Summary of Product Characteristics
last updated on the eMC:
20/01/2009
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 20/01/2009 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: 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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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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Change to section 4.2 - Posology and method of administration
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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 16/04/2008 and displayed until 15/07/2008
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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-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
Update date of approval.
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Updated on 31/03/2008 and displayed until 16/04/2008
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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 4.4 - 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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Section 4.3 - The concomitant administration of ergotamine or derivatives of ergotamine (including methysergide) or any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist with sumatriptan is contraindicated. (see section 4.5)
Section 4.4 - There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of a selective serotonin reuptake inhibitor (SSRI) and sumatriptan. Serotonin syndrome has been reported following concomitant treatment with triptans and serotonin noradrenaline reuptake inhibitors (SNRIs). If concomitant treatment with sumatriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised.
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.There have been rare post-marketing reports describing patients with serotonin syndrome (including altered mental status, autonomic instability and neuromuscular abnormalities) following the use of SSRIs and sumatriptan. Serotonin syndrome has also been reported following concomitant treatment with triptans and SNRIs (see 4.4 Special Warnings and Precautions for Use).
Section 4.8 - whole section
Section 10 - Date of (Partial) Revision of Text 13/02/2008
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Updated on 24/05/2006 and displayed until 31/03/2008
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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 06/03/2006 and displayed until 24/05/2006
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Change to section 4.2 - Posology and Method of Administration
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Updated on 24/01/2006 and displayed until 06/03/2006
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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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Change to section 4.8 - Undesirable Effects
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 18/02/2005 and displayed until 20/01/2006
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 06/11/2003 and displayed until 18/02/2005
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 10/03/2003 and displayed until 06/11/2003
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Change to section 7 - Marketing Authorisation Holder
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Updated on 10/08/2001 and displayed until 10/03/2003
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Change to section 4.4 - Special Warnings and Precautions for Use
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Updated on 03/04/2001 and displayed until 10/08/2001
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Updated on 27/01/2000 and displayed until 03/04/2001
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Updated on 06/09/1999 and displayed until 27/01/2000
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