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.
Warning added:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose.
Section 5.1
ATC code added
Section 7
New PA holder: McNeil Healthcare (Ireland) Ltd, Airton Road, Tallaght, Dublin 24
Section 8
New PA number: PA 823/53/1
Change to section 4.8 – Undesirable effects
Update to MedDRA and addition of ‘Very rare: Loss of consciousness, depressed level of consciousness’
Change to section 10 – Date of revision of text
August 2008
Change to section 2 – quantitative and qualitative composition
Update QRD
Change to section 4.1 – Therapeutic Indications
Change to section 4.2 – Posology and |Method of Administration
Change to section 4.3 – Contra-indications
Update QRD Lactose
Change to section 4.4 – Special Warnings and Precautions for Use
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
Change to section 4.6 – Pregnancy and Lactation
Change to section 4.7 - Effects on Ability to Drive and Use Machines
Update to MedDRA and Loss of consciousness, depressed level of consciousness,
Change to section 5.1 - Pharmacodynamic properties
ATC code
Change to section 5.2 - Pharmacokinetic properties
Update to QRD
Change to section 5.3 - Preclinical Safety Data
Change to section 6.1 – List of Excipients
Change to section 6.6 – Instructions for use, handling and disposal