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.
MAH address change in section 7
PA number change section 8
Date of revision of text
Section 1 – update to trade name
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 - Lorazepam may have abuse potential especially in patients with a history of drug and/or alcohol abuse.
Section 4.4 – Addition of text - There is evidence that tolerance develops to the sedative effects of benzodiazepines.
Section 4.5 – Addition of text - Not recommended: Concomitant intake with alcohol
Section 4.5 – Addition of text - There have been reports of marked sedation, excessive salivation, and ataxia when lorazepam and clozapine have been given concomitantly.
Concurrent administration of lorazepam with sodium valproate may result in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with sodium valproate.
Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.
Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.
Section 4.6 – Rewording of text in first paragraph
Section 4.6 – Addiation of information regarding breast feeding
Section 4.8 – Addition of full list of Adverse reactions divided into frequency
Section 4.9 –
Addition of text - In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs.
Addition of information on Lorazepam glucuronide, the inactive metabolite, may be highly dialysable.
Addition of text - The physician should be aware of a risk of seizure in association with flumenazil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.
Section 6.4 – Addition of ‘in order to protect from light’
Section 1 - update to trade name
Section 2 - addition of excipient information
Section 4.5 - addition of 'Not recommended: Concomitant intake with alcohol'
Section 6.2 - addition of text reffering to section 4.2
Section 6.3 - rewording of section
Section 6.4 - addition of text 'in order to protect from light'
Section 6.6 - addition of text reffering to section 4.2
Section 9 - addition of date of last renewal
Section 10 - update to date of last revision
Change to section 3
update