This drug belongs to the clinical-pharmacological group of enzymes. Mezim forte replenishes missing enzymes for better digestion of food. It is available without a doctor's prescription, which is not a reason for the uncontrolled use of this drug.
Before using it, it is advisable to consult a specialist: a gastroenterologist or therapist. Particular caution should be used when using the drug to alleviate the condition of children and the elderly. Let's find out the composition of the drug Mezim forte.
Pharmacological properties
Pharmacodynamics.
The active ingredient of the drug Mezim Forte is a powder from the pancreas (pancreatin) of mammals, usually pigs, which, in addition to excretory pancreatic enzymes (lipase, alpha-amylase, trypsin and chymotrypsin), also contains other enzymes. Pancreatin also contains other related substances that do not have enzymatic activity. Pharmacokinetics. Suction. Powder from the pancreas is not absorbed in the gastrointestinal tract and is excreted in the feces. Most of it disintegrates or denatures under the action of digestive juices or bacteria.
Bioavailability. The enteric coating of the tablets, resistant to the action of gastric juice, protects acid-sensitive enzymes from inactivation when passing through the stomach. Only after reaching a neutral or slightly alkaline environment in the small intestine are enzymes released after dissolution of the membrane. Due to the fact that the powder from the pancreas is not absorbed into the gastrointestinal tract, there is no information on its pharmacokinetics and bioavailability.
The effectiveness of pancreas powder is determined by the degree and rate of enzyme release from the dosage form.
Application
Recommended dose per meal: 2–4 tablets Mezim Forte 10,000 or 1–2 tablets Mezim Forte 20,000 (corresponds to 20,000–40,000 units of e.f. lipase).
The dose of Mezim forte is determined according to the severity of the existing pancreatic insufficiency. Typically the recommended dose of lipase is 20,000–40,000 IU EF per meal, but it may be higher.
The goal of treatment with Mezim Forte is to achieve or maintain normal body weight and normalize the frequency of bowel movements or stool consistency. Increasing the dose should only be carried out under the supervision of a physician and in order to reduce the severity of symptoms (for example, steatorrhea, stomach pain).
The daily dose of enzymes should not exceed 15,000–20,000 units of lipase per kilogram of body weight.
Mezim Forte tablets should be swallowed whole, with plenty of liquid, during meals, since the effectiveness of the drug Mezim Forte may decrease when chewed; the enzymes contained in the drug, when released in the oral cavity, can damage its mucous membrane.
The duration of treatment depends on the course of the disease and is determined by the doctor.
Composition of the drug
The main active ingredient of Mezim Forte is pancreatin, obtained from pig pancreas tissue and undergone special processing. Depending on the concentration of pancreatin, one tablet contains:
- Mezim forte – 93-108 mg;
- Mezim forte 10000 – 125 mg;
- Mezim forte 20000 – 220-293 mg.
The components of pancreatin are active enzymes such as:
- amylase (Mezim forte - 4200 units, Mezim forte 10000 - 7500 units, Mezim forte 20000 - 12000 units);
- lipase (Mezim forte - 3500 units, Mezim forte 10000 - 10000 units, Mezim forte 20000 - 20000 units);
- protease (Mezim forte - 250 units, Mezim forte 10000 - 375 units, Mezim forte 20000 - 900 units).
In addition to these enzymes, the drug contains excipients.
Side effects
To assess the frequency of side effects, the following classification is used: very often (≥1/10), often (≥1/100 and 1/10), infrequently (≥1/1000 and 1/100), rarely (≥1/10,000 and 1/1000), very rare (1/10,000), frequency unknown (estimate cannot be made from available data).
From the immune system. Very rare: immediate allergic reactions (skin rash, sneezing, lacrimation, bronchospasm, dyspnea), hypersensitivity reactions localized in the gastrointestinal tract.
From the gastrointestinal tract. Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting. The formation of strictures in the ileocecal region and in the ascending colon has been described after the administration of a preparation containing pancreatic powder in high doses.
Reports of suspected adverse reactions. Reporting of suspected adverse reactions after drug registration plays an important role. This allows continued monitoring of the benefit-risk ratio of the drug. Healthcare professionals should report any suspected adverse reactions.
Side effects and contraindications
Mezim Forte is not used during acute pancreatitis and exacerbations of its chronic form. Contraindications to its use are:
- individual intolerance to the components of the drug (pancreatin, components of the tablet shell);
- intestinal obstruction due to obstruction (mechanical obstruction).
