Salofalk rectal suppositories 250 mg strip No. 10

Salofalk rectal suppositories are used to treat exacerbations and prevent relapses of ulcerative colitis limited to the rectum.

Composition

The active substance is mesalazine (1 suppository contains 250 mg of mesalazine (5-aminosalicylic acid)).

The excipient is solid fat.

Contraindication

Hypersensitivity to mesalazine, to any of the components of the drug or to salicylates, gastric and duodenal ulcer in the acute stage, severe hepatic and/or renal failure, hemorrhagic diathesis.

Method of application

The medicine is intended for rectal administration.

Treatment of exacerbations of ulcerative colitis (adults): 2 suppositories of Salofalk 250 mg are administered rectally 3 times a day (equivalent to 1500 mg of mesalazine per day).

Prevention of relapses of ulcerative colitis (adults): 1 suppository "Salofalk" 250 mg 3 times a day (equivalent to 750 mg of mesalazine per day).

General dosage instructions: When Salofalk suppositories are intended for use 3 times a day, they are inserted into the rectum in the morning, afternoon and evening. The desired therapeutic effect can only be achieved with regular and continuous use of Salofalk. Usually, exacerbations of ulcerative colitis subside within 8-12 weeks. The duration of use is determined by the doctor.

Application features

Pregnant women

Salofalk suppositories should be taken during pregnancy only if the expected benefit from use outweighs the possible risk.

This drug should be used during breastfeeding only if the expected benefit to the mother outweighs the possible risk to the child. If the infant develops diarrhea, breastfeeding should be discontinued.

Children

There is insufficient data on the use of this medicine in children.

Drivers

No effect on the ability to drive and use machines has been observed. In cases where dizziness occurs during treatment, driving and operating machinery should be avoided.

Overdose

No cases of intoxication and no specific antidotes have been reported so far. There are reports of overdose (e.g. intentional suicide with a high oral dose of mesalazine) which do not indicate renal or hepatic toxicity. There is no specific antidote, treatment should be symptomatic and supportive. If necessary, electrolyte infusion (forced diuresis) should be used.

Side effects

Nervous system: rare (≥ 1/10,000; <1/1000) - headache, dizziness.

Cardiovascular system: rare (≥ 1/10,000; <1/1000) - myocarditis, pericarditis.

Gastrointestinal tract: rare (≥ 1/10,000; <1/1000) - abdominal pain, diarrhea, flatulence, nausea and vomiting.

Storage conditions

Store in the original packaging to protect from light at a temperature not exceeding 30 °C, out of the reach of children.

Shelf life - 3 years.