Instructions for Vis-nol capsules 120 mg blister No. 30
Composition
active ingredient: bismuth subcitrate;
One capsule contains 499.8 mg of colloidal bismuth subcitrate, equivalent to 120 mg of Bi2O3;
excipients: potato starch, calcium stearate;
The gelatin capsule contains: gelatin, titanium dioxide (E171), quinoline yellow (E104), sunset yellow FCF (E110).
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules of cylindrical shape No. 1, white body, yellow cap. The contents of the capsules are a powdery granular mixture of white or white with a slightly yellowish tint, the smell of ammonia is allowed.
Pharmacotherapeutic group
Drugs for the treatment of peptic ulcer and gastroesophageal reflux disease. Bismuth subcitrate. ATC code A02B X05.
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, which promotes their scarring and protects the mucous membrane from the effects of gastric juice. The drug stimulates the synthesis of prostaglandin E2, increases the formation of mucin and secretion of bicarbonate, leads to the accumulation of epidermal growth factor in the defect zone, reduces the activity of pepsin and pepsinogen.
The drug has antimicrobial activity against Helicobacter pylori.
Pharmacokinetics.
Bismuth subcitrate colloidal is practically not absorbed in the gastrointestinal tract, only a small amount of the active substance enters the blood and is excreted in the urine, while the concentration of bismuth in the blood plasma decreases rapidly after the end of treatment. It is excreted mainly with feces.
Indication
Gastric and duodenal ulcers, chronic gastritis, including those caused by Helicobacter pylori (as part of anti-Helicobacter therapy regimens).
Contraindication
Hypersensitivity to the active substance or to any of the components of the drug. Severe renal failure.
Interaction with other medicinal products and other types of interactions
No other medicines, food or drinks, antacids, milk, fruit or fruit juices should be consumed half an hour before or after taking Vis-Nol®, as they may alter its effect.
Reduces the absorption of tetracyclines; simultaneous use of drugs containing bismuth (Vicalin, Vicair) increases the risk of excessive increase in the concentration of bismuth in the blood.
Application features
When using the drug, stool may turn black. In this case, you should consult a doctor.
You should not take antacids or consume milk half an hour before and half an hour after taking the drug, as the available gastric juice is needed to form a protective layer.
Long-term use of high doses of bismuth compounds is not recommended due to the occurrence of reversible encephalopathy in rare cases. If the recommended regimen is followed, the risk of this side effect is very small. However, it is not recommended to take other drugs containing bismuth while taking Vis-Nol®.
The medicine contains yellow FCF (E110), which may cause allergic reactions.
Use during pregnancy or breastfeeding
Not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of Vis-Nol® on reaction speed. However, the effect of the drug is unlikely.
Method of administration and doses
Take orally, with a small amount of water.
Adults and children over 14 years of age should take 1 capsule 4 times a day 30 minutes before meals and at night or 2 capsules 2 times a day.
Children aged 8 to 14 years should be prescribed 1 capsule 2 times a day 30 minutes before meals.
Children aged 4 to 8 years should be prescribed at a dose of 8 mg/kg/day, dividing the daily dose into 2 doses, but not more than 2 capsules per day.
The duration of the treatment course is 4–8 weeks. During the next 8 weeks, you should not take medications containing bismuth.
If Helicobacter pylori is present, use Vis-Nol® in anti-helicobacter therapy regimens as prescribed by a doctor.
Children
Vis-Nol® should be used in children over 4 years of age.
Overdose
Symptoms of intoxication.
Acute massive overdose may result in renal failure with a delayed onset of up to 10 days.
Treatment of intoxication.
After a single ingestion of a very high dose, treatment consists of gastric lavage followed by doses of activated charcoal and osmotic laxatives. This therapy usually reduces the absorption of bismuth, so additional measures are not necessary.
Bismuth concentrations in blood and urine should be determined in cases of acute and chronic intoxication to identify the relationship of any symptoms to increased bismuth exposure.
In case of severe renal failure, chelation therapy should be accompanied by hemodialysis.
Adverse reactions
Very common (>1/10)
On the part of the digestive tract: black stools may occur due to the formation of bismuth sulfide. Such stools can be easily distinguished from melena.
Uncommon (>1/1000, <1/100)
On the part of the digestive tract: nausea, vomiting, constipation, diarrhea.
Skin and subcutaneous tissue disorders: mild skin allergic reactions (rash, itching).
Very rare (<1/10,000), frequency unknown (cannot be estimated from available data):
Immune system disorders: anaphylactic reaction.
Expiration date
4 years.
Do not use the drug after the expiration date indicated on the package.
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 a blister.
Vacation category
Without a prescription.
Producer
JSC "Farmak".
Location of the manufacturer and its business address.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
