Instructions Creazim 20000 hard capsules 0.28 g blister No. 20
Composition
active ingredient:
Creazim 20000: 1 capsule contains pancreatin in enteric-coated granules with enzymatic activities of not less than: 20000 lipolytic U Ph. Eur., 16000 amylolytic U Ph. Eur., 1200 proteolytic U Ph. Eur.;
excipients: polyethylene glycol 4000 (macrogol 4000), methacrylate copolymer dispersion, simethicone, talc, triethyl citrate;
capsule composition (Creazim 20000): titanium dioxide (E 171), sunset yellow FCF (E 110), carmoisine (E 122), diamond black BN (E 151), iron oxide (E 172), gelatin.
Dosage form
The capsules are hard, enteric-coated.
Main physicochemical properties: hard gelatin capsules of cylindrical shape with an opaque red body and an opaque black cap, containing beige-brown granules (Creazim 20000).
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations. ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
Creazim is an enzyme preparation of animal origin. The drug improves digestion processes. The therapeutic effect of the drug is based on the activity of pancreatic enzymes lipase, amylase and protease, which are part of pancreatin and ensure the digestion of fats, carbohydrates and proteins, contributing to a more complete absorption of nutrients in the small intestine.
The special dosage form of the drug avoids a decrease in enzyme activity due to inactivation by gastric juice.
Pharmacokinetics
The drug granules, contained in a capsule and having an acid-resistant coating, move evenly with the contents of the stomach and enter the duodenum. The release and activation of enzymes begins in the small intestine (at pH 5.5), where the coating of the granules disintegrates.
Indication
Replacement therapy for exocrine pancreatic insufficiency in the following conditions:
chronic pancreatitis; pancreatectomy; pancreatic cancer; obstruction of the pancreatic or common bile duct (e.g., by a tumor); Shwachman-Diamond syndrome; other diseases accompanied by exocrine pancreatic insufficiency.
Contraindication
Hypersensitivity to pancreatin of animal origin or to any other component of the drug; acute inflammation of the pancreas in the early stages; exacerbation of chronic pancreatitis.
Interaction with other medicinal products and other types of interactions
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 pancreatic enzyme preparations, therefore monitoring of folic acid levels is recommended during concomitant use.
Acarbose, miglitol. It is possible that pancreatic enzyme preparations may reduce the effect of these antidiabetic agents. Therefore, monitoring of the effect of antidiabetic agents on the patient's blood sugar level is recommended during concomitant treatment with pancreatin.
Application features
Pancreatin preparations contain active proteins that may cause mucosal damage (e.g., mouth ulcers) when released into the oral cavity (e.g., by chewing). Therefore, the drug should be taken without chewing.
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.
It should be used with caution in patients with renal failure and hyperuricemia.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the negative impact of Creazim on the ability to drive vehicles or operate dangerous machinery.
Use during pregnancy or breastfeeding
Due to the lack of clinical data on the effect of pancreatic enzymes on the course of pregnancy, the drug should be prescribed with caution during pregnancy. Animal studies have shown no signs of absorption of pancreatic enzymes. Thus, the possibility of toxic effects on reproductive function and fetal development is excluded.
Use during pregnancy and breastfeeding is possible if, in the opinion of the doctor, the expected positive effect for the mother outweighs the potential risk to the fetus or child.
Method of administration and doses
The dosage of the drug is based on the individual needs of the patient and depends on the degree of digestive disorders and the composition of the food.
Capsules with granules should be swallowed whole, without chewing and washed down with a sufficient amount of liquid (approximately 100 ml). If the capsule cannot be swallowed whole (elderly people), it can be opened and the granules added to liquid food that does not require chewing, or to a liquid with a pH of less than 5.0 (e.g. grated apple, yogurt). This mixture should be taken immediately and not stored.
During treatment with Creazim 10000 and 20000, it is very important to drink enough fluids, especially during periods of increased fluid loss. Fluid deficiency can worsen constipation.
Dosage for other types of exocrine pancreatic insufficiency.
The dose should be selected individually, depending on the degree of indigestion and the fat content of the food.
The usual starting dose is 10,000 to 20,000 IU of lipase with each main meal. However, it is possible that some patients may require higher doses to eliminate steatorrhea and maintain adequate nutritional status. Therefore, the dose for administration during main meals (breakfast, lunch or dinner) may be 20,000 to 70,000 IU of lipase, and with additional light meals between main meals - 5,000 to 20,000 IU of lipase.
If the dose per dose is a multiple of 20,000 U of lipase, it is more convenient to use the drug Creazim 20,000, which contains 20,000 U of lipase in one capsule.
The duration of treatment can vary from several days (in case of nutritional disorders due to dietary errors) to several months and even years (if permanent replacement therapy is necessary).
Children
The medicine is not used in children.
Overdose
Hyperuricemia and hyperuricuria have been observed with extremely high doses of other pancreatin preparations.
Adverse reactions
Gastrointestinal: abdominal pain, flatulence, constipation, changes in bowel habits, diarrhea, vomiting and nausea.
In order to exclude colonic involvement, any unusual symptoms or changes in the abdominal cavity should be monitored, especially when the patient is taking the drug at a dose of more than 10,000 lipase units/kg/day.
Immune system disorders: hypersensitivity reactions, including bronchospasm.
Skin and subcutaneous tissue disorders: Allergic skin reactions may occur, including rash, itching, urticaria, and skin hyperemia.
General disorders: weakness.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 capsules in a blister, 2 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
Technolog PJSC.
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
