Summary of Product Characteristics
last updated on the eMC:
11/05/2011
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 11/05/2011 and displayed until Current
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Reasons for adding or updating:
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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: 18-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Revision date - 18 March 2011
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Updated on 29/09/2010 and displayed until 11/05/2011
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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 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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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: 21-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections:
4.2 safety update
4.4 safety update
4.5 safety update
4.7 safety update
4.8 safety update
10 date change
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Updated on 20/01/2009 and displayed until 29/09/2010
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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: 30-Dec-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 - (Special Warnings) of the SPC to include wording relating to medication over-use headache (MOH)
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Updated on 15/07/2008 and displayed until 20/01/2009
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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 5.1 - Pharmacodynamic Properties
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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: 24-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.2 - Children (under 12 years of age)
Sumatriptan tablets are not recommended for use in children below 12 as sumatriptan tablets have not been studied in children.
Adolescents (12 to 17 years of age)
The efficacy of sumatriptan tablets in adolescents could not be demonstrated in the clinical studies performed in this age group. Therefore the use in adolescent is not recommended (see section 5.1 Pharmacodynamic Properties).
Section 5.1 - A number of placebo-controlled clinical studies assessed the safety and efficacy of oral sumatriptan in approximately 600 adolescent migraineurs aged 12 - 17 years. These studies failed to demonstrate relevant differences in headache relief at 2 hours between placebo and any sumatriptan dose.
Section 10 - 24 June 2008
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Updated on 18/04/2008 and displayed until 15/07/2008
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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: 31-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8 -
Addition of the following beneath "Vascular Disorders":
"Respiratory, Thoracic and Mediastinal Disorders
Common Dyspnoea."
Section 10 - updated date of approval
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Updated on 18/03/2008 and displayed until 18/04/2008
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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To update Section 3 pharmaceutical form of the SPC, with a consequential change to section 4.2 posology and method of administration.
To update section 4.8 Undesirable effects to include sensory disturbances and angina
To update section 4.3 contraindications, 4.4 Special warnings and precautions, and 4.5 Interactions with other medicinal products and other forms of interaction.
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Updated on 24/05/2006 and displayed until 18/03/2008
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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 10 (date of (partial) revision of the text
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| Date of revision of text on the SPC: 11/05/06 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
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Updated on 15/03/2006 and displayed until 24/05/2006
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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 5.1 - Pharmacodynamic Properties
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Updated on 24/01/2006 and displayed until 15/03/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 20/01/2006 and displayed until 24/01/2006
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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