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 – rewording of text for withdrawal and rebound phemonemon
Section 4.4 – addition of text for severe anaphylactic/anaphylactoid reactions and angioedema.
Section 4.4 - Addition of text regarding withdrawal symptoms
Section 4.4 - Addition of text - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Section 4.8 – addition of angiodema, impaired attention/concentration, balance disorder
Section 4.9 – addition of information on Lorazepam glucuronide, the inactive metabolite, may be highly dialysable.
Section 5.1 – addition of Pharmacological class, Therapeutic class and ATC code
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lorazepam 1mg.
Excipient: lactose monohydrate 67.65mg per tablet.(additional text)
For excipients, see 6.1
For a full list of excipients, see section 6.1.(additional text) 3. PHARMACEUTICAL FORM
Round, flat, white, bevelled-edged tablets impressed with “1.0” on one side, and a breakbar on the other. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.(additional text)
6.5 Nature and Contents of Container
1. PVC blister packs of 30 and 100 tablets.
2. Strips of aluminium foil with PE-film strips of 10, 20 or 100 tablets.
3. Amber glass bottles with screw caps of 100 or 500 tablets.
Not all pack sizes may be marketed. (additional text)
10. DATE OF (PARTIAL) REVISION OF THE TEXT
19 June 2006
09 November 2007 (addional text)