Updated on 15/11/2011 and displayed until Current
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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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| 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 08/10/2010 and displayed until 15/11/2011
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Change to section 4.2 - Posology and method of administration
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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 |
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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 08/10/2010
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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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| 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 10947/0006
10 Date of Revision of the Text
2010-05-01
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Updated on 17/03/2010 and displayed until 20/05/2010
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Change to section 6. 3 - Shelf Life
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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-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 6.3
Shelf‑life
5 years. This was previously 3 years.
Section 10
Date of revision has also been revised.
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Updated on 12/01/2009 and displayed until 17/03/2010
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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) hair loss has been added. The following text has also been added:
"Hepatobiliary disorders:
serious hepatic disorders. In most of the reported cases the patients were also treated with other products known to cause hepatic disorders."
Section 10 Date of Revision of Text has been updated to the following:
2008-09-19
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Updated on 15/09/2008 and displayed until 12/01/2009
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Change to section 2 - Qualitative and quantitative composition
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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| Date of revision of text on the SPC: 13-Aug-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
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| 2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium (equivalent to 32.5 mg
risedronic acid).
Excipients: Each film-coated tablet contains lactose.
For a full list of excipients, see section 6.1.
4.4 Special warnings and precautions for use
Bisphosphonates have been associated with oesophagitis, gastritis, oesophageal
ulcerations and gastroduodenal ulcerations. Thus, caution should be used:
If risedronate is given to patients with active or recent oesophageal or upper
gastrointestinal problems.
Prescribers should emphasise to patients the importance of paying attention to the
dosing instructions and be alert to any signs and symptoms of possible oesophageal
reaction. The patients should be instructed to seek timely medical attention if they
develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing,
retrosternal pain or new/worsened heartburn.
4.8 Undesirable effects
In a 2-year study in men with osteoporosis, the overall safety and tolerability were
similar between the treatment and the placebo groups. Adverse experiences were
consistent with those previously observed in women.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
3 December 2002/19 July 2007
10 DATE OF REVISION OF THE TEXT
13 August 2007
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Updated on 18/05/2007 and displayed until 15/09/2008
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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: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.4 Special warnings and special precautions for use
Addition of osteonecrosis of the jaw
4.8 Undesirable effects
Addition of osteonecrosis of the jaw, iritis and uveitis text
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Updated on 13/12/2004 and displayed until 22/02/2005
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Improved Electronic Presentation
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Updated on 13/12/2004 and displayed until 13/12/2004
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SPC Submitted in error
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Updated on 10/12/2004 and displayed until 13/12/2004
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Change to section 4.8 - Undesirable Effects
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Pending awaiting re-submission
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Updated on 12/02/2003 and displayed until 10/12/2004
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Addition of Black Triangle
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Updated on 03/02/2003 and displayed until 12/02/2003
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