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Servier Laboratories Limited
Gallions, Wexham Springs, Framewood Road, Wexham, Slough, SL3 6RJ
Telephone: +44 (0)1753 662744
Fax: +44 (0)1753 663456
Medical Information Direct Line: +44 (0)1753 666409
Medical Information e-mail: medical.information@uk.netgrs.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 30/11/2011
SPC Protelos

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 30/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to Protelos SPC

 

 

Section 7 (Marketing Authorisation Holder)

Change of address of Les Laboratoires Servier:

50, rue Carnot

92284 Suresnes cedex

France

 

 

Section 10 (Date of revision of the text)

09/2011
Updated on 31/08/2011 and displayed until 30/11/2011
Reasons for adding or updating:
  • 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-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.8 (amendments in red)

System Organ Class (SOC)

Frequency category

Adverse   Reaction

Percentage of Patients Experiencing the adverse reaction

Treatment

Strontium ranelate

(n=3352)

Placebo

(n=3317)

Psychiatric disorders

 

 

Frequency unknown:a

 

 

Confusional state

-

-

Insomnia

-

-

Gastrointestinal disorders

 

 

Common:

 

 

Nausea

7.1%

4.6%

Diarrhoea

7.0%

5.0%

Loose stools

1.0%

0.2%

Frequency unknown:a

 

 

Vomiting

-

-

Abdominal pain

-

-

Oral mucosal irritation (stomatitis and/or mouth ulceration)

-

-

Gastrooesophageal reflux

-

-

Dyspepsia

-

-

Constipation

-

-

Flatulence

-

-

Hepatobiliary disorders

 

 

Frequency unknown:a

 

 

Serum transaminase increased (in association with hypersensitivity skin reactions)

-

-

Hepatitis

-

-

Section 10
08/2011
Updated on 04/03/2011 and displayed until 31/08/2011
Reasons for adding or updating:
  • 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-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Changes to Protelos SPC

 

 

Section 4.8 (Undesirable effects):

Bone marrow failure, Eosinophilia (in association with hypersensivity skin reactions) and Lymphadenopathy (in association with hypersensivity skin reactions) have been added as Blood and Lymphatic disorders (Frequency unknown)  


Section 10 (Date of revision of the text): February 2011

 
Updated on 10/09/2010 and displayed until 04/03/2011
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
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Added in Section 4.2 (Posology and Method of Administration):
Paediatric Population The safety and efficacy of PROTELOS in children aged below 18 years have not been established.  No safety data are available.

Rewording of Section 4.6 (Fertility, Pregnancy and Lactation) to comply with Guideline.

In Section 4.8 (undesirable effects) Alopecia has been added.  Creatine kinase has been changed to Creatine phosphokinase (CPK)

Added in Section 5.1:
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).

Date of revision of the text amended to August 2010.
Updated on 08/02/2010 and displayed until 10/09/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 4.8, the following highlighted sentences have been added:

Hepatobiliary disorders

Frequency unknown:a

Serum transaminase increased (in association with hypersensitivity skin reactions)

Skin and subcutaneous tissue disorders

Common:

Dermatitis

Eczema

Frequency unknown:a

Hypersensitivity skin reactions (rash, pruritus, urticaria, angioedema)

Severe hypersensitivity syndromes including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS (see Section 4.4)

General disorders and administration site conditions

Frequency unknown:a

Peripheral oedema

Pyrexia (in association with hypersensitivity skin reactions)

 

Sections 9 and 10 have also been amended
Updated on 17/11/2009 and displayed until 08/02/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
  • Removal of Black Triangle
Date of revision of text on the SPC:   01-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The black triangle has been removed

- In section 2: each sachet also contains 20mg of aspartame

- In section 4.1: the therapeutic indication has been updated

- In section 4.2: the following sections have been updated
* Renal impairment section
* Use in children and adolescents section
* Method of administration section

- In section 4.4: titles have been added.
Skin reactions section has been added

- In section 4.5: one paragraph has moved on the top.

