Summary of Product Characteristics
last updated on the eMC:
30/03/2010
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 30/03/2010 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 4.5 - 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: 23-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2- Formatting Changes
Section 4.5- Formatting Changes
Section 4.8- Update
Section 10- Update
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Updated on 18/03/2008 and displayed until 30/03/2010
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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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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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1) Update section 4.4 and 4.5 of the SPC with regards to SSRI/SNRi asnd serotonin syndrome (GDS 20);
2) Update Section 4.8 of the SPC with regards to events associated with triptan sensations reported in clinical trials (GDS 20).
3) To update section 4.8 with the inclusion of Angina as a very rare cardiac adverse event (GDS20).
4) to update section 4.8 FUM variation (GDS21)
5) To update section 4.4 relating to Medication overuse Headache (MOH) (GDS21)
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Updated on 06/02/2008 and displayed until 18/03/2008
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.3: The concomitant administration of ergotamine, or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist is contraindicated (see Section 4.5 Interaction With Other Medicinal Products).
Section 4.5: There are limited data on an interaction with preparations containing ergotamine or another triptan/5-HT1 receptor agonist. The increased risk of coronary vasospasm is a theoretical possibility and concomitant administration is contraindicated (see section 4.3).
The period of time that should elapse between the use of sumatriptan and ergotamine-containing preparations or another triptan/5-HT1 receptor agonist is not known. This will also depend on the doses and types of products used. The effects may be additive. It is advised to wait at least 24 hours following the use of ergotamine-containing preparations or another triptan/5-HT1 receptor agonist before administering sumatriptan. Conversely, it is advised to wait at least 6 hours following use of sumatriptan before administering an ergotamine-containing product and at least 24 hours before administering another triptan/5-HT1 receptor agonist.
Section 10: Updated to 09/01/2008
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Updated on 27/06/2007 and displayed until 06/02/2008
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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 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 4.6 - Pregnancy and Lactation
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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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: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Minor text changes to sections 2, 4.2, 4.3, 4.5 and 4.6
Section 4.2: Added lack of suitability for Sumatriptan in children under 12
Section 4.4: Added that Sumatriptan should not be given to patients with risk factors for ischaemic heart disease without prior cardiovascular evaluation
Section 4.7: Added "No studies have been performed on the ability to drive or use machines"
Section 4.8: Combined undesireable effects from pre-clinical and post authorisation data
Section 5.1: Added information relating to reactions in animals
Section 5.1: Refined statement on reduced efficacy in adolescents
Section 5.3: Added statement on toxicity
Section 10: Now 13/12/2006
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Updated on 24/05/2006 and displayed until 27/06/2007
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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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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 05/08/2004 and displayed until 24/05/2006
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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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Updated on 27/06/2003 and displayed until 05/08/2004
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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