Panzinorm 10000

Panzinorm 10000 – the fermental means compensating insufficiency of vneshnesekretorny function of a pancreas.

Form of release and structure

Dosage form – capsules: gelatinous firm, opaque, white color; contents – pellets of beige-brown color (on 7 pieces in blisters, on 3 or 12 blisters in a pack cardboard).

Active agent of drug – Pancreatinum, its contents in 1 capsule makes 96,6-123,9 mg that corresponds to activity:

• Lipase – 10 000 PIECES of Ph.Eur.;
• Amylase – not less than 7200 PIECES of Ph.Eur.;
• Proteases – not less than 400 PIECES of Ph.Eur.

Additional substances: dry weight (polysorbate 80 and sodium lauryl sulfate), dispersion of 30%, copolymer of methacrylic acid and ethyl acrylate (1:1), simetikon emulsion of 20%, talc, triethyl citrate.

Structure of a capsular cover: sodium lauryl sulfate, gelatin and titanium dioxide (E171).

Indications to use

Panzinorm 10000 – means for treatment of insufficiency of vneshnesekretorny function of a pancreas.

Also drug can be used at patients with normal function of digestive tract for the purpose of improvement of digestion of food (in case of errors in food).

Contraindications

Absolute:

• Children's age up to 3 years;
• Mucoviscidosis at children aged up to 15 years;
• Exacerbation of chronic pancreatitis;
• Acute pancreatitis;
• Hypersensitivity to any component of drug or pork protein.

With care: pregnancy, lactation period.

Route of administration and dosage

Panzinorm 10000 it is necessary to accept inside during food or easy having a snack: to swallow of capsules entirely, without chewing and to wash down with enough liquid.

The doctor defines doses and duration of treatment individually for each patient taking into account his age, degree of insufficiency of function of a pancreas and the held diet.

In an initiation of treatment the adult appoint 1-2 capsules during each main meal (a breakfast, a lunch and a dinner), and also on 1 capsule during each having a snack. If the clinical effect of drug is not enough, the dose is gradually increased. The effective daily dose is individual and can vary within 4-15 capsules.

To children 3 years are more senior use drug only on doctor's orders. The usual dosage makes 1-2 capsules 3 times a day (during food or easy having a snack).

Treatment duration depending on indications can be as in the form of single the prima, and to make several days (at errors in a diet), months and even years (when performing replacement therapy).

Side effects

Panzinorm 10000 is had generally well, causes side effects seldom.

Possible undesirable reactions:

• From the alimentary system: at administration of drug in high doses – irritation of a mucous membrane of an oral cavity, a diarrhea/lock, nausea, vomiting, perianal irritation, an abdominal pain (including intestinal colic); at exceeding of a necessary dose of Pancreatinum (more than 10 000 PIECES of Ph.Eur. lipases on body weight kg) at patients with a mucoviscidosis – strictures (a fibrous colonopathy) in ileocecal department and in the ascending colon;
• Allergic reactions: obstruction of respiratory tracts, hypersensitivity reactions, including skin itch, rash, dermahemia;
• Others: insufficiency of folates, hyperuricemia, hyper uricosuria.

Special instructions

Panzinorm 10000 it is necessary to apply in the smallest effective dose.

At a mucoviscidosis the dose of drug has to correspond to the amount of enzymes necessary for absorption of fats. At the same time it is necessary to consider quality and amount of the consumed food.

In case of development of symptoms on the basis of which it is possible to suspect development of intestinal impassability it is necessary to conduct examination to exclude a fibrous colonopathy.

In need of performing long-term treatment it is recommended to appoint at the same time iron preparations.

Cases of a negative impact of Pancreatinum on the speed of reactions and ability to the increased concentration of attention are not known.

Medicinal interaction

Pancreatinum accepted in high doses reduces absorption of iron and folic acid therefore it is necessary to control the level of folates in blood and if necessary to appoint in addition drugs of folic acid. The same concerns cases of simultaneous use of bicarbonates or Cimetidinum.

Pancreatinum can reduce effects of a miglitol and acarbose.

The capsular cover of Panzinorm 10000 is dissolved in a 12-perstny gut. At low PH value in a 12-perstny gut Pancreatinum is not released. At simultaneous use of inhibitors of the protonew pump, hydrocarbonates or blockers histamine _{H2 receptors} raise efficiency of Pancreatinum thanks to what there is an opportunity to lower Panzinorm's dose 10000.

Terms and storage conditions

To store in the place, unavailable to children. Not to exceed temperature of 30 °C.

Period of validity – 3 years.