GlaxoSmithKline (Ireland) Ltd

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’.

Section 3

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

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