Country: Holland
Tungumál: hollenska
Heimild: 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 200 mg tabletten – RVG 118926 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 200 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 200 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 • treat cold sores, genital herpes and other herpes simplex infections • stop these problems returning after you have had them • stop these problems in people whose immune systems work less well, which means their bodies are less able to fight infections. 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 ph Lestu allt skjalið
Aciclovir Apotex 200 mg tabletten – RVG 118926 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 200 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of aciclovir For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, biconvex tablets, with embossement “200” on one side (9.0±0.2 mm) 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aciclovir Apotex 200 mg tablets are indicated for the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children). Aciclovir Apotex 200 mg tablets are indicated for the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients. Aciclovir Apotex 200 mg tablets are indicated for the prophylaxis of herpes simplex infections in immunocompromised patients. Aciclovir Apotex 200 mg tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Dosage in adults _ Treatment of herpes simplex infections: 200 mg Aciclovir Apotex should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended. Aciclovir Apotex 200 mg, tabletten – RVG 118926 MODULE 1.3 Product Information Version: 2019-01-11 MODULE 1.3.1 Summary of Product Characteristics Replaces : 2017-10-27 2 In severely immunocompromised patients (e.g. after marrow transplant) or in patients with impaired absorption from the gut the dose can be doubled to 400 mg Aciclovir Apotex or alternatively intravenous dosing could be considered. Dosing should begin as early as possible after the Lestu allt skjalið