Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Didanosine
Bristol-Myers Squibb Pharmaceuticals uc
J05AF; J05AF02
Didanosine
200 milligram(s)
Gastro-resistant capsule
Product subject to prescription which may not be renewed (A)
Nucleoside and nucleotide reverse transcriptase inhibitors; didanosine
Marketed
2000-09-15
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIDEX 125 MG GASTRO-RESISTANT HARD CAPSULES VIDEX 200 MG GASTRO-RESISTANT HARD CAPSULES VIDEX 250 MG GASTRO-RESISTANT HARD CAPSULES VIDEX 400 MG GASTRO-RESISTANT HARD CAPSULES Didanosine 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 Videx is and what it is used for 2. What you need to know before you take Videx 3. How to take Videx 4. Possible side effects 5. How to store Videx 6. Contents of the pack and other information 1. WHAT VIDEX IS AND WHAT IT IS USED FOR VIDEX IS AN ANTIVIRAL (OR ANTIRETROVIRAL) MEDICINE, USED TO TREAT HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION. Videx belongs to a group of medicines called nucleoside reverse transcriptase inhibitors (NRTIs). It is normally used in combination with other anti-HIV medicines. VIDEX IS NOT A CURE FOR HIV INFECTION. You may continue to develop infections or other illnesses linked to HIV infection. You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIDEX Videx will only be prescribed to you by a doctor with experience in medicines to treat HIV infection. DO NOT TAKE VIDEX IF YOU ARE ALLERGIC to didanosine or any of the other ingredients of this medicine (listed in section 6). CHILDREN YOUNGER THAN 6 YEARS: Videx gastro-resistant capsules must not be taken by this age group. Other more appropr read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Videx EC 200 mg gastro-resistant hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gastro-resistant hard capsule contains 200 mg of didanosine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gastro-resistant capsule, hard Gastro-resistant capsules are opaque white and embossed in green with "6672" on one half, and "BMS 200 mg" on the other half. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Videx is indicated in combination with other antiretroviral drugs for the treatment of HIV-1 infected patients only when other antiretrovirals cannot be used. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Because didanosine absorption is reduced in the presence of food, Videx gastro - resistant capsules must be administered on an empty stomach (at least 2 hours before or 2 hours after a meal) (see section 5.2). POSOLOGY Videx gastro-resistant capsules are administered on a once daily or a twice daily regimen (see section 5.1). The recommended total daily dose is based on patient body weight (kg): for patients weighing at least 60 kg: 400 mg per day for patients weighing less than 60 kg: 250 mg per day The following table defines the administration schedule for all strengths of the gastro-resistant capsules: Patient Weight Total Daily Dose Corresponding Regimen at least 60 kg 400 mg 1 capsule of 400 mg (once daily) or 1 capsule of 200 mg (twice daily) less than 60 kg 250 mg 1 capsule of 250 mg (once daily) or 1 capsule of 125 mg (twice daily) H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ read_full_document