Instructions for use

Pharmacotherapeutic group: digestive enzyme medication

Excipients in the contents of entersoluble pellet shell

methacrylic acid and ethyl acrylate copolymer [1:1] (in the form of 30 % dispersion, which additionally contains polysorbate 80, sodium lauryl sulfate) -25.3 mg/63.2 mg, triethyl citrate - 5.1 mg /12.6 mg, simethicone emulsion 30 %, dry weight (32.6 %) – 0.1 mg /0.3 mg in total: dimethicone -27.8%; colloidal silica, precipitated -1.3 %; colloidal silica, fluidized -0.9 %; methyl cellulose -2.5 %; sorbic acid -0.1 %, water -67.4 %, talc -12.6 mg /31.6 mg.

Capsule shell contents:

body: gelatin – up to 100 %, water -13-16 % cap: gelatin – up to 100 %, water -13-16 %, carmine dye (ponseau 4R) – 0.6666 % / 0.7999 %, quinoline yellow dye – 0.1000 % / 0.3166 %, patent blue dye – 0.0200 % / 0.0053 %, titanium dioxide – 1.2999 % / 2.9574%.

Description

Hard gelatin capsules No. 2, transparent body and brown cap (for dose of 10000 au) and No. 0, transparent body and dark-orange cap (for dose of 25000 au). Capsule contents – cylindrical of spherical pellets with color ranging from light-brown to brown with specific smell.

Pharmacological properties

Micrasim® consists of pancreatine microgranules in capsules. The medication contains natural enzymes from animal pancreatic glands – protease, lipase and amylase, which help in digesting proteins, fats and carbohydrates.

After taking Micrasim® the capsule is fast dissolved in the stomach, and discharges the microgranules of pancreatine, covered with special layer to be dissolved in the intestine. Because of their small size, microgranules are easily and evenly mixed with food, and together with processed food they get to the duodenum, and then to the thin intestine, where pancreatic enzymes are released and start working actively, helping fast and complete digestion of proteins, fats and carbohydrates from food.

Fast mixing of panctreatine pellets with stomach contents, their even distribution and passage at the same time with chime, as well as protection of enzymes before they start working in the intestine (thanks to entersoluble pellet shell) ensure higher digesting properties and make drug action maximally similar to the natural digestion process. Enzyme activity of Micrasim® is maximal in 30 minutes after oral administration, which provides fast effect.

After interaction with substrate, protease, amylase and lipase lose their activity in the bottom parts of the intestine and are discharged together with intestinal contents.

Micrasim® is not absorbed from the gastrointestinal tract and only acts in the opening of the intestine.

Indications for use

Replacement therapy in cases of pancreas’ exocrine insufficiency: chronic pancreatitis, pancreatectomy, state after irradiation, indigestion, cystic fibrosis; flatulence, diarrhea of noninfectious origin.

Indigestion (condition after resection of the stomach and the thin intestine): for better digestion for persons with normal function of gastrointestinal tract in cases of bat nutrition choices (fatty foods, too much food, irregular meals) and in cases when chewing function is impaired, in cases of sedentary lifestyle, long immobilization. Roemheld syndrome (gastrocardiac syndrome).

Preparing for X-ray tests and for ultrasound of the abdomen.

Contraindications

Individual intolerance to pancreatine or to separate components of the drug. Acute pancreatitis, exacerbation of chronic pancreatitis.

Use during pregnancy and lactation

Information on potential risks of pancreatine use during pregnancy and lactation is absent, so the drug should only be prescribed to pregnant and breastfeeding women in cases, when presumed benefits of the therapy are higher than possible risks.

Information on possible influence of the drug on ability to drive transportation vehicles and to control mechanisms.

No specific data exists.

Dosing and Administration

Dose of the drug is selected individually according to age, degree of severity of symptoms and diet. Selection of dose is done by the use of registered medications Micrasim® 10 000 AU and Micrasim® 25 000 AU

Capsules are administered orally, with necessary amount of non-alkaline fluid (water, fruit juice). If single doze consists of more than 1 capsule, half of the capsules should be taken before the meal and the other half – with the meal. If single dose in 1 capsule, it should be taken with food.

If swallowing is difficult (for instance, for children or elderly people), capsule should be opened and preparation should be taken in pellets, mixing them with liquid (pH <5.0) or with food that does now require chewing (applesauce, yoghurt). Crushing or chewing, or adding food with pH over 5.5 destroys pellet shell, which protects it from the stomach fluid. Any mixture of pellets with food should be administered directly after preparing.

Allowed dose for the children under 1.5 is 50 000 AU/day; over 1.5 years - 100 000 AU/day.

Duration of pancreatine intake may vary from several days (digestion problems) to several months or years (replacement therapy).

Replacement therapy in different cases of exocrine insufficiency of the pancreas.

The dose is selected individually and depends on the degree of severity of exocrine insufficiency, in individual food habits and on patient’s age.

Steatorrhea (over 15 g of fat in feces in a day).

In cases of diarrhea, decrease of bodily mass and no effect from the diet therapy 25000 AU of lipase is prescribed with each food intake. If necessary and in case of good tolerance the dose may be increased to 30000-35000 AU each time. Further increase of the dose, usually, does not benefit treatment results and requires revising the diagnosis, decreasing fat in the ratio and/or additional prescription of proton pump inhibitors.

If steatorrhea is not severe and does not cause diarrhea and decrease in the bodily mass, 10000 AU to 25000 AU of lipase per serving is prescribed.

Cystic fibrosis.

Starting dose for children under 4 years is 1000 AU of lipase per kilogram of bodily mass with each meal, for children over 4 years of age – 500 AU of lipase per kilogram of bodily mass with each meal. The dose should be selected individually depending on the severity of illness, manifestations of steatorrhea and nutrition status. Supporting dose for most patients should not exceed 10000 AU of lipase per kilogram of bodily mass per day.

Side effects

There are possible allergic reactions to the drug components. With the use of high doses of the drug there are rarely observed: diarrhea, nausea, constipations, and discomfort in the epigastria. In cases of long term administration in high doses there is possible hyperuricosuria, hyperuricemia.

Overdose

Symptoms: increase of uric acid content in urine (hyperuricosuria), and in blood (hyperuricemia). Constipations in children.
Treatment: stop medications, treat according to symptoms.

Interaction with other drugs

When pancreatine is taken simultaneously with iron preparations the absorption of iron may be decreased.

Cautions

Children and adults, who received pancreatine therapy for a long time in high doses, should be under observation of a specialist.
Main reasons for the ineffective therapy are: inactivation of enzymes in the duodenum because its contents became acidy; accompanying illness of the thin intestine (helminth invasions, dysbiosis); non-compliance of patients with recommended treatment regiments; use of enzymes, that have lost their active properties.

Presentation

Capsules 10000 AU and 25000 AU
By 3 (for 10000 AU dose) or by 10 capsules in the contour cell package made of polyvinylchloride film and aluminum printed glossed foil.
By 20, 30, 40 or 50 capsules in the dark glass bottles, sealed with tight plugs made of high pressure polyethylene.
Free space in the bottles is filled with hygroscopic medical cotton.
By 20, 30, 40 or 50 capsules in polymeric bottles with screw caps or in plastic flasks with screw caps.
Each bottle, flask and each 1, 2, 3, 4 or 5 contour cell package together with the instruction are places in the cardboard box.

Storage conditions

Store in a place, protected from moisture and light, at the temperature not exceeding 25°C. Keep away from the reach of children.

Expiry date

2 years. Preparation should not be used after the expiry date!

Conditions of sale in pharmacies

Without receipt.