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 4.2 “Posology and method of administration” is being amended in order to clarify the information to prescribers and to prevent the potential of abuse and overdose of fentanyl.
1. Section 4.3 “Contraindications” is being amended in order to: · strengthen the information related to the necessity for maintenance opioid treatment (with consequential changes to section 4.4 ‘Special warnings and precautions for use’ of the SmPC). · Contraindicate treatment of acute pain other than breakthrough pain (e.g. postoperative pain, headache, migraine). 2. Section 4.4 ‘Special warnings and precautions for use’ of the SmPC is being amended in order to update the information regarding risk of accidental exposure in children, with a consequential deletion of a very similar warning statement for accidental exposure of Actiq in children from section 6.6 “Special precautions for disposal”. 3. Section 4.8 ‘Undesirable effects’ of the SmPC is being amended, with the addition of “Tooth loss, dental caries, gingival recession”. This is also reflected in the updated section 4.4 “Special warnings and precautions for use”, where an additional warning on dental decay has been added at the end of the section.
· strengthen the information related to the necessity for maintenance opioid treatment (with consequential changes to section 4.4 ‘Special warnings and precautions for use’ of the SmPC). · Contraindicate treatment of acute pain other than breakthrough pain (e.g. postoperative pain, headache, migraine). 2. Section 4.4 ‘Special warnings and precautions for use’ of the SmPC is being amended in order to update the information regarding risk of accidental exposure in children, with a consequential deletion of a very similar warning statement for accidental exposure of Actiq in children from section 6.6 “Special precautions for disposal”. 3. Section 4.8 ‘Undesirable effects’ of the SmPC is being amended, with the addition of “Tooth loss, dental caries, gingival recession”. This is also reflected in the updated section 4.4 “Special warnings and precautions for use”, where an additional warning on dental decay has been added at the end of the section.
· Contraindicate treatment of acute pain other than breakthrough pain (e.g. postoperative pain, headache, migraine). 2. Section 4.4 ‘Special warnings and precautions for use’ of the SmPC is being amended in order to update the information regarding risk of accidental exposure in children, with a consequential deletion of a very similar warning statement for accidental exposure of Actiq in children from section 6.6 “Special precautions for disposal”. 3. Section 4.8 ‘Undesirable effects’ of the SmPC is being amended, with the addition of “Tooth loss, dental caries, gingival recession”. This is also reflected in the updated section 4.4 “Special warnings and precautions for use”, where an additional warning on dental decay has been added at the end of the section.
2. Section 4.4 ‘Special warnings and precautions for use’ of the SmPC is being amended in order to update the information regarding risk of accidental exposure in children, with a consequential deletion of a very similar warning statement for accidental exposure of Actiq in children from section 6.6 “Special precautions for disposal”. 3. Section 4.8 ‘Undesirable effects’ of the SmPC is being amended, with the addition of “Tooth loss, dental caries, gingival recession”. This is also reflected in the updated section 4.4 “Special warnings and precautions for use”, where an additional warning on dental decay has been added at the end of the section.
3. Section 4.8 ‘Undesirable effects’ of the SmPC is being amended, with the addition of “Tooth loss, dental caries, gingival recession”. This is also reflected in the updated section 4.4 “Special warnings and precautions for use”, where an additional warning on dental decay has been added at the end of the section.
Update to Section 5.3: Given that new non-clinical data from carcinogenicity and developmental/reproductive studies have become available, section 5.3 “Preclinical safety data” of the SmPC is being updated accordingly.
Typographical /QRD format changes to section 2 & 4.8: Slight changes to section 2 the qualitative & quantitative composition which does not change the meaning of the text.; typographical/QRD format changes in section 4.8 as per the updated Medora classification (the content in section 4.8 has not been changed).
Changes were made to:
Section 2 additional information on excipients such as dextrates, glucose, sucrose ethanol and propylene glycol
Section 4.4 additional statement on sugar intolerances
Section 4.5 additional statement on interactions with azole antifungals
Section 4.8 reclassified undesirable effects under MedDRA system headings
Section 6.1 provide E numbers and reclassify some terminology
Section 6.4 remove statement about keeping Actiq stored away from children
Section 6.6 add store out of reach and site of children, and advise on the disposal of used and unused medicine
Section 9 update renewal date
section 10 update revision of text date