Lipitor 10 mg film-coated tablets

  • Name:

    Lipitor 10 mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Atorvastatin calcium trihydrate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 19/11/19

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Summary of Product Characteristics last updated on medicines.ie: 19/11/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
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 BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 227 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 19 November 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 19 November 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
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 31 July 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 31 July 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC: Updated as follows:

 Section 4.8- updated to include “Muscle rapture” under rare side effects on PRAC recommendation (All strengths).

Updated on 13 May 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 May 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Sections 4.8, 10 has been updated as per the CMDh endorsed PRAC recommendation to include lupus related events.

Updated on 11 January 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 11 January 2019 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The following changes to the labelling have been approved.  Please refer to attached copy/copies of labelling documentation for full details.

The SPC has been updated as follows: Sections 4.2, 4.3, 4.4, 4.5, 5.1, 5.2 Change in line with PRAC recommendations (drug drug interactions of atorvastatin with HCV protease inhibitor combinations elbasvir/grazoprevir and glecaprevir/pibrentasvir) and section 4.8 ADR reporting

The PIL has been updated to reflect the SPC changes. See PIL tick list for sections updated.

Updated on 28 November 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 30 August 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.5: a correction to the drug interaction study duration for atorvastatin with colestipol presented in ‘Table 1: Effect of co-administered medicinal products on the pharmacokinetics of atorvastatin’.

Section 5.1: an editorial update to the footnote for Table 3

Updated on 17 February 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 February 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 1, 2, 3, 4.6, 5.2, 5.3, 6.4, 6.6 – administrative update

Section 4.2, 4.8, 5.1 - paediatric data update

Section 4.4 – paediatric data update,  CMDh wording for fusidic acid interaction

Section 4.5 - CMDh wording for fusidic acid interaction, harmonised presentation of the drug interaction data

Updated on 16 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 February 2017 PIL

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 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 4 January 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

updates to sections:

2, 3, 4.2, 4.3, 4.4, 4.5, 4.8, 5.2, 6.1. 9 and 10 - to bring in line with QRD template

Updated on 22 December 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision
  • Change to appearance of the medicine
  • Change to name of manufacturer

Updated on 8 April 2015 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows

Section 4.4: Special warnings and precautions for use

Sub-heading: Concomitant treatment with other medicinal products

Update to wording on ‘immune-mediated necrotizing myopathy (IMNM)’ to bring it in line with the PRAC wording.

Section 4.8. Undesirable effects

Sub-heading: Musculoskeletal and connective tissue disorders

Addition of reference to section 4.4.

Updated on 30 March 2015 PIL

Reasons for updating

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

Updated on 29 May 2014 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to sections 4.4, 4.5 & 4.8

Updated on 20 May 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 7 November 2013 SmPC

Reasons for updating

  • 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
  • Improved electronic presentation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to sections 4.4, 4.5, 4.8

Updated on 1 November 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 5 July 2012 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC (update to section 4.4 & 4.8 with wording on statins and diabetes)

Updated on 2 July 2012 PIL

Reasons for updating

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

Updated on 11 January 2012 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SmPC update to section 7, 8 and 10.

Updated on 9 January 2012 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 3 January 2012 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC update to section 6.5

Updated on 21 December 2011 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 2 September 2011 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update to section 6.5

Updated on 31 August 2011 PIL

Reasons for updating

  • Introduction of new pack/pack size

Updated on 10 May 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Correction of typo

Updated on 10 May 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 21 March 2011 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 10 March 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • 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 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 5.4 - Radiation dosimetry
  • Change to section 6 - Pharmaceutical particulars
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated to harmonise the text according to the article 30 referral. This has resulted in a rewrite of the full SPC. As part of the module 3 harmonisation we have switched from the heritage oval tablets to the small round tablets

Updated on 19 October 2010 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company


SmPC Sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2 and 10 have changed

Updated on 15 October 2010 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to date of revision
  • Change to dosage and administration

Updated on 4 June 2010 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to warnings and precautions, side effects and a correction to a typo in section 4.5.

Updated on 1 June 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 13 May 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 19 April 2010 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  1. 
  2. Section 6.1 list of excipients has been updated to reflect the change

    Updated on 8 April 2010 PIL

    Reasons for updating

    • Change of inactive ingredient

    Updated on 4 January 2010 PIL

    Reasons for updating

    • Change of manufacturer

    Updated on 10 September 2009 PIL

    Reasons for updating

    • Change due to user-testing of patient information

    Updated on 23 January 2009 SmPC

    Reasons for updating

    • Improved electronic presentation

    Legal category: Product subject to medical prescription which may be renewed (B)

    Updated on 6 January 2009 SmPC

    Reasons for updating

    • Improved electronic presentation

    Legal category: Product subject to medical prescription which may be renewed (B)

    Updated on 22 December 2008 PIL

    Reasons for updating

    • Change to drug interactions

    Updated on 19 December 2008 SmPC

    Reasons for updating

    • 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

    Legal category: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    4.4.            Special warnings and special precautions for use

    Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy (see Section 4.5)

     

    4.5.            Interactions with other medicinal products and other forms of interaction

     

    Erythromycin, clarithromycin: Erythromycin and clarithromycin are known.At atorvastatin doses exceeding 40mg, clinical monitoring, including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the clarithromycin treatment course is completed and CPK has returned to baseline values.

