Salofalk granules 1000mg, No. 50
Expiration Date: 11/2025
Russian Pharmacy name:
Салофальк гранулы 1000мг, №50
exacerbation of moderate and mild ulcerative colitis;
maintenance of remission and / or long-term therapy of ulcerative colitis.
Inside. Salofalk granules must not be chewed. The prescribed dose of Salofalk granules should be taken in the morning, at lunchtime and in the evening, or the entire dose once in the morning. Salofalk granules should be put on the tongue and swallowed without chewing, drinking plenty of liquid.
For the treatment of exacerbation of ulcerative colitis
Depends on the clinical need in each individual case, 1 sachet of 500-1000 mg mesalazine 3 times a day or 3 sachets 1 time per day (corresponds to 1.5-3.0 g of mesalazine per day).
To maintain remission of ulcerative colitis
500 mg of mesalazine 3 times a day or 3 sachets 1 time a day (corresponds to 1.5 g of mesalazine per day).
Children under 6 years old
Salofalk granules should not be prescribed to children under 6 years of age, since the experience of using the drug in patients of this age group is very limited.
Children over 6 and adolescents
With an exacerbation of the disease, depending on its severity, mesalazine is prescribed in a dose of 30-50 mg / kg / day with the distribution of the daily dose in 3 doses or in 1 dose. To maintain remission, mesalazine is prescribed at a dose of 15-30 mg / kg / day, while the daily dose can be divided into 2 doses. Children weighing up to 40 kg are usually advised to prescribe half the adult dose, children weighing more than 40 kg - the adult dose.
Both in the treatment of exacerbations of the inflammatory process, and with long-term use in order to maintain remission, granules should be taken regularly and consistently, which allows you to achieve the desired therapeutic effect. Exacerbation of ulcerative colitis usually subsides after 8-12 weeks, after which the dose of mesalazine in most patients can be reduced to 1.5 g per day.
| Enteric-coated granules, prolonged release | 1 dose (package) |
| active substance: | |
| mesalazine (5-aminosalicylic acid) | 500 mg |
| 1000 mg | |
| Excipients | |
| core: MCC - 200/400 mg; hypromellose - 18/36 mg; colloidal anhydrous silicon dioxide - 0.25 / 0.5 mg; Eudrajit NE 40D (40% dispersion of copolymer of methyl methacrylate and ethyl acrylate (2: 1) and 2% nonoxynol) in terms of dry matter - 45/90 mg; magnesium stearate - 7.75 / 15.5 mg; dry matter 33% simethicone emulsion (consists of 92% simethicone 7.7% methylcellulose, 0.3% sorbic acid) - 0.5 / 1 mg | |
| inner shell: hypromellose 2/4 mg; copolymer of methacrylic acid and methyl methacrylate (1: 1) (Eudrajit L100) - 75/150 mg; triethyl citrate - 7.5 / 15 mg; talc - 20/40 mg; magnesium stearate - 5/10 mg; titanium dioxide - 12.5 / 25 mg | |
| outer shell: sodium carmellose - 15/30 mg; titanium dioxide - 5/10 mg; aspartame - 1/2 mg; anhydrous citric acid - 3/6 mg; vanilla flavoring - 2/4 mg; talc - 5.5 / 11 mg; povidone K-25 - 5/10 mg |
hypersensitivity to the components of the drug and other derivatives of salicylic acid;
blood diseases;
peptic ulcer of the stomach and duodenum;
deficiency of glucose-6-phosphate dehydrogenase;
hemorrhagic diathesis;
severe renal / hepatic impairment;
children's age (up to 6 years old);
phenylketonuria.
With caution: pregnancy (I trimester), renal / hepatic failure of mild and moderate severity, lung disease (especially bronchial asthma).