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Brand name: Dilart HCT 160/12.5 mg TM

Active ingredients: valsartan + hydrochlorothiazide

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

• DILART valsartan film-coated tablet blister pack
• DILART HCT valsartan and hydrochlorothiazide film-coated tablet blister pack

Recall commencement date: 22 Nov 2018

Batch number: All Batches

Reason/Issue: Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India.

EDQM has now suspended the manufacturer’s CEP effectively prohibiting the use of its valsartan in EU medicines. In addition, national authorities in the EU have started recalling affected batches of medicines containing Mylan’s valsartan and are conducting further tests to determine the extent of the contamination. NDEA and the related compound N-nitrosodimethylamine (NDMA), which have been seen in ‘sartans’ from other manufacturers, are classified as probable human carcinogens (substances that could cause cancer).

As with previous findings of NDEA and NDMA, there is no immediate risk to patients. It is riskier for patients to suddenly stop taking high blood pressure medication.

Patients should therefore not stop any treatments without consulting their doctor or pharmacist.

Find out more about this recall on the TGA website: http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2018-RN-01488-1

What it is used for

DilartHCT is indicated for the treatment of hypertension. Treatment should not be initiated with these combinations.

How to take it

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

  • The way to take this medicine: Oral
  • Store below 25 degrees Celsius
  • Store in Original Container
  • Shelf lifetime is 36 Months.

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

Visual appearance

A reddish, film-coated, oval, biconvex tablet debossed with VH 2 on one side of the tablet and M on other side.

Images are the copyright of the Pharmacy Guild of Australia

Do I need a prescription?

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

Pregnant or planning a pregnancy?

For the active ingredient valsartan + hydrochlorothiazide

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.

Download leaflet

For side effects, taking other medicines and more

Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website

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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