Instructions for use Pancreatin-Health Forte 14000 enteric-coated tablets blister pack No. 50
Composition
active ingredient: pancreatin;
1 tablet contains 384 mg of pancreatin with an activity of at least 10,000 amylolytic IU (Ph. Eur. U.), 14,000 lipolytic IU, 800 proteolytic IU;
excipients: lactose, monohydrate; microcrystalline cellulose, croscarmellose sodium, crospovidone, povidone, colloidal anhydrous silica, magnesium stearate, polyethylene glycol, azorubine (E 122); dry mixture "Acryl-eze white", containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium bicarbonate, silicon dioxide.
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: film-coated tablets, round in shape with a biconvex surface, light pink in color, with a faint specific odor. Two layers are visible on the cross section.
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations. ATX code A09A A02.
Pharmacological properties
Pharmacodynamics. A polyenzyme preparation that promotes digestion. The preparation contains the main pancreatic digestive enzymes: lipase, α-amylase, proteases (trypsin and chymotrypsin), which have a lipolytic, amylolytic and proteolytic effect, enhance the breakdown of proteins, carbohydrates and fats in the duodenum, the proximal part of the small intestine, which contributes to their more complete absorption. Improves the functional state of the digestive tract and normalizes digestive processes.
The tablets have a protective coating that is insoluble in the acidic contents of the stomach, which prevents the destruction of pancreatic enzymes under the action of gastric juice. Pancreatic enzymes are active only in an alkaline environment and are released from the dosage form in the alkaline environment of the small intestine, acting in the intestinal lumen.
Pharmacokinetics. The enzymes that make up the drug are not absorbed in the digestive tract, therefore they are not detected in the systemic bloodstream; they are inactivated during hydrolysis and digested. A small part of the enzymes that have not undergone hydrolysis is excreted unchanged with feces.
Indication
Replacement therapy for exocrine pancreatic insufficiency: chronic pancreatitis, conditions after pancreatectomy, pancreatic cancer, dyspepsia.
Flatulence, diarrhea of non-infectious origin.
Malabsorption (condition after resection of the stomach and small intestine).
In order to improve digestion of food in people with normal digestive tract function, with chewing function disorders, when consuming difficult-to-digest vegetable, fatty or unusual foods; consumption of excessive amounts of food.
Preparation for X-ray examination and ultrasound diagnostic examinations of the abdominal organs (intestinal degassing).
Contraindication
Hypersensitivity to porcine pancreatin/other components of the drug, acute pancreatitis, exacerbation of chronic pancreatitis, intestinal obstruction.
Interaction with other medicinal products and other types of interactions
When using the drug, it is possible to reduce the absorption of iron, folic acid, reduce the hypoglycemic effect of acarbose. When used simultaneously with antacids containing calcium carbonate and/or magnesium hydroxide, with tannin, alcohol-containing products, the effectiveness of pancreatin is reduced.
Application features
With prolonged use, simultaneous administration of iron preparations is recommended.
The drug contains lactose, therefore, if the patient has been diagnosed with intolerance to some sugars, you should consult a doctor before taking this drug.
Azorubine (E 122) may cause allergic reactions.
Use during pregnancy or breastfeeding
The safety of pancreatin use during pregnancy has not been sufficiently studied.
During pregnancy or breastfeeding, the drug should be taken as prescribed by a doctor if the expected benefit to the mother outweighs the potential risk to the fetus/child.
The ability to influence the reaction speed when driving or working with other mechanisms
Does not affect.
Method of administration and doses
Take orally during or immediately after meals, the tablets should be swallowed whole, without chewing, with plenty of liquid (water, fruit juices). The dosage of the drug is based on the individual needs of the patient and depends on his age, the degree of digestive disorders and the composition of the food.
It is recommended to take 1-2 tablets (14000-28000 IU lipase) with each meal. However, it is possible that some patients may need to increase the dose by 1.5-2 times or even more to eliminate steatorrhea and maintain proper nutritional status. It is not recommended to exceed the dose of 15000-20000 IU lipase/kg body weight/day.
The duration of treatment can vary from several days (in case of indigestion due to excessive food consumption) to several months or even years (if permanent replacement therapy is necessary).
Children
The drug is recommended for use in children aged 4 years and older.
Overdose
Symptoms: hyperuricosuria, hyperuricemia; in children - constipation.
Treatment: drug withdrawal, adequate hydration, symptomatic therapy.
Side effects
On the part of the digestive system: very rarely - nausea, vomiting, flatulence, diarrhea, discomfort in the epigastric region, change in the nature of stools.
Hypersensitivity reactions (including rash, itching, sneezing, lacrimation, bronchospasm, urticaria, anaphylactic reactions), perianal irritation are possible.
Expiration date
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
Tablets No. 10, No. 10´2, No. 10´5 in blisters in a box.
Vacation category
Without a prescription.
Producer
Limited Liability Company "Pharmaceutical Company "Zdorovya".
Address
Ukraine, 61013, Kharkiv region, Kharkiv city, Shevchenko street, building 22.