Taking the drug without consulting a doctor may cause the following side effects:
- allergic manifestations – runny nose, dermatitis, bronchospasm, lacrimation;
- functional disorders of the gastrointestinal tract - diarrhea, nausea, abdominal pain, constipation;
- in patients with cystic fibrosis - narrowing of the colon or ileocecal canal;
- in patients with cystic fibrosis - increased secretion of uric acid.
special instructions
If unusual abdominal discomfort or changes in symptoms occur, it is recommended as a precautionary measure to undergo an examination to exclude intestinal damage, especially if the patient is using a dose of 20,000 U f.u. lipase per 1 kg of body weight per day.
The drug contains active enzymes that can damage the oral mucosa, including the formation of ulcers, so the tablets should be swallowed whole without chewing.
Mezim Forte should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
During pregnancy and breastfeeding. There is no sufficient data on the use of the drug Mezim Forte in pregnant women. There is insufficient data from animal experiments regarding the effects on pregnancy, embryo/fetal development, childbirth or postnatal development, so the potential risk to humans is unknown. In this regard, the drug Mezim forte should not be taken during pregnancy and breastfeeding, unless its use is absolutely necessary.
Children. The drug Mezim forte is used in children over 3 years of age. The dose and duration of use are determined by the doctor.
The ability to influence reaction speed when driving vehicles or working with other mechanisms. The effect of Mezim Forte on the ability to drive vehicles or operate other machinery is absent or insignificant.
Mezim 20000 20 pcs. enteric-coated tablets
pharmachologic effect
Replenishes pancreatic enzyme deficiency.
Composition and release form Mezim 20000 20 pcs. enteric-coated tablets
Tablets - 1 tablet:
- Active ingredient: Pancreatin* with minimal activity: amylase 12000 IU; lipase 20,000 units; protease 900 units;
- Excipients: microcrystalline cellulose (type 12), crospovidone (type A), colloidal anhydrous silicon dioxide, magnesium stearate, lactose monohydrate.
- Shell: hypromellose, methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30% (dry weight), triethyl citrate, titanium dioxide, E 171, talc, simethicone emulsion 30% (dry weight), vanilla flavor, scented flavor bergamot, macrogol 6000, carmellose sodium, polysorbate 80, hydroxide.
*obtained from pork pancreas
Enteric tablets, film-coated, 20,000 units.
10 tablets in a blister pack (blister) [aluminum foil/aluminum foil].
1, 2 or 5 blisters with instructions for use in a cardboard box.
Description of the dosage form
Round, biconvex, film-coated tablets, from white to white with a grayish tint, with a smooth surface, with a specific odor, brown inclusions are possible at the break.
Directions for use and doses
The dose of Mezim® 20000 is set individually depending on the disease and severity of symptoms.
Unless otherwise indicated, adults should take 1-2 tablets of Mezim® 20000 with meals. The drug is taken orally without breaking or chewing the tablet (the effectiveness of Mezim® 20000 may decrease when chewed and pancreatic enzymes, when released, may irritate the oral mucosa), with a sufficient amount of liquid (for example, a glass of water).
It is not recommended to exceed the daily dose of pancreatic enzymes corresponding to 15,000-20,000 IU of lipase/kg of body weight.
Increasing the dose should only be done under the supervision of a physician, focusing on symptoms (for example, a decrease in steatorrhea and abdominal pain).
The duration of treatment is determined by the doctor and can vary from several days (in case of indigestion due to an error in diet) to several months and even years (if constant replacement therapy is necessary).
In children, the dosage is determined by the doctor.
Dose for children and adults with cystic fibrosis
In patients with cystic fibrosis, the dose should be adjusted based on the severity of symptoms of the disease, control of steatorrhea, and maintenance of adequate nutritional status (see section "Special Instructions").
The dose should not exceed 10,000 IU lipase/kg body weight per day.
In children, the dosage regimen and duration of treatment are determined by the doctor depending on the severity of digestive disorders and the composition of the diet, at the rate of 1000 IU of lipase/kg of child’s body weight for each meal for children under 4 years of age and 500 IU of lipase/kg of child’s body weight for each meals for children over 4 years old.
If there is no improvement after treatment, or symptoms worsen, or new symptoms appear, you should consult your doctor.
Use the drug only according to the indications, method of administration and in the doses indicated in the instructions.
Pharmacodynamics
Pancreatin is a powder made from porcine pancreas. Pancreatic enzymes, which are part of pancreatin, have a proteolytic, amylolytic and lipolytic effect and promote the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT), thus normalizing digestive processes.
