soft gel pessary being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation. Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product. The cream should be thinly applied to the vulva and surrounding area, two or three times daily and rubbed in gently. 2 Treatment with the cream should be continued until symptoms of the infection disappear. However, if after concomitant treatment of the vaginitis, the symptoms do not improve within seven days, the patient should consult a physician. Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected. Children Not for use in children under 16. 4.3 CONTRAINDICATIONS Hyp Les hele dokumentet