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.
New text added in bold:
25 mg Tablets
Each tablet contains 25 mg Atenolol.
50 mg Tablets
Each tablet contains 50 mg Atenolol.
100 mg Tablets
Each tablet contains 100 mg Atenolol.
Each 100 mg tablet contains 0.8 mg Sunset Yellow Lake (E110).
For a full list of excipients, see section 6.1.
New sentence added to end of section 3:
The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Date changed to 13 August 2007:
Tenormin 25 mg Film-coated Tablets
14 August 1992/13 August 2007
Tenormin 50 mg Film-coated Tablets
04 February 1976/13 August 2007
Tenormin 100 mg Film-coated Tablets
17 May 1978/13 August 2007
Section 10
- Reference to intravenous Tenormin has been removed.
- The paragraphs on ‘Early’ and ‘Late’ Intervention after Myocardial Infarction have been merged into one paragraph.
- Paragraphs on the withdrawal and discontinuation of therapy before surgery have been added.
The following warnings have been added:
- Tenormin ‘may mask the symptoms of hypoglycaemia, in particular, tachycardia’.
- Tenormin ‘should only be given to patients with psoriasis after careful consideration, as psoriasis may be aggravated’.
- ‘Since Tenormin is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2’.
- ‘As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly’.
- Drug class headings have been added to each paragraph.
- Neonatal bradycardia has been added.
- Frequencies have been added to the undesired events table.