Expiration date: 03/2025

Release form and composition: 

Capsules solid gelatine, oblong, the size of the No. 2 cap - brown, opaque, body - colorless, transparent capsule contents - mikrotabletki, film-coated whitish-grey, convex tolerance characteristic smell of microtablets.

Excipients: cellulose microcrystalline, crospovidone, silica colloidal anhydrous, magnesium stearate.

The composition of the operculum capsules: gelatin, red iron oxide (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate

The composition of the body of capsules: gelatin, sodium lauryl sulfate.

The composition of the film mikrotabletki shell: copolymer of methacrylic acid and ethylacrylate (1:1), triethylcitrate, talc, simethicone (20% emulsion, based on dry mass 23%) polishing substance, Montan glycol wax.

20 PCs. - vials dark glass (1) - packs of cardboard.

50 PCs. - vials dark glass (1) - packs of cardboard.

Capsules solid gelatine, oblong, size 0 cap - brown, opaque, body - colorless, transparent capsule contents - mikrotabletki, film-coated whitish-grey, convex tolerance characteristic smell of microtablets.

1 capsulecontains:

Pancreatin 87.28-112.96 mg

EMR enzymatic activity:

mrlopez 10 000 UNITS

mramirez 9 000 IU

embraces 500 U

Excipients: cellulose microcrystalline, crospovidone, silica colloidal anhydrous, magnesium stearate.

The composition of the operculum capsules: gelatin, red iron oxide (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate.

The composition of the body of capsules: gelatin, sodium lauryl sulfate.

The composition of the film mikrotabletki shell: copolymer of methacrylic acid and ethylacrylate (1:1), triethylcitrate, talc, simethicone (20% emulsion, based on dry mass 23%) polishing substance, Montan glycol wax.

20 PCs. - vials dark glass (1) - packs of cardboard.

50 PCs. - vials dark glass (1) - packs of cardboard.

Capsules solid gelatine, oblong, size 00 cap - brown, opaque, body - colorless, transparent capsule - mikrotabletki, film-coated whitish-grey, convex tolerance characteristic smell of microtablets.

1 capsile contains:

Pancreatin 218.2-282.4 mg

EMR enzymatic activity:

mrlopez 25 000 UNITS

mramirez 22 500 U

embraces 1 U 250

Excipients: cellulose microcrystalline, crospovidone, silica colloidal anhydrous, magnesium stearate.

The composition of the operculum capsules: gelatin, red iron oxide (E172), iron oxide black (E172), titanium dioxide (E171), sodium lauryl sulfate.

The composition of the body of capsules: gelatin, sodium lauryl sulfate.

The composition of the film mikrotabletki shell: copolymer of methacrylic acid and ethylacrylate (1:1), triethylcitrate, talc, simethicone (20% emulsion, based on dry mass 23%) polishing substance, Montan glycol wax.

20 PCs. - vials dark glass (1) - packs of cardboard.

50 PCs. - vials dark glass (1) - packs of cardboard.

Pharmacological action:

Germeny drug. Armetale contains a standard, highly active Pancreatin obtained from the pancreas of a pig in the form of microtablets resistant to the action of gastric juice. The drug compensates for a deficiency of pancreatic enzymes having proteolytic, amylolytic and lipolytic action. Its constituent enzymes (lipase, alpha-amylase, trypsin, chymotrypsin) contribute to the breakdown of proteins to amino acids, fats to glycerol and fatty acids, starch to dextrins and sugars, improves the functional state of the gastrointestinal tract, normalize digestion.

Release form of the drug ensures full release of are resistant to the action of gastric juice microtablets from the capsule in the stomach with a subsequent fine mixing microtablets with intestinal content and chyme and fast release of enzymes from microtablets in the duodenum when pHgt5. Cleavage products of pancreatic enzymes are absorbed in the intestine, either directly or after cleavage by intestinal enzymes.

Pharmacokinetics:

The pancreatic enzymes contained in Armidale not absorbed into the blood. Enzymes can be inactivated and digested in the gut as proteins by autolysis and proteolysis. Residual enzymatic activity can be determined in feces.

Indications:

• to improve food digestion in patients with normal function of the gastrointestinal tract in case of errors in the diet
  
• replacement therapy in exocrine pancreatic insufficiency: cystic fibrosis, chronic pancreatitis, pancreatectomy, pancreatic cancer, ductal obstruction due to neoplasm (including obstruction of the ducts of the pancreas, common bile duct), syndrome Shwachman-diamond, senile age
  
• symptomatic therapy of digestive disorders: a condition after cholecystectomy, partial gastrectomy (Billroth-I/II), total gastrectomy, duodenum and gastrosis, biliary obstruction, cholestatic hepatitis, liver cirrhosis, Crohn's disease, goiter.
  

Dosing regimen:

The preparation appoint adults inside. Dose choose individually depending on the severity of the disease and diet. Calculation of dose is done in terms of the unit of activity of lipase.

The recommended dose is 2-4 caps. Armetale, 10 000 IU, or 1-2 caps. Armetale 25, 000 IU, or 1 capsule. Armetale 36, 000 UNITS during each meal. If necessary, the dose may be increased. Higher doses should be under medical supervision. It is impossible to exceed a daily dose of enzymes in the range of 15-20 thousand lipase units per kg of body weight. Therapy should be undertaken against the background of abundant intake of fluids.

Capsules should be swallowed whole but with food, drinking plenty of fluids (water, juices) when you difficulty swallowing capsules can be opened and their contents added to the liquid food. Crushing or chewing microtablets or adding them to foods ??t5.5 leads to the destruction of their shell, which protects it from the action of gastric juice.

Side effects:

Allergic reactions: reactions of immediate type - hives, watery eyes, runny nose, bronchospasm.

From the digestive system: irritation of the mucous membrane of the digestive tract and also anus rarely get diarrhea or constipation, nausea, discomfort in the epigastric region with long-term use of high doses in patients with cystic fibrosis - stricture at the ileocecal Department and in the ascending colon.

Other: with prolonged use at high doses – hyperuricosuria.

Contraindications:

Absolute contraindications:

• hypersensitivity to the preparation components
  
• hypersensitivity to pancreatic enzymes.
  

Relative contraindications:

• acute pancreatitis
  
• exacerbation of chronic pancreatitis
  
• pregnancy.
  

Pregnancy and lactation:

Application of pregnancy is contraindicated.

The use of the drug during lactation (breastfeeding) is possible only in the case when the expected benefit of therapy for the mother outweighs the potential risk to the infant.

Special instructions:

When taken in high doses, it is necessary to carefully monitor any unusual symptoms and side-effects from the digestive system.

Long-term use in cystic fibrosis may develop constipation, strictures of the ileum and cecum, colitis.

Overdose:

Symptoms: hyperuricosuria, hyperuricemia.

Treatment: cancel the drug, symptomatic therapy.

Drug interactions:

While taking the drug, Armidale possibly reduced absorption of folic acid.

Armidale, reduces the absorption of iron.

On the background of drug treatment, Armetal may decrease the effectiveness of hypoglycemic agents for oral administration - acarbose and miglitol.

Terms and conditions of storage:

The drug should be stored out of reach of children at temperature not exceeding 25°C. shelf Life - 3 years.