Mezym® capsules 10000

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEZYM® CAPSULES 10000 / MEZYM® CAPSULES 25000 (MEZYM® CAPSULES 10000 / MEZYM® CAPSULES 25000)

Composition:

Active substance: pancreatic powder (from pigs);

MEZYM® CAPSULES 10000: 1 hard capsule contains 153.5 (98.3 – 178.6) mg of pancreatic powder (from pigs) with a minimum lipolytic activity of 10000 IU Ph. Eur. (European Pharmacopoeia units), minimum amylolytic activity of 9000 IU Ph. Eur., and minimum proteolytic activity of 500 IU Ph. Eur.;

MEZYM® CAPSULES 25000: 1 hard capsule contains 356.1 (245.6 – 446.6) mg of pancreatic powder (from pigs) with a minimum lipolytic activity of 25000 IU Ph. Eur., minimum amylolytic activity of 22500 IU Ph. Eur., and minimum proteolytic activity of 1250 IU Ph. Eur.;

Excipients: microcrystalline cellulose, sodium croscarmellose, hydrogenated castor oil, colloidal anhydrous silicon dioxide, 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), yellow iron oxide (E 172), red iron oxide (E 172), simethicone emulsion 30% dry mass (consisting of simethicone, sorbitan tristearate polyethylene glycol, methylcellulose, polyethylene glycol stearate, hydroxyl-terminated dimethylsiloxane, mono- and diglycerides, polyethylene glycol, xanthan gum, triglycerides, benzoic acid (E 210), glycerin, sodium chloride, octamethylcyclotetrasiloxane, sorbic acid, sulfuric acid, purified water).

Pharmaceutical form. Hard capsules containing enteric-coated mini-tablets.

Main physicochemical properties:

MEZYM® CAPSULES 10000: hard capsules of size 2 with an opaque yellowish-green cap and an opaque light-orange body, containing light-brown, shiny, homogeneous mini-tablets.

MEZYM® CAPSULES 25000: hard elongated capsules of size 0 with an opaque yellowish-green cap and an opaque light-orange body, containing light-brown, shiny, homogeneous mini-tablets.

Pharmacotherapeutic group.

Digestive enzymes. Pancreatic enzyme preparations.

ATC code A09AA02.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the medicinal product MEZIM® CAPSULES is pancreatic powder (from pigs), which participates in the breakdown of fats, proteins, and carbohydrates in the gastrointestinal tract. The activity of the preparation is mainly determined by the enzymatic activity of lipase, as well as the content of trypsin, whereas amylolytic activity is relevant only in the treatment of cystic fibrosis.

Pharmacokinetics.

Mini-tablets are released from the soluble capsules already in the stomach, where they mix uniformly with food masses. In the stomach, the coating of mini-tablets, resistant to gastric juice, protects acid-sensitive enzymes from inactivation by hydrochloric acid. Enzymes are released only after reaching the neutral or slightly alkaline environment of the small intestine, following dissolution of the coating. Since pancreatic powder is not absorbed in the gastrointestinal tract, information regarding its pharmacokinetics and bioavailability is lacking.

The efficacy of pancreatic powder is determined by the extent and rate of enzyme release from the dosage form.

Clinical characteristics.

Indications.

Exocrine pancreatic insufficiency associated with impaired digestion.

Contraindications.

• Hypersensitivity to the active substance, pork meat (allergy to pork), or to any of the excipients of the medicinal product.
• Acute pancreatitis or acute exacerbation of chronic pancreatitis. However, if digestive disturbances persist, occasional use of the drug may be appropriate during the resolving phase of exacerbation when expanding the diet.

Interaction with other medicinal products and other forms of interaction.

Folic acid.

When using medicinal products containing pancreatic powder, absorption of folic acid may be reduced, which may require additional supplementation.

Acarbose, miglitol.

The blood glucose-lowering effect of oral antidiabetic agents acarbose and miglitol may be reduced when used concomitantly with MEZIM® CAPSULES.

Special precautions for use.

Intestinal obstruction is a known complication in patients with cystic fibrosis; therefore, intestinal strictures should be considered in patients presenting symptoms resembling those of intestinal obstruction (see also section "Adverse reactions"). In case of unusual abdominal discomfort or changes in symptoms, precautionary examination should be performed to exclude intestinal involvement, especially if the patient is receiving a dose exceeding 10,000 IU EPI of lipase per kilogram of body weight per day.

