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GlaxoSmithKline (Ireland) Ltd

Stonemason's Way, Rathfarnham, Dublin 16,
Telephone: +353 1 495 5000
Fax: +353 1 495 5105
Medical Information Direct Line: 1 800 244 255
Medical Information Facsimile: +353 1 495 5242
Summary of Product Characteristics last updated on medicines.ie: 23/01/2014
SPC Malarone Film Coated Tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 23/01/2014 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   11-Nov-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Editorial changes to sections 2, 4.2, 4.3, 4.6 and 5.2 due to QRD template update.

 

4.2     Posology and method of administration

Under the subheading ‘Dosage in Adults’ added the clarification:

Malarone paediatric tablets are recommended for malaria prophylaxis in persons weighing <40 kg.

 

4.8         Undesirable effects

·        Changed frequency of ‘hallucinations’ from ‘not known’ to ‘rare’

·        Added ‘Psychotic disorder’ with the frequency ‘not known’

·        Added the contact details for the IMB regarding the reporting of side effects

 

5.1     Pharmacodynamic properties

Under the subheading ‘Microbiology’, amended the upper limit of in vitro IC50 against P. falciparum from 1.4 to 1.43, i.e.:

Atovaquone has potent activity against Plasmodium spp (in vitro IC50 against P. falciparum 0.23-1.43 ng/mL).

 

6.6     Special precautions for disposal

Added the following statement:

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Updated on 28/09/2012 and displayed until 23/01/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   06-Sep-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



  

SPC UPDATES

 

4.2     Posology and method of administration

Under the subheadings, Posology, Prophylaxis, removed the statement that the period of stay ‘should not exceed 28 days’ to read:

 

Prophylaxis should

·           commence 24 or 48 hours prior to entering a malaria-endemic area,

·           continue during the period of the stay.

·           continue for 7 days after leaving the area.

 

In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Malarone has been established in studies of up to 12 weeks.

 

Added the following statement regarding the average duration of exposure in clinical studies in non-immune subjects:

In non-immune subjects, the average duration of exposure in clinical studies was 27 days.

 

Updated on 01/06/2012 and displayed until 28/09/2012
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   11-Apr-2012
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes to:

Section 4.2 - Posology and method of administration,
Section 4.3 - Contraindications,
Section 4.4 - Special warnings and precautions for use,
Section 4.5 - Interaction with other medicinal products and other forms of interaction, Section 4.6 - Pregnancy and lactation,
Section 4.8 - Undesirable effects,
Section 4.9 - Overdose

Updated on 18/03/2010 and displayed until 01/06/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



SPC UPDATE

 

Section 4.8 Undesirable effects

·         Added the term ‘seizure’ in the system organ class ‘nervous system disorders’ with frequency classification ‘unknown’.

·         Corrected the reference on the side effect ‘Pancytopenia in patients with severe renal impairment’ from ‘observed from post-marketing spontaneous reports and the frequency is therefore unknown’ to ‘observed with proguanil and the frequency is therefore unknown’.

 

Updated on 13/10/2009 and displayed until 18/03/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Sep-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Section 3

 

The SPC was updated to include the following description of engraving on the tablet: 'engraved ‘GX CM3’ on one side.'

Updated on 25/08/2009 and displayed until 13/10/2009
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 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   01-Jul-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Malarone 250mg/100mg Film-coated Tablets (PA 1077/111/1, UK/H/0170/001)

Changes made in Red

 

UK/H/0170/001/II/040

IMB CRN 2053333

Updates to QRD format throughout the SPC and PL. Safety updates to sections 4.3 and 4.8 of the SPC, with corresponding updates to the PL. Pharamceutical update to section 6.1.

 

UK/H/0170/001/II/041

IMB CRN 2058832

Update statement in section 4.4 regarding severe allergic reactions and correction to side effects in section 4.8

 

 

Updates to SUMMARY OF PRODUCT CHARACTERISTICS

 

Minor editorial changes to sections 1, 2, 3, 4.1, 4.2, 4.4, 4.5, 4.9, 5.1, 5.2, 5.3, 6.4, 10 with the specific updates to the following sections:

 

 

 

Section 4.3 Contraindications

Statement regarding hypersensitivity updated from:

Malarone is contra-indicated in individuals with known sensitivity to atovaquone or proguanil hydrochloride or any component of the formulation.

 

to:

Hypersensitivity to the active substances or to any of the excipients.

 

 

 

Section 4.4 Special warnings and special precautions for use

Inserted the following paragraph regarding severe allergic reactions:

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 Undesirable effects

-          Rash and urticaria reclassified under Skin and subcutaneous tissue disorders’ previously listed under ‘Immune system disorders’, with no change to frequency classification.

-          Stevens-Johnson Syndrome, Erythema multiforme, Blister, Skin exfoliation added under Skin and subcutaneous tissue disorders’.

-          Source of frequency determination for the side effect ‘palpitations’ corrected from footnote 3 to footnote 1

 

Section 6.1 List of excipients

-          Pharmacopoeial references (BP, Ph. Eur., USNF) removed

-          Sodium Starch Glycollate specified as (Type A)

-          ‘Methylhydroxypropyl cellulose’ updated to ‘Hypromellose’

-          E numbers added for Titanium Dioxide (E171) and Iron Oxide Red (E172)

 

 

Updated on 22/09/2008 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   09/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
 
Addition to :
 
Section 4.8
Undesirable Effects added: Psychiatric: abnormal dreams, depression, anxiety, panic attacks, crying, hallucination, nightmares.

Cardiac: palpitations, tachycardia.

Updated on 30/05/2008 and displayed until 22/09/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Complete revision of PL layout and implementation of warnings/listing of safety issues interaction with anti-coagulants and hepatitis

Updated on 27/08/2007 and displayed until 30/05/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 08/12/2005 and displayed until 27/08/2007
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Atovaquone
   Proguanil Hydrochloride