Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Econazole nitrate
Sigma Pharmaceuticals Plc
D01AC03
Econazole nitrate
10mg/1gram
Vaginal cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 07020200
PACKAGE LEAFLET: INFORMATION FOR THE USER PEVARYL ® 1% TOPICAL CREAM Econazole nitrate Pevaryl is a registered trademark READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leafl et. 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 eff ects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leafl et. See section 4. WHAT IS IN THIS LEAFL ET 1 WHAT PEVARYL IS AND WHAT IT IS USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU USE PEVARYL 3 HOW TO USE PEVARYL 4 POSSIBLE SIDE EFF ECTS 5 HOW TO STORE PEVARYL 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT PEVARYL IS AND WHAT IT IS USED FOR The name of your medicine is Pevaryl 1% topical cream. It is called ‘Pevaryl’ in this leafl et. Pevaryl contains a medicine called econazole nitrate. This belongs to a group of medicines called ‘antifungals’. Pevaryl is used for skin infections caused by certain fungi and yeasts. 2 WHAT YOU NEED TO KNOW BEFORE YOU USE PEVARYL DO NOT USE PEVARYL: • if you are allergic to econazole nitrate or any of the other ingredients of this medicine (listed in section 6). Do not use this medicine if this applies to you. If you are not sure, talk to your doctor or pharmacist before using Pevaryl. WARNINGS AND PRECAUTIONS • Talk to your doctor or pharmacist before using Pevaryl if you have infl amed, red, dry and scaly skin (eczema) • Keep this medicine away from your eyes and mouth. If you get any cream in your eyes, rinse with water straight away. Keep your eyes open when you rinse. OTHER MEDICINES AND PEVARYL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription or herbal me Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pevaryl 1% Topical cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Econazole nitrate - 1.0% w/w. Each gram of cream contains 10 mg econazole nitrate Excipients: each gram of cream contains 2 mg benzoic acid and 52 micrograms butylhydroxyanisole For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cream. 4.1 THERAPEUTIC INDICATIONS For the treatment of cutaneous candidiasis, dermatophytosis and pityriasis versicolor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous administration. DOSAGE The dosage regimen is the same for all patients. Apply twice daily to the affected part and rub into the skin gently with the finger. THE USUAL TREATMENT DURATION IS 2 TO 4 WEEKS. _If no improvement in symptoms is experienced after 4 weeks, the treatment _ _should be reassessed. _ 4.3 CONTRAINDICATIONS Pevaryl Topical Cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Care should be taken not to get Pevaryl Topical Cream in the eyes or mouth. If the product is accidently applied to the eyes the patient should wash with clean water or saline and seek medical attention if symptoms persist. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Care should be taken in the presence of eczematous dermatitis 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Econazole 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 and acenocoumarol, caution should be exercised and anticoagulant effect should be monitored more frequently. Adjustment of the oral anticoagulant dosage may be necessary during the treatment with econazole and after its termination 4.6 FERTILITY, PREGNA Izlasiet visu dokumentu