Salofalk

Salofalk Description

mesalazine

Manufacturer:

Dr Falk

Distributor:

DCH Auriga
Full Prescribing Info
Description
Gastro-resistant tablet: 1 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. Excipient with known effect: cetyl alcohol.
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 1.5 g/3 g contains 1.5 g/3 g mesalazine.
Excipients/Inactive Ingredients:
Gastro-resistant tablet: Basic butylated methylacrylate copolymer ((rel. molar mass: approx. 150000)) (=Eudragit E), Calcium stearate, Croscarmellose sodium (only present in Salofalk 500mg Tablets), Glycine, Hydrated iron(III) oxide (E 172), Hypromellose, Macrogol 6000, Methacrylic acid-methyl methacrylate copolymer (1:1) ((rel.molar mass: approx. 135000)) (=Eudragit L), Microcrystalline cellulose, Povidone K25, Silica colloidal anhydrous, Sodium carbonate anhydrous, Talc, Titanium dioxide (E 171).
Suppository: Hard fat; Docusate sodium; Hexadecane-1-ol.
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.), water, purified, xanthan gum.
Gastro-resistant prolonged release granules: Aspartame (E 951); Carmellose sodium (Ph.Eur.); Citric acid, anhydrous; Silica, colloidal anhydrous; Hypromellose; Magnesium stearate (Ph.Eur.); Methacrylic acid-methyl methacrylate copolymer (1:1) (Ph.Eur.); ((MW approx. 135000)) (Eudragit L 100); Methylcellulose; Cellulose, microcrystalline; Polyacrylate dispersion 40 % (Eudragit NE 40 D containing 2 % Nonoxynol 100); Povidone K 25; Simeticone; Sorbic acid (Ph.Eur.); Talc; Titanium dioxide (E 171); Triethyl citrate; Vanilla custard flavouring (containing propylene glycol).
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