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

Sections 9 and 10 have also been amended

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

• A warning has been added about severe hypersensitivity syndromes, including in particular, drug rash with eosinophilia and systemic syndromes (DRESS)

• 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."

- 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

- 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