Composition, form of production and packaging
? Tablets coated with enteric-coated white or light gray color, smooth, round, biconvex, with the smell of vanillin and bergamot.
1 tab.
pancreatin with minimal enzymatic activity:
lipase 20 000 units Ph.Eur.
amylase 12 000 U.S. Ph.Eur.
protease 900 ED Ph.Eur.
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, silicon dioxide colloidal anhydrous, magnesium stearate.
Sheath composition: hypromellose, methacrylic acid-ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla aromatizer 54286C, bergamot flavoring 54253T, macrogol 6000, carmellose sodium, polysorbate 80.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Enzyme preparation. Compensates the insufficiency of the exocrine function of the pancreas. The effect of the drug is due to its constituent components. High lipase activity plays an important role in the treatment of maldigestii due to pancreatic enzyme deficiency. Lipase breaks fats by hydrolysis into fatty acids and glycerol, thus facilitating their absorption and absorption of fat-soluble vitamins. Amylase splits carbohydrates into dextrins and sugars, while protease cleaves proteins.
The tablet has a protective coating, due to which the active enzymes contained in the tablet are released in the small intestine where pancreatic enzymes act.
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. Eliminates the symptoms arising from digestive disorders (feeling of heaviness and overflow of the stomach, flatulence, lack of air, shortness of breath due to the accumulation of gases in the intestines, diarrhea). Improves the process of digestion of food in children; stimulates the release of its own enzymes of the pancreas, stomach and small intestine, as well as bile.
PHARMACOKINETICS
Pancreatic enzymes are released from the dosage form in the alkaline medium of the small intestine. are protected from the action of gastric juice by a film membrane.A small part of the digestive enzymes are released through the intestine.
INDICATIONS
- Insufficiency of the exocrine function of the pancreas (including chronic pancreatitis, cystic fibrosis);
- chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder; 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, in violation of masticatory function (damage to teeth and gums, during the period of habituation to dentures), sedentary lifestyle, prolonged immobilization;
- Preparation for X-ray and ultrasound examination of the abdominal cavity organs.
DOSING MODE
Tablets should be taken orally, during meals, without chewing, with a sufficient amount of liquid.
The dose and duration of therapy is determined individually, depending on the age and degree of pancreatic insufficiency.
For adult Pansinorm В® forte 20 000 appoint at the beginning of treatment 1 tab. 3 times / day, during each main meal. You can take Pannosinorm Fort 20 000 during a light snack. If necessary, single dose is increased 2 times. The average daily dose: 1-2 tablespoons. 3 times.
Before X-ray and ultrasound studies - 2 tab. 2-3 times / day for 2-3 days before the examination.
In children, the drug is used only as directed by a doctor.
For children over the age of 3, the drug is prescribed in a dose of 100,000 units of Ph.Eur./sut (in terms of lipase).
The duration of treatment can vary from a single dose or for 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 EFFECT
Allergic reactions: skin hyperemia, skin rash, itching, sneezing, choking, lacrimation.
From the side of the digestive system (with prolonged intake in large doses): nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, constipation, perianal irritation, irritation of the oral mucosa. In case of cystic fibrosis, if the necessary dose of pancreatin is exceeded (more than 10 000 ED Ph. Eur lipase per 1 kg of body weight), strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be developed.
Other: hyperuricemia, hyperuricosuria, folate deficiency.
CONTRAINDICATIONS
acute pancreatitis;
- exacerbation of chronic pancreatitis;
- Children under 3 years of age (for this dosage form);
- children with cystic fibrosis before the age of 15;
- Hypersensitivity to the pork protein or other components of the drug.
Caution should be prescribed during pregnancy.
PREGNANCY AND LACTATION
The use of the drug Pansinorm В® forte 20 000 during pregnancy and lactation (breastfeeding) is possible only if the expected positive effect of therapy exceeds the possible risk, due to the lack of clinical data confirming the safety of the use of pancreatic enzymes in this category of patients.
APPLICATION FOR CHILDREN
The drug should not be administered to children under the age of 15 years with concomitant cystic fibrosis. In children, the drug is used only as directed by a doctor.
SPECIAL INSTRUCTIONS
In case of cystic fibrosis, if the necessary dose of pancreatin is exceeded (more than 10 000 ED Ph. Eur lipase per 1 kg of body weight), strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be developed. Therefore, in cystic fibrosis, 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.
Impact on the ability to drive vehicles and manage mechanisms
It is not known about the negative impact on the ability to drive and work with other mechanisms.
OVERDOSE
Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation, fibrotic colonopathy (with cystic fibrosis).
Treatment: withdrawal of the drug, hydration, symptomatic therapy.
DRUG INTERACTION
With simultaneous use with pancreatin, it is possible to reduce absorption of iron preparations (clinically insignificant) and folic acid. It is recommended that folate levels and / or folic acid are monitored periodically.
The acid-resistant shell of the PanzinormВ® forte tablets is dissolved in the duodenum. At a low pH in the duodenum, pancreatin is not released. The simultaneous use of blockers of histamine H 2 receptors (cimetidine), antacid preparations (hydrogen carbonates), proton pump inhibitors can lead to an increase 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 in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Shelf life - 3 years.
