Panzinorm forte 20,000 tablets p / o, No. 30

Lack of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder; conditions after resection or irradiation of these organs, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy).

To improve digestion, write in patients with normal function of the gastrointestinal tract in case of errors in nutrition, in case of impaired chewing function (damage to teeth and gums, during the period of getting used to dentures), a sedentary lifestyle; prolonged immobilization.

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

Inside, take with meals. The tablets should be taken without chewing with sufficient liquid.
The dose and duration of therapy is determined individually, depending on the age and degree of pancreatic insufficiency.
Adults Panzinorm forte 20,000 are recommended to take (in the absence of other prescriptions) at the beginning of treatment, 1 tablet 3 times a day, during each main meal. It is possible to take Panzinorm forte 20,000 with a light snack. If necessary, a single dose is doubled. Average daily dose: 1-2 tablets 3 times. Before X-ray and ultrasound examinations - 2 tablets 2-3 times a day 2-3 days before the examination.
In children, the drug is used as directed by a doctor. Children over the age of 3 years -100 thousand units / day (in terms of lipase).

The 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 constant substitution therapy is necessary).

1 tablet contains:
NUCLEUS:
Active substance:
pancreatin (porcine) (with enzymatic activity: lipase 20,000 Eur.Pharm., Amylase 12,000 Eur.Pharm. And drotease 900 Eur.Pharm.) 269.12 mg - 279.44 mg (15% of the excess of pancreatin is due to technical losses during the production process. 10% of the excess of pancreatin is used to compensate for losses during decay during the storage period.)

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, anhydrous, magnesium stearate.

Shell: hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavor 54286 C, bergamot flavor 54253 T, macrogol 6000, sodium carmellose, polysorbate 80.

• Hypersensitivity to 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 old with cystic fibrosis.

With care: pregnancy.

Trade name: Panzinorm forte 20 000

International non-proprietary name or grouping name: pancreatin

Dosage form:

enteric-coated tablets.

Composition
1 tablet contains:
NUCLEUS:
Active substance:
pancreatin (porcine) (with enzyme activity: lipase 20,000 Eur.Pharm., Amylase 12,000 Eur.Pharm. And drotease 900 Eur.Pharm.) 269, 12 mg - 279.44 mg (15% excess pancreatin is due to technical losses during the production process. 10% excess pancreatin is used to compensate for losses during decay during the storage period.)

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, anhydrous, magnesium stearate.

SHELL: hypromellose, methacrylic acid and ethyl acrylate copolymer, triethyl citrate, titanium dioxide (E171), talc, simethicone emulsion, vanilla flavor 54286 C, bergamot flavor 54253 T, macrogol 6000, sodium carmellose, polysorbate 80.

Description
Smooth, round, biconvex, film-coated tablets of white or light gray color with the smell of vanillin and bergamot.

Pharmacotherapeutic group:

digestive enzyme agent.

Pharmacological properties
The drug compensates for the insufficiency of the exocrine function of the pancreas. Combined drug, the action of which is due to the components that make up its composition. High lipase activity plays an important role in the treatment of maldigestion caused by pancreatic enzyme deficiency. Lipase breaks down fats by hydrolysis into fatty acids and glycerol, thus facilitating their absorption and the absorption of fat-soluble vitamins. Amylase breaks down carbohydrates into dextrins and sugars, while protease breaks down proteins. It has a protective membrane, due to which active enzymes are released in the small intestine, where pancreatic enzymes act.

The enzymes lipase, amylase and protease, which are part of pancreatin, facilitate the digestion of fats, carbohydrates and proteins, which contributes to their more complete absorption in the small intestine. Eliminates the symptoms arising from digestive disorders (feeling of heaviness and fullness of the stomach, flatulence, feeling short of breath, shortness of breath caused by the accumulation of gas in the intestines, diarrhea). Improves the process of food digestion in children; stimulates the secretion 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, because protected from the action of gastric juice by a film membrane. A small part of the digestive enzymes is excreted through the intestines.

Indications for use
Insufficiency of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, etc.).

Chronic inflammatory-dystrophic diseases of the stomach, intestines, liver, gallbladder; conditions after resection or irradiation of these organs, accompanied by impaired digestion of food, flatulence, diarrhea (as part of combination therapy).

To improve digestion, write in patients with normal function of the gastrointestinal tract in case of errors in nutrition, in case of impaired chewing function (damage to teeth and gums, during the period of getting used to dentures), a sedentary lifestyle; prolonged immobilization.

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

Contraindications

• Hypersensitivity to 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 old with cystic fibrosis.

With care: pregnancy.

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

Dosage and administration
Inside, take with meals. The tablets should be taken without chewing with sufficient liquid.
The dose and duration of therapy is determined individually, depending on the age and degree of pancreatic insufficiency.
Adults Panzinorm forte 20,000 are recommended to take (in the absence of other prescriptions) at the beginning of treatment, 1 tablet 3 times a day, during each main meal. It is possible to take Panzinorm forte 20,000 with a light snack. If necessary, a single dose is doubled. Average daily dose: 1-2 tablets 3 times. Before X-ray and ultrasound examinations - 2 tablets 2-3 times a day 2-3 days before the examination.
In children, the drug is used as directed by a doctor. Children over the age of 3 years -100 thousand units / day (in terms of lipase).

The 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 constant substitution therapy is necessary).

Side effect
Allergic reactions: flushing of the skin, skin rash, itching, sneezing, choking, lacrimation.

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

Others: hyperuricemia, hyperuricosuria, folate deficiency.

Overdose
Symptoms: nausea, vomiting, diarrhea, hyperuricosuria, hyperuricemia, perianal irritation, fibrous colonopathy (with mucovicidosis). Treatment: drug withdrawal, hydration, symptomatic therapy.

Interaction with other drugs
With simultaneous use with pancreatin, a decrease in the absorption of iron preparations (clinically insignificant) and folic acid is possible . It is recommended to periodically monitor the level of folate and / or the appointment of folic acid. The acid-resistant coating of Panzinorm forte 20,000 tablets dissolves in the duodenum. At a low pH in the duodenum, pancreatin is not released. The simultaneous use of blockers of H2-histamine receptors (cimetidine), bicarbonates, proton pump inhibitors can lead to an increase in the effectiveness of pancreatin.

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

With cystic fibrosis, if the required dose of pancreatin is exceeded (more than 10,000 U Ph. Eur. Lipase per 1 kg of body weight), strictures (fibrous colonopathy) may develop in the ileocecal region and in the ascending colon. Therefore, in cystic fibrosis, the dose should be adequate to the amount of enzymes that are necessary for the absorption of fats, taking into account the quality and quantity of food consumed.

Do not swallow the hydrosorbent capsule!

Influence on the ability to drive a car and other mechanical means: there is no known negative effect on the ability to drive a car and work with other mechanisms.

Release form
Enteric-coated tablets.
10, 30 or 100 tablets in an amber glass bottle (type III) with a hydrosorbent capsule, closed with a screw cap, with a first opening control. 1 bottle is placed in a cardboard box along with instructions for use.
There are 10 tablets in a blister. 1, 3 or 10 blisters are placed in a cardboard box along with instructions for use.

Storage
conditions Store in a dry place at a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life is
3 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies
Without prescription.