Xanax Tablets 250 micrograms

  • Name:

    Xanax Tablets 250 micrograms

  • Company:
    info
  • Active Ingredients:

    Alprazolam

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 12/10/18

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Summary of Product Characteristics last updated on medicines.ie: 27/2/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

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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
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
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
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
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 27 February 2019 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Section 5.3 Preclinical safety data is updated to include text related to neurotoxic effects of anesthetic and sedation drugs used in young children and pregnant women.

Updated on 12 October 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 12 October 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

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:

  • Section 2 Addition of excipient with known effect
  • Section 4.4 Addition of warning
  • Section 4.5 Addition of rug interaction text related to benzodiazepine/opioid interaction

Sections 4.2, 4.7, 5.3 and 6.5: QRD updates

Updated on 23 May 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 May 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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:

·         Section 4.4: Warning added for elderly patients that Benzodiazepines and related products should be used with caution due to the risk of sedation and / or musculoskeletal weakness that can promote falls, often with serious consequences in this population.

 

Sections 2, 4.2, 4.3, 4.4, 4.6, 4.7, 6.5 and 6.6: updated in line with QRD v9.1

Updated on 23 May 2016 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

·         Section 4.4: Warning added for elderly patients that Benzodiazepines and related products should be used with caution due to the risk of sedation and / or musculoskeletal weakness that can promote falls, often with serious consequences in this population.

 

Sections 2, 4.2, 4.3, 4.4, 4.6, 4.7, 6.5 and 6.6: updated in line with QRD v9.1

Updated on 19 May 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 December 2014 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Section 4.8:     Revision of the ADRs and frequencies table to align with the CDS

                        Update to include HPRA details for reporting of suspected adverse reactions.

Section 6.6:    Revision of section title in line with QRD

Updated on 2 December 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Section 4.8:     Revision of the ADRs and frequencies table to align with the CDS

                        Update to include HPRA details for reporting of suspected adverse reactions.

Section 6.6:    Revision of section title in line with QRD

Updated on 20 January 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

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

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.2, 4.4, 4.5, 4.7, 4.8 & 5.1 

Updated on 20 January 2014 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Updates to Sections 4.2, 4.4, 4.5, 4.7, 4.8 & 5.1 

Updated on 31 May 2012 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

4.2: additional info on discontinuation and use in paediatric patients.

4.3: formatting change

4.4: formatting and layout changes, additional info on paediatric use, tolerance, discontinuation, hypomania, dependence

4.5: further clarification re known interactions

4.6: new information re pregnancy and lactation

4.8: addition of 2 side effects and explanation re frequencies

4.9: formatting and layout change, no new info

5.3: addition of preclinical safety data s not present until now

6.6: change of heading

Updated on 31 May 2012 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

4.2: additional info on discontinuation and use in paediatric patients.

4.3: formatting change

4.4: formatting and layout changes, additional info on paediatric use, tolerance, discontinuation, hypomania, dependence

4.5: further clarification re known interactions

4.6: new information re pregnancy and lactation

4.8: addition of 2 side effects and explanation re frequencies

4.9: formatting and layout change, no new info

5.3: addition of preclinical safety data s not present until now

6.6: change of heading

Updated on 8 May 2012 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

SPC: PL number, revision date and MA holder name have been updated to reflect Change of ownership

Updated on 8 May 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

SPC: PL number, revision date and MA holder name have been updated to reflect Change of ownership

Updated on 17 October 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company


SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 17 October 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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


SmPC change of the name of MA holder from Pharmacia Ireland Limited to Pharmacia Ireland

Updated on 19 November 2010 PIL

Reasons for updating

  • Change to section 6.3 - Shelf life

Free text change information supplied by the pharmaceutical company

Section 6.3 shelf life (changed from 5 years to 3 years)

Updated on 19 November 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

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

Free text change information supplied by the pharmaceutical company

Section 6.3 shelf life (changed from 5 years to 3 years)

Updated on 26 February 2008 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

 

2.2 – addition of word “Excipients”under qualitative and quantitative composition

3.0 – addition of scoreline statement under each strength of the tablet

6.4 – deletion of bottle pack

6.5 - deletion of glass bottle and metal screw cap   

 

Updated on 26 February 2008 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

 

2.2 – addition of word “Excipients”under qualitative and quantitative composition

3.0 – addition of scoreline statement under each strength of the tablet

6.4 – deletion of bottle pack

6.5 - deletion of glass bottle and metal screw cap   

 

Updated on 11 September 2006 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling

Updated on 11 September 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling

Updated on 1 September 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

 
  • Section 2 – to include the quantity of lactose monohydrate
  • Section 4.2 – a caution has been added
  • Section 4.3 – hypersensitivity updated to include any component of the formulation
  • Section 4.4 – additional symptoms of dependence added, the duration of treatment  updated to include discontinuation of the product and specific patient  groups  updated.
  • Section 4.5 – interactions updated based on data currently available.
  • Section 4.6 – updated to include Xanax
  • Section 4.7 – updated to include the effects of alcohol.
  • Section 4.8 – undesirable effects updated.
  • Section 4.9 – overdosage updated.
  • Section 6.6 – Sub heading updated to include precautions of use and disposal.

Updated on 1 September 2006 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

 
  • Section 2 – to include the quantity of lactose monohydrate
  • Section 4.2 – a caution has been added
  • Section 4.3 – hypersensitivity updated to include any component of the formulation
  • Section 4.4 – additional symptoms of dependence added, the duration of treatment  updated to include discontinuation of the product and specific patient  groups  updated.
  • Section 4.5 – interactions updated based on data currently available.
  • Section 4.6 – updated to include Xanax
  • Section 4.7 – updated to include the effects of alcohol.
  • Section 4.8 – undesirable effects updated.
  • Section 4.9 – overdosage updated.
  • Section 6.6 – Sub heading updated to include precautions of use and disposal.

Updated on 2 August 2006 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

 
 
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling

Updated on 2 August 2006 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling

Free text change information supplied by the pharmaceutical company

 
 
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.2 - Posology and Method of Administration, Change to section 4.3 - Contra-indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation, Change to section 4.7 - Effects on Ability to Drive and Use Machines, Change to section 4.8 - Undesirable Effects, Change to section 4.9 - Overdose, Change to section 6. 6 - Instruction for Use/Handling

Updated on 7 April 2006 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Updated on 7 April 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 26 May 2005 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 26 May 2005 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Updated on 6 August 2004 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 6 August 2004 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 7 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 7 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie