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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: 11/05/2010
SPC Naramig Tablets 2.5mg

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 11/05/2010 and displayed until Current
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 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   30-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - Clarification for contraindications.

Section 4.4 - Additional text included as requested by MHRA.

Section 4.5 -Additional text included as requested by MHRA.

Section 4.6 -Additional text included as requested by MHRA.

Section 4.8 -Additional text included as requested by MHRA.

Section 4.9 -Additional text included as requested by MHRA.

Section 10 - Variation approval date inserted.
Updated on 31/10/2008 and displayed until 11/05/2010
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
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - Addition of statements regarding concomitant use of sumatriptan and 5HT1 agonists

Section 4.4 - Addition of information regarding serotonin syndrome

Section 4.5 - Addition of statements regarding concomitant use of sumatriptan and 5HT1 agonists and addition of information regarding serotonin syndrome
Updated on 21/08/2008 and displayed until 31/10/2008
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

Section 10 - 11 August 2008
Updated on 01/06/2006 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.4 - Special Warnings and Precautions for Use
Date of revision of text on the SPC:   23/11/05
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8  angina and myocardial infarction have been added as adverse events 
Section 4.4.  A cross reference to the above is included under Section 4.4
Updated on 05/08/2004 and displayed until 01/06/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 10/03/2003 and displayed until 05/08/2004
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 25/04/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/04/2002 and displayed until 25/04/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/08/2001 and displayed until 18/04/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 22/09/2000 and displayed until 10/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/07/2000 and displayed until 22/09/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/04/2000 and displayed until 12/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 12/04/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  naratriptan hydrochloride