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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: 08/11/2011
SPC ADIZEM-XL 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 08/11/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2 Qualatitative and Quantitative Composition

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 26/10/2011 and displayed until 08/11/2011
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-Oct-2011
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

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 21/07/2011 and displayed until 26/10/2011
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
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
Sections 4.3 Contra-indications, 4.4 Speical warnings and special precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.6 Pregnancy and lactation, 4.7 Effects on ability to drive and use machines, Section 4.8 Undersibale effects - have all been  re-written
Updated on 07/06/2011 and displayed until 21/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
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 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 25/01/2010 and displayed until 07/06/2011
Reasons for adding or 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
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
4.3: Addition of contraindications in patients with peanut or soya allergies

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 04/03/2009 and displayed until 25/01/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/01/2009 and displayed until 04/03/2009
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 Isolated cases of liver transaminases paragraph added as per CCDS
Section 4.5 - sectrion rewritten in line with CCDS
Section 4.8 rewritten in line with CCDS and classified by body system
Updated on 18/08/2008 and displayed until 05/01/2009
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.3 - Shelife life changed to two years
Section 10 - Revision date updated
Updated on 02/03/2007 and displayed until 18/08/2008
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
Sections 4.2 and 4.5 updated to include warnings and interactions with alcohol
Updated on 16/05/2005 and displayed until 02/03/2007
Reasons for adding or 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
Updated on 18/06/2003 and displayed until 16/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Diltiazem Hydrochloride