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Brand name: Tenofovir Disoproxil Emtricitabine 300/200 (Mylan) TM

Active ingredients: tenofovir disoproxil + emtricitabine

The Therapeutic Goods Administration (TGA) has a recall notice on this product.

Tenofovir Disoproxil Emtricitabine 300/200 (Mylan) Tablets

Recall action commencement date: 21 December 2020

Consumers and health professionals are advised that Alphapharm Pty Ltd, in consultation with the TGA, is undertaking a recall of all batches of Tenofovir Disoproxil Emtricitabine Mylan 300/200 tablets due to the potential for broken/split tablets. If an affected tablet was not consumed entirely, this could result in an ineffective dose.

Information for consumers: If you or someone you provide care for have been prescribed Tenofovir Disoproxil Emtricitabine Mylan 300/200 please consult your treating physician for individual advice. You should return the tablets to your pharmacist for a refund.

Further information on this recall can be found at www.tga.gov.au/alert/tenofovir-disoproxil-emtricitabine-mylan-300200

What it is used for

Treatment of HIV-1 infection: TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200 is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents. Pre-Exposure Prophylaxis: TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200 is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see CLINICAL STUDIES).

How to take it

The way to take this medicine is: Oral. This medicine is taken by mouth.

  • Store below 25 degrees Celsius
  • Shelf lifetime is 18 Months.

You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.

Always read the label. If symptoms persist see your healthcare professional.

Visual appearance

A light green, film-coated, capsule shaped, biconvex tablet debossed with 'M' on one side of the tablet and 'ETM' on the other side.

Do I need a prescription?

This medicine is available from a pharmacist and requires a prescription. It is Schedule 4 : Prescription Only Medicine.

Is this medicine subsidised?

This medicine was verified as being available on the PBS (Pharmaceutical Benefits Scheme) on April 1, 2021. To learn more about this subsidy, visit the Pharmaceutical Benefits Scheme (PBS) website.

Pregnant or planning a pregnancy?

For the active ingredient tenofovir disoproxil + emtricitabine

You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.

Reporting side effects

You can help ensure medicines are safe by reporting the side effects you experience.

You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems

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