ADIZEM-XL Capsules * Pharmacy Only: Prescription
Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 13 June 2022
File name
62a759f197ee2.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.6 - Addition of sub-section on fertility
Section 4.9 - Addition of hyperglycaemia as a recognised complication of overdose.
Minor editorial updates to section 4.3.
Updated on 13 April 2022
File name
pil_1649858508.pdf
Reasons for updating
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Deletion of UK manufacturer following Brexit.
Updated on 25 November 2020
File name
spc_1606293799.pdf
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
File name
pil_1606293556.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 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
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
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
File name
PIL_8347_247.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2017
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 08 November 2011
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 07 November 2011
Reasons for updating
- Change of inactive ingredient
- Change of contraindications
- Change to date of revision
Updated on 26 October 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 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
Reasons for updating
- Change of licence holder
Updated on 21 July 2011
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
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 07 June 2011
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
Reasons for updating
- Change of inactive ingredient
- Change to storage instructions
- Change to further information section
Updated on 08 June 2010
Reasons for updating
- Correction of spelling/typing errors
Updated on 18 May 2010
Reasons for updating
- Improved electronic presentation
Updated on 10 February 2010
Reasons for updating
- Improved electronic presentation
Updated on 25 January 2010
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 08 December 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 04 March 2009
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 06 January 2009
Reasons for updating
- Change of contraindications
- Change to date of revision
- Change to side-effects
- Change to drug interactions
Updated on 05 January 2009
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
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 02 March 2007
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 02 March 2007
Reasons for updating
- Change to information about drinking alcohol
Updated on 02 June 2005
Reasons for updating
- Correction of spelling/typing errors
Updated on 16 May 2005
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
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)