Festal Neo 10000 tab. p/o enteric-sol. blister, 20

Storage:

active substance: pancreatin;

1 tablet contains pancreatin corresponding to the minimum enzymatic activity:

10,000 lipolytic IU, 7,500 amylolytic IU, 375 proteolytic IU;

excipients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, crospovidone, hypromellose, silicon dioxide colloidal anhydrous, magnesium stearate;

shell: polyethylene glycol, dry mixture “Acryl-eze white”, containing talc, titanium dioxide (E 171), methacrylate copolymer, sodium lauryl sulfate, sodium carbonate, silicon dioxide colloidal anhydrous.

Pharmaceutical form. Film-coated tablets, enteric-soluble.

Main physicochemical properties: coated tablets, round, with a biconvex surface, white or almost white in color, with a weak specific smell. The cross-section shows two layers.

Pharmacotherapeutic group.

Means that improve digestion, including enzymes. Polyenzyme preparations
Clinical characteristics.

Indication.

Diseases that are accompanied by disturbances in the process of food digestion due to insufficient secretion of digestive enzymes by the pancreas, such as chronic pancreatitis.

Conditions after simultaneous resection of the stomach and small intestine, conditions after pancreatectomy.

Functional acceleration of the passage of food through the intestines.

Flatulence, dyspepsia, intestinal disorders.

Preparation for x-ray or ultrasound diagnostic examinations of abdominal organs (intestinal degassing).

To improve the digestion of food in persons with normal gastrointestinal tract function, in case of disturbances in masticatory function, when consuming difficult-to-digest vegetable, fatty or unusual food, consuming an excessive amount of food.

Contraindication.

Hypersensitivity to pancreatin of porcine origin or to auxiliary substances of the drug. Acute pancreatitis or chronic pancreatitis in the exacerbation stage, acute hepatitis, mechanical jaundice. The drug should not be used by patients with intestinal obstruction.
Method of application and dosage.

The dose of Festal® NEO 10,000 depends on the deficiency of pancreatic enzymes in the duodenum and is set individually. If there are no other recommendations and in case of consumption of hard-to-digest vegetable food, fatty or unusual food, take 1-2 tablets once. In other cases, when digestive disorders occur, the recommended single dose is 2-4 tablets. If necessary, the dose of the drug can be increased. Increasing the dose to reduce the symptoms of the disease, such as steatorrhea or symptoms of chronic pancreatitis, should be carried out only under the supervision of a doctor. The daily dose of lipase should not exceed 15,000-20,000 IU per 1 kg of body weight.

Tablets should be taken during meals, swallowing whole and with a large amount of liquid, for example, a glass of water.

The duration of treatment depends on the course of the disease and is determined by the doctor individually.

Children.

Apply to children over 3 years old. The question about the dose of the drug and the duration of treatment for children is decided by the doctor. The drug is prescribed in a daily dose necessary to normalize bowel movements, during each main meal, but no more than 1500 units of lipase per 1 kg of body weight of a child under 12 years of age. For children over 12 years of age, the daily dose of enzymes should not exceed 15,000-20,000 IU of lipase per 1 kg of body weight.

Overdose.

Side effects may increase. Hyperuricemia and hyperuricosuria were observed when taking extremely high doses of other drugs from the powder of the pancreas, and constipation in children. Symptomatic treatment: discontinuation of the drug, adequate hydration.
Storage conditions.

Store in the original packaging at a temperature not higher than 25 ºС.

Keep out of the reach of children.

Packaging. No. 20 (20 × 1): 20 tablets in a blister, 1 blister in a cardboard box.

Release category. Without a prescription.

Producer.

“Pharmex Group” LLC.

The location of the manufacturer and the address of the place of its activity.

Ukraine, 08301, Kyiv region, Boryspil city, Shevchenka street, building 100.

The applicant

“Opella Helskea Ukraine” LLC, Ukraine.
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