Adizem-SR Capsules
- Name:
Adizem-SR 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
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
- 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
Free text change information supplied by the pharmaceutical company
Section 4.2: Correction of headings.
Section 4.4: Addition of excipient warning, spelling correction, removal of reference to Adizem tablets.
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 - interactions with other medicines, food or drink
- 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 looks like and pack contents
Free text change information supplied by the pharmaceutical company
Section 2: Rewording to improve clarity; Spelling corrections and removal of reference to products no longer available; Addition of information about sodium content of the capsules
Section 3: Spelling corrections and rewording to improve clarity
Section 4: Spelling corrections and rewording to improve clarity; updated reporting information.
Section 5: Rewording to improve clarity.
Section 6: Re-formatted.
Updated on 10 July 2018 PIL
Reasons for updating
- Change to Section 1 - what the product is
- 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 - 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
Updated on 30 May 2017
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 30 May 2017 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.5 - 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 5.1 - Pharmacodynamic properties
- 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 30 January 2012 PIL
Reasons for updating
- New PIL for new product
Updated on 30 January 2012 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
Mundipharma Pharmaceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8 Marketing Authorisation Numbers are now:
PA 1688/001/001-003
Updated on 30 January 2012 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation 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
- 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
4.4 Special warnings and precuations for use
4.5 Interaction with other medicincal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
4.7 Effects on abitlity to drive and use machines
4.8 Undesirable effects
Have all been rewritten.
Updated on 20 July 2011 PIL
Reasons for updating
- Change to date of revision
- Change due to user-testing of patient information
Updated on 30 November 2010 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
"Excipients: also contains sucrose 18.26 mg per capsule (90 mg only)"
"Excipients: also contains sucrose 24.35 mg per capsule (120 mg only)"
"Excipients: also contains sucrose 26.53mg per capsule (180 mg only)" has been added.
Section 6.1
"Poly (o-ethyl) cellulose" has been deleted
"1-hexadecanol" has been deleted
"Cetyl alcohol" has been added
Updated on 17 November 2010 PIL
Reasons for updating
- Change to storage instructions
- Change to further information section
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 4.6 - 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
· Section 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.
· Section 4.7: Advice changed from ‘None known’ to include text informing patients that some side effects of the tablets (such as dizziness) may impair their ability to drive.
· Section 4.8: Frequency of adverse events categorised 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 6 January 2009 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change of contraindications
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 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 27 May 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 18 May 2005 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 4.8 - 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 be renewed (B)
Updated on 19 August 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 17 July 2003 SPC
Reasons for updating
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
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)