| 2 – Addition of sentence “Excipient(s): Lactose monohydrate”
Amended sentence “For excipients see 6.1” amended to “For a full list of excipients see 6.1”
4.2 - Section updated and information regarding use in children and adolescents revised.
4.3 - Statement regarding pregnancy and lactation updated and contra-indication in children under 16 years added.
4.4 - The following changes were made:
- Addition of statement “Meloxicam is not appropriate for the treatment of patients requiring relief from acute pain.”
- Update of statement regarding patients receiving concomitant medications which could increase the risk of ulceration or bleeding
- Addition of statement under the subsection Cardiovascular and cerebrovascular effects - “Clinical monitoring of blood pressure for patients at risk is recommended at baseline and especially during treatment initiation with meloxicam.”
- Update of the wording relating to renal failure and sodium, potassium and water retention
- Addition of statement “Mobic 15 mg tablets contain lactose”
4.5 - Update to wording relating to NSAIDS, corticosteroids and cyclosporin. Addition of further information relating to anticoagulants and heparin.
4.6 - Statement on lactation has been revised from “administration should therefore be avoided in women who are breastfeeding” to “Administration therefore is not recommended in women who are breastfeeding”
4.8 - Frequencies of side effects updated.
Minor changes to sections:
1 - “Tablet” amended to “tablets”
5.2 – Minor wording change to the section “Hepatic/renal Insufficiency”
6.6 - Update to heading and addition of statement “Any unused product or waste material should be disposed of in accordance with local requirements”
10 - Date of revision updated to 30/04/2009.
|
