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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: 24/08/2011
SPC PHYLLOCONTIN CONTINUS Tablets

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 24/08/2011 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-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 7

MA Holder is now

Mundipharma Pharamceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland

Section 8

PA number is now PA 1688/008/001
Updated on 09/05/2007 and displayed until 24/08/2011
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 1 updated to read name, strength and pharmaceutiacl form
Section 2 updated to include: for a full list of excipients, see 6.1
Section 4.2 updated with potential effects form chewing or crushing the tablets
Section 4.5 updated interactions
Section 4.8 updated undesirable effects
Section 4.9 added symptoms of overdose
Section 5.1 added pharmacotherapeutic group and ATC code
Section 6.5 updated to included: Not all pack sizes may be marketed
Section 6.6 updated to read: No special requirements
Section 10 date of revision of text updated.
Updated on 05/01/2006 and displayed until 09/05/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
Updated on 17/10/2005 and displayed until 05/01/2006
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Updated on 05/08/2005 and displayed until 17/10/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Updated on 18/05/2005 and displayed until 05/08/2005
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Updated on 24/06/2003 and displayed until 18/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Aminophylline Hydrate