Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
CLOTRIMAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
G01AF02
VAGINAL CREAM
CLOTRIMAZOLE 2 %
VAGINAL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
CLOTRIMAZOLE
CLOTRIMAZOLE
Broad spectrum antimycotic with fungicidal action
2015-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only AGISTEN V 2% VAGINAL CREAM CLOTRIMAZOLE 2% Inactive ingredients and allergens in the preparation - see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. The medicine is intended for adolescent girls and women between the ages of 16 and 60. Patients under the age of 16 or over the age of 60 – consult the doctor. The symptoms generally pass after 7 days of treatment. If there is no improvement in your condition within 3 days, consult the doctor. 1. WHAT IS THE MEDICINE INTENDED FOR? Broad spectrum antifungal medicine. THERAPEUTIC GROUP: Imidazole antifungal. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: ∙ if you are sensitive (allergic) to the active ingredient, to cetostearyl alcohol, to any of the other ingredients included in the medicine or to other antifungal agents from the same family. ∙ when menstruating, since the treatment may be less effective. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE During treatment, abstain from vaginal intercourse, as the disease can be transmitted to your partner. This medicine may reduce the effectiveness of contraceptives made of rubber, such as: condoms or diaphragms made of latex. Therefore, it is recommended to use alternative contraceptives for at least 5 days after using the medicine. Do not use tampons, vaginal douching preparations, spermicides or other vaginal preparations during the course of treatment. BEFORE TREATMENT WITH AGISTEN V 2% VAGINAL CREAM, INFORM THE DOCTOR IF: ∙ you are sensitive to any food or medicine. ∙ you are unsure if you have a fungus or this is the first time Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 .NAME OF THE MEDICINAL PRODUCT Agisten V 2% Vaginal Cream 2 .QUALITATIVE AND QUANTITATIVE COMPOSITION Cltorimazole 2% Excipient with known effect: Cetostearyl alcohol, Benzyl alcohol For full list of excipients, see section 6.1 3 .PHARMACEUTICAL FORM VAGINAL CREAM 4 .CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Broad spectrum antimycotic with fungicidal action 4.2 POSOLOGY AND METHOD OF ADMINISTRATION One applicator charge daily (approximately 5 g) should be introduced as deep as possible into the vagina before retiring for 3 consecutive days. This is best achieved when lying on the back . Male Partner The vaginal cream should be applied 2-3 times a day in a thin layer on the penis for balanitis (whether symptomatic or asymptomatic). The normal period of treatment is 1-2 weeks. GENERALLY • If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor • The treatments can be repeated if necessary however recurrent infections may indicate an underlying medical cause, including diabetes or HIV infections. Patients should seek the medical advice if symptoms return within 2 months • Since the vagina and vulva are usually both affected, a combination treatment (treatment of both of these areas) should be performed • Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation • If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given. The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present • Do not use tampons, intravaginal douches, spermicidies or other vaginal products while using this product . • Avoidance of vaginal intercourse is recommended while using this product because the infection could be transferred to your partner, and the effectiveness and safety of latex products such as condoms and diaphragms may be reduce Прочитайте повний документ