Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
tenofovir disoproxil fumarate, Quantity: 300 mg
Arrotex Pharmaceuticals Pty Ltd
Tenofovir disoproxil fumarate
Tablet
Excipient Ingredients: lactose; crospovidone; colloidal anhydrous silica; hypromellose; hyprolose; indigo carmine aluminium lake; titanium dioxide; calcium stearate; macrogol 8000
Oral
30
(S4) Prescription Only Medicine
Tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older.,Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation.
Visual Identification: Light blue, almond shaped, biconvex, coated tablet. Engraved 'TEN' over '300' on one side, 'APO' on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-04-29
TENOFOVIR APOTEX 1 TENOFOVIR APOTEX _Tenofovir disoproxil fumarate _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about tenofovir. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Tenofovir belongs to a group of medicines called nucleoside analog reverse transcriptase inhibitors (NRTIs). CHRONIC HEPATITIS B (CHB) Tenofovir is an antiviral medication used to treat CHB in adults and children aged over 12 years and weighing at least 35 kg. Tenofovir works by interfering with the normal working of enzymes that are essential for HBV to reproduce itself. This may help lower the amount of hepatitis B virus in your body by lowering the ability of the virus to multiply and infect new liver cells. It can improve the inflammation and scar tissue caused by the hepatitis B virus in your liver. Lowering the amount of virus in your body may reduce the chance of developing cirrhosis, liver failure and liver cancer. We do not know how long this medicine may help treat your hepatitis. Sometimes viruses change in your body and medicines no longer work. This is called drug resistance. HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) INFECTION Tenofovir is also used to treat HIV-1 infection in adults and children aged over 12 years and weighing at least 35 kg. It is always used in combination with other anti-HIV-1 medicines to treat people with HIV-1 infection. HIV-1 infection destroys CD4 (T) cells, which are important to the immune system. After many T cells are destroyed, acquired immune deficiency syndrome (AIDS) develops. This medici Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION TENOFOVIR APOTEX (TENOFOVIR DISOPROXIL FUMARATE) TABLETS 1 NAME OF THE MEDICINE Tenofovir disoproxil fumarate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg tenofovir disoproxil fumarate as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM Light blue, almond shaped, biconvex, coated tablet. Engraved “TEN” over “300” on one side, “APO” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tenofovir disoproxil fumarate in combination with other antiretroviral agents is indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older. Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in adults (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). Tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation. 4.2 DOSE AND METHOD OF ADMINISTRATION Tenofovir APOTEX tablets are intended for oral administration. DOSAGE ADULTS The recommended dose is 300 mg (one tablet) once daily taken orally. In order to optimize the absorption of tenofovir, it is recommended that the tablet be taken with food. PAEDIATRIC PATIENTS (≥ 12 YEARS OF AGE AND ≥ 35 KG) The recommended dose for paediatric patients (12 years of age and older), who weigh ≥ 35 kg, is 300 mg (one tablet) once daily taken orally. In order to optimize the absorption of tenofovir, it is recommended that the tablet be taken with food. 2 The safety and efficacy of tenofovir disoproxil fumarate in patients under the age of 12 years have not been established. Tenofovir disoproxil fumarate must not be administered to children under 12, until further data become Read the complete document