Pfizer Australia - Advil ibuprofen adult and children's products

Therapeutic Goods Act 1989

Approval under section 42DF for use of restricted representations by Pfizer Australia Pty Limited

I, Jenny Mason, Advertising Compliance Unit, Regulatory Practice, Education and Compliance Branch and Delegate of the Secretary to the Department of Health, on receipt of an application from Pfizer Australia Pty Ltd, have approved under section 42DF of the Therapeutic Goods Act 1989 (the Act) the restricted representations described in paragraph (a) below for use in advertisements directed to consumers, for the product identified in paragraph (b)

1. Warnings
   • Do not use this product:
     • If you/your child have/has a current or past history of stomach ulcer/bleeding/disorders.
     • If you/your child have/has impaired kidney function or heart failure.
   • Unless your doctor has told you do not use this product/Ask the doctor before use:
     • If you/your child have/suffers from asthma, high blood pressure, heart or liver disease.
     • If you are breast feeding.
     • If you are/your child is taking aspirin for heart attack or stroke as ibuprofen may decrease this benefit of aspirin.
     • With other medicines if your child is taking other medicines containing ibuprofen, aspirin, other anti-inflammatory medicines, blood thinners or any other medicines you/your child take regularly
   • While 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 dose. Excessive use can be harmful and increase the risk of heart attack, stroke or liver damage
     • Long term and continuous use may increase the risk of heart attack or stroke.
   • Frequently asked questions:
     • Can I take Advil if have (any of the conditions/diseases mentioned on the label)?
       • Can I/my child take Advil if I/my child have/has a stomach ulcer?
       • Do not take Advil if you/your child have/has a current or past history of stomach ulcer / bleeding / disorders.
       •  
       • Can I/my child take Advil if I/my child have/has impaired kidney function?
       • Do not take Advil if you/your child have/has impaired kidney function.
       •  
       • Can I/my child take Advil if I/my child have/has heart failure?
       • Do not take Advil if you/your child have/has heart failure.
       •  
       • Can I/my child take Advil if I/my child have/has asthma?
       • Ask your doctor before use if you/your child have/has asthma
       •  
       • Can I/my child take Advil if I/my child have/has high blood pressure?
       • Ask your doctor before use if you/your child have/has high blood pressure.
       •  
       • Can I/my child take Advil if I/my child have/has heart disease?
       • Ask your doctor before use if you/your child have/has heart disease.
       •  
       • Can I/my child take Advil if I/my child have/has liver disease?
       • Ask your doctor before use if you/your child have/has liver disease.
       •  
       • Can I/my child take Advil if I/my child am/is taking aspirin for heart attack or stroke?
       • Ask your doctor before use if you/your child are/is taking aspirin for heart attack or stroke as ibuprofen may decrease this benefit of aspirin.
       •  
       • Can I/my child take Advil if I/my child am/is taking blood thinners?
       • Ask your doctor before use if you/your child are/is taking blood thinners.^[1]
     • ¹ some of these representations may not in fact be restricted representations, for example a representation which refers to breast feeding is not taken to be a restricted representation.
2. Advil ibuprofen adult and children's products (AUST R Nos. 97229, 104221, 178432, 178433, 178622, 178663, 288707, 288710)

Dated this 22nd day of May 2018

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