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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: 16/05/2012
SPC Malarone

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 16/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
9  Renewal date 18/10/2011

10 Revision 18/10/0211
Updated on 12/03/2012 and displayed until 16/05/2012
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   10-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 14/06/2011 and displayed until 12/03/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • 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:   10-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.2  Minor text changes
4.3 Minor text chnages
4.4 Addition of warnings re use with some other medicines as well as vlarification of existing wording
4.5 Additional information regarding interactions with some other medicines
4.8  Updated frequency informaton.  Additon of pruitus and photosensitivity reactions.
10.  Updated with new revision date
Updated on 14/09/2009 and displayed until 14/06/2011
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Sep-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
3 - Round, biconvex, pink tablets engraved ‘GX CM3’ on one side.
10 - 02 September 2009
Updated on 25/08/2009 and displayed until 14/09/2009
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:   18-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8 - Seizure added

Corrected superscript for renal impairments

10 - 18 August 2009

 

 
Updated on 20/07/2009 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   25-Jun-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - Added "Occasionally, severe allergic reactions (including anaphylaxis) have been reported in patients taking Malarone. If patients experience an allergic reaction (see section 4.8) Malarone should be discontinued promptly and appropriate treatment initiated."

 

Section 4.8 - Corrected superscript typographical error for "palpitations".

 

Section 10 - Approval date "25 June 2009"
Updated on 18/03/2009 and displayed until 20/07/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - Updated to include the strength in the name

Section 4.3 - Changed from "Hypersensitivity to Atovaquone or proguanil hydrochloride…" to "Hypersensitivity to the active substances…"

Section 4.8 - Addition of Stevens-Johnson syndrome, erythema multiforme, blister & skin exfoliation (frequency unknown). Rash and Urticaria relocated from Immune System disorders to Skin and subcutaneous tissue disorders.

Section 4.9 - Changed from "There have been no reports of overdosage …" to " No case of overdose has been reported…."


Section 6.1 - Removal of the pharmacopoeia references next to the excipient names.

 

 

Section 6.4 - Changed from: " No special precautions for storage" to "This medicinal product does not require any special storage conditions."


Section 10 - Updated to approval date

 

 
Updated on 03/07/2008 and displayed until 18/03/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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:   10-May-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - minor clarification

Section 4.2 - formatting

Section 4.4 - Malarone formulation clarified

Section 4.8 - Addition of Psychiatric and Cardiac adverse events

Section 10 - approval date updated
Updated on 24/09/2007 and displayed until 03/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 4.8 'Vasculitis' and 'Cholestasis' will not be added
Updated on 27/06/2007 and displayed until 24/09/2007
Reasons for adding or updating:
  • 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:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.5: Addition of warfarin and related anticoagulants interaction statement
Section 4.8: Tabulation of adverse events section with addition of Hepatitis and Cholestasis under 'hepatobiliary disorders' and Vasculitis under 'immune system'
Section 10: Now 17/06/2007
Updated on 14/04/2005 and displayed until 27/06/2007
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Updated on 14/03/2005 and displayed until 14/04/2005
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 16/12/2002 and displayed until 14/03/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/09/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 10/01/2002 and displayed until 25/09/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/12/2001 and displayed until 10/01/2002
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 05/12/2001 and displayed until 07/12/2001
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 27/06/2001 and displayed until 05/12/2001
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 5 - Pharmacological Properties
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 12/02/2001 and displayed until 27/06/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 20/12/2000 and displayed until 12/02/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 20/12/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  atovaquone
  proguanil hydrochloride