ADIZEM-XL Capsules
- Name:
ADIZEM-XL Capsules
- Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/11/20

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

Company Products
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 November 2020 SPC
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
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4: Addition of excipient warning, correction of dosage form, spelling correction.
Section 4.5: Spelling corrections and removal of reference to products no longer available.
Section 4.8: Spelling corrections and updated wording for reporting adverse events.
Section 6.6: Correction of section heading.
Updated on 25 November 2020 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 2 - excipient warnings
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Free text change information supplied by the pharmaceutical company
Section 2: Rewording to improve clarity; Corrected dosage form; Spelling corrections and removal of reference to products no longer available; Addition of information about sodium content of the capsules.
Section 3: Rewording to improve clarity
Section 4: Spelling corrections and rewording to improve clarity; Updated reporting details.
Section 5: Rewording to improve clarity.
Section 6: Re-formatted.
Updated on 23 May 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 23 May 2017 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- 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
Updated on 28 March 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 28 March 2017 PIL
Reasons for updating
- Change to Section 1 - what the product is
- 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 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 2 - excipient warnings
- Change to section 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 8 November 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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
Deleted: Excipients also contains soya lecithin, trace quantaties per capsule
Section 4.3 Contra-indications
Deleted: Peanut or soya allergies
Section 6.1 List of excipients
Deleted: Soya lecithin
2-ethoxyethanol
Dimeticone changed to Simeticone
Updated on 7 November 2011 PIL
Reasons for updating
- Change of inactive ingredient
- Change of contraindications
- Change to date of revision
Updated on 26 October 2011 SPC
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
Now Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8. Marketing Authorisation Number
Now reads PA 1688/1/4-7
Updated on 25 October 2011 PIL
Reasons for updating
- Change of licence holder
Updated on 21 July 2011 SPC
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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- 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
Updated on 23 June 2011 PIL
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 7 June 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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
"Excipients : also contians soya lecithin, trace quantities per capsule" has been added
Section 6.1 Capsule shell
"Iron oxide black (E172) (180 mg capsule only)" has been added
"Iron oxide yellow (E172) (240 mg capsule only)" has been added
Updated on 17 November 2010 PIL
Reasons for updating
- Change of inactive ingredient
- Change to storage instructions
- Change to further information section
Updated on 8 June 2010 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 May 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 10 February 2010 PIL
Reasons for updating
- Improved electronic presentation
Updated on 25 January 2010 SPC
Reasons for updating
- Change to section 4.3 - Contraindications
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
4.6 Change of warning from 'Not recommended' in pregnancy to a contraindication in pregnant women or women of child bearing potential. Use in nursing mothers remains not recommended.
4.7 Advice changed from 'None know' to include text informing patients that some side effects of the tablets (such as dizziness) may impair their ability to drive.
4.8 Frequency of adverse events catergorised as common or uncommon. Adverse event 'rash' deleted.
Updated on 8 December 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 4 March 2009 SPC
Reasons for updating
- Correction of spelling/typing errors
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 January 2009 PIL
Reasons for updating
- Change of contraindications
- Change to date of revision
- Change to side-effects
- Change to drug interactions
Updated on 5 January 2009 SPC
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
- 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
Updated on 18 August 2008 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Updated on 2 March 2007 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 2 March 2007 SPC
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 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
Updated on 2 June 2005 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 May 2005 SPC
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 4.9 - Overdose
- Change to section 5 - Pharmacological properties
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- 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)
Updated on 25 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)