Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Didanosine
Bristol-Myers Squibb Pharmaceuticals Ltd
J05AF02
Didanosine
125mg
Gastro-resistant capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5012712002376
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 the complete document
OBJECT 1 VIDEX EC 125MG GASTRO-RESISTANT CAPSULES Summary of Product Characteristics Updated 24-May-2016 | Bristol-Myers Squibb Pharmaceuticals limited 1. Name of the medicinal product 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 2. Qualitative and quantitative composition Each gastro-resistant hard capsule contains 125 mg, 200 mg, 250 mg, 400 mg of didanosine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant capsule, hard 125 mg:Gastro-resistant capsules are opaque white and embossed in tan with "6671" on one half, and "BMS 125 mg" on the other half. 200 mg: Gastro-resistant capsules are opaque white and embossed in green with "6672" on one half, and "BMS 200 mg" on the other half. 250 mg: Gastro-resistant capsules are opaque white and embossed in blue with "6673" on one half, and "BMS 250 mg" on the other half. 400 mg: Gastro-resistant capsules are opaque white and embossed in red with "6674" on one half, and "BMS 400 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 Read the complete document