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Organon Laboratories Limited
(Merck Sharp & Dohme Ireland (Human Health) Limited), P.O. Box 2857, Drynarn Road, Swords, Co Dublin, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 06/08/2009
SPC Implanon

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 06/08/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • 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
Date of revision of text on the SPC:   31-Jan-2008
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
 Changes made to SPC :

• Section 2 “Qualitative and quantitative Composition”
    -    addition of wording " approximately" 60-70µg/day
    -    addition of wording "a full list" of excipients

• Section 4.2.1 “How to use Implanon? Pregnancy should be excluded before insertion of Implanon. ”
    - deleted "organised by Organon" and replaced with " by the company supplying Implanon"

• Section 4.2.3“ When to insert Implanon?”
    -     addition of wording "See section 4.6 Pregnancy and lactation"

• Section 4.2.5 “How to replace Implanon”
    -     At point 8, deleted wording  "48 hours" and replaced with "24 hours"

• Section 4.4.4 “Changes in the vaginal bleeding pattern”
    -     Rewording of the paragraph

• Section 4.5 “Interaction with other medicinal products and other forms of interaction”
 Sub heading 4.5.1 "Interactions"
    -     addition of  word "nevirapine"

• Section 4.8 “Undesirable effects”
-     Rewording of the paragraph e.g bleeding patterns and clinical trial information.
-     deletion of word "decreased" from the MedDRA table from the Body system : "metabolism and nutrion disorder"under the heading "common"

• Section 10 “Date of Revision of the text
    -    date of  revision of text updated
Updated on 04/01/2008 and displayed until 06/08/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 - update to instructions for insertion and removal of Implanon 
Section 4.8 - addition of an undesirable effect
Section 10 - date of revision updated
Updated on 04/09/2006 and displayed until 04/01/2008
Reasons for adding or 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 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Details updated in all sub-sections
Section 4.4 - Additional warning
Section 4.8 - Revision of table of undesirable effects
Section 6.4 - text revised
Section 10 - Revision dated updated
Updated on 18/02/2005 and displayed until 04/09/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 29/04/2004 and displayed until 18/02/2005
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 4.3 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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 19/08/2003 and displayed until 29/04/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/06/2003 and displayed until 19/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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