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CMEC Meeting 08, 16 September 1998

Complementary Medicines Evaluation Committee

16 September 1998

Extracted ratified minutes

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CMEC Meeting 8 extracted ratified minutes (pdf,44kb)

Public recommendation summary

Item 3.1.3 Drug Binding Reported in Conjunction with Chitosan Consumption

Recommendation to TGA:

Therapeutic goods containing chitosan require the following statement as safety information:

'Chitosan should be taken at least one hour after any other medication, as it may reduce the effect of other medications'.

Recommendation to TGA:

A condition of listing of chitosan is that manufacturers include directions that the powdered chitosan product should be either mixed with fluid or food, and should never to be taken as a dry powder on its own, or similar words.

Item 5.2.2 Warning statements on anthranoid laxatives

Recommendations to TGA:

  1. Label warnings be required on all laxative products with a daily dose of 10 mg derived from hydroxyanthracene derivatives as follows:
    • 'This product may have a laxative effect';
      'Prolonged use may cause serious bowel problems'
    • followed by the three warnings from the guidelines;
      • LAX1 Drink plenty of water. Increase fibre in diet (or words to that effect)
      • DIG1 If digestive symptoms persist, seek health practitioner advice (or words to that effect) or
      • GEN If symptoms persist, seek health practitioner's advice (or words to that effect).
    1. For products promoted as laxatives depending on claims being made, the following two warnings:
      • LAX2 Prolonged use may cause serious bowel problems (or words to that effect)
      • LAX3 Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast-feeding seek health practitioner advice before taking this product (or words to that effect).
    2. For products not promoted as laxatives, the following two additional warnings:
      • HAD1 This product contains [name of the herb(s) or the chemical component(s). Prolonged use may cause serious bowel problems (or words to that effect).
      • HAD2 Do not use when diarrhoea, abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast-feeding seek health practitioner advice before taking this product (or words to that effect).
  2. That laxative products containing hydroxyanthracene derivatives be required to have the following label warning:
    • 'Use in children under 12 years is contraindicated, except on medical prescription'.
  3. No label warnings are required on products containing less than 10 mg daily dose of hydroxyanthracene derivatives.
  4. The phase in period for the changes to labels for products containing hydroxyanthracene derivatives is six months from the date of notification to industry and the distribution of the finalised guidelines.

Item 7 Application to vary conditions of registration of peppermint oil capsule product

Recommendations to TGA:

The product is efficacious in relieving the symptoms of irritable bowel syndrome and has an apparently good safety record the continued registration of the product together with this label claim should be approved.

Certain changes to the leaflet insert were recommended.

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