Ativan 1mg Tablets

  • Name:

    Ativan 1mg Tablets

  • Company:
    info
  • Active Ingredients:

    Lorazepam

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/01/19

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Summary of Product Characteristics last updated on medicines.ie: 25/1/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
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Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
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Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
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Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
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Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name Atorvastatin Pfizer 10 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 20 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 40 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name Atorvastatin Pfizer 80 mg Film Coated Tablets Active Ingredients Atorvastatin calcium trihydrate
Medicine Name BeneFIX Active Ingredients nonacog alfa
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1 - 0 of 231 items.Total: Infinity pages

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 25 January 2019 SmPC

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 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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 12 September 2017 SmPC

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 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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 PIL

Reasons for updating

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

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 SmPC

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 SmPC

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