Tenaviron 300 mg 30 film-coated tablets

Available at Pharmaegy Pharmacy. Use as directed by your doctor.

Trade name: Tenaviron 300 mg 30 film-coated tablets Composition: Each film-coated tablet contains 245 mg tenofovir disoproxil (as fumarate) eq to 300mg tenofovir disoproxil. Indications: -HIV-1 infection -Tenaviron is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults -Tenaviron is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. -Tenaviron is indicated for the treatment of chronic hepatitis B in adults with: compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. evidence of lamivudine-resistant hepatitis B virus. decompensated liver disease. Tenofovir disoproxil 245 mg film-coated tablets are indicated for the treatment of chronic hepatitis B in adolescents 12 to < 18 years of age with: compensated liver disease and evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels and histological evidence of active inflammation and/or fibrosis Posology and method of administration: Method of administration: Tenaviron should be taken once daily, orally with food. However, in exceptional circumstances Tenaviron can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice. Therapy should be initiated by a physician experienced in the management of HIV infection and/or treatment of chronic hepatitis B. Posology: Adults: The recommended dose of Tenaviron for the treatment of HIV or for the treatment of chronic hepatitis B is one tablet once daily taken orally with food. Paediatric population: -HIV-1: In adolescents aged 12 to < 18 years and weighing ≥ 35 kg, the recommended dose of Tenaviron is 245 mg is one tablet once daily taken orally with food. -Chronic hepatitis B In adolescents aged 12 to < 18 years and weighing ≥ 35 kg, the recommended dose of Tenaviron is 300 mg one tablet once daily (as fumarate), taken orally with food. -Severe renal impairment: 300 mg tenofovir disoproxil fumarate may be administered every 72-96 hours (dosing twice a week). Contraindications Hypersensitivity to the active substance or to any of the excipients. Special warnings and precautions: Renal impairment: -Tenaviron is eliminated by renal excretion and the exposure to tenofovir increases in patients with renal dysfunction. -In adult patients with renal impairment Tenaviron should only be used if the potential benefits of treatment are considered to outweigh the potential risks. A reduced daily dose of Tenaviron or dose interval adjustments are recommended for adult patients with creatinine clearance < 50 ml/min, including haemodialysis patients. Paediatric population: The use of tenofovir disoproxil fumarate is not recommended in paediatric patients with renal impairment -HIV antibody testing should be offered to all HBV infected patients before initiating tenofovir disoproxilfumarate therapy. -Co-administration of other medicinal products: Tenaviron should not be administered concomitantly with other medicinal products containing tenofovir disoproxil or tenofovir alafenamide. Tenaviron should also not be administered concomitantly with adefovir dipivoxil. Co-administration of Tenaviron and didanosine is not recommended. Renal and bone effects in adult population: Renal effects: Tenaviron is principally eliminated via the kidney. Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil fumarate in clinical practice. Co-administration and risk of renal toxicity: Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product (e.g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2). Pregnancy and lactation: Pregnancy: The use of tenofovir disoproxil may be considered during pregnancy, if necessary. In the literature, exposure to tenofovir disoproxil in the third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if tenofovir disoproxil is given to mothers, in addition to hepatitis B immune globulin and hepatitis B vaccine in infants. Breast-feeding: Tenofovir has been shown to be excreted in human milk. Therefore tenofovir disoproxil should not be used during breast-feeding. As a general rule, it is recommended that HIV and HBV infected women do not breast-feed their infants in order to avoid transmission of HIV and HBV to the infant. Side Effects: Hypophosphataemia, Dizziness, Headache, diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, increased transaminases, hepatic Side Effects: Hypophosphataemia, Dizziness, Headache, diarrhoea, vomiting, nausea, abdominal pain, abdominal distension, flatulence, increased transaminases, hepatic steatosis, hepatitis, Rash, Asthenia, Fatigue. Package: A carton box contains 3 blisters, 10 tablets each and leaflet.