Note: This guidance document contains references to warning statements that are being included in the current updating of the RASML document. Warning statements marked with an (*) which are included in the updated version of the RASML document will be removed from this guidance document once the updated RASML is implemented.
On this page: Rubefacients | Sodium bicarbonate | Sodium content | Sodium salts - oral preparations for bowel cleansing | Soft gel capsules for sedation | Sore throat treatments - antimicrobial | Sympathomimetic amines | Teething products | Tryptophan
The following indications (or similar) will generally be accepted for rubefacient products:
- For the temporary relief of the pain of rheumatism, arthritis, fibrositis, lumbago, muscular aches and strains.
Lumbago is defined as backache in the lumbar or lumbosacral regions.
Sciatica, neuritis, bruising, swelling or cramps will not be approved as indications for rubefacient products unless the sponsor provides evidence of the efficacy and safety of the product for the requested indication(s).
Due to the possibility of myolysis when rubefacients are used in conjunction with heat pads, product labels should contain a statement such as:
- This product should not be used in conjunction with heat pads.
The use of sodium bicarbonate and other alkaline bicarbonates as antacids is undesirable. While effervescent preparations containing sodium bicarbonate will be considered for registration, products containing high levels of sodium and bicarbonate are discouraged.
See also 'Sodium content'.
Products for oral administration containing more than 120 mg of sodium per maximum recommended daily dose should comply with the requirements of Therapeutic Goods Order No. 69 - General requirements for labels for medicines.
The sodium content of the formulation should be justified for products for oral administration with a recommended adult dosage that provides 23 mg (1 mmol) or more of sodium per dose.
Sodium salts - oral preparations for bowel cleansing
See 'Bowel cleansing oral preparations - sodium salts'
Soft gel capsules for sedation
Applications for registration of OTC medicines indicated for sedation and presented as soft gel capsules are strongly discouraged on safety grounds, as these products may be subject to abuse by injection, and may be rejected on the grounds of 'unacceptable presentation'.
See 'Antihistamines - use as hypnotics'
Sore throat treatments - antimicrobial
The indications for sore throat treatments (e.g. gargles, sprays and lozenges) containing antimicrobial agents should be restricted to symptomatic relief of sore throat.
Claims that the presence of an antimicrobial agent will reduce the severity or duration of a sore throat are not acceptable unless the sponsor provides appropriate clinical evidence of efficacy for the proposed formulation to substantiate the claim.
Alternatively, if the sponsor wishes to make unsubstantiated antimicrobial, antibacterial or antiseptic claims, the label should include a statement consistent with the following:
- The presence of the antibacterial/antimicrobial/antiseptic agent in this product has not been shown to have a beneficial effect on the severity or duration of a sore throat.
Clinical efficacy and safety data (see ARGOM Appendix 1 - Guideline on efficacy and safety aspects of OTC application) will be required to support the registration of any sore throat treatment containing an antimicrobial active ingredient that has not been included as an active ingredient in a product registered on the ARTG. Some examples of substances which have been included in products for relief of sore throats include cetylpyridinium chloride, amylmetacresol, dichlorobenzyl alcohol or benzyl alcohol in lozenges, and povidone iodine in throat gargles.
See also 'Anaesthetic lozenges'
See 'Decongestant products, oral'
Teething generally occurs in babies between approximately 6-24 months of age. While teething does not generally require medication, oral or topical analgesic products may be useful for relieving pain and discomfort associated with teething.
Inclusion of relief of pain and discomfort associated with teething in the indications of paediatric oral products containing paracetamol or ibuprofen is acceptable, provided the products comply with the requirements of the respective guidelines on 'Paracetamol' or 'Ibuprofen'.
Topical gel products containing choline salicylate 87 mg/g will be accepted for relief of pain associated with teething, without requiring provision of clinical efficacy or safety data.
Clinical efficacy and safety data will be required to support claims for relief of pain and/or discomfort associated with teething for products containing choline salicylate in any concentration other than 87 mg/g, and/or any other substances (e.g. local anaesthetics), alone or in combination.
See also 'Ibuprofen' and 'Paracetamol'
Products containing tryptophan will not be approved for indications such as insomnia, anxiety or other depressive illness in the absence of scientific evidence of efficacy and safety. Reports of interactions with antidepressants resulting in adverse effects are further reason for caution.