Pharmacokinetics
Mezim® 20000 tablets are coated with an acid-resistant coating, which is resistant to the effects of gastric hydrochloric acid and, thereby, protects the pancreatic enzymes contained in the drug from inactivation. Dissolution of the enteric coating and release of enzymes occurs at neutral or slightly alkaline pH values.
Indications for use Mezim 20000 20 pcs. enteric-coated tablets
- Insufficiency of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.);
- Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder;
- Conditions after resection or irradiation of the gastrointestinal tract, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy);
- To improve food digestion in patients with normal gastrointestinal function in case of dietary errors;
- Preparation for x-ray and ultrasound examination of the abdominal organs;
- Functional gastrointestinal disorders (acute intestinal infections, irritable bowel syndrome, etc.).
Contraindications
- Hypersensitivity to any of the components of the drug;
- Acute pancreatitis or chronic pancreatitis in the acute stage. However, it is possible to use it in the phase of a fading exacerbation when expanding the diet, if there are signs of digestive disorders;
- Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;
- Children up to 3 years of age (for this dosage form).
Application Mezim 20000 20 pcs. Enteric-coated tablets during pregnancy and breastfeeding
Before using Mezim® 20000, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.
During breastfeeding, before using Mezim® 20000, you should consult your doctor.
There are no data on the use of pancreatin during pregnancy and breastfeeding.
During pregnancy and breastfeeding, the prescription of pancreatin by the attending physician is possible only if the expected benefit to the mother outweighs the possible risk to the fetus or child.
special instructions
In case of acute pancreatitis or exacerbation of chronic pancreatitis (at the stage of attenuation of the exacerbation), during the period of restorative dietary nutrition, it is advisable to take the drug Mezim® 20000 against the background of existing and/or remaining exocrine pancreatic insufficiency.
In patients with cystic fibrosis, especially when taking high doses of pancreatin, hyperuricosuria may occur, so the concentration of uric acid in the urine should be monitored in this group of patients.
In the above group of patients, strictures in the ileocecal and ascending colon are described.
As a precautionary measure, if unusual abdominal discomfort occurs or changes in the nature of complaints, especially when taking more than 10,000 IU of lipase/kg body weight per day, a medical examination is necessary.
The drug Mezim® 20000 contains active enzymes that, when released in the oral cavity, for example during chewing, can damage the oral mucosa (including the formation of ulcers). Therefore, the tablet must be swallowed whole.
The drug contains lactose, so it is contraindicated in patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.
The drug Mezim® 20000 does not affect or has an insignificant effect on the ability to drive vehicles and other mechanisms.
Storage conditions:
Store at a temperature not exceeding 30 °C.
Overdose
Symptoms: hyperuricosuria and hyperuricemia (especially in patients with cystic fibrosis taking high doses of enzyme preparations).
Treatment: symptomatic therapy, drug withdrawal.
Side effects Mezim 20000 20 pcs. enteric-coated tablets
Possible side effects are listed below in descending frequency of occurrence: very often (≥ 1/10), often (>1/100.1/1000.1/10000,
Immune system disorders
Very rare: immediate allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), gastrointestinal hypersensitivity.
Gastrointestinal disorders
Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; formation of strictures in the ileocecal and ascending colon in patients with cystic fibrosis when using high doses of pancreatin.
Disorders of the genitourinary system
Frequency unknown: hyperuricosuria (see section "Special instructions").
If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, tell your doctor.
Drug interactions
It is possible to reduce the absorption of folic acid when used simultaneously with pancreatin preparations. The effect of oral hypoglycemic agents (such as acarbose, miglitol) may be reduced when used simultaneously with digestive enzyme preparations containing enzymes that break down carbohydrates (for example, amylase).
If you are using the above or other medications (including over-the-counter medications), consult your doctor before using Mezim® 20000.
Note!
Description of the drug Mezim forte 20000 tablets. No. 20 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
Release form
Mezim forte: tablets
The drug is available in tablets, the active substance of which is coated with a protective coating. Depending on the concentration of the active substance, there are:
- Mezim forte - pink cylindrical tablets, packed in blisters of 20 pcs.;
- Mezim forte 10000 - pink cylindrical tablets, packed in blisters of 10 pcs.;
- Mezim forte 20000 – round white tablets with spots at the break, packed in blisters of 10 pcs.
Packages of this product may contain 10, 20, 50, 80 tablets that have a characteristic odor. The popularity of the drug and the presence of counterfeits prompted the manufacturer, the German pharmaceutical company Berlin-Chemie AG/Menarini Group, to develop anti-counterfeit protection for Mezim Forte.
The original packaging has a hologram on the top right of the packaging, under the top layer of which, when erased with any hard object, a stylized letter “M” is revealed.
