Promensil Menopause (Pharmacare Laboratories Pty Ltd)
Product Name
Promensil Menopause
Sponsor
Date of review outcome
Date of publication
Mar-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims related to 'with menopause', 'during menopause' and 'throughout menopause' were not substantiated by the sponsor. Claims related to mild anxiety, night sweats, moodiness, mood swings and symptoms of menopause were also not supported at the recommended dosage of 40 mg/day. Additionally, the medicine may not work as expected in relation to claims associated with vitality.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims related to 'with menopause', 'during menopause' and 'throughout menopause'. The evidence was not sufficient as the subjects included in the clinical studies were post-menopausal women only. Claims related to mild anxiety, night sweats, moodiness, mood swings and symptoms of menopause were also not supported at the recommended dosage of 40 mg/day. The dosage of active ingredient in the clinical studies provided as evidence was greater than the recommended dosage for the medicine.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor removed claims related to 'with menopause', 'during menopause' and 'throughout menopause' from the label, website and ARTG record. The sponsor removed the claim 'vitality' from the label. The sponsor amended the dosage on the label to 2 tablets per day and amended the dosage on the ARTG record.