Country: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole
Waymade Healthcare Plc
G01AF02
Clotrimazole
100mg/1gram
Vaginal cream
Vaginal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07020200
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 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. • You must contact a doctor if your symptoms worsen or do not impro ve 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 Internal Cream and what is it used for? 2. Before you use Canesten Thrush Internal Cream 3. How to use Canesten Thrush Internal Cream 4. Possible side effects 5. How to store Canesten Thrush Internal Cream 6. Further information 1. WHAT IS CANESTEN® THRUSH INTERNAL CREAM AND WHAT IS IT USED FOR? Canesten Thrush 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. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING VAGINAL THRUSH. The active substance in Canesten Thrush 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. BEFORE YOU USE CANESTEN® THRUSH INTERNAL CREAM DO NOT USE CANESTEN® THRUSH INTERNAL CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Thrush Internal Cream ( _see Section 6. Further_ _Information_). • During your period as it may be less effective. BEFORE USING CANESTEN® THRUSH INTERNAL CREAM, YOU SHOULD SEE YOUR DOCTOR IF: • You are unsure whether you have thrush or this is the first time you have had these symptoms. • You have had more than two infections of thrush in the last six months. • You or your partner have ever had a sexually tran Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Canesten Thrush Internal Cream 10% w/w vaginal cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 10% w/w Excipients with known effects: cetostearyl alcohol For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Vaginal cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Canesten Thrush Internal Cream is indicated for the treatment of candidal vaginitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The cream should be administered intravaginally using the applicator supplied. _ _ _ADULTS:_ The contents of the filled applicator (5g) should be inserted as deeply as possible into the vagina, preferably at night. A second treatment may be carried out if necessary. Generally: treatment during the menstrual period should not be performed due to the risk of the cream 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. 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 Hypersensitivity to clotrimazole or any other excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis. Before using Canesten Thrush Internal Cream, medical advice must be sought if any of the following are applicable: • more than two infections of candidal vaginitis in the last 6 months. • previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease • pregnancy or suspected pregnancy • aged under 16 or over 60 years • known hypersensitivity to imidazoles or other vaginal antifungal products Canesten Thrush Internal Cream should not be used if the patient has a Прочитајте комплетан документ