Summary of Product Characteristics
last updated on the eMC:
12/10/2011
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 12/10/2011 and displayed until Current
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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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| Date of revision of text on the SPC: 04-Oct-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.4: A warning for the excipient Sunset Yellow has been added. It already appears in the Patient Information Leaflet.
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Updated on 27/09/2011 and displayed until 12/10/2011
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 16-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The following points have been added to the beginning of Section 4.4 , Special warnings and precautions for use:
Physicians should consider patients receiving Restandol Testocaps for monitoring before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:
• digital rectal examination (DRE) of the prostate and PSA in men over the age of 45 years, to exclude prostate cancer (see section 4.3)
• hematocrit and hemoglobin to exclude polycythemia. In case of severe polycythemia, treatment with Restandol Testocaps should be stopped or the dosage should be lowered.
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Updated on 17/02/2010 and displayed until 27/09/2011
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 29-Jan-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change details
Section 4.6
Heading title changed from Pregnancy & Lactation to Fertility, Pregnancy and Lactation
Section 4.8 Undesirable effects
Addition of following text:
In a few patients diarrhoea and abdominal pain or discomfort have been reported during use of Restandol Testocaps.
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Updated on 29/02/2008 and displayed until 17/02/2010
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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 3 - Pharmaceutical form
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Change to section 4. Clinical Particulars
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Change to section 5 - Pharmacological Properties
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 6. 3 - Shelf Life
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 6. 6 - Instructions for use, handling and disposal
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 09/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Due to the extensive change to the SPC please follow the link below:
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Updated on 30/09/2002 and displayed until 29/02/2008
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Reasons for adding or updating:
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Change to section 1 - trade name
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Updated on 08/04/2002 and displayed until 30/09/2002
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Reasons for adding or updating:
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Change to section 10 (date of (partial) revision of the text
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