Ativan 1mg Tablets
- Name:
Ativan 1mg Tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/20
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, 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.
Updated on 3 December 2020 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 December 2020 PIL
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 25 January 2019 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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The SPC has been updated as follows: update to section 4.2 and 4.4 of SPC with information regarding a risk of falls for the elderly. |
Updated on 3 January 2019 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to information for healthcare professionals
Updated on 12 September 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 12 September 2017 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 11 September 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 11 September 2017 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product looks like and pack contents
- Change of distributor details
Updated on 7 March 2016 SPC
Reasons for updating
- Correction of spelling/typing errors
- Improved electronic presentation
- Change to improve clarity and readability
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
1) SPC has been updated in line with the latest QRD template and HPRA contact details.Updated on 4 March 2016 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to instructions about missed dose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
Updated on 18 December 2014 PIL
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 9 October 2013 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and Method of Administration –Addition of text to patients with renal or hepatic impairment
Section 4.4 Special Warnings and Special Precautions for Use – addition of wording on renal function and hepatic insufficiency
Updated on 2 October 2013 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Change to dosage and administration
Updated on 4 May 2012 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 21 December 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to dosage and administration
- Change to improve clarity and readability
- Change due to user-testing of patient information
Updated on 18 July 2011 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 7 - MAH address change
Section 8 - PA number change
Section 10 - Revision of text
Updated on 14 July 2011 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
- Change to MA holder contact details
Updated on 8 March 2011 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 11 February 2010 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 10 - date of revision updated
Updated on 18 May 2009 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 16 October 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 16 October 2008 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
Updated on 14 February 2008 PIL
Reasons for updating
- Improved electronic presentation
- Change to date of revision
- Change to warnings or special precautions for use
Updated on 6 February 2008 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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
Tablet
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)
Updated on 3 August 2006 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 3 August 2006 PIL
Reasons for updating
- New PIL for new product