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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 30/01/2012
SPC Adizem-SR Capsules

When a pharmaceutical company changes an SPC or PIL, 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 30/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2012
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 21/07/2011 and displayed until 30/01/2012
Reasons for adding or 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
Date of revision of text on the SPC:   01-Apr-2011
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 30/11/2010 and displayed until 21/07/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Nov-2010
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 25/01/2010 and displayed until 30/11/2010
Reasons for adding or 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
Date of revision of text on the SPC:   01-Nov-2009
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 05/01/2009 and displayed until 25/01/2010
Reasons for adding or 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
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

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 02/03/2007 and displayed until 05/01/2009
Reasons for adding or 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
Date of revision of text on the SPC:   11/2006
Legal Category:   prescription only

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 18/05/2005 and displayed until 02/03/2007
Reasons for adding or 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
Updated on 17/07/2003 and displayed until 18/05/2005
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Updated on 18/06/2003 and displayed until 17/07/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Diltiazem Hydrochloride