Salofalk Description

Gastro-resistant tablet: Each gastro-resistant tablet contains 500 mg mesalazine.
PR granules: Each sachet of Salofalk 1.5g granules contains 1.5 g mesalazine.
Suppository: 1 Salofalk 500 mg suppository contains: Mesalazine (5-aminosalicylic acid) 500 mg.
Enema: Salofalk 2g/30ml enemas: 1 Salofalk 2g/30ml enema (= 30 g rectal suspension) contains 2 g mesalazine.
Excipients with known effect: Gastro-resistant tablet: sodium carbonate and croscarmellose sodium.
PR granules: Each sachet of Salofalk 1.5g granules contains 3.0 mg aspartame.
Suppository: Hard fat, docusate sodium, cetyl alcohol.
Enema: One Salofalk 2g/30ml enema contains 140.4 mg potassium metabisulphite and 30 mg sodium benzoate.
Excipients/Inactive Ingredients: Gastro-resistant tablet: Basic butylated methylacrylate copolymer (Ph.Eur.) (rel. molar mass: approx. 150000 (= Eudragit E)), Calcium stearate (Ph.Eur.) [herbal], Croscarmellose sodium, Iron oxide yellow (E 172), Glycine, Colloidal anhydrous silica, Hypromellose, Macrogol 6000, Methacrylic acid methyl methacrylate copolymer (1:1) (Ph.Eur.) (rel. molar mass: approx. 135000 (= Eudragit L)), Microcrystalline cellulose, Sodium carbonate, Povidone K25, Talc, Titanium dioxide (E 171).
PR granules: Aspartame (E 951), Carmellose sodium, Citric acid, Colloidal anhydrous silica, Hypromellose, Magnesium stearate, Methacrylic acid-methyl methacrylate copolymer (1:1) ((MW approx. 135000)) (Eudragit L 100), Methylcellulose, Microcrystalline Cellulose, Polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% Nonoxynol 100), Povidone K 25, Simeticone, Sorbic acid, Talc, Titanium dioxide (E 171), Triethyl citrate, Vanilla custard flavouring, Ethanol (only present as residue in the final product, up to 1.25 %).
Enema: Salofalk 2g/30ml enemas: Carbomer 35 000, potassium acetate, potassium metabisulphite (max. 0.14 g, equivalent to max. 0.08 g SO₂), sodium benzoate, Disodium edetate, purified water, xanthan gum.