Universal reference book for medicines
Product name: GASTENORM FORTE 10 000 (GASTENORM FORTE 10 000)

Active substance: pancreatin

Type: Enzyme preparation

Manufacturer: RUSAN PHARMA (India)
Composition, form of production and packaging
?
Tablets covered with enteric-coated shell of white or almost white color, round, biconvex; tolerable lightly rough surface.
1 tab.

pancreatin 140 mg

with minimal enzymatic activity:

lipase 3 500 units FIP

amylase 4 200 units FIP

protease 250 units FIP

Additives: povidone K-30, sodium chloride, microcrystalline cellulose, lactose monohydrate, sodium glycolate, silicon dioxide colloid, talc, magnesium stearate, opadrai white OY-IN-58903 (cellase, triacetin, titanium dioxide, sorbitan oleate).

10 pieces.
- blisters (2) - packs of cardboard.
10 pieces.
- blisters (5) - packs of cardboard.
Gastenorm forte 10 000

?
Tablets covered with enteric-coated shell of white or almost white color, round, biconvex, lightly rough surface permissible.
1 tab.

pancreatin 225 mg

with minimal enzymatic activity:

lipase 10 000 units FIP

amylase 7 500 units FIP

protease 375 units FIP

Excipients: povidone K-30, sodium chloride, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, silicon dioxide colloid, talc, magnesium stearate, opadrai white OY-IN-58903 (cellase, triacetin, titanium dioxide, sorbitan oleate).

10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

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

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

PHARMACOKINETICS

Data on pharmacokinetics are not available.

INDICATIONS

- Insufficiency of the exocrine function of the pancreas (chronic pancreatitis, cystic fibrosis);

- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder.
Conditions after resection or irradiation of these organs, accompanied by a violation of food digestion, flatulence, diarrhea (as part of combination therapy);
- to improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition, as well as violations of the masticatory function, forced long-term immobilization, sedentary lifestyle;

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

DOSING MODE

The dose is determined individually depending on the degree of digestion disorders.

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

Gastenorm forte

Adults (in the absence of other prescriptions): 1-4 tablespoons.
while eating, without chewing and drinking with a sufficient amount of liquid. Do not exceed the daily dose of enzymes, which is 15,000 units of FIP lipase per kg of body weight.
In children, the drug is used as directed by a doctor.
Usually assigned to 1 tab. 3 times / day during meals.
Gastenorm forte 10 000

Adults (in the absence of other prescriptions): 1-2 tab.
while eating, without chewing and drinking with a sufficient amount of liquid.
In children, the drug is used as directed by a doctor.

SIDE EFFECT

Allergic reactions: sneezing, lacrimation, skin rash.

Rarely: diarrhea or constipation, nausea, discomfort in the epigastric region.

With prolonged use in high doses, it is possible to develop hyperuricosuria, an increase in the level of uric acid in the blood plasma.

In cystic fibrosis in case of excess of the required dose , the development of strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be possible.

When
the use of pancreatin in high doses in children may cause perianal irritation and irritation of the mucous membrane of the oral cavity.
CONTRAINDICATIONS

acute pancreatitis;

- exacerbation of chronic pancreatitis;

- children's age till 3 years;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

The safety of pancreatin in 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.
During the lactation period, the use of pancreatin is not contraindicated.

APPLICATION FOR CHILDREN

Contraindicated: children under 3 years.

In children, the drug is used as directed by a doctor.
Usually assigned to 1 tab. 3 times / day during meals.
SPECIAL INSTRUCTIONS

With prolonged use, iron preparations are simultaneously prescribed.

OVERDOSE

Symptoms: hyperuricosuria, hyperuricemia;
children have constipation.
Treatment: withdrawal of the drug, symptomatic therapy.

DRUG INTERACTION

With the simultaneous use of pancreatin with iron preparations, it is possible to reduce absorption of the latter.

Simultaneous use of antacid agents containing calcium carbonate and / or magnesium hydroxide can lead to a decrease in the effectiveness of pancreatin.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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