FERMIN [Digestive Enzyme] Capsule

FERMIN

instructions for medical use of the medicinal product

Tradename

Fermin, Фермин

International non-proprietary name

Pancreatin, Панкреатин

Compound

Each capsule contains:

active substances: pepsin 144 U, pancreatic protease 480 U, pancreatic amylase 5700 U, pancreatic lipase 3000 U

excipients: hypromellose, talc, polyethylene glycol and methacrylate-ethylene-ethyl acrylate copolymer.

Dosage form

Capsules.

Pharmacotherapeutic group

Digestive Enzyme .

Pharmacological properties

An enzyme preparation that improves the digestive processes in adults and children, and thereby significantly reduces the symptoms of pancreatic enzyme deficiency, including abdominal pain, flatulence, changes in the frequency and consistency of the stool. Pancreatic enzymes, which are part of the drug, facilitate the breakdown of proteins, fats, carbohydrates, which leads to their complete absorption in the small intestine.

Capsules quickly dissolve in the stomach, releasing hundreds of mini-microspheres. This principle was developed with the aim of simultaneous passage (intake) of minimicrospheres with food from the stomach to the intestines and thorough mixing of minimicrospheres with intestinal contents, and, ultimately, a better distribution of enzymes after their release within the intestinal contents.

Indications for use

Replacement therapy of insufficiency of exocrine pancreatic function in adults and children, caused by a decrease in the enzymatic activity of the pancreas due to impaired production, regulation of secretion, delivery of pancreatic enzymes or their increased destruction in the intestinal lumen, which is caused by a variety of diseases of the gastrointestinal tract.

To improve the digestion of food in patients with normal gastrointestinal function in cases of nutritional errors (eating fatty foods, overeating, irregular meals, etc.).

Contraindications

Hypersensitivity to any of the components of the drug.

Dosage and administration

Inside, during or immediately after each meal, swallow whole, do not break or chew, drinking plenty of liquid.

When swallowing is difficult (for example, in young children or elderly patients), the capsules are carefully opened, and the minimicrospheres are added to soft food that does not require chewing and has a sour taste (pH<5.5), or taken with a liquid that also has a sour taste (pH< 5.5). For example, minimicrospheres can be added to applesauce, yogurt, or fruit juice (apple, orange, or pineapple) with a pH less than 5.5. It is not recommended to add the contents of the capsules to hot food. Any mixture of minimicrospheres with food or liquid should not be stored and should be taken immediately after preparation.

Crushing or chewing mini-microspheres, as well as mixing them with food or liquid with a pH of more than 5.5, can destroy their protective shell. This can lead to early release of enzymes in the oral cavity, reduced effectiveness and irritation of the mucous membranes. It is necessary to make sure that there are no mini-microspheres left in the mouth.

The dose and course of treatment is determined by the doctor depending on the severity of the symptoms of the disease and the individual characteristics of the patient (degree of indigestion and fat content in food). The usual dose is 1 capsule 3 times a day.

In children, the drug should be used in accordance with the doctor's prescription.

Special instructions and precautions

To avoid complications, the drug should be used only after consulting a doctor.

In patients with cystic fibrosis treated with high doses of pancreatin preparations, strictures of the ileum and caecum and large intestine (fibrosing colonopathy) have been described. As a precautionary measure, if unusual symptoms or changes in the abdominal cavity appear, a medical examination is necessary to rule out fibrosing colonopathy, especially in patients taking the drug at a dose of more than 10,000 lipase units / kg body weight / day.

Influence on the ability to drive vehicles and mechanisms

The use of the drug Fermin does not affect or has a slight effect on the ability to drive a car and mechanisms.

Use during pregnancy and during breastfeeding

Clinical data on the treatment of pregnant women with drugs containing pancreatic enzymes are not available.

The drug should be prescribed to pregnant women with caution if the intended benefit to the mother outweighs the potential risk to the fetus.

You can take pancreatic enzymes while breastfeeding.

If necessary, during pregnancy or lactation, the drug should be taken in doses sufficient to maintain an adequate nutritional status.

Interaction with other drugs

Interaction studies with other medicinal products have not been conducted.

Side effect

From the digestive system: very often - pain in the abdomen; often - nausea, vomiting, constipation, bloating, diarrhea; the frequency is unknown - strictures of the ileum, blind and large intestine (fibrosing colonopathy). Gastrointestinal disorders are associated mainly with the underlying disease.

From the skin and subcutaneous tissues: infrequently - rash; frequency unknown - itching, urticaria.

From the immune system: the frequency is unknown - hypersensitivity (anaphylactic reactions). Allergic reactions were observed mainly from the skin, but other manifestations of allergy were also noted.

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: hyperuricosuria and hyperuricemia.

Treatment: drug withdrawal, symptomatic therapy.

Storage conditions

Store in a dry and cool place, at a temperature not exceeding 30 ⁰ C.

Keep out of the reach of children!

Best before date

2 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

10 capsules in an aluminum foil blister. 2 blisters with instructions for use in a cardboard box.