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.
Change to section 10 - Date of revision of the text
June 2010
Change to section 4.8 - Undesirable effects
Updated into MedRA format.
Change to section 7 – Marketing Authorisation Holder
Change of address
Change to section 10 – Date of revision of text
August 2008
Change to section 4.2 – Posology and Method of Administration
Information added regarding application and removal of patches.
Change to section 4.4 – Special Warnings and Precautions for Use
Information added to sections “Drug dependence and potential for abuse” and “Patients with fever/external heat”.
Change to section 4.6 – Pregnancy and Lactation
Information added regarding use in pregnancy, childbirth and breast feeding.
Change to section 4.8 – Undesirable effects
Information added regarding neonatal withdrawal syndrome.
Change to section 5.3 - Preclinical Safety Data
Information added regarding in vitro and in vivo studies.
July 2008
Change to section 9 – Date of Renewal of Authorisation
Change to section 4.2 – Posology and |Method of Administration
Addition of paediatric Posology
Addition of paediatric information. Wording included on accidental ingestion.
Addition of AEs in children and adolescents
Change to section 5.1 - Pharmacodynamic properties
Addition of Clinical Trial data on paediatric patients
Change to section 5.2 - Pharmacokinetic properties
Addition of paediatric PK information
Change to section 6.6 – Instructions for use, handling and disposal
Addition of wording informing there is no safety and PK data available for other application sites.
Further details added for application site, use in opioid tolerant patients, use in opioid-naive patients, withdrawal symptoms.
Change to section 4.3 – Contra-indications
- Change in wording regarding respiratory depression.
- Addition of paragraph for "Opioid-naïve and not opioid-tolerant states"
- Addition of text regarding potential for abuse, misuse or addiction of product
- Addition of paragraph regarding "Interactions with CYP3A4 Inhibitors"
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
- Further details added for concomitant use with CNS depressants, potent CYP3A4 inhibitors.
- Addition of paragraph regarding "Monoamine Oxidase Inhibitors
- Information added for Clinical Trials and Postmarketing Experience.
May 2007
4.4
Special Warnings and Precautions for Use
Text added advising that patients should not be changed from one brand of fentanyl transdermal patches to another without specific counselling on the change from their healthcare professionals.
10.
DATE OF REVISION OF THE TEXT
November 2006
1.
Addition of 12 microgram/hour information to the SmPC
2.
4.2
Posology and method of administration
5.2
Pharmacokinetic properties
6.1
List of excipients
8.
MARKETING AUTHORISATION NUMBER(S)
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
September 2006