Summary of Product Characteristics
last updated on the eMC:
12/01/2009
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 12/01/2009 and displayed until Current
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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) 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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Reasons for adding or updating:
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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 |
Free-text change information supplied by the pharmaceutical company
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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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Reasons for adding or updating:
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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 22/02/2005 and displayed until 18/05/2007
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 13/12/2004 and displayed until 22/02/2005
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Reasons for adding or updating:
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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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Reasons for adding or updating:
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Addition of Black Triangle
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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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Reasons for adding or updating:
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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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Reasons for adding or updating:
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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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Reasons for adding or updating:
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