Gastropharm^® (Tablets) Instructions for Use

Marketing Authorization Holder

Biovet (Bulgaria)

ATC Code

A02BX (Other drugs for the treatment of gastric and duodenal ulcers and GERD)

Dosage Form

Gastropharm^®

Tablets: 6 or 18 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, flat, with smooth edges, beige-brown in color; the presence of specks and color heterogeneity in the form of “marbling” is allowed, with a break line on one side; diameter 25 mm.

	1 tab.
Substance	1.575 g,
Containing dried viable cells of Lactobacillus delbrueckii spp. bulgaricus strain 51 (LB-51)	Not less than 1×10² cells,
And also
Protein	From 25% to 35%,
Which in terms of Total nitrogen is	From 4% to 5.6%
Lactic acid	From 6.3% to 12.6%

Excipients : sucrose – not more than 0.9 g, magnesium stearate – 0.025 g.

6 pcs. – blisters (1) – cardboard packs.
6 pcs. – blisters (3) – cardboard packs.

Clinical-Pharmacological Group

Drug exerting a protective effect on the gastric and duodenal mucosa

Pharmacotherapeutic Group

Eubiotic

Pharmacological Action

A drug that has a protective effect on the gastric and intestinal mucosa.

The action of the drug is provided by the presence of Lactobacillus bulgaris and biologically active products of their vital activity (lactic and malic acid, nucleic acids, a number of alpha-amino acids, polypeptides and polysaccharides), as well as a high protein content (25-30%), which have a protective effect on the gastrointestinal mucosa, stimulating regeneration processes in the gastric and duodenal mucosa. The drug also has an analgesic and antacid effect due to the buffering properties of the protein included in its composition.

Pharmacokinetics

Data on the pharmacokinetics of Gastropharm^® are not provided.

Indications

Acute and chronic gastritis accompanied by increased acidity of gastric juice;
Gastric and duodenal ulcer;
As a prophylactic agent during and after treatment with drugs that have an irritating effect on the gastrointestinal tract;
As a prophylactic agent after dietary indiscretions (consumption of food that causes an increase in the acidity of gastric juice) and excessive alcohol consumption and smoking.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
K25	Gastric ulcer
K26	Duodenal ulcer
K27	Peptic ulcer
K29	Gastritis and duodenitis
K30	Functional dyspepsia (digestive disorder)
R12	Heartburn

ICD-11 code	Indication
DA42.Z	Gastritis, unspecified
DA51.Z	Duodenitis, unspecified
DA60.Z	Gastric ulcer, unspecified
DA61	Peptic ulcer of unspecified site
DA63.Z	Duodenal ulcer, unspecified
DA7Z	Diseases of stomach or duodenum, unspecified
DD90.0	Globus sensation
DD90.1	Functional dysphagia
DD90.3	Functional dyspepsia
DD90.Z	Functional disorders of esophagus or gastroduodenal system, unspecified
MD95	Heartburn

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets are taken orally 30 minutes before meals, chewed with a small amount of water or pre-crushed and mixed with a small amount of boiled water at room temperature.

For acute and chronic gastritis and with increased acidity of gastric juice, adults are prescribed 1-2 tablets 3 times/day; children aged 3 to 12 years – 1/2 tablet, aged 12 to 18 years – 1 tablet 3 times/day. The course of treatment is 30 days.

For acute gastritis and insufficient effectiveness of therapy, the daily dose can be doubled.

The effect is usually observed by the end of the first week of treatment.

For gastric and duodenal ulcer, adults are prescribed 3-4 tablets 3 times/day for 30 days.

For prevention, the drug is used at a dose of 1-2 tablets 3 times/day for 15 days; for alcohol abuse or smoking – 1-2 tablets 2-3 times/day.

Adverse Reactions

When using the drug according to the indications in the recommended doses, no adverse effects have been identified.

Contraindications

Not established when used according to the indications and in the recommended doses.

Use in Pregnancy and Lactation

Data on the use of the drug during pregnancy and lactation (breastfeeding) are not provided.

Pediatric Use

The drug is prescribed to children over 3 years of age (see Dosage Regimen).

Special Precautions

The drug is harmless and non-toxic.

When prescribing the drug to patients with diabetes mellitus, it should be taken into account that 1 tablet contains 0.9 g of sucrose.

Effect on ability to drive vehicles and machinery

The drug does not affect the ability to drive vehicles.

Overdose

Currently, no cases of overdose with Gastropharm^® have been reported.

Drug Interactions

Drug interaction of Gastropharm^® has not been established and the drug can be used with other medicines.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer