Salofalk Description

Gastro-resistant tablet: One Salofalk 500 mg gastro-resistant tablet contains 500 mg mesalazine as the therapeutically active substance.
Suppository: Each suppository contains 500 mg mesalazine as the medically active ingredient.
Enema: Each Salofalk 2 g/30 ml enema (= 30 g suspension) contains 2 g mesalazine as the active substance.
Gastro-resistant prolonged-release granules: Each sachet of Salofalk granules 1.5 g or 3 g contains 1.5 g or 3 g mesalazine, respectively.
Excipients with known effect: Gastro-resistant tablet: sodium carbonate and croscarmellose sodium.
Suppository: cetyl alcohol.
Enema: Each Salofalk 2 g/30 ml enema contains 140.4 mg potassium metabisulphite and 30 mg sodium benzoate.
Gastro-resistant prolonged-release granules: Each sachet of Salofalk granules 1.5 g contains 3.0 mg aspartame and 0.06 mg sucrose.
Each sachet of Salofalk granules 3 g contains 6.0 mg aspartame and 0.12 mg sucrose.
Excipients/Inactive Ingredients: Gastro-resistant tablet: Basic butylated methylacrylate copolymer (rel. molar mass: approx. 150000), calcium stearate, croscarmellose sodium, glycine, hydrated iron(III) oxide (E 172), hypromellose, macrogol 6000, methacrylic acid-methyl methacrylate copolymer (1:1) (rel.molar mass: approx. 135000), microcrystalline cellulose, povidone K25, colloidal anhydrous silica, sodium carbonate, talc, titanium dioxide (E 171).
Suppository: 1. Hard fat; 2. Docusate sodium; 3. Cetyl alcohol.
Enema: Carbomer 35 000, potassium acetate, potassium metabisulphite (E 224, max. 0.14 g, equivalent to max. 0.08 g SO₂), sodium benzoate (E 211), disodium edetate (Ph.Eur.), purified water, xanthan gum.
Gastro-resistant prolonged-release granules: Aspartame (E 951); carmellose sodium (Ph.Eur.); citric acid; colloidal anhydrous silica; hypromellose; magnesium stearate (Ph.Eur.); methacrylic acid-methyl methacrylate copolymer (1:1) (Ph.Eur.) (MW approx. 135000); methylcellulose; cellulose; microcrystalline; polyacrylate dispersion 40% (Eudragit NE 40 D containing 2% Nonoxynol 100); povidone K 25; simethicone; sorbic acid (Ph.Eur.); talc; titanium dioxide (E 171); triethyl citrate; vanilla custard flavouring (containing sucrose).