- In section 4.6: Strontium ranelate must not be given to nursing women

- In section 4.8: all the section has been updated and a table has been introduced

- In section 6.3: a sentence has been added in addition of the 3 years of shelf life.
Updated on 14/04/2009 and displayed until 17/11/2009
Reasons for adding or updating:
  • 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:   06-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
- In section 4.8 (undesirable effects), this wording has been added :

General disorders and administration site conditions

Frequency unknown: peripheral oedema

Psychiatric disorders

Frequency unknown: confusional state

- In section 10, the date of revision of the text has been updated : 6 March 2009
Updated on 23/01/2008 and displayed until 14/04/2009
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:   01/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 (Special warnings and precautions for use)
  • A warning has been added about severe hypersensitivity syndromes, including in particular, drug rash with eosinophilia and systemic syndromes (DRESS)
 
Section 4.8 (Undesirable effects)
  • Under gastrointestinal disorders "very rare 1/10,000" has been replaced with "frequency unknown".
  • Under section Skin and subcutaneous tissue disorders, addition of "frequency unknown - Steven-Johnson syndrome and DRESS" added.
  • A new subheading has been added "Musculoskeletal and connective tissue disorders: Frequency unknown: musculoskeletal pain including muscle spasm, myalgia, bone pain, arthralgia and pain in extremity."
Updated on 02/05/2007 and displayed until 23/01/2008
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 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

- Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of aspartame “Excipient: also contains 20 mg of aspartame (E951).”

Rewording of a template sentence: “For a full list of excipients, see section 6.1.”

 

- Section 4.2 Posology and method of administration

Modification of the phrasing concerning Use in children and adolescents

"PROTELOS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy."

 

 

- Section 4.4 Special warnings and precautions for use replaces Special warnings and special precautions for use

Addition of the following sentence "Treatment with PROTELOS should be discontinued in case of serious allergic reaction."

 

- Section 4.8 Undesirable effects

Update of all the section.

Follow up is now up to 60 months (instead of 50 months).

All percentages have been updated.

The following information has been added:

"The following events have been reported in post-marketing experience:

Gastrointestinal disorders

Very rare (<1/10,000): vomiting, abdominal pain, oral mucosal irritation including stomatitis and/or mouth ulceration

Skin and subcutaneous tissue disorders

Very rare (<1/10,000): hypersensitivity reactions including rash, pruritus, urticaria, angioedema"

 

- Section 5.3 Preclinical safety data

Pre-clinical data replaced by "Non-clinical"

 

- Section 6.6 Previously called Instructions for use and handling, now called "Special precautions for disposal"

 

- 9. Date of first authorisation/renewal of the authorisation

Format change

Updated on 01/05/2007 and displayed until 02/05/2007
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
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company

- Section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Addition of aspartame “Excipient: also contains 20 mg of aspartame (E951).”

Rewording of a template sentence: “For a full list of excipients, see section 6.1.”

 

- Section 4.2 Posology and method of administration

Modification of the phrasing concerning Use in children and adolescents

"PROTELOS is not recommended for use in children and adolescents due to a lack of data on safety and efficacy."

 

 

- Section 4.4 Special warnings and precautions for use replaces Special warnings and special precautions for use

Addition of the following sentence "Treatment with PROTELOS should be discontinued in case of serious allergic reaction."

 

- Section 4.8 Undesirable effects

Update of all the section.

Follow up is now up to 60 months (instead of 50 months).

All percentages have been updated.

The following information has been added:

"The following events have been reported in post-marketing experience:

Gastrointestinal disorders

Very rare (<1/10,000): vomiting, abdominal pain, oral mucosal irritation including stomatitis and/or mouth ulceration

Skin and subcutaneous tissue disorders

Very rare (<1/10,000): hypersensitivity reactions including rash, pruritus, urticaria, angioedema"

 

- Section 5.3 Preclinical safety data

Pre-clinical data replaced by "Non-clinical"

 

- Section 6.6 Previously called Instructions for use and handling, now called "Special precautions for disposal"

 

- 9. Date of first authorisation/renewal of the authorisation

Format change

Updated on 24/11/2004 and displayed until 01/05/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  strontium ranelate