Instructions for Mezim 25000 capsules No. 20
Composition
active ingredient: powder from pancreas (pigs);
MEZIM® CAPSULES 10000: 1 hard capsule contains 153.5 (98.3 – 178.6) mg of pancreatic powder (pigs), which has a minimum lipolytic activity of 10,000 EF units (European Pharmacopoeia units), a minimum amylolytic activity of 9,000 EF units, and a minimum proteolytic activity of 500 EF units;
MEZIM® CAPSULES 25000: 1 hard capsule contains 356.1 (245.6 – 446.6) mg of pancreatic powder (pigs), which has a minimum lipolytic activity of 25000 EF units, a minimum amylolytic activity of 22500 EF units, and a minimum proteolytic activity of 1250 EF units;
excipients: microcrystalline cellulose, croscarmellose sodium, hydrated castor oil, colloidal anhydrous silica, magnesium stearate, methacrylic acid and ethacrylate copolymer (1:1) dispersion 30%, talc, triethyl citrate, gelatin, titanium dioxide (E 171), quinoline yellow (E 104), indigo carmine (E 132), iron oxide yellow (E 172), iron oxide red (E 172), simethicone emulsion 30% dry weight (consisting of simethicone, polyethylene glycol sorbitan tristearate, methylcellulose, polyethylene glycol stearate, dimethylsiloxane with hydroxylated end groups, mono- and diglycerides, polyethylene glycol, xanthan gum, triglycerides, benzoic acid (E 210), glycerin, sodium chloride, octamethylcyclotetrasiloxane, sorbic acid, sulfuric acid, purified water).
Dosage form
Hard capsules with enteric-coated mini-tablets.
Main physicochemical properties:
MEZIM® CAPSULES 10000: size 2 hard capsules with an opaque yellowish-green cap and an opaque light orange body, containing light brown shiny homogeneous mini-tablets.
MEZIM® CAPSULES 25000: hard capsules size 0, elongated, with an opaque yellowish-green cap and an opaque light orange body, containing light brown shiny homogeneous mini-tablets.
Pharmacotherapeutic group
Digestive aids, including enzymes. Polyenzyme preparations.
ATX code A09A A02.
Pharmacological properties
Pharmacodynamics
The active substance of the drug MEZIM® CAPSULES is a powder from the pancreas (pigs), which is involved in the process of breaking down fats, proteins and carbohydrates in the digestive tract. The activity of the drug is mainly determined by the enzymatic activity of lipase, as well as the content of trypsin, while the amylolytic activity is of importance only in the therapy of cystic fibrosis.
Pharmacokinetics
Mini-tablets are released from soluble capsules in the stomach, where they are evenly mixed with food. In the stomach, the shell of the mini-tablets, resistant to the action of gastric juice, protects the acid-sensitive enzymes from inactivation by hydrochloric acid. Only after reaching a neutral or slightly alkaline environment in the small intestine are the enzymes released after dissolution of the shell. Due to the fact that the pancreatic powder is not absorbed in the digestive tract, there is no information on its pharmacokinetics and bioavailability.
The effectiveness of pancreatic powder is determined by the degree and rate of enzyme release from the dosage form.
Indication
Disturbances of the exocrine function of the pancreas, accompanied by digestive disorders.
Contraindication
Hypersensitivity to the active substance, pig meat (pork allergy) or to any of the excipients of the medicinal product.
Acute pancreatitis or chronic pancreatitis in the exacerbation stage. However, if digestive disorders persist, episodic administration of the drug is advisable in the phase of subsiding exacerbation with expansion of the diet.
Interaction with other medicinal products and other types of interactions
Folic acid.
When using preparations containing pancreatic powder, the absorption of folic acid may decrease, which may require additional intake into the body.
Acarbose, miglitol.
The blood sugar-lowering effect of the oral antidiabetic drugs acarbose and miglitol may be reduced with simultaneous use of MEZIM® CAPSULES.
Application features
Intestinal obstruction is a known complication in patients with cystic fibrosis, therefore, in case of symptoms similar to those of intestinal obstruction, the possibility of intestinal strictures should be considered (see also section "Adverse reactions"). In case of unusual abdominal discomfort or changes in symptoms, it is recommended to undergo an examination as a precaution to exclude intestinal damage, especially if the patient uses a dose of more than 10,000 IU of EF lipase per kilogram of body weight per day.
