Gastro-norm®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GASTRO-NORM® (GASTRO-NORM)

Composition:

Active substance: bismuth subcitrate;

One tablet contains 320 mg of bismuth subcitrate, equivalent to 120 mg of bismuth oxide;

Excipients: corn starch, povidone, potassium polacrilin, magnesium stearate, coating mixture (polyethylene glycol, titanium dioxide (E 171), polyvinyl alcohol, talc).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: film-coated tablets, white or almost white, round-shaped, with a convex surface, odorless or with a slight ammonia odor.

Pharmacotherapeutic group. Agents for treatment of peptic ulcer and gastroesophageal reflux disease. Bismuth subcitrate. ATC code A02BX05.

Pharmacological properties.

Pharmacodynamics.

In the acidic environment of the stomach, the medicinal product forms a protective film on the surface of ulcers and erosions, promoting their healing and protecting them from the action of gastric juice; increases the synthesis of prostaglandin E2, stimulates the production of mucus and bicarbonates, promotes accumulation of epidermal growth factor in the area of defect, reduces the activity of pepsin and pepsinogen. The drug has bactericidal activity against Helicobacter pylori.

Pharmacokinetics.

The drug is practically not absorbed from the gastrointestinal tract; only a negligible amount of the active substance enters the blood and is excreted in urine, while the concentration of bismuth in blood plasma rapidly decreases after completion of treatment. It is excreted predominantly in feces.

Clinical characteristics.

Indications.

Peptic ulcer of the stomach and duodenum, chronic gastritis, including that caused by Helicobacter pylori (as part of anti-Helicobacter therapy regimens).

Contraindications.

Hypersensitivity to the active substance or to any of the excipients. Severe renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

No other medications, food or beverages, antacids, milk, fruits or fruit juices should be consumed within half an hour before or after taking Gastro-norm® medication, as they may alter its effect.

Decreases absorption of tetracyclines; concomitant use of bismuth-containing drugs (e.g., Vikalin, Vikair) increases the risk of excessive bismuth concentration in the blood.

Special precautions for use.

Discoloration of feces to a black color may occur. In such a case, consult a physician. Do not take antacid preparations or consume milk within half an hour before or after taking the medication, as gastric juice is required for the formation of the protective layer.

Prolonged use of high doses of bismuth compounds is not recommended due to the rare occurrence of reversible encephalopathy. When following the recommended dosage regimen, the risk of this adverse effect is very low. However, during treatment, it is not recommended to take other bismuth-containing medications.

Use during pregnancy or breastfeeding. Not recommended.

Ability to affect reaction speed when driving or operating machinery. There is no data on the effect of bismuth subcitrate on the ability to drive or operate machinery. However, such an effect of Gastro-Norm® is unlikely.

Method of Administration and Dosage

For adults and children aged 14 years and older: administer 1 tablet 4 times daily, 30 minutes before meals and at bedtime, or 2 tablets twice daily.

For children aged 8 to 14 years: administer 1 tablet twice daily, 30 minutes before meals.

For children aged 4 to 8 years: administer at a dose of 8 mg/kg/day, divided into two doses, but not exceeding 2 tablets per day.

Tablets should be taken with a small amount of water.

Duration of treatment: 4–8 weeks. During the following 8 weeks, avoid using medications containing bismuth.

In the presence of Helicobacter pylori, use according to current treatment guidelines in combination regimens.

Children. Gastro-Norm® is indicated for children aged 4 years and older.

Overdose.

Symptoms of intoxication. Acute severe overdose may lead to renal failure due to elevated bismuth levels in plasma, with onset possibly delayed up to 10 days.

Treatment of intoxication. After a single ingestion of a very high dose: gastric lavage followed by administration of activated charcoal and osmotic laxatives. This therapy usually reduces bismuth absorption, so additional measures are generally not required.

Blood and urine bismuth concentrations should be measured in cases of acute or chronic intoxication to identify any correlation between symptoms and elevated bismuth levels.

Chelation therapy with dimercaptosuccinic acid (DMSA) and dimercaptopropanesulfonic acid (DMPS) should be used if symptoms are caused by acute or chronic bismuth overdose.

In cases of severe renal failure, chelation therapy should be accompanied by hemodialysis.

Side effects.

Very common (>1/10)

Gastrointestinal: black stools due to the formation of bismuth sulfide. Such stools can be easily distinguished from melena.

Uncommon (>1/1000, <1/100)

Gastrointestinal: nausea, vomiting, constipation, diarrhea.

Skin and subcutaneous tissue: mild allergic skin reactions (rash, itching).

Very rare (<1/10000), frequency unknown (cannot be estimated from available data)

Immune system: anaphylactic reaction.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 10 tablets per blister, 4 or 10 blisters per carton.

Supply category. Over-the-counter.

Manufacturer: JSC "Halychpharm"

or JSC "Kyivmedpreparat".

Manufacturer's location and address of the place of business: Ukraine, 79024, Lviv, Opryshkovska St., 6/8

or Ukraine, 01032, Kyiv, Saksaganского St., 139.