Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Clotrimazole
Bayer Plc
G01AF02
Clotrimazole
100mg/1gram
Vaginal cream
Vaginal
No Controlled Drug Status
Valid as a prescribable product
BNF: 07020200; GTIN: 5010605054099
10/01/17 TL017668 8092739-14 04384044 A TR1209604 JAMES CLAYTON G=1; O=0; R=1; - JC - 10/01/17 08:30:03 N/A N/A 10001(48) N/A N/A Kern Pharma Generic Bayer White Paper 1 LTH PANTONE 485 C 2 LTH PANTONE COOL GRAY 11 C 3 LTH PROCESS BLACK COLOURS READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not give it to anyone else under any circumstances. • If you have any unusual effects after using this product, tell your doctor. IN THIS LEAFLET 1. What is Canesten Vaginal Cream and what is it used for? 2. Before you use Canesten Vaginal Cream 3. How to use Canesten Vaginal Cream 4. Possible side effects 5. How to store Canesten Vaginal Cream 6. Further information 1. WHAT IS CANESTEN® VAGINAL CREAM AND WHAT IS IT USED FOR? Canesten Vaginal Cream is a single application, full course treatment for vaginal thrush (candidiasis). It is a soothing intravaginal cream in a pre-filled applicator for treatment at the site of infection. The active substance in Canesten Vaginal 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® VAGINAL CREAM DO NOT USE CANESTEN® VAGINAL CREAM: • If you are allergic (hypersensitive) to clotrimazole or any of the other ingredients, including cetostearyl alcohol, of Canesten Vaginal Cream_ (see Section 6. Further_ _Information)._ • During your period as it may be less effective. IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS: This product contains cetostearyl alcohol which may cause local skin irritation (e.g. rash, itching or redness). SPECIAL PRECAUTIONS: As with other creams, this product may reduce the effectiveness of rubber contraceptives, such as condoms or diaphragms. Consequently, you should use alternative precautions for at leas Perskaitykite visą dokumentą
OBJECT 1 CANESTEN 10% W/W VAGINAL CREAM Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc 1. Name of the medicinal product Canesten 10% w/w Vaginal Cream 2. Qualitative and quantitative composition Clotrimazole 10% w/w For excipients, see 6.1 3. Pharmaceutical form Vaginal cream. 4. Clinical particulars 4.1 Therapeutic indications Canesten vaginal cream is recommended 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 Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten Vaginal Cream. Canesten Vaginal Cream can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician. This product contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). 4.5 Interaction with other medicinal products and other forms of interaction Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequ Perskaitykite visą dokumentą