Pancreasim - instructions for use, dose, side effects, contraindications

Each tablet, coated with an enteric coating, contains as an active substance pancreatin powder 240 mg, which corresponds to the activity, not less than:

- 5600 amylolytic units FIP,

- 8000 lipolytic ED FIP,

- 370 proteolytic ED FIP.

Excipients: sodium chloride - 19 mg, silicon dioxide colloidal - 2.8 mg, cellulose microcrystalline - 15 mg, crospovidone CL) - 22 mg, magnesium stearate - 1.2 mg;

enteric coating: methacrylic acid - ethyl acrylate copolymer (1: 1) dispersion 30 % (colloidate MAE 30 DP) 20.4 mg, talc 3.28 mg, propylene glycol 5.04 mg, titanium dioxide 1.25 mg, dye azorubin (acid red 2 C) 0.03 mg.

Description:

Round, biconvex tablets, covered with a film coat, pink, with a weak specific odor.

On the puncture of the tablet, the core is visible from light yellow to light brown in color with a grayish tinge, with patches of light brown to dark brown and a film shell of pink color.

Pharmacotherapeutic group:digestive enzyme.

ATX: & nbsp

A.09.A.A Enzyme preparations

A.09.A.A.02 Pancreatin

Pharmacodynamics:

The drug compensates for the lack of exocrine function of the pancreas.

Enzymes of amylase, lipase and protease, included in pancreatin, facilitate the digestion of carbohydrates, fats and proteins, which contributes to their fuller absorption in the small intestine.

Indications:

Insufficiency of the exocrine function of the pancreas (chronic pancreatitis, cystic fibrosis, etc.).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder; state after resection or irradiation of these organs, accompanied by disruption of food digestion, flatulence, diarrhea (as part of combination therapy).

To improve the digestion of food in patients with normal gastrointestinal function,intestinal tract in cases of errors in nutrition;

Preparation for X-ray and ultrasound examination of the abdominal organs.

Contraindications:

Hypersensitivity to the components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, children under 3 years.

Pregnancy and lactation:

The safety of the use of pancreatin during pregnancy is not well understood. The application is possible in cases where the expected benefit for the mother exceeds the potential risk to the fetus.

Dosing and Administration:

The drug is taken orally, without chewing, during or after a meal.

Adults: usually 2-4 tablets 3-4 times a day.

Children - as prescribed by the doctor. Single doses for children: 3-7 years - 1 tablet, 8-9 years - 1-2 tablets, 10-14 years - 2 tablets.

The duration of treatment can vary from several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or years (if necessary, permanent replacement therapy).

Side effects:

Allergic reactions are possible. In some cases - diarrhea, constipation, a feeling of discomfort in the stomach, nausea (the cause-and-effect relationship of the development of these reactions with the action of pancreatin is not established, tk.these phenomena refer to symptoms of exocrine pancreatic insufficiency). With prolonged use in high doses, it is possible to develop hyperuricosuria, an increase in the level of uric acid in the blood plasma. When using pancreatin in high doses, children may experience perianal irritation and irritation of the mucous membrane of the oral cavity. When using high doses in patients with cystic fibrosis, the development of strictures in the ileocecal region and in the ascending colon can be possible.

Overdose:

Symptoms: hyperuricuria, hyperuricemia. Children have constipation. Treatment: withdrawal of the drug, symptomatic therapy.

Interaction:

With the simultaneous use of pancreatin with iron preparations, it is possible to reduce absorption of the latter. The simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin.

Special instructions:

Cystic fibrosis does not recommend the use of pancreatin in high doses due to an increased risk of stricture (fibrous colonopathy).The dose should be adequate to the number of enzymes that are needed to absorb fat, taking into account the quality and quantity of food consumed.

Form release / dosage:

Tablets, covered with enteric coating.

Packaging:

For 10 tablets in contour cell packs.

2, 4, 5 or 6 contour mesh packages together with instructions for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013996 / 01

Date of registration:23.07.2008

The owner of the registration certificate:TECHNOLOG, JSC TECHNOLOG, JSC Ukraine

Manufacturer: & nbsp

TECHNOLOG, JSC Ukraine

Representation: & nbspAlfa Grand TD, LLCAlfa Grand TD, LLCRussia

Information update date: & nbsp19.08.2015

Illustrated instructions

Instructions

Pancreatic (Pancreasim)