País: Holanda
Língua: holandês
Origem: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
ACICLOVIR
Apotex Europe BV Archimedesweg 2 2333 CN LEIDEN
J05AB01
ACICLOVIR
Tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201), CELLULOSE, MICROKRISTALLIJN (E 460) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201),
Oraal gebruik
Aciclovir
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POVIDON K 30 (E 1201);
2017-09-29
Aciclovir Apotex 800 mg tabletten – RVG 118927 MODULE 1.3 Product Information Version: 2017-10-27 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-09-29 PACKAGE LEAFLET: INFORMATION FOR THE USER ACICLOVIR APOTEX 800 MG TABLETTEN Aciclovir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. 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 effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aciclovir Apotex is and what it is used for 2. What you need to know before you take Aciclovir Apotex 3. How to take Aciclovir Apotex 4. Possible side effects 5. How to store Aciclovir Apotex 6. Contents of the pack and other information 1. WHAT ACICLOVIR APOTEX IS AND WHAT IT IS USED FOR Aciclovir Apotex 800 mg tablets contain a medicine called aciclovir. This belongs to a group of medicines known as antivirals. It works by killing or stopping the growth of viruses. Aciclovir Apotex can be used to: • treat chickenpox and shingles 2. WHAT YOUR NEED TO KNOW BEFORE YOU TAKE ACICLOVIR APOTEX DO NOT TAKE ACICLOVIR APOTEX: • if you are allergic to aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6). Do not take Aciclovir Apotex if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Aciclovir Apotex. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Aciclovir Apotex if: • you have kidney problems • you are over 65 years of age If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Aciclovir Apotex. Aciclovir Apotex 800 mg tabletten – RVG Leia o documento completo
Aciclovir Apotex 800 mg tabletten – RVG 118927 MODULE 1.3 Product Information Version: 2019-01-11 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-10-27 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aciclovir Apotex 800 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 800 mg of aciclovir For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, elongated, biconvex tablets score on one side (length 19.3±0.2 mm, width 10.5±0.2 mm) The score line is only to faciliate breaking for ease of swallowing and not to divide in equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir Apotex 800 tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Dosage in adults _ Treatment of varicella and herpes zoster infections: 800 mg of aciclovir should be taken five times daily at approximately four-hourly intervals, omitting the night time dose. Treatment should continue for seven days. In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut, consideration should be given to intravenous dosing. Dosing should begin as early as possible after the start of an infection: Treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after onset of the rash. _Paediatric population _ Aciclovir Apotex 800 mg, tabletten – RVG 118927 MODULE 1.3 Product Information Version: 2019-01-11 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-10-27 2 Treatment of varicella infection 6 years and over: 800 mg acyclovir four times daily Treatment should continue for five days. No specific data are available on the treatment of herpes zoster infec Leia o documento completo