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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 29/09/2010
SPC Imigran Injection, Subject

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 29/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Sep-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections:

4.2 safety update
4.4 safety update
4.5 saferty update
4.7 safety update
4.8 safety update
10 date change
Updated on 20/01/2009 and displayed until 29/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
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
Section 4.4 - (Special Warnings) of the SPC to include wording relating to medication over-use headache (MOH)
Updated on 15/07/2008 and displayed until 20/01/2009
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
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
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
Updated on 16/04/2008 and displayed until 15/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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
Section 4.8 

Addition of the following beneath "Vascular Disorders":

"Respiratory, Thoracic and Mediastinal Disorders

Common Dyspnoea."

Section 10

Update date of approval.
Updated on 31/03/2008 and displayed until 16/04/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
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
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
Updated on 24/05/2006 and displayed until 31/03/2008
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 (date of (partial) revision of the text
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

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 06/03/2006 and displayed until 24/05/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 24/01/2006 and displayed until 06/03/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/01/2006 and displayed until 24/01/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 18/02/2005 and displayed until 20/01/2006
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 06/11/2003 and displayed until 18/02/2005
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 10/03/2003 and displayed until 06/11/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 10/08/2001 and displayed until 10/03/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 03/04/2001 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 27/01/2000 and displayed until 03/04/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 27/01/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sumatriptan succinate