     

    Itraconazole: Concomitant administration At atorvastatin doses exceeding 40 mg, clinical monitoring including CPK measurement, of these patients is recommended. If these levels are significantly elevated (>5 times ULN), treatment with atorvastatin should be stopped (see Section 4.4), until the itraconazole treatment course is completed and CPK has returned to baseline values.

     

    Fusidic Acid: Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe muscle problems such as rhabdomyolysis have been reported in post-marketing experience with this combination. Patients should be closely monitored, including measurement of serum creatine phosphokinase (CPK) and temporary suspension of atorvastatin treatment may be appropriate.

    Updated on 21 August 2008 PIL

    Reasons for updating

    • Change of trade or active ingredient name
    • Change to date of revision

    Updated on 21 August 2008 SmPC

    Reasons for updating

    • Change to section 1 - Name of medicinal product

    Legal category: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Section1: The name of the product has been updated to include the pharmaceutical form.

    Updated on 18 December 2007 SmPC

    Reasons for updating

    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 5.1 - Pharmacodynamic properties
    • 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 be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Section 4.4 and 5.1 – additional of SPARCL data and information

    Section 4.4 and 4.5 – inclusion of information about drug-drug interactions with atorvastatin

    Section 4.8 – Update Adverse Drug Reaction information after the completion of the MRP renewal

    Updated on 18 December 2007 PIL

    Reasons for updating

    • Change to warnings or special precautions for use
    • Change to side-effects
    • Change to drug interactions
    • Change to date of revision

    Updated on 24 January 2007 PIL

    Reasons for updating

    • Change to, or new use for medicine

    Updated on 16 January 2007 SmPC

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • Change to section 4.2 - Posology and method of administration
    • Change to section 5.1 - Pharmacodynamic properties

    Legal category: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

     Sections:

    4.1       - update to existing primary prevention indication

    4.2       - addition of dosing information relating to primary prevention studies

    5.1       - addition of CARDS primary prevention study description

                - modification of existing ASCOT study description wording

                - addition of MIRACL acute coronary syndrome study description

    Updated on 31 October 2006 SmPC

    Reasons for updating

    • Change to section 4.2 - Posology and method of administration

    Legal category: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

     

    Update to section 4.2 of the SmPC for Lipitor Tablets (all strengths) to include the paediatric dosing information below:

     Paediatric use
     
    Paediatric use should only be carried out by specialists.  Experience in paediatrics is limited to a small number of  patients (age 4 - 17 years) with severe dyslipidaemias, such as homozygous familial hypercholesterolaemia. The recommended starting dose in this population is 10 mg of atorvastatin per day. The dose may be increased to 80 mg daily, according to the response and tolerability. Developmental safety data in this population have not been evaluated

    Updated on 1 September 2006 PIL

    Reasons for updating

    • Improved electronic presentation

    Updated on 14 August 2006 SmPC

    Reasons for updating

    • Change to section 2 - Qualitative and quantitative composition
    • Change to section 6.4 - Special precautions for storage
    • Change to section 4.4 - Special warnings and precautions for use
    • Change to section 4.8 - Undesirable effects
    • Change to section 4.1 - Therapeutic indications
    • 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 4.6 - Pregnancy and lactation

    Legal category: Product subject to medical prescription which may be renewed (B)

    Free text change information supplied by the pharmaceutical company

    Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 6. 4 - Special Precautions for Storage, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.8 - Undesirable Effects, Change to section 4.1 - Therapeutic Indications, Change to section 4.2 - Posology and Method of Administration, Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction, Change to section 4.6 - Pregnancy and Lactation

    Updated on 20 September 2005 PIL

    Reasons for updating

    • Correction of spelling/typing errors

    Updated on 16 September 2005 SmPC

    Reasons for updating

    • Correction of spelling/typing errors

    Legal category: Product subject to medical prescription which may be renewed (B)

    Updated on 6 July 2005 SmPC

    Reasons for updating

    • Change to section 4.1 - Therapeutic indications
    • Change to section 5.1 - Pharmacodynamic properties

    Legal category: Product subject to medical prescription which may be renewed (B)

    Updated on 4 July 2005 PIL

    Reasons for updating

    • Change to how the medicine works

    Updated on 16 September 2004 PIL

    Reasons for updating

    • New PIL for medicines.ie

    Updated on 24 March 2004 SmPC

    Reasons for updating

    • Change to section 4.8 - Undesirable effects
    • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
    • Addition of joint SPC covering all presentations

    Legal category: Product subject to medical prescription which may be renewed (B)