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Servier Laboratories Ireland Ltd
Block 2, West Pier Business Campus, Old Dunleary Road, Dun Laoghaire, Co. Dublin,
Telephone: +353 1 663 8110
Fax: +353 1 663 8120
Summary of Product Characteristics last updated on medicines.ie: 13/04/2012
SPC Protelos 2 g granules for oral suspension

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 13/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   30-Mar-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Changes to sections:
4.4 Special warnings and precautions for use
4.8 Undesirable effects
Updated on 29/11/2011 and displayed until 13/04/2012
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Date of revision of text on the SPC:   25-Nov-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):

change from:

Les Laboratoires Servier

22, rue Garnier

92200 Neuilly-sur-Seine

France

to

LES LABORATOIRES SERVIER

50, rue Carnot

92284 Suresnes cedex

France
Updated on 05/09/2011 and displayed until 29/11/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   18-Aug-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
$0In section 4.8 the following have been added:$0$0$0$0$0Psychiatric disorders:$0$0Insomnia (frequencyunknown)$0$0 $0$0Gastrointestinal disorders:$0$0dyspepsia (frequencyunknown)$0$0gastroeosophageal reflux(frequency unknown) $0$0constipation (frequencyunknown) $0$0flatulence (frequencyunknown)$0$0 $0$0Hepatobiliary disorders:$0$0hepatitis (frequencyunknown$0
Updated on 04/03/2011 and displayed until 05/09/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Addition of bone marrow failure (frequency unknown), eosinophilia (in association with hypersensitivity skin reaction) (frequency unknown) and lymphadenopathy (in association with hypersensitivity skin reaction) (frequency unknown).
Updated on 25/02/2011 and displayed until 04/03/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Further update of safety sections of the SPC (section 4.8) with the addition of the following adverse events reported during post-marketing experience :

  1. bone marrow failure (frequency unknown),
  2. eosinophilia (in association with hypersensitivity skin reaction) (frequency unknown)
  3. lymphadenopathy (in association with hypersensitivity skin reaction) (frequency unknown)

.
Updated on 13/09/2010 and displayed until 25/02/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 4.2: "Paediatric population" replaced "Use in children and adolescents"

                    "The safety and efficacy of PROTELOS in children aged below 18 years have not been established. No data are available." replaces "PROTELOS is not recommended for use in children and adolescents (below the age of 18) due to a lack of data on safety and efficacy.


Section4.6:    Pregnancy: "There are no data from the use of strontium ranelate in pregnant women." replaces "No clinical data on exposed pregnancies     are available for strontium ranelate" 

                    Breast-feeding: "Physico-chemical data suggest excretion of Strontium ranelate in human milk. PROTELOS should not be used during breast-                    feeding." replaced "Strontium is excreted in milk. Strontium ranelate should not be given to nursing women.
        
                    Fertility: "No effects were observed on males and females fertility in animal studies." was inserted.


Section 4.8: Undesirable effects: "Alopecia" has been entered under the "frequency unknown" area of the ADR table.




Section 5.1 Pharmacodynamic properties- "Paediatric population-The European Medicines Agency has waived the obligation to submit the results of studies with PROTELOS in all subsets of the paediatric population in osteoporosis (see section 4.2 for information on paediatric use)." has been inserted.

 

 

     "There are no data from the use of strontium ranelate in pregnant women." replaces "No clinical data on exposed pregnancies     are available for strontium ranelate"                     : "
Updated on 15/04/2010 and displayed until 13/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
pyrexia was added
Updated on 02/03/2010 and displayed until 15/04/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   22-Jan-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Pyrexia (in association with hypersensitivity skin reactions) has been added.

"Hepatobiliary disorders" in section 4.8 of the SPC has been added.

Skin and subcutaneous tissue disorders have been updated
Updated on 27/11/2009 and displayed until 02/03/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   23-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
This section now includes info from post-marketing studies- increase in serum transaminase and pyrexia are now listed in the undesirable effects section.
Updated on 02/09/2009 and displayed until 27/11/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jun-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Information on the following added:
toxic epidermal necrolysis

Respiratory, thoracic and mediastinal disorders
Frequency unknown: bronchial hyperreactivity
Updated on 19/03/2009 and displayed until 02/09/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.8 has been changed to report ADRs observed in post marketing experience: Peripheral odema and confusional state
Updated on 27/11/2007 and displayed until 19/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Update of the SPC to include re-wording of Special Warnings and Precautions for Use (section 4.4) and skin and subcutaneous disorders under Undesirable Effects (section 4.8).
 
Updated on 28/08/2007 and displayed until 27/11/2007
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   08/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Changes to sections 2, 4.2, 4.4 and 4.8.
Updated on 26/10/2004 and displayed until 28/08/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
  Strontium Ranelate