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Ativan 1mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Lorazepam

    *Additional information is available within the SPC or upon request to the company

Updated on 21 September 2023

File name

Reg PIL AT Tab 11_0 IE.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 22 March 2023

File name

Reg SPC AT91 tablet IE.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 March 2023

File name

Reg PIL ATTab 101 IE.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 13 February 2023

File name

DEC202081015_Reg SPC AT 8_0 tablet IE.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 December 2020

File name

DEC202081015_Reg SPC AT 8_0 tablet IE.pdf

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 03 December 2020

File name

DEC202081015_Reg PIL AT Tab 9_0.pdf

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

File name

DEC201903413_clean Reg SPC AT 7_1 tablet IE.pdf

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

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 03 January 2019

File name

DEC201900220_Reg PIL AT Tab 8_1 IE clean.pdf

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

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

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

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 11 September 2017

File name

PIL_11160_279.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 September 2017

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 07 March 2016

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 04 March 2016

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

Reasons for updating

  • Change of manufacturer
  • Change to date of revision

Updated on 09 October 2013

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 02 October 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 04 May 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 December 2011

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

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

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to MA holder contact details

Updated on 08 March 2011

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 11 February 2010

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 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 May 2009

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

Section 3: addition of wording stating ‘That the tablet can be divided into equal halves’.

Updated on 16 October 2008

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

 

Section 10 – updated

Updated on 16 October 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 14 February 2008

Reasons for updating

  • Improved electronic presentation
  • Change to date of revision
  • Change to warnings or special precautions for use

Updated on 06 February 2008

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 03 August 2006

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 03 August 2006

Reasons for updating

  • New PIL for new product