Instructions for use Firulin 10000 capsules 150 mg blister No. 20
Composition
active ingredient: pancreatin;
1 hard capsule contains 150 mg of pancreatin in gastro-resistant granules, which have enzymatic activity: lipase 10,000 units EF, amylase 8,000 units EF, protease 600 units EF;
excipients: macrogol 8000, hypromellose, hypromellose phthalate, triethyl citrate, dimethicone;
hard capsule: gelatin, purified water, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.
Dosage form
Hard capsules with gastro-resistant granules.
Main physicochemical properties: hard gelatin capsule size 1 with an opaque brown cap and a transparent colorless body containing brownish gastro-resistant granules.
Pharmacotherapeutic group
Preparations that improve digestion, including enzymes. Polyenzyme preparations.
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
FIRULIN 10000 contains porcine pancreatin in the form of enteric-coated (acid-resistant) granules in gelatin capsules. The capsules dissolve rapidly in the stomach, releasing a large number of granules in a multidose manner, which ensures good mixing with the stomach contents, transport from the stomach together with its contents and good distribution of enzymes in the intestinal contents after release. When the granules enter the small intestine, the shell dissolves rapidly (at pH > 5.5), releasing enzymes with lipolytic, amylolytic and proteolytic activity, which ensures the breakdown of fats, carbohydrates and proteins. The products of pancreatic digestion are then absorbed either immediately or after further hydrolysis by intestinal enzymes.
Clinical efficacy
Pancreatin treatment has been shown to significantly reduce symptoms caused by impaired exocrine pancreatic function, including stool consistency, abdominal pain, flatulence, and stool frequency, regardless of the underlying disease in patients with exocrine pancreatic insufficiency.
Preclinical safety data
Non-clinical data do not indicate relevant acute, subchronic or chronic toxicity. No genotoxicity, carcinogenicity or reproductive toxicity studies have been conducted.
Pharmacokinetics
Animal studies have not shown any evidence of absorption of the enzymes in their unchanged form, so classical pharmacokinetic studies have not been conducted. Medicinal products containing pancreatic enzymes do not require absorption to achieve their effect. On the contrary, their full therapeutic effect is manifested in the lumen of the gastrointestinal tract. In addition, like proteins, they undergo proteolytic digestion as they pass through the gastrointestinal tract before being absorbed as peptides and amino acids.
Indication
Treatment of exocrine pancreatic insufficiency in adults and children caused by various diseases and conditions, including but not limited to the following:
chronic pancreatitis;
pancreatectomy;
gastrectomy;
operations with the imposition of a gastrointestinal anastomosis (for example, Billroth II gastroenterostomy);
Schwachmann-Diamond syndrome;
condition after an attack of acute pancreatitis and resumption of enteral or oral nutrition.
Contraindication
Hypersensitivity to the active substance, to pork (pork allergy) or to any other component of the medicinal product.
Acute hepatitis.
Mechanical jaundice.
Obstructive intestinal obstruction.
Interaction with other medicinal products and other types of interactions
Iron. With simultaneous use of pancreatin with iron preparations, a decrease in the absorption of the latter is possible.
Folic acid: Folic acid absorption may be reduced in patients taking pancreatin, therefore monitoring of folic acid levels is recommended during concomitant use.
Acarbose, miglitol. Pancreatin may reduce the effectiveness of acarbose and miglitol. Therefore, monitoring of blood glucose levels in patients is recommended during their concomitant use.
Application features
Narrowing of the ileocecal and colonic mucosa (fibrosing colonopathy) has been reported with high doses of pancreatin. Therefore, in case of unusual abdominal symptoms or a change in the nature of abdominal symptoms, it is recommended to consult a doctor to exclude fibrosing colonopathy, especially if the patient is taking more than 10,000 units of EF lipase/kg/day (see section "Adverse reactions").
There is a theoretical risk of transmission of viral infections of pigs, including infections caused by new or unidentified viruses. The presence of porcine viruses that can infect humans cannot be completely ruled out. However, no case of transmission of infectious disease has been reported to date due to the use of porcine pancreatin preparations.
Should not be used in acute or chronic pancreatitis in the acute phase until the patient is transferred to enteral nutrition.
Excipients
This medicinal product contains 0.00022 mmol sodium/capsule, i.e. essentially sodium-free.
