REGULATORY INFORMATION

Home  |  Consumers  |  Health Professionals  |  Regulatory  |  Other  |  Hot Topics  |  Search

• Guidelines & Codes
• Forms and Templates
• Schedule of Fees
• Credit Card Payments
• Gazette Notices
• MAAC
• Pharmacovigilance
• Classification of Medicines
• Unapproved Medicines
• Medical Devices / WAND
• Dietary Supplements
• Licensed Manufacturing Sites
• GMP Certified Testing Labs
• Clinical Trials
• Certified Clinical Trial Sites
• Weight Management/Weight Loss Products
• Consultants
• Influenza vaccine composition
• Product/Application Search
• Medical Device Queries
• Regulatory Feedback

Guidelines and Codes

Update to Section 12.10.11 Ibuprofen
[NZRGM, Volume 1, 5th edition]

Added to web site: April 2006

Ibuprofen liquid oral dose forms

Liquid oral dose forms containing ibuprofen can be sold as Pharmacy Only Medicines when the follow conditions are applied:

1. It must be sold in the manufacturer’s original pack
2. The maximum daily dose should not exceed 1200mg
3. The maximum pack size should not exceed 4gm of total ibuprofen content
4. That packs should have concentrations of 100mg/5mL or 200mg/5mL only
5. The indications should be limited to relief of pain and reduction of fever or inflammation. (Juvenile rheumatoid arthritis is not an approved indication for OTC sale of ibuprofen).
6. The dose is in the order of:
   • 6 – 12 months 50mg three or four times daily
   • 1 – 3 years 100mg three or four times daily
   • 4 – 6 years 150mg three or four times daily
   • 7 – 9 years 200mg three or four times daily
   • 10 – 12 years 300mg three or four times daily
7. The following warning statements or words of similar meaning, should be present on the label:
   • Do not give to babies under 6 months
   • Do not give to children under 1 year without medical advice
   • Use of the medicine without a doctor’s advice is contraindicated in children suffering dehydration through diarrhoea and/or vomiting
   • Use of the medicine without a doctor’s advice is contraindicated in children with gastric ulceration, indigestion, stomach pain, or bleeding
   • Use of the medicine without a doctor’s advice is contraindicated in children who have previously shown hypersensitivity to aspirin, ibuprofen, or other NSAID’s.
8. The following precautions should be present on the label: This medicine should NOT be taken without medical supervision by:
   • children who have impaired renal function
   • children who are taking other medicines
   • children suffering from asthma, urticaria or rhinitis
   • prolonged use without medical supervision could be harmful

Ibuprofen solid oral dose forms

A. Requirements for sale as a General Sales Medicine

1. It must be sold in the manufacturer’s original pack
2. The strength of ibuprofen in each dose unit should not exceed 200mg per tablet
3. The maximum daily dose should not exceed 1200mg
4. The pack size must not exceed 25 dose units.
5. The following warning statements, or words of similar meaning, are also required on the labelling
    
   • Do not use if you have a stomach ulcer
   • Do not use in the last 3 months of pregnancy (except in preparations exclusively for the treatment of dysmenorrhoea)
   • Do not use if you are allergic to ibuprofen or other anti-inflammatory medicines.
   • Unless a doctor has told you to, do not use for more than a few days at a time
   • Unless a doctor has told you to, do not use with other medicines containing aspirin or other anti-inflammatory medicines
   • Unless a doctor has told you to, do not use with other medicines you are taking regularly
   • Unless a doctor has told you to, do not use if you have asthma
   • Unless a doctor has told you to, do not use in children 6 years of age or less
   • Unless a doctor has told you to, do not use if you are aged 65 or over
   • Unless a doctor has told you to, do not use if you are pregnant (except in preparations exclusively for the treatment of dysmenorrhoea)

B. Requirements for sale as a Pharmacy Only Medicine

1. It must be sold in the manufacturer’s original pack
2. The strength of ibuprofen in each dose unit should not exceed 200mg per tablet
3. The maximum daily dose should not exceed 1200mg
4. The maximum pack size should not exceed 100 dose units
5. The following warning statements, or words of similar meaning, are also required on the labelling
    
   • Do not use if you have a stomach ulcer
   • Do not use in the last 3 months of pregnancy (except in preparations exclusively for the treatment of dysmenorrhoea)
   • Do not use if you are allergic to aspirin, ibuprofen or other anti-inflammatory medicines.
   • Unless a doctor has told you to, do not use for more than a few days at a time
   • Unless a doctor has told you to, do not use with other medicines containing aspirin or other anti-inflammatory medicines
   • Ask your doctor before use if you are pregnant or are taking anticoagulant medication, medication for high blood pressure, diuretics, lithium, methotrexate or other medicines for pain relief.
   • Do not use in the presence of a stomach ulcer or other stomach disorders, impaired kidney function or heart failure.

The above guidelines will be included in the next edition of the New Zealand Regulatory Guidelines for Medicines, Volume 1, but will become effective from the date of publication on the Medsafe website.

Please note that only packs approved for distribution as general sales pack can be sold through this route. Approval for distribution as a general sales medicine requires the submission of, and consent to, a Changed Medicine Notification for products which only have pack sizes of less than 25 dose units approved, or submission of a New Medicine Application for marketing a product with an additional classification if the product range includes pack sizes that will continue to be sold as Pharmacy Only Medicines.b