Summary of Product Characteristics
last updated on the eMC:
18/11/2011
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 18/11/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updates to Section 4.4, 4.2 and 4.8
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Updated on 11/10/2010 and displayed until 18/11/2011
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 10 date of revision of the text
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 10-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Bold text has been inluded in the SPC
Section 4.2
Children: Safety and efficacy of Actonel Combi has not been established in children and adolescents.
Paediatric population: Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy (also see section 5.1).
Section 4.8
Skin and subcutaneous tissue disorders:
hypersensitivity and skin reactions, including angioedema, generalised rash, urticaria and bullous skin reactions, some severe including isolated reports of Stevens-Johnson syndrome, and toxic epidermal necrolysis and and leukocytoclastic vasculitis.
hair loss.
Section 5.1
Paediatric population: The safety and efficacy of risedronate sodium is being investigated in an on-going study of paediatric patients aged 4 to less than 16 years with osteogenesis imperfecta. After completion of its one-year randomized, double-blind, placebo controlled phase, a statistically significant increase in lumbar spine BMD in the risedronate group versus placebo group was demonstrated; however an increased number of at least 1 new morphometric (identified by x-ray) vertebral fracture was found in the risedronate group compared to placebo. Overall, results do not support the use of risedronate sodium in paediatric patients with osteogenesis imperfecta.
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Updated on 20/05/2010 and displayed until 11/10/2010
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 01-May-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| 7 Marketing Authorisation Holder
Warner Chilcott UK Limited
Old Belfast Road,
Millbrook Road,
Larne,
County Antrim,
BT40 2SH
8 Marketing Authorisation Number(s)
PL 10947/0007
10 Date of Revision of the Text
2010-05-01
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Updated on 19/02/2009 and displayed until 20/05/2010
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 19-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.8 (undesirable effects) the following text has been added:
'hair loss'
'Hepatobiliary disorders: serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders.'
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Updated on 21/01/2008 and displayed until 19/02/2009
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Reasons for adding or updating:
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