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.
4.8 Undesirable effects
· Updated the format of the frequency categorisation · Added angiodema as a rare side effect
· Added angiodema as a rare side effect
Renewal: 4.4 Removal of wording re self-administration and pregnancy, change of nomenclature of Pneumacystis carinii pneumonia, timeline of 4 months for liver function and HBV tests added, 4.5 Removal of statement re use in combination with zalcitabine, change of nomenclature of Pneumacystis carinii pneumonia, 4.6 Removed statements re cross-placenta movement of lamivudine and zidovudine, carcinogenicity and mutagenicity and fertility, 4.8 Minor editorial changes, 5.1 Classification updated
Section 4.4 Addition of following:
Osteonecrosis: Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Section 4.8, addition of following:
Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term combined antiretroviral exposure (cART). The frequency of which is unknown (see section 4.4).