Panzinorm® 10,000 (Panzinorm® 10,000)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Similar drugsTo uncover
Dosage form: & nbspcapsules
Composition:

Contents 1 capsules (pellets):

THE NUCLEUS OF PELLETS:

Active substance:

Pancreatin powder (pork, in the form of pellets) 96.6 - 123.9 mg

corresponding to:

- lipase activity: 10 000 Ed.Evr.F.

- amylase activity: not less than 7 200 Еd.Evr.F.

- total proteolytic activity: not less than 400 units .Eur.F.

excess for stability:

- by weight 10% 9.6-12.4 mg

- by enzymatic activity:

only with respect to lipase activity of 10%

Mass of active substance in total: 106.2 - 136.3 mg

PELLET SHELL: methacrylic acid and ethyl acrylate copolymer (1: 1), dispersion 30%, dry weight (excipients: sodium lauryl sulfate Ph.Eur./NF and polysorbate 80 Ph.Eur./NF), triethyl citrate, talc, simethicone emulsion 20%, dry weight (23%).

Composition of the empty capsule:

Capsule cap: gelatin, titanium dioxide (E171), sodium lauryl sulfate.

Capsule body: gelatin, titanium dioxide (E171), sodium lauryl sulfate.

Description:Solid, opaque gelatin capsules are filled with pellets of beige-brown color. The capsule body and capsule are white.
Pharmacotherapeutic group:digestive enzyme.
Pharmacodynamics:

The drug compensates for the lack of exocrine function of the pancreas. Combined drug, the effect of which is due to the components that make up its composition.High lipase activity plays an important role in the treatment of maldigestii due to pancreatic enzyme deficiency. Lipase cleaves fats by hydrolysis into fatty acids and glycerol, thus, facilitates their absorption and absorption of fat-soluble vitamins. Amylase cleaves carbohydrates into dextrins and sugars, whereas protease splits proteins. Has a protective shell, due to which active enzymes are released in the small intestine, where the pancreatic enzymes act. The pancreatin enzymes of lipase, amylase and protease facilitate the digestion of fats, carbohydrates and proteins, which contributes to their fuller absorption in the small intestine. Eliminates the symptoms arising from digestive disorders (feeling of heaviness and overflow of the stomach, flatulence, lack of air, shortness of breath due to the accumulation of gases in the intestines, diarrhea). Improves the process of digestion of food in children; stimulates the release of its own enzymes of the pancreas, stomach and small intestine, as well as bile.

Pharmacokinetics:

Penzinorm 10 000 is available in the form of a capsule, inside which are contained pellets, coated with a film sheath.The film membrane of the pellet protects the active enzymes from the action of the acidic environment of the stomach, which allows the enzymes to be released in the small intestine. Most of the enzymes are inactivated, as a result of autolysis and proteolysis. A small part of the digestive enzymes are released through the intestine.

Indications:

- Insufficiency of the exocrine function of the pancreas.

- To improve the digestion of food in patients with normal gastrointestinal function in the event of errors in nutrition.

Contraindications:

- Hypersensitivity to the pork protein or other components of the drug;

- Acute pancreatitis, exacerbation of chronic pancreatitis;

- Children under 3 years old (for this dosage form) and children under 15 years of age suffering from cystic fibrosis.

Carefully:Pregnancy.
Pregnancy and lactation:

The application of Pansinorm 10 000 during pregnancy and during lactation (breastfeeding) is possible only if the expected positive effect of therapy exceeds the possible risk, due to the lack of clinical data confirming the safety of pancreatic enzymes in this category of patients.

Dosing and Administration:

Inside, take with meals or light snacks. Capsules should be taken whole, not liquid with enough liquid.

The dose and duration of therapy is determined individually, depending on the age, degree of pancreatic function deficiency and diet.

Adult Pansinorm 10 000 is recommended to take at the beginning of treatment the minimum dose: 1-2 capsules 3 times a day, during each main meal (breakfast, lunch, dinner) and 1 capsule during each snack. If necessary, the single dose is gradually increased. The effective daily dose is from 4 to 15 capsules of Panzinorma 10000.

The lowest effective doses should be taken, especially in patients with cystic fibrosis.

In children, the drug is used as directed by a doctor. Children over the age of 3 years - 1-2 capsules of Panzinorma 10,000 during meals or light snacks.

Duration of treatment can vary from a single dose or several days (if the digestive process is disturbed due to inaccuracies in the diet) to several months or years (if necessary, permanent replacement therapy).

Side effects:

Pansinorm 10,000 rarely causes undesirable effects.

Allergic reactions: reactions of hypersensitivity, incl. hyperemia of the skin, skin rash, itchy skin; obstruction of the airways.

From the digestive system (when taking large doses of the drug); nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, constipation, perianal irritation, irritation of the oral mucosa. In case of cystic fibrosis, if the necessary dose of pancreatin is exceeded (more than 10 000 units of E. ev. F. lipase per 1 kg of body weight), stricture (fibrous colonopathy) in the ileocecal region and in the ascending colon is rarely possible.

Other: hyperuricemia, hyperuricosuria, folate deficiency.

Overdose:

Overdose of Penzinorm 10 000 does not cause systemic intoxication.

Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation; rarely develops fibrous colonopathy (with cystic fibrosis).

Treatment: cancellation of the drug, hydration, symptomatic therapy.

Interaction:

With simultaneous long-term use with pancreatin in high doses, it is possible to reduce absorption iron preparations (clinically insignificant) and folic acid. It is recommended that folate levels and / or folic acid are monitored periodically.

When used simultaneously with cimetidine, bicarbonates it is also recommended to periodically monitor folate levels and / or the administration of folic acid. Pancreatin can reduce the effectiveness of acarbose and miglitol.

Acid-resistant pellet shell Penzinorm 10 000 is dissolved in the duodenum. At a low pH in the duodenum pancreatin not released. Simultaneous application blockers H2-gistaminovyh receptors (cimetidine), hydrogen carbonates, proton pump inhibitors can lead to an increase in the effectiveness of pancreatin, which allows you to reduce the dose of Pansinorm 10 000.

Special instructions:

Panzinorm 10 000 should be taken without chewing, with enough liquid.

In case of cystic fibrosis, if the necessary dose of pancreatin is exceeded (more than 10 000 units of Eu.F. lipase per 1 kg of body weight), strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon can be developed. Therefore, in cystic fibrosis, the dose should be adequate to the number of enzymes that are needed to absorb fat, taking into account the quality and quantity of food consumed.

If, on the background of taking Penzinorm 10,000 capsules, symptoms of intestinal obstruction appear, fibrotic colonopathy should be excluded.

With prolonged use, iron preparations are simultaneously prescribed.

Effect on the ability to drive transp. cf. and fur:

It is not known about the negative impact on the ability to drive and work with other mechanisms.

Form release / dosage:

Capsules.

Packaging:7 capsules per blister. By 3, 8 or 12 blisters in a pack of cardboard along with instructions for use.
Storage conditions:

Store at a temperature not exceeding 30 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use the drug after the expiration date.
Terms of leave from pharmacies:Without recipe
Registration number:LSR-000101/09
Date of registration:14.01.2009
The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Manufacturer: & nbsp
KRKA, d.d. Slovenia
Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
Information update date: & nbsp19.08.2015
Illustrated instructions
    Instructions
    Up