Мезим® forte 10000

General characteristics. Structure:

Active agent: Pancreatinum mg powder-137,5 with the minimum enzymatic activity:
• lipases of 10000 PIECES of Ph. Eur.
• amylases of 7500 PIECES Ph. Eur.
• proteases of 375 PIECES Ph. Eur.

Excipients: lactoses monohydrate, cellulose microcrystallic, silicon dioxide colloid, кросповидон, magnesium stearate; cover: gipromelloza (~ 5 MPas • c), methacrylic acid and ethyl acrylate of copolymer (1:1) dispersions of 30% (dry weight), triethyl citrate, titanium dioxide (Е 171), talc, simetikon emulsion of 30% (dry weight), macrogoal 6000, karmelloza of sodium (~ 30 MPas • c), polysorbate 80, azoruby varnish (Е 122), sodium hydroxide.

Pharmacological properties:

Pharmacodynamics. The fermental drug improving digestion. Pancreatinum represents powder from pork pancreases which along with vneshnesekretorny pancreatic enzymes - a lipase, amylase, protease, trypsin and chymotrypsin contains also other enzymes.

The pancreatic enzymes which are a part of drug facilitate the proteolysis, fats and carbohydrates that leads to their fuller absorption in a small bowel. Trypsin suppresses stimulated secretion of a pancreas, having analgeziruyushchy effect. The maximum enzymatic activity of drug is noted in 30-45 min. after oral administration.

Pharmacokinetics. The tablets Mezim® forte 10000 are covered with an acid resisting cover which is not dissolved under the influence of hydrochloric acid of a stomach and by that protects the enzymes which are contained in drug from an inactivation.

Dissolution of a cover and release of enzymes happens at value рН close to neutral or alkalescent.

Indications to use:

• replacement therapy at vneshnesekretorny insufficiency of functions of a pancreas (including chronic pancreatitis, a mucoviscidosis);
• chronic inflammatory and dystrophic diseases of a stomach, intestines, liver, gall bladder;
• the states after a resection or radiation of bodies of a GIT which are followed by disturbance of digestion of food, a meteorism, diarrhea (as a part of a combination therapy);
• disorder of a GIT of functional character (at intestinal infectious diseases, a syndrome of the angry intestines, etc.);
• for improvement of digestion of food at patients with the GIT normal function in case of errors in food;
• preparation for radiological and ultrasonic researches of abdominal organs.

Route of administration and doses:

The drug Mezim® dose forte 10000 is established individually depending on degree of manifestation of a disease and structure of food. If there are no other instructions, the average single dose for adults makes 2-4 tablets Mezim® forte 10000 on meal. It is recommended to accept a half or a third of a single dose at the beginning of food, and other part during it. Drug is accepted inside, without chewing and washing down with enough liquid. Increase in a dose which should be carried out only under control of the doctor is possible, being guided at the same time by weakening of symptomatology (for example, steatorrheas, abdominal pains). The maximum daily dose - 15000-20000 PIECES of Ph. Eur. body weight lipases/kg.

To children the mode of dosing is set by the doctor depending on degree of manifestation of a disease and structure of food at the rate of 500-1000 PIECES of Ph. Eur. lipases/kg of body weight of the child on each meal.

Duration of treatment can vary of several days (at disturbance of digestion, an error in a diet) up to several months and even years (in need of continuous replacement therapy).

Features of use:

At acute pancreatitis or an exacerbation of chronic pancreatitis (at a stage of attenuation of an aggravation), during recovery dietary food. it is reasonable to appoint Mezim® forte 10000 against the background of the insufficiency of function of a pancreas taking place or remaining further. Мезим® forte 10000, taking into account a firm indivisible dosage form, it is contraindicated to children up to 3 years.

Influence of drug on ability to driving of motor transport and to control of mechanisms

Мезим® forte 10000 does not exert impact on speed of psychomotor reactions and
ability to perception or assessment of the situation.

Side effects:

Development of side effects or complications even is not revealed at prolonged and regular use of the drug Mezim® forte 10000 at patients with the broken function of a pancreas.

In some cases after reception of Pancreatinum development of allergic reactions is possible, it is rare - diarrhea or a lock, nausea, discomfort in epigastric area. In isolated cases at the patients suffering from a mucoviscidosis at prolonged use of high doses of drug development of a hyper uricosuria is possible (increase in level of uric acid in a blood plasma), formation of strictures in ileocecal area and the ascending large intestine is possible.

Interaction with other medicines:

At administration of drugs, containing Pancreatinum, reduction of absorption of folic acid is possible. Effect of glucose-lowering drugs (acarbose, a miglitol) can decrease at a concomitant use with Pancreatinum. At simultaneous use of Pancreatinum with iron preparations decrease in absorption of the last is possible. Simultaneous use of the antiacid means containing calcium a carbonate and/or magnesium hydroxide can lead to decrease in efficiency of drug.

Contraindications:

• acute pancreatitis;
• exacerbation of chronic pancreatitis;
• hypersensitivity to Pancreatinum or other components of drug;
• hereditary intolerance of a galactose, lack of lactase or syndrome of glyukozo-galaktozny malabsorption;
• children's age up to 3 years (an indivisible dosage form).

Use at pregnancy and a lactation

In view of lack of sufficient data about use of enzymes of a pancreas for the person during pregnancy and in the period of a lactation, drug Mezim® use forte 10000 is possible only if the expected advantage for mother exceeds possible risk for a fruit or the child.

Overdose:

There are no data on cases of overdose and intoxication drug. Are possible: a hyper uricosuria, a hyperuricemia, children have locks.

Storage conditions:

At a temperature not above 30 °C. To store medicine in the place, unavailable to children! Period of validity 3 years. Not to apply after expiry date.

Issue conditions:

Without recipe

Packaging:

The tablets covered with a kishechnorastvorimy cover.

On 10 tablets in a blister strip packaging (blister) [aluminum / PVC / polyamide].

On 1 or 2 blisters together with the application instruction in a cardboard pack.