Instructions for Vis-nol capsules 120 mg blister No. 100
Composition
active ingredient: bismuth subcitrate;
1 capsule contains 499.8 mg of colloidal bismuth subcitrate, equivalent to 120 mg of Bi2O3;
excipients: potato starch, calcium stearate.
Dosage form
Capsules.
Main physical and chemical properties: hard gelatin capsules of cylindrical shape No. 1, white body, yellow cap. Capsule contents – powdery granular mixture of white or white with a slightly yellowish tint, ammonia smell 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 ulcer, gastritis, including those caused by Helicobacter pylori (as part of anti-Helicobacter therapy regimens);
– chronic gastritis and gastroduodenitis in the acute phase, including those caused by Helicobacter pylori.
Contraindication
Hypersensitivity to the components of the drug. Severe renal failure.
Special safety measures.
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 bismuth compounds is not recommended due to the occurrence of encephalopathy in rare cases. If the recommended dosage regimen is followed, the risk of this side effect is very small. However, it is not recommended to take other bismuth-containing drugs while taking Vis-Nol®.
Interaction with other drugs 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, Roter) increases the risk of excessive increase in the concentration of bismuth in the blood.
Use during pregnancy or breastfeeding
Not recommended.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the negative effect of Vis-Nol® on reaction speed. However, such an 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 30 minutes before meals.
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 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 drugs containing bismuth.
In the presence of Helicobacter pylori, use Vis-Nol® in anti-helicobacter therapy regimens as prescribed by a doctor. In quadruple therapy, it is recommended to combine Vis-Nol® 120 mg 4 times a day with tetracycline 500 mg 4 times a day, metronidazole 500 mg 3 times a day and a proton pump inhibitor (omeprazole, lansaprozole, pantaprazole or esomeprazole) in a standard therapeutic dose 2 times a day. The duration of combination therapy is 10-14 days.
To improve the regeneration of the ulcer defect, further treatment with Vis-Nol® is possible: 1 capsule 4 times a day 30 minutes before breakfast, lunch and dinner, the 4th time - before bedtime. The total duration of therapy with Vis-Nol® is up to 6 weeks (maximum 8 weeks).
Children
Vis-Nol® should be used in children over 4 years of age.
Overdose
With frequent use of large doses of the drug, an overdose is possible, which may manifest itself after 10 days with symptoms characteristic of renal failure (increased levels of bismuth in the blood plasma).
Treatment consists of gastric lavage followed by doses of activated charcoal and osmotic laxatives. Bismuth absorption as an additional treatment is optional. In case of concomitant severe kidney diseases, hemodialysis should be performed.
Adverse reactions
On the part of the digestive tract: black stools, nausea, vomiting, constipation, diarrhea.
Skin and subcutaneous tissue disorders: rash, itching.
Immune system disorders: anaphylactic reactions.
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
10 capsules in a blister. 3 or 10 blisters in a pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and address of its place of business
Ukraine, 04080, Kyiv, Frunze St., 74.
