Panzinorm forte 20000 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspenteric coated tablets

Composition:1 tablet contains:

CORE

Active substance:

Pancreatin (pork) * 269.12 mg - 279.44 mg

Excipients: lactose monohydrate 53.90 mg to 64.22 mg, microcrystalline cellulose 72.66 mg, crospovidone 10.40 mg, Silica colloidal dioxide, anhydrous 1.60 mg, magnesium stearate 2.00 mg

SHELL:

hypromellose 6.25 mg, methacrylic acid and ethyl acrylate copolymer 1: 1 15.89 mg, triethyl citrate 5.07 mg, titanium dioxide (E171) 6.58 mg, talc 9.60 mg, simethicone emulsion 0.43 mg, flavoring vanilla 54286 C 0.34 mg, bergamot flavoring 54253 T 0.16 mg, macrogol 6000 0.25 mg, carmellose sodium 0.55 mg, polysorbate 80 0.88 mg

*from enzymatic activity: lipase 20 000 Ed.Eur.Pharm., Amylases 12 000 Ed.Eur.Pharm. and a protease of 900 units.

Description:

Smooth, round, biconcave, tablets covered with a film coat of white or light gray with the smell of vanillin and bergamot.

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 splits carbohydrates into dextrins and sugars, while protease cleaves 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 symptoms arising from digestive disorders (feeling of heaviness and overflow of the stomach, flatulence, a feeling of lack of air, shortness of breath due to the accumulation of gases in the intestines, diarrhea). Improves the process of digestionand I food in children; stimulates the release of its own enzymes of the pancreas, stomach and small intestine, as well as bile.

Pharmacokinetics:

Pancreatic enzymes are released from the dosage form in the alkaline medium of the small intestine. are protected from the action of gastric juice by a film membrane. A small part of the digestive enzymes are released through the intestine.

Indications:

Insufficiency of the exocrine function of the pancreas (chronic pancreatitis, cystic fibrosis, etc.).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gall bladder; state after resection or irradiation of these organs, accompanied by digestion disorders food, meteorism, diarrhea (as part of combination therapy).

To improve the digestion of the poor in patients with normal function of the gastrointestinal tract in the case of errors in nutrition, with violations of the masticatory function (damage to teeth and gums, during the period of habituation to dentures), a sedentary lifestyle; prolonged immobilization.

Preparation for X-ray and ultrasound examination of the abdominal organs.

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 use of the Panchinorm forte 20 000 during pregnancy and lactation (breastfeeding) is possible only in the event that,if the expected positive effect of therapy exceeds the possible risk, due to the lack of clinical data confirming the safety of the use of pancreatic enzymes in this category of patients.

Dosing and Administration:

Inside, take with food. Tablets should be taken without chewing with sufficient liquid.

The dose and duration of therapy is determined individually, depending on the increasing degree of pancreatic insufficiency.

Adult Pansinorm forte 20 000 is recommended to take (in the absence of other prescriptions) at the beginning of treatment 1 tablet 3 times a day, during each main reception food. You can take Pannosinorm Fort 20 000 during a light snack. If necessary, single dose is increased 2 times. The average daily dose: 1-2 tablets 3 times. Before x-ray and ultrasound examinations - 2 tablets 2-3 times a day for 2-3 days before the examination.

In children, the drug is used as directed by a doctor. Children over the age of 3 -100 thousand ED / day (in terms of lipase).

The duration of treatment can vary from a single dose or several days (if the digestive process is disrupteddue to inaccuracies in the diet) up to several months or years (if necessary permanent replacement therapy).

Side effects:

Allergic reactions: hyperemia of the skin, skin rash, itching, sneezing, choking, lacrimation.

From the digestive system (with prolonged admission in large doses); nausea, vomiting, abdominal pain (including intestinal colic), diarrhea, constipation, perianal irritation, irritation of the oral mucosa. In cystic fibrosis, if the necessary dose of pancreatin is exceeded (more than 10 000 units Ph. Eur. lipase per 1 kg of body weight) may develop strictures (fibrous colonopathy) in the ileocecal region and in the ascending colon.

Other: hyperuricemia, hyperuricosuria, folate deficiency.

Overdose:

Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation, fibrotic colonopathy (with mucovicidosis).

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

Interaction:

With simultaneous application with pancreatin 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. The acid-resistant sheath of Penzinorm forte 20,000 tablets dissolves 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 increased effectiveness of pancreatin.

Special instructions:

Penzinorm forte 20 000 should be taken without chewing, with a sufficient amount of liquid.

In case of cystic fibrosis in case of exceeding the necessary dose of pancreatin (more than 10 000 units of the European Pharmacopeia 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.

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:Tablets, covered with enteric coating.

Packaging:10 tablets in a blister pack. For 1, 3 or 10 blisters are placed in a cardboard box together with instructions for use.

Storage conditions:At a temperature not exceeding 25°C, in the original packaging.

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:П N014602 / 01

Date of registration:07.08.2008

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

Panzinorm® forte 20000 (Panzinorm® forte 20,000)