MEZIM® CAPSULES contain active enzymes which, if released in the oral cavity (e.g., by chewing), may damage the mucous membrane and cause ulceration. Therefore, the capsules should be swallowed whole.

Use during pregnancy or breastfeeding.

There are insufficient data on the use of Mezim® Capsules in pregnant women. There is also insufficient information from animal studies regarding the effects on pregnancy, embryonic/fetal development, labor, or postnatal development; therefore, the potential risk to humans is unknown. For this reason, Mezim® Capsules should not be used during pregnancy or lactation, except when absolutely necessary.

Ability to affect reaction speed while driving or operating machinery.

The effect of Mezim® Capsules on the ability to drive vehicles or operate machinery is absent or negligible.

Dosage and Administration.

Administration

The dosage of the medication is determined individually for each patient depending on the degree of digestive impairment and the composition of food. For individual dosage selection, two dosage forms of the drug are available – CREON® CAPSULES 10000 and CREON® CAPSULES 25000.

Capsules should be swallowed whole with a large amount of liquid, preferably during meals, since the effectiveness of CREON® CAPSULES may decrease if chewed, and enzymes released in the oral cavity may damage its mucous membrane.

For easier administration (e.g., in children or elderly patients), hard capsules may also be opened, and only the contents swallowed with a small amount of liquid.

Dosage

The dose should be individually adjusted according to the severity of digestive impairment and the amount of fat in the food. The recommended dose per meal is: 2–4 capsules of CREON® CAPSULES 10000 (corresponding to 20,000–40,000 IU Ph. Eur. of lipase) or 1 capsule of CREON® CAPSULES 25000 (corresponding to 25,000 IU Ph. Eur. of lipase). The usual recommended dose is 20,000–50,000 IU Ph. Eur. of lipase per meal, but depending on the type of food and the severity of digestive disorders, the dose may be higher.

The daily dose of enzymes should not exceed 15,000–20,000 IU of lipase per kilogram of body weight.

The enzyme dose required for adequate fat absorption should not be exceeded, taking into account the quantity and composition of food, especially in patients with cystic fibrosis.

Dose increases should only be performed under medical supervision.

Duration of Use

The duration of treatment with CREON® CAPSULES is determined by the physician depending on the nature and course of the disease.

Children.

CREON® CAPSULES may be used in the treatment of children. Dosage and duration of treatment are determined by a physician.

Overdose.

Administration of very high doses of pancreatic enzymes, particularly in patients with cystic fibrosis, may be associated with hyperuricosuria and hyperuricemia.

Side effects

The following classification is used to assess the frequency of adverse reactions: very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1,000 to < 1/100; rare: ≥ 1/10,000 to < 1/1,000; very rare: < 1/10,000; not known (cannot be estimated from the available data).

Gastrointestinal disorders

Very rare: abdominal pain, nausea, diarrhea, abdominal discomfort, vomiting. In patients with cystic fibrosis, use of high doses of pancreatic enzyme powder may lead to the formation of strictures in the ileocecal region and ascending colon.

Urinary system disorders

Not known: in patients with cystic fibrosis, increased urinary excretion of uric acid may occur, particularly when high doses of pancreatic enzyme powder are used. Therefore, to prevent formation of uric acid calculi, urinary uric acid levels should be monitored in such patients.

Immune system disorders

Very rare: immediate-type allergic reactions (such as skin rash, urticaria, sneezing, lacrimation, bronchospasm, dyspnea), hypersensitivity reactions localized in the gastrointestinal tract.

Reporting suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions.

Shelf life

2 years.

After first opening of the bottle – 6 months (for polypropylene bottle).

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep the medicinal product out of the reach of children.

Packaging

Polypropylene bottle containing 20 or 50 hard capsules and silica gel as desiccant; one polypropylene bottle per cardboard box.

10 hard capsules in an aluminum-aluminum blister; 2 or 5 blisters per cardboard box.

Supply classification

Over-the-counter (without prescription).

Manufacturer

BERLIN-CHEMIE AG

Manufacturer's address and place of business

Glienicker Weg 125, 12489 Berlin, Germany

Marketing authorization holder

Menarini International Operations Luxembourg S.A.

Address of the marketing authorization holder

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg