Land: Malta
Sprache: Englisch
Quelle: Malta Medicines Authority
KETOCONAZOLE
Janssen-Cilag International NV
D01AC08
KETOCONAZOLE
CUTANEOUS LIQUID
KETOCONAZOLE 2 percent weight/weight
OTC
ANTIFUNGALS FOR DERMATOLOGICAL USE
Authorised
2007-03-02
PACKAGE LEAFLET: INFORMATION FOR THE USER NIZORAL 20MG/G SHAMPOO ketoconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Nizoral Shampoo is and what it is used for 2. What you need to know before you take Nizoral Shampoo 3. How to use Nizoral Shampoo 4. Possible side effects 5. How to store Nizoral Shampoo 6. Contents of the pack and other information 1. WHAT NIZORAL SHAMPOO IS AND WHAT IT IS USED FOR Nizoral Shampoo is used to treat and prevent dandruff and dry or greasy scaling of the scalp (seborrhoeic dermatitis), which is a more severe kind of dandruff. It is also used to treat the irregular white to brown patches which occur on the body and sometimes appear after being in the sun (tinea/pityriasis versicolor). The shampoo contains ketoconazole, which is an antifungal that targets an increased number of yeasts on the skin called _Malassezia_. These yeasts occur naturally on everyone’s skin, however, people with dandruff and seborrhoeic dermatitis seem to have more _Malassezia. _Tinea versicolor (otherwise known as pityriasis versicolor), a condition which causes white to brown patches to develop on parts of the body, is also associated with _Malassezia_. The shampoo also treats the inflammation associated with dandruff, relieving scalp redness and itching. This product is for use in adults and children of 12 years and older. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NIZORAL SHAMPOO This product is suitable for most adults and adolescents aged 12 years and over, but a few people Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Nizoral 20mg/g Shampoo 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram contains 20 mg of ketoconazole. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Shampoo Pink viscous shampoo 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of infections in which the yeast _Malassezia_ (previously called as _Pityrosporum_ ) infection maybe a factor, such as dandruff and seborrhoeic dermatitis.Treatment of tinea (pityriasis) versicolor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Paediatric population The safe and effective use of Nizoral 20mg/g Shampoo in infants and children under the age of 12 years has not been established. Nizoral shampoo is for use in adults and adolescents aged 12 years and over. Seborrhoea capitis Apply the shampoo to the affected scalp, leave for three minutes, then rinse. Seborrhoeic dermatitis Wash the affected area with shampoo and leave for 3 to 5 minutes before rinsing. Treatment should be repeated twice weekly for 2 to 4 weeks. For prophylaxis use once, every 1 to 2 weeks. Tinea versicolor Use once daily for 1 to 5 days. Method of administration Cutaneous use. Usually, a palmful of shampoo suffices for one wash. 4.3 CONTRAINDICATIONS Use in patients showing hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE In patients who have been on prolonged treatment with topical corticosteroids, it is recommended that the steroid therapy be gradually withdrawn over a period of 2 to 3 weeks, while using Nizoral Shampoo, to prevent any potential rebound effect. Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with water. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed. 4.6 FERTILITY, PREGNANCY AND LACTATION There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate Lesen Sie das vollständige Dokument