Tenofovir Disoproxil Fumarate

COMPOSITION: Each film-coated tablet contains:

Tenofovir disoproxil fumarate 300mg
POINT:

Treatment and prevention of HIV infection
Treatment of chronic hepatitis B virus
CONTRAINDICATIONS

Contraindicated in patients with known hypersensitivity to tenoforvir disoproxil fumarate or any of the excipients.
Severe kidney failure.
Patients with abnormal neutrophils (<0.75x109g/l) or abnormal hemoglobin concentration <75g/l).
DOSAGE & HOW TO USE

Treatment of HIV infection: 1 tablet/time/day, in combination with other antiretroviral drugs.
Prophylaxis of HIV infection after occupational exposure: 1 tablet once daily, in combination with other antiretroviral agents (usually in combination with lamivudine or emtricitabine) and continued for the next 4 weeks if tolerated. Prophylaxis should begin as soon as possible after exposure (preferably within a few hours).
Treatment of non-occupational HIV infection: 1 tablet/time/day, in combination with at least 2 other antiretroviral drugs. Prophylaxis should begin as soon as possible after exposure (preferably within 72 hours).
Treatment of chronic hepatitis B: 1 tablet / time / day, for more than 48 weeks.
EFFECTS OF DRUGS WHEN DRIVING AND OPERATING MACHINERY:

The drug can cause dizziness, so it should be used with caution when driving or operating machinery.
ADVERSE EFFECTS OF DRUGS:

Common: diarrhea, vomiting, nausea, abdominal pain, flatulence, dyspepsia, anorexia, possible elevated serum amylase levels or pancreatitis, hypophosphatemia, peripheral neuropathy, headache, dizziness face, insomnia, depression, weakness, sweating and muscle pain.
Uncommon: skin rash.
PREGNANCY AND LACTATION:

Pregnancy: There is no information on the use of the drug during pregnancy, it should only be used when the demonstrated benefit outweighs the risk to the fetus.
Because the risk of increased fertility is unknown, the use of the drug in women of reproductive age should be accompanied by effective methods of contraception.
Lactation: There is no information on the excretion of tenofovir in breast milk, so the drug should not be used in nursing women.
PACKAGING: 1 bottle x 30 tablets

STORAGE: Temperature not exceeding 30oC, protect from light and moisture.

SHELF LIFE: 36 months from date of manufacture.

Manufacturer:

Mylan Laboratories Limited

F-4 & F-12, MIDC, Malegaon, Tal.Sinnar, Nashik 422, Maharashtra state, India

Exclusive Distributor:
Tung Linh Pharmaceutical Joint Stock Company
Address: House B-TT8-4, Him Lam Van Phuc Residential Area, Van Phuc Ward, Ha Dong District, Hanoi City, Vietnam
Tel: 024 6297 7875

DOSAGE & HOW TO USE

Treatment of HIV infection: 1 tablet/time/day, combined with other antiretroviral drugs.
Prophylaxis of HIV infection after exposure due to occupational causes: 1 tablet/time/day, combined with other antiretroviral drugs (usually combined with lamivudine or emtricitabine) and continue for the next 4 weeks if tolerated. Prophylaxis should begin as soon as possible after exposure (preferably within a few hours).
Treatment of non-occupational HIV infection: 1 tablet/time/day, combined with at least 2 other antiretroviral drugs. Prophylaxis should begin as soon as possible after exposure (preferably within 72 hours).
Treatment of chronic hepatitis B: 1 tablet/time/day, for more than 48 weeks.

PACKAGING: 1 Bottle x 30 tablets