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Adizem-SR Capsules *
Pharmacy Only: Prescription

Updated on 13 June 2022

File name

62a7571dd30c9.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 2, section 4.3 and section 4.4.

Updated on 25 November 2020

File name

spc_1606293081.pdf

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

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

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

File name

pil_1606292584.pdf

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

File name

Proposed_PIL_clean_Prolonged_Release_Capsules_English_Adizem-SR.pdf

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 SPC for new product

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

Updated on 30 May 2017

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

$0Section 2:$0$0‘For a full list of excipients,’ hasbeen changed to ‘For the full list of excipients,’ in line with the QRD template.$0$0 $0$0Section 4.1:$0$0Thedescription of hypertension has been updated to include ‘mild to moderate’.$0$0Thestatement ‘ADIZEM-SR capsules areindicated for use in adults only’.$0$0 $0$0Section 4.2:$0$0Theinformation regarding route of administration has been moved to the end of thissection, and information about swallowing the capsules whole has been added.$0$0Thesubheadings ‘Posology’ and ‘Elderly and patients with impaired renalfunction’ have been added.$0$0Informationregarding use in paediatric populations has been added.$0$0 $0$0Section 4.3:$0$0This sectionhas been updated in line with the QRD template/SPC Guideline and a spellingerror has been corrected.$0$0 $0$0Section 4.5:$0$0‘Diltiazem may increase serum levels ofphenytoin’ has been added.$0$0 $0$0Section 4.6:$0$0Thesubheadings ‘Pregnancy’ and ‘Breast Feeding’ have been added.$0$0 $0$0Section 4.8:$0$0‘Hypersensitivity’ has been added under ‘Immune system disorders’ with afrequency of uncommon.$0$0Gastrointestinaldisorder has been removed.$0$0‘Pruritus’ has been added under ‘Skin and subcutaneous tissue disorders’ witha frequency of common.$0$0Informationabout the reporting of suspected adverse reactions has been added at the end ofthis section.$0$0 $0$0Section 4.9:$0$0Informationabout the clinical effects of overdose, conduction disturbances, and the treatmentof overdose has been updated.$0$0 $0$0Section 5.1:$0$0Informationabout the mechanism of action of diltiazem has been added.$0$0 $0$0Section 5.2:$0$0Informationregarding Absorption, Biotransformation, Elimination andLinearity/non-linearity has been added under the relevant subheadings.$0$0 $0$0Section 5.3:$0$0Informationregarding Genotoxicity and carcinogenicity, and Reproductive and developmentaltoxicity has been added under the relevant subheadings.$0$0 $0$0Section 10:$0$0The date ofrevision has been updated to 16 May 2017.$0

Updated on 30 January 2012

File name

PIL_8207_340.pdf

Reasons for updating

  • New PIL for new product

Updated on 30 January 2012

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

            Section 7 Marketing Authorisation Holder is now:

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

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation 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
  • 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

Sections 4.3 Contraindications
              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

Reasons for updating

  • Change to date of revision
  • Change due to user-testing of patient information

Updated on 30 November 2010

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

Section 2
"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

Reasons for updating

  • Change to storage instructions
  • Change to further information section

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 4.6 - 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 08 December 2009

Reasons for updating

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

Updated on 06 January 2009

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change of contraindications

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

Section 4.4 acute porphyria statement added
Section 4.5 updated in line with CCDS (complete rewrite)
Section 4.8 - updated in line with CCDS and clasified with body system

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

Section 4.2 and 4.5 updated to include the warning and interaction not to take with alcohol

Updated on 02 March 2007

Reasons for updating

  • Change to information about drinking alcohol

Updated on 27 May 2005

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

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 July 2003

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

Reasons for updating

  • New SPC for medicines.ie

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