Vis-nol®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VISIONOL® (VIS-NOL)

Composition:

Active substance: bismuth subcitrate;

One capsule contains 499.8 mg of colloidal bismuth subcitrate, equivalent to 120 mg of Bi₂O₃;

Excipients: potato starch, calcium stearate;

Gelatin capsule contains: gelatin, titanium dioxide (E171), quinoline yellow (E104), yellow sunset FCF (E110).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules, cylindrical shape, size №1, white body and yellow cap. The capsule contents are a white or white with slightly yellowish tinge powder-like granular mixture; an ammonia odor may be present.

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

Pharmacological properties.

Pharmacodynamics.

Has a gastroprotective effect. In the acidic environment of the stomach, colloidal bismuth subcitrate forms a protective film on the surface of ulcers and erosions, promoting their healing and protecting the mucosa from the action of gastric juice. The drug stimulates the synthesis of prostaglandin E2, increases mucin production and bicarbonate secretion, leads to the accumulation of epidermal growth factor in the area of the defect, and reduces the activity of pepsin and pepsinogen.

The drug has antimicrobial activity against Helicobacter pylori.

Pharmacokinetics.

Colloidal bismuth subcitrate is practically not absorbed in the gastrointestinal tract; only a negligible amount of the active substance enters the bloodstream and is excreted in urine, with bismuth concentration in blood plasma rapidly decreasing after completion of treatment. It is predominantly eliminated with feces.

Clinical characteristics.

Indications.

Peptic ulcer disease 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 of the medicinal product. Severe renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

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

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

Special precautions for use.

When using the drug, black discoloration of the stool may occur. In such a case, consult a physician.

Antacid drugs and milk should not be taken within half an hour before or after taking the drug, 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 with Vis-Nol® it is not recommended to take other bismuth-containing drugs.

The medicine contains Sunset Yellow FCF (E110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

Not recommended.

Ability to influence reaction rate when driving or operating machinery.

There are no data on the effect of Vis-Nol® on reaction speed. However, the effect of the drug is unlikely.

Dosage and Administration

Take orally, swallowing with a small amount of water.

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

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

For children aged 4 to 8 years: 8 mg/kg/day divided into 2 doses, but not exceeding 2 capsules per day.

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

In cases of Helicobacter pylori infection, use Vis-Nol® as part of anti-H. pylori therapy regimens as prescribed by a physician.

Children

Vis-Nol® can be used in children aged 4 years and older.

Overdose

Symptoms of intoxication.

Acute massive overdose may lead to renal failure with delayed onset up to 10 days.

Treatment of intoxication.

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

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

Chelation therapy with dimercaptosuccinic acid (DMSA) or dimercaptopropanesulfonic acid (DMPS) is indicated when 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 disorders: bowel movements may turn black due to formation of bismuth sulfide. Such discoloration can be easily distinguished from melena.

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

Gastrointestinal disorders: nausea, vomiting, constipation, diarrhea.

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

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

Immune system disorders: anaphylactic reaction.

Shelf life. 4 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging. No. 30 (10x3), No. 100 (10x10) in blisters.

Supply category. Over-the-counter.

Manufacturer. JSC "Farmak".

Address of manufacturer and location of business activity.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.