GlaxoSmithKline Consumer Healthcare - Advil and AdvilDuo

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by GlaxoSmithKline Consumer Healthcare Pty Ltd

I, Nicole McLay, Delegate of the Secretary to the Department of Health, on receipt of an application on by GlaxoSmithKline Consumer Healthcare Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraphs (a) - (c) below for use in advertisements directed to consumers, for the registered medicines identified in paragraph (d)(i) and (ii):

1. "For the temporary relief of pain associated with arthritis and rheumatic pain"

2. Warnings:

   "Do not use this product:

   • If you have a current of past history of stomach ulcer/bleeding/disorders
   • If you have impaired kidney function or heart failure

   Unless your doctor has told you do not use this product:

   • If you have asthma, high blood pressure, heart or liver disease
   • With other medicines containing ibuprofen, aspirin, other anti-inflammatory medicines, blood thinners or any other medicines you take regularly
   • If you are taking aspirin for heart attack or stroke as ibuprofen may decrease this benefit of aspirin

   While you are using this product:

   • Do not use for more than a few days at a time unless a doctor has told you to. Do not exceed the recommended does. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage."

3. Frequently asked questions:

   "Can I take Advil if I have (any of the conditions/diseases mentioned on the label)?

   Can I take Advil if I have a stomach ulcer?
   Do not take Advil if you have a current or past history of stomach ulcer/bleeding/disorders.

   Can I take Advil if I have impaired kidney function?
   Do not take Advil if you have impaired kidney function.

   Can I take Advil if I have heart failure?
   Do not take Advil if you have heart failure.

   Can I take Advil if I have asthma?
   Ask your doctor before use if you have asthma.

   Can I take Advil if I have high blood pressure?
   Ask your doctor before use if you have high blood pressure.

   Can I take Advil if I have heart disease?
   Ask your doctor before use if you have heart disease.

   Can I take Advil if I have liver disease?
   Ask your doctor before use if you have liver disease.

   Can I take Advil if I am taking aspirin for heart attack or stroke?
   Ask your doctor before use if you are taking aspirin for heart attack or stroke as ibuprofen may decrease this benefit of aspirin.

   Can I take Advil if I am taking blood thinners?
   Ask your doctor before use if you are taking blood thinners."

4.  
   1. Advil ibuprofen 200mg soft capsule (AUST R 311280); and
   2. AdvilDuo Paracetamol + Ibuprofen film coated tablet (AUST R 286841).

Dated this 19th day of October 2020

Signed electronically

Nicole McLay
Delegate of the Secretary to the Department of Health
Advertising Compliance Unit
Regulatory Practice, Education and Compliance Branch