Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
FLUCONAZOLE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
J02AC01
FLUCONAZOLE 150 mg
HARD CAPSULE
FLUCONAZOLE 150 mg
OTC
ANTIMYCOTICS FOR SYSTEMIC USE
Authorised
2006-12-28
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MEDOFLUCON 150 MG CAPSULES Fluconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse after 7 days. WHAT IS IN THIS LEAFLET 1. What Medoflucon is and what it is used for 2. What you need to know before you take Medoflucon 3. How to take Medoflucon 4. Possible side effects 5. How to store Medoflucon 6. Contents of the pack and other information 1. WHAT MEDOFLUCON IS AND WHAT IT IS USED FOR Medoflucon is a full course of treatment for thrush. ONLY USE THIS PRODUCT IF YOU HAVE BEEN PREVIOUSLY DIAGNOSED BY YOUR DOCTOR AS HAVING THRUSH. The active substance in Medoflucon is fluconazole. Fluconazole belongs to a group of medicines called azoles and is an antifungal agent which fights the cause of infections such as thrush. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MEDOFLUCON DO NOT TAKE MEDOFLUCON: • If you are allergic to fluconazole or to any of the other ingredients of this medicine (listed in section 6). • If you are taking the antihistamine terfenadine, the medicine cisapride or an ergot-derivative (e.g. ergotamine used for migraine). 2 DO NOT USE MEDOFLUCON WITHOUT FIRST CONSULTING YOUR DOCTOR: • If you are under 16 or over 60 years of age. • If you are allergic to any of the ingredients in Medoflucon or other antifungals and other thrush treatments. • If you are taking any other medicine other than the capsule. • If you are taking the antihistamine terfenadine or the prescription medicine cisapride. • If you have had thrush more than twice Lesen Sie das vollständige Dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Medoflucon 150mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Medoflucon 150mg capsule contains 150mg of fluconazole. Excipients with known effect: lactose. Each Medoflucon 150mg capsule contains 145.0 mg lactose. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Hard gelatin capsules with a powder blue cap and powder blue body, containing a white, free flowing powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Medoflucon is recommended for the treatment of candida vaginitis, acute or recurrent. It should also be used for the treatment of partners with associated candidal balanitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults (16 to 60 years) _ One capsule should be swallowed whole. _Children (under 16 years) _ Page 2 of 15 Paediatric use is not recommended. _Elderly _ Not recommended in patients over 60 years. _Renal impairment _ There is no separate dosage schedule in patients with renal impairment for single dose therapy. Method of administration Medoflucon may be administered orally. The capsules should be swallowed whole and independent of food intake. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to related azole substances, or to any of the excipients listed in section 6.1). Fluconazole should not be administered concomitantly with terfenadine, cisapride or ergot- derivatives (see section 4.5). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The product available from pharmacies without prescription will include a leaflet that advises the patient - _Do not use Medoflucon without first consulting your doctor_ : • If you are under 16 or over 60 years of age. • If you are allergic to any of the ingredients in Medoflucon or other antifungals and other thrush treatments. • If you are taking any other medicine other than the contraceptive pill. • If you are taking the antihistamine terfenadine or the prescription medicine cisapride. • I Lesen Sie das vollständige Dokument