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.
4.6 Pregnancy and Lactation
Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that 0.5 – 07% of a single 60 mg dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours. has been corrected to: Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that 0.5 – 0.7% of a single 60 mg dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.
Pseudoephedrine is excreted in breast milk in small amounts but the effect of this on breast-fed infants is not known. It has been estimated that 0.5 – 0.7% of a single 60 mg dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours.
Section 4.2
Statement added –
when simple measures have failed to provide adequate relief. Do not use for more than 5 days without consulting your doctor or pharmacist. Do not exceed the stated dose.
Section 4.3
Not to be used in children under 6 years.
Consult a pharmacist or doctor before use in children aged 6-12 years.
Section 10
Changed to June 2009
To change the MAH from Pfizer Consumer Healthcare, Pottery Road, Dun Laoghaire, Co. Dublin to McNeil Healthcare (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland.