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