Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
ACICLOVIR
Clonmel Healthcare Ltd
D06BB; D06BB03
ACICLOVIR
50 milligram(s)/gram
Cream
Product not subject to medical prescription
Antivirals; aciclovir
Marketed
1998-11-27
Page 1 of 3 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRALIEF 50MG/G CREAM aciclovir 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 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 effect 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 14 days. WHAT IS IN THIS LEAFLET 1. What Viralief 50 mg/g cream is and what it is used for 2. What you need to know before you use Viralief 50 mg/g cream 3. How to use Viralief 50 mg/g cream 4. Possible side effects 5. How to store Viralief 50 mg/g cream 6. Contents of the pack and other information 1. WHAT VIRALIEF 50 MG/G CREAM IS AND WHAT IT IS USED FOR Viralief 50 mg/g cream is a medicine against viral infections (antiviral agents). VIRALIEF 50 MG/G CREAM IS USED FOR the treatment of cold sores caused by _Herpes simplex _virus. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE VIRALIEF 50 MG/G CREAM DO NOT USE VIRALIEF 50 MG/G CREAM if you are allergic to aciclovir, valaciclovir or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before using Viralief 50 mg/g cream if you have or in the past have had any medical conditions or illnesses, especially severe deficiency of the immune system, e.g. - AIDS patients - people who have received a bone marrow transplant. In this case, your doctor may decide to prescribe you tablets instead. You should not use Viralief 50 mg/g cream on mucous membranes (e.g. in the mouth, eye or vagina) to avoid local irritation. Accidental eye contact must also be prevented If your immune system is seriously weakened talk to your doctor about the Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 06 February 2020 CRN0098T8 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Viralief 50 mg/g Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of cream contains 50 mg aciclovir. Excipient(s) with known effect Each gram of cream contains 150 mg propylene glycol (E1520) and 15 mg cetyl alcohol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. White to off-white cream 4 CLINICAL PARTICULARS Treatment of cold sores caused by herpes simplex virus. 4.1 THERAPEUTIC INDICATIONS Treatment of cold sores caused by herpes simplex virus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Viralief 50 mg/g cream should be applied to infected lips 5 times daily at approximately 4 hourly intervals, omitting the night time application. Viralief 50 mg/g cream should be applied to the lesions or impending lesions as early as possible after the start of an infection. Treatment should be continued for 5 days. If, after 5 days, healing is not complete then treatment can be continued for up to an additional 5 days. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance, to valaciclovir or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Aciclovir cream is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye. In severely immune-compromised patients (e.g. AIDS patients or bone marrow transplant recipients) oral aciclovir dosing should be considered. Such patients should be encouraged to consult a physician concerning the treatment of any infection. Excipients The excipient cetyl alcohol may cause local skin reactions (e.g. contact dermatitis). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS No clinically significant interactions have been identified. Health Products Regulatory Authority 06 February 2020 CRN0098T8 Page 2 of 4 4. Կարդացեք ամբողջական փաստաթուղթը