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 4.4 - Changes to Cardiovascular disorders section. Addition of section regarding MI and alteration to section regarding VTE. Addition to section regarding patients with renal/hepatic impairment. Section 4.5 - "Non-enzymatic hydrolysis suggests that the potential for drug-drug interactions with thalidomide is low." added to first paragraph. Section 4.6 - title altered to "Fertility, pregnancy and lactation". Addition of "hypersensitivity, hearing impaired or deafness, renal failure, myocardial infarction and worsening of Parkinson’s disease symptoms" to adverse reaction experienced in post marketing surveillance. Section 4.8 - Pancytopenia also added. Venous and arterial thromboembolic events section altered: "An increased risk of venous thromboembolism (such as deep vein thrombosis and pulmonary embolism) and arterial thromboembolism (such as myocardial infarction and cerebrovascular event) has been reported in patients treated with thalidomide (see section 4.4)." 5.1 - ATC code: L04AX 02. Previously read: LO4AX 5.2 - Sentence added: "Thalidomide is metabolised almost exclusively by non-enzymatic hydrolysis." Second paragraph added under Elimination. Additional information added to Hepatic and Renal insufficiency section. 10 – Date of revision 04/05/2011
10 – Date of revision 04/05/2011