MEZIM® CAPSULES contain active enzymes that, when released in the oral cavity, for example, when chewed, can damage its mucous membrane with the formation of ulcers, therefore the capsules should be swallowed whole.
Use during pregnancy or breastfeeding
There are no adequate data on the use of the drug MEZIM® CAPSULES in pregnant women. There is insufficient data on the effects on pregnancy, embryonal/fetal development, childbirth or postnatal development obtained in animal experiments, so the potential risk to humans is unknown. In this regard, the drug MEZIM® CAPSULES should not be taken during pregnancy and lactation, except in cases where its use is absolutely necessary.
The ability to influence the reaction speed when driving or working with other mechanisms
The effect of MEZIM® CAPSULES on the ability to drive vehicles or operate other mechanisms is absent or insignificant.
Method of administration and doses
Method of application
The dosage of the drug is determined individually for each patient depending on the degree of digestive disorders and the composition of the food. For individual dose selection, there are two types of dosage of the drug - MEZIM® CAPSULES 10000 and MEZIM® CAPSULES 25000.
The capsules should be swallowed whole with plenty of liquid, preferably during meals, as the effectiveness of the drug MEZIM® CAPSULES may decrease when chewed, and the enzymes contained in the drug, when released in the oral cavity, may damage its mucous membrane.
For ease of use (e.g. children, elderly patients), hard capsules can also be opened and only their contents swallowed with a small amount of liquid.
Dosage
The dose should be selected individually, depending on the severity of the digestive disorder and the amount of fat in the food. The recommended dose per meal: 2-4 capsules of MEZIM® CAPSULES 10000 (corresponding to 20000-40000 EF lipase units) or 1 capsule of MEZIM® CAPSULES 25000 (corresponding to 25000 EF lipase units). Usually the recommended dose is a dose of lipase 20000-50000 EF lipase units per meal, but depending on the type of food, as well as the severity of the digestive disorder, the dose of the drug may be higher.
The daily dose of enzymes should not be exceeded, which is 15,000 - 20,000 U of lipase per kilogram of body weight.
The dose of enzymes necessary for sufficient fat absorption, taking into account the amount and composition of food, should not be exceeded, especially in patients with cystic fibrosis.
Increasing the dose should only be done under the supervision of a doctor.
Duration of use
The course of treatment with the drug MEZIM® CAPSULES is determined by the doctor depending on the nature and course of the disease.
Children
The drug MEZIM® CAPSULES is used to treat children. The dosage and duration of treatment are determined by the doctor.
Overdose
The use of very high doses of pancreatic enzymes, particularly in patients with cystic fibrosis, may be accompanied by hyperuricosuria and hyperuricemia.
Side effects
The following classification is used to estimate the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 - < 1/10; uncommon: ≥ 1/1000 - < 1/100; rare: ≥ 1/10000 - < 1/1000; very rare: < 1/10000, unknown (cannot be determined from the available data).
Digestive tract disorders.
Very rare: abdominal pain, nausea, diarrhea, abdominal discomfort, vomiting. In patients with cystic fibrosis, when using high doses of pancreatic powder, strictures may form in the ileocecal region and in the ascending part of the colon.
Disorders of the genitourinary system.
Unknown: in patients with cystic fibrosis, especially when using high doses of pancreatic powder, increased urinary excretion of uric acid is possible, therefore, to avoid the formation of uric acid stones in such patients, its content in the urine should be monitored.
Immune system disorders.
Very rare: immediate-type allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnoea), hypersensitivity reactions localized in the gastrointestinal tract.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicine has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.
Expiration date
2 years. After the first opening of the can – 6 months.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 25 °C.
Keep the medicine out of the reach of children.
Packaging
Polypropylene jar containing 20 or 50 hard capsules and silica gel as a desiccant; 1 polypropylene jar in a cardboard box.
Vacation category
Without a prescription.
Producer
BERLIN-CHEMI AG.
Address
1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg.
Applicant
Menarini International Operations Luxembourg S.A.
