Salofalk of the tab. of p/o of 500 mg No. 100

tablets "Salofalk" are applied at the following indications:

• ulcer colitis: treatment of aggravations and prevention of a recurrence;
• Crohn's disease: treatment of aggravations.

Structure

Active ingredient - mesalazin (one tablet, coated, contains 500 mg of a mesalazin (5-aminosalicylic acid)).

Excipients: sodium carbonate anhydrous, glycine, povidone (K25), cellulose microcrystalline, silicon dioxide colloidal anhydrous, calcium stearate, croscarmellose sodium, gipromelloza, methacrylate copolymer (type A), talc, titan dioxide (E 171), gland hydroxide yellow (E172), macrogoal 6000, acrylate copolymer.

Contraindication

Hypersensitivity to a mesalazin, to any of components of medicament or to salicylates, a peptic ulcer of a stomach and duodenum in an aggravation stage, a heavy liver and/or renal failure, hemorrhagic diathesis.

Route of administration

If the recommended dose exceeds 1.5 g of a mesalazin a day, usually apply the tablets "Salofalk" of 500 mg.

Depending on the clinical need for each separate case by

following daily doses:

• Crohn's disease (aggravation) - from one tablet × 3 times a day to three tablets × 3 times a day;
• ulcer colitis (aggravation) from one tablet × 3 times a day to two tablets × 3 times a day;
• ulcer colitis (prevention of a recurrence / long therapy) - on one tablet 3 times a day.

Children aged from 6 years

At bad attacks 30-50 mg mesalazina/kg/sutki, in 3 receptions. Maximum dose of 75 mg mesalazina/kg/sutki. The general daily dose should not exceed the maximum dose for adults.

For prevention of a recurrence (nonspecific ulcer colitis) medicament is appointed individually, since 15-30 mg mesalazina/kg/sutki, in 2-3 receptions. The general daily dose should not exceed the maximum dose for adults.

In general to children with body weight to 40 kg more than 40 kg - a usual dose for adults are recommended to accept a half of a dose for adults, to children with body weight.

Tablet "Salofalk" up to 6 years because experience of use of medicament in this age group is insufficient.

General recommendations about use

needs to take the Pill "Salofalk" in the morning, during the lunchtime and in the evening in 1 hour prior to food. It is necessary to swallow of tablets entirely, without chewing, with enough liquid.

Both at acute conditions at inflammation, and at prolonged use for achievement of desirable therapeutic effect of the tablet "Salofalk" it is necessary to accept regularly and constantly.

Duration of use is defined by the doctor. Usually aggravations in ulcer colitis and Crohn's disease abates in 8-12 weeks.

For prevention of a recurrence of ulcer colitis a dose can be lowered to 1.5 g of a mesalazin a day (adults and children with body weight more than 40 kg), to 0.75 mg of a mesalazin a day (children).

Feature of use

Pregnant

needs to take the Pill "Salofalk" during pregnancy only when the expected advantage of use exceeds possible risk.

This medicament has to be used during feeding by a breast only when the expected advantage for mother prevails over possible risk for the child. If at the baby the diarrhea develops, feeding by a breast should be stopped.

Influence on ability to drive the car and to work with mechanisms was not observed by

. In cases if during treatment the dizziness is observed, it is necessary to refrain from control of vehicles and work with mechanisms.

to

Overdose

Still about cases of intoxication and specific antidotes it was not reported. There are data on overdose cases (for example intentional suicide by a high oral dose of a mesalazin) which do not indicate renal or hepatic toxicity. Specific antidote does not exist, treatment has to be symptomatic and supporting. In case of need perform infusion of electrolytes (compulsory diuresis).

Side effects

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

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

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

to Store

at a temperature not above 25 °C, out of children's reach.

Expiration date - 3 years.