Use during pregnancy or breastfeeding
There are no data on the use of pancreatin by women during pregnancy. Animal studies are insufficient to determine the effect of pancreatin on the course of pregnancy, intrauterine development of the embryo/fetus, childbirth and postnatal development of the child. The potential risk to humans is unknown. Therefore, the drug FIRULIN 10000 should not be taken during pregnancy and breastfeeding, except in individual cases when, in the opinion of the doctor, the benefits of its use outweigh the possible risks.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect of the drug on the ability to drive vehicles or operate other mechanisms is absent or insignificant.
Method of administration and doses
Method of application
It is recommended to take the medicine during or immediately after meals.
Capsules and granules should be swallowed whole, without breaking or chewing, and washed down with sufficient liquid during or after meals, including a light snack.
If the patient is unable to swallow the capsule whole (e.g. children and elderly patients), the capsule can be carefully opened and the granules added to soft, acidic food (pH < 5.5) that does not require chewing, or to an acidic liquid (pH < 5.5). This can be applesauce, yogurt, or fruit juice with a pH < 5.5, such as apple, orange, or pineapple.
If the granules are mixed with liquid or food, it is important to take them immediately. This mixture should not be stored.
Breaking and chewing the granules or adding them to food or liquids with a pH > 5.5 may disrupt their protective enteric coating. This may lead to premature release of enzymes in the oral cavity, as well as reduced efficacy of the medicinal product and mucosal irritation.
It is necessary to ensure that no drug remains in the oral cavity.
It is very important to drink enough fluids during treatment with pancreatin, especially during periods of increased fluid loss. Fluid deficiency can worsen constipation.
Any mixture of granules with food or liquids should be taken immediately and not stored.
Doses
The dosage of the drug is based on the individual needs of the patient and depends on the severity of the disease and the composition of the food.
Therapy should be initiated at the lowest recommended dose and titrated gradually, with careful observation of the patient's response to treatment, symptoms, and nutritional status. Patients should be cautioned against self-inflicted dose increases. Dosage adjustments may take several days.
Adults
The usual starting dose is 10,000 to 25,000 units of EF lipase with each main meal. However, it is possible that some patients may require higher doses to eliminate steatorrhea and maintain adequate nutritional status. According to generally accepted clinical practice, at least 20,000 to 50,000 units of EF lipase should be taken with meals. The dose for administration during main meals (breakfast, lunch or dinner) can be 25,000 to 80,000 units of EF lipase, and for additional light meals between main meals it should be half the individual dose.
Children (from birth to 18 years old)
The dosage and duration of treatment for children are determined by the doctor individually.
Duration of treatment
The duration of the treatment course is determined by the doctor depending on the nature and course of the disease.
Children
The drug FIRULIN 10000 can be used in children (see the section "Method of administration and doses").
Overdose
Cases of hyperuricosuria and hyperuricemia have been reported in association with extremely high doses of pancreatin.
Supportive measures are recommended, including discontinuation of enzyme therapy and ensuring adequate rehydration.
Side effects
The most frequently reported adverse reactions were gastrointestinal, mostly mild to moderate in severity, and were mainly related to the underlying disease.
The frequency category of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000); frequency unknown (cannot be estimated from the available data).
From the gastrointestinal tract:
very common - abdominal pain*;
often - nausea, vomiting, constipation, bloating, diarrhea*;
very rarely - change in bowel habits, skin irritation around the mouth or anus, especially after taking high doses;
frequency unknown - narrowing of the ileocecal section of the intestine and ascending colon (fibrosing colonopathy)**.
From the skin and subcutaneous tissue:
infrequently - rash;
frequency unknown - itching, urticaria.
On the part of the immune system:
frequency unknown - immediate allergic reactions***, hypersensitivity (anaphylactic reactions and reactions localized in the gastrointestinal tract).
frequency unknown - hyperuricemia, hyperuricosuria, folic acid deficiency.
* The incidence was similar to or lower than with placebo.
** Narrowing of the ileocecal part of the intestine and colon (fibrosing colonopathy) has been reported in patients taking high doses of pancreatin preparations (see section "Special instructions").
*** Allergic reactions were mainly manifested on the skin (rash, urticaria), among other manifestations - sneezing, lacrimation, bronchospasm, dyspnea.
Children
No specific adverse reactions have been identified in children. The frequency, type and severity of adverse reactions in children are similar to those in adults.
Reporting of suspected adverse reactions
Reporting adverse reactions after registration of a medicinal product is of great importance. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of a medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
10 capsules in a blister, 2 or 10 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Kusum Healthcare Pvt Ltd.
Location of the manufacturer and address of its place of business
Plot No. M-3, Indore Special Economic Zone, Phase-II, Pithampur, Distt. Dhar, Madhya Pradesh, Pin 454774, India.
