When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Details of Changes
4.6
Previous Wording
Available preclinical studies as well as clinical experience to date have shown no evidence of ill effects during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially
during the first trimester should be observed.
The drug is expected to enter breast milk and thus should be avoided during lactation.
Updated Wording
Bromhexine crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Clinical
experience to date has shown no evidence of harmful effects on the foetus during pregnancy. Nonetheless the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during
the first trimester, the use of BISOLVON is not recommended.
Bromhexine is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, BISOLVON is not recommended for use in nursing mothers.
4.8
Re-formatted using frequencies of undesirable effects.
4.9
Toxic effects following overdosage have never been reported, but animal studies suggest that these may include listlessness, anorexia, ataxia, cyanosis, pulmonary rales, hypothermia, diuresis, respiratory failure,
convulsion or coma. These should be treated symptomatically.
No specific overdose symptoms have been reported in man to date. Based on accidental
overdose and/or medication error reports the observed symptoms are consistent with the
known side effects of Bisolvon at recommended doses and may need symptomatic treatment.
For full list of excipients, see Section 6.1
3 years.
In-use: 12 months.
Unopened: 3 years.
In-use: Use within 12 months of opening bottle.
Section 4.3 has been updated to now state:
In case of rare hereditary conditions that may be incompatible with an excipient of the product (please refer to “Special warnings and precautions”) the use of this product is contraindicated.
Section 4.4 has been updated to include the following warning:
There have been very rare reports of severe skin lesions such as Stevens Johnson syndrome and Lyell’s syndrome in temporal association with the administration of mucolytic substances such as bromhexine. Mostly these could be explained by the severity of the underlying disease or concomitant medication. If new skin or mucosal lesions occur, medical advice should be sought immediately and treatment with bromhexine discontinued as a precaution.