Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
MICONAZOLE NITRATE
J-C HEALTH CARE LTD
D01AC02
CREAM
MICONAZOLE NITRATE 20 MG/G
DERMAL
Not required
JANSSEN PHARMACEUTICA N.V.,BELGIUM
MICONAZOLE
MICONAZOLE
Broad spectrum antimycotic
2015-10-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription DAKTARIN ® CREAM ACTIVE INGREDIENT - Each gram contains 20 mg (2%) miconazole nitrate Inactive and allergenic ingredients: see section 6 “Further Information”. 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. You must use it in the correct manner. Consult the pharmacist if you need further information. Refer to the doctor if signs of the illness (symptoms) worsen or if they do not improve after one month. 1. WHAT IS THE MEDICINE INTENDED FOR? Daktarin Cream is intended for the treatment of external infections caused by fungi. What is Daktarin Daktarin Cream is a medicine which is used for the treatment of fungi and fungi-associated bacterial infections of the skin. Skin infections may appear on the hands, feet, outer ear, trunk or groin, including athlete’s foot, jock itch, and intertrigo. The cream contains miconazole nitrate, which works by destroying both the fungi that cause the infection and some of the associated bacteria, which may also be present in the infected areas. The cream also has moisturizing properties to help soothe red and cracked skin. THERAPEUTIC GROUP: Skin anti-infective. 2. BEFORE USING THE MEDICINE The medicine is suitable for most adults and children, but certain people should not use it. If you are in any doubt whatsoever, consult your doctor or pharmacist. DO NOT USE THE MEDICINE IF: You are sensitive (allergic) to the active ingredient, to similar antifungal medicines or to any of the additional ingredients contained in the medicine (see section 6 “Further Information”). SPECIAL WARNINGS REGARDING USE OF THE MEDICINE ∙ Avoid contact with the eyes. ∙ Daktarin may cause severe allergic reactions. You must be aware of the signs of an allergic reaction when you use Daktarin Pročitajte cijeli dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Daktarin Cream. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Miconazole nitrate 2% w/w. Excipients: Benzoic acid, Butylated hydroxyanisole For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Cream White homogeneous cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Broad spectrum antimycotic 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Route of administration: _ Cutaneous use. Recommended dosage: For all ages: Fungal infections of the skin: Apply some cream to the lesions two times daily. Rub the cream into the skin with your finger until it has fully penetrated. The duration of therapy varies from 2 to 6 weeks depending on the localisation and the severity of the lesion. Treatment should be continued at least one week after disappearance of all signs and symptoms. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances, other imidazole derivatives or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Daktarin Cream must not come into contact with the mucosa of the eyes. Severe hypersensitivity reactions, including anaphylaxis and angioedema, have been reported during treatment with Daktarin Cream and with other miconazole topical formulations (see Adverse Reactions). If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. 2 Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous membranes. Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. 4 Pročitajte cijeli dokument