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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 12/09/2017
SPC Ativan 1mg Tablets

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.

Updated on 12/09/2017 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Sep-2017
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: update as per CDS with concomitant use of venzodiazepines and opioids (section 4.3, 4.4, 4.5, 4.8) and QRD.
Updated on 07/03/2016 and displayed until 12/09/2017
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Improved electronic presentation
  • Change to improve clarity and readability
Date of revision of text on the SPC:   01-Feb-2016
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 09/10/2013 and displayed until 07/03/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   01-Sep-2013
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 18/07/2011 and displayed until 09/10/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
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 11/02/2010 and displayed until 18/07/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Jan-2010
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 – Addition of the following text into section 4.2 of the SPC ‘Ativan tablets are for oral administration only’.

Section 10 - date of revision updated
Updated on 18/05/2009 and displayed until 11/02/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   21-Apr-2009
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 3: addition of wording stating ‘That the tablet can be divided into equal halves’.
Updated on 16/10/2008 and displayed until 18/05/2009
Reasons for adding or 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
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

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

 

Section 10 – updated
Updated on 06/02/2008 and displayed until 16/10/2008
Reasons for adding or 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
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

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 03/08/2006 and displayed until 06/02/2008
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Lorazepam