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.
Section 4.3: “listed in Section 6.1” was added at the end of the proposed contraindication regarding excipients
Section 4.7: text changed to read Sudafed Decongestant Syrup has a negligible influence on the ability to drive and use machines
Section 5.1: Addition of the Pharmacotherapeutic Group and the ATC Code
Although pseudoephedrine has virtually no pressor effects in normotensive patients, Non-Drowsy SUDAFED Decongestant Syrup should be used with caution in patients taking antihypertensive agents, tricyclic antidepressants or other sympathomimetic agents (such as decongestants, appetite suppressants and amphetamine-like psychostimulants). The effects of a single dose of Non-Drowsy SUDAFED Decongestant Syrup on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment.
As with other sympathomimetic agents, Non-Drowsy SUDAFED Decongestant Syrup should be used with caution in patients with hypertension, heart disease, diabetes, hyperthyroidism, elevated intraocular pressure and prostatic enlargement.
There have been no specific studies of Non-Drowsy SUDAFED Decongestant Syrup in patients with hepatic and/or renal dysfunction. Caution should be exercised when using the product in the presence of severe hepatic impairment or moderate to severe renal impairment.
Patients with rare hereditary problems of fructose intolerance, glucose – galactose malabsorption or sucrase – isomaltase insuffiency should not take this medicine.
Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose.
Do not take with any other cough and cold medicine.
Consult a pharmacist or other healthcare professional before use in children aged 6 to 12 years.
Section 4.2: Removal of indication for use in children under 6 years of age. Addition of maximum daily dose information Addition of extra warnings:
Use only when simple measures have failed to provide adequate relief.
Use for more than 5 consecutive days is not recommended Section 4.3 CI in children under 6. Section 4.4 Children 2 to 6 years: Not more than 3 doses should be given in any 24 hours.
changed to:
Children 6 to 12 years: Not more than 3 doses should be given in any 24 hours.
Consult a pharmacist or other healthcare professional before use in children under 6 years. changed to:
Consult a pharmacist or other healthcare professional before use in children under 12 years.
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.