Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Penciclovir
Omega Pharma Ltd
D06BB06
Penciclovir
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13100300; GTIN: 0000050080755
PACKAGE LEAFLET: INFORMATION FOR THE USER FENISTIL COLD SORE CREAM PENCICLOVIR READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always use this medicine exactly as described in this leaflet or as your 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 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 4 days. WHAT IS IN THIS LEAFLET 1. What Fenistil Cold Sore Cream is and what it is used for 2. What you need to know before you use Fenistil Cold Sore Cream 3. How to use Fenistil Cold Sore Cream 4. Possible side effects 5. How to store Fenistil Cold Sore Cream 6. Contents of the pack and other information 1. WHAT FENISTIL COLD SORE CREAM IS AND WHAT IT IS USED FOR The active ingredient in this medicine is Penciclovir, an antiviral which is used to treat infections caused by viruses. Fenistil Cold Sore Cream can be used to treat cold sores on the lips and around the mouth. You must talk to a doctor if you do not feel better or if you feel worse after 4 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FENISTIL COLD SORE CREAM DO NOT USE FENISTIL COLD SORE CREAM • If you are allergic to penciclovir, famciclovir or any of the other ingredients of Fenistil Cold Sore Cream (listed in section 6.) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Fenistil Cold Sore Cream. DO NOT USE the cream inside your mouth, in or near your eyes, nose or on your genital area. Avoid applying the cream near your eyes. Please check with your doctor or pharmacist before using Fenistil Cold Sore Cream: • if you are unsure that your sore is a cold sore, • if you have a condition, or are receiving treatment which weakens your immune system (i.e. the way your body fights infection), for example, Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fenistil Cold Sore Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of the cream contains: 10 mg penciclovir Excipients with known effect: cetostearyl alcohol, propylene glycol For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream Smooth white cream of homogeneous appearance. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fenistil Cold Sore Cream is indicated for the treatment of herpes simplex virus infections of the lips and face (herpes labialis) in adults (including older people) and children over 12 years of age. Immunocompromised patients: Fenistil Cold Sore Cream is not recommended for use in immunocompromised patients; such patients should consult a physician concerning the treatment of any infection. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including older people) and children over 12 years of age Fenistil Cold Sore Cream should be applied at approximately two hourly intervals during waking hours, (approximately 8 times a day). Treatment should be continued for 4 days. If the condition gets worse or does not improve after 4 days treatment, seek medical advice. Treatment should be started as early as possible after the first sign of an infection. Paediatric population Children (under 12 years): The safety and efficacy of Fenistil Cold Sore Cream in children below 12 years of age have not been established. No data are available. 4.3 CONTRAINDICATIONS Hypersensitivity to penciclovir, famciclovir or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The cream should only be used on cold sores on the lips and around the mouth. It is not recommended for application to mucous membranes (e.g. in the eyes, mouth, or nose or on the genitals). Particular care should be taken to avoid application in or near the eyes. Patient with particularly severe cold sores should be encouraged to seek medical advice. Patients should be advised to avoid transmitting the virus, p Pročitajte cijeli dokument