Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
PENCICLOVIR
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
D06BB06
CREAM
PENCICLOVIR 10 MG/G
TOPICAL
Not required
OMEGA PHARMA LTD. UNITED KINGDOM
PENCICLOVIR
For the topical treatment for cold sores (oral herpes).
2018-07-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 The medicine is dispensed without a doctor’s prescription FENLIPS Cream 1 gram of cream contains: Penciclovir 10 mg Inactive ingredients and allergens in the medicine are listed in section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Use the medicine according to the instructions in the dosage section of this leaflet. Consult a pharmacist if you need more information. Refer to the doctor if the symptoms of illness worsen or do not improve after 4 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Fenlips is intended for local treatment of cold sores )Herpes labialis(. THERAPEUTIC GROUP: Anti-viral for local use. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • you are hypersensitive )allergic( to the active ingredient penciclovir, to famciclovir or to any of the other ingredients the medicine contains )mentioned in section 6(. SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE • 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. Talk to the doctor or pharmacist before starting to use Fenlips. ! BEFORE TREATMENT WITH FENLIPS CONSULT THE DOCTOR IF: • you are unsure that your sore is a cold sore. • you have a condition, or are receiving treatment which weakens your immune system )i.e. the way your body fights infection(, for example, HIV infection, a bone marrow transplant or cancer treatment. • you need to treat ulcers or blisters which appear around your eyes or genital area. Contact your doctor if your cold sore gets worse or is severe. ! CHILDREN AND ADOLESCENTS • Fenlips is not recommended for the treatment of children under 12 years of age. ! DRUG INTERACTIONS IF YOU ARE TAKING OR HAVE RECENTLY TAKEN OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPL Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCTS Fenlips / Fenlips Color 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 Fenlips / Fenlips Color is indicated for the topical treatment of cold sores (oral herpes). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (including older people) and children over 12 years of age: Fenlips / Fenlips Color 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; moreover the product has been shown to be beneficial in accelerating lesion healing, reducing lesion pain and shortening the duration of viral shedding even in patients who begin treatment later in the disease (e.g. when the papule or vesicle has developed). Children (under 12 years): No work has been carried out in children below 12 years of age. 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, particularly when active lesions are present. Immunocompromised patients (e.g. AIDs patients or bone marrow transplant recipients) shoul Прочитайте повний документ