Ulcevis®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Ulcavis® (Ulcavis®)

Composition:

Active substance: bismuth subcitrate;

One film-coated tablet contains 120 mg of bismuth oxide in the form of bismuth tripotassium dicitrate (bismuth subcitrate);

Excipients: maize starch, povidone K-30, potassium polacrilin, macrogol 6000, magnesium stearate;

Film coating: Opadry II Clear (contains: polyvinyl alcohol, macrogol 4000, talc), titanium dioxide (E 171).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: white to almost white, round, slightly biconvex, film-coated tablets with beveled edges.

Pharmacotherapeutic group. Drugs 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 drug forms a protective film on the surface of ulcers and erosions, promoting their healing and protecting them from the effects of gastric juice. It increases the synthesis of prostaglandin E2, stimulates the production of mucus and bicarbonate, promotes accumulation of epidermal growth factor in the area of the defect, reduces the activity of pepsin and pepsinogen. The medicinal product 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 bloodstream and is excreted in urine, with bismuth plasma concentrations rapidly decreasing after completion of treatment. It is predominantly excreted in feces.

Clinical characteristics.

Indications.

Peptic ulcer of the stomach and duodenum, including those caused by Helicobacter pylori (as part of anti-Helicobacter therapy regimens);

chronic gastritis and gastroduodenitis in the exacerbation phase, including those caused by Helicobacter pylori.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Severe renal insufficiency.

Interaction with other medicinal products and other forms of interactions.

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

Reduced absorption of tetracyclines is theoretically possible when used concomitantly with Ulcavis®.

Concomitant use of bismuth-containing preparations increases the risk of excessive accumulation of bismuth in the blood.

Special precautions for use.

A change in stool color to black may occur; if this happens, consult a physician. Do not take antacid medications 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 bismuth-containing compounds is not recommended due to the rare occurrence of encephalopathy. When following the recommended dosage regimen, the risk of this adverse effect is very low; however, during treatment with this medicinal product, concomitant use of other bismuth-containing preparations is not recommended.

Potassium

This medicinal product contains 1.19 mmol (or 46.58 mg) of potassium per tablet. Caution is advised in patients with impaired renal function or those on a potassium-controlled diet.

Use during pregnancy or breastfeeding.

Due to insufficient data, use during pregnancy or breastfeeding is not recommended.

Ability to influence reaction speed while driving or operating machinery.

There are no data on the effect of the drug on the ability to drive or operate machinery. However, such an effect of the medicinal product Ulkavis® is unlikely.

Method of Administration and Dosage

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

For children aged 8 to 14 years: administer 1 tablet 2 times daily, 30 minutes before meals.

For children aged 4 to 8 years: the dose is 8 mg/kg/day according to body weight:

• For children weighing 15 to 30 kg: administer 1 tablet daily, 30 minutes before meals.
• For children weighing more than 30 kg: administer 1 tablet 2 times daily, 30 minutes before meals.

Tablets should be swallowed whole and taken with sufficient amount of water. The duration of treatment is 4–8 weeks. For at least the following 2 months, avoid using medications containing bismuth.

In cases of Helicobacter pylori infection, use in treatment regimens: for quadruple therapy, it is recommended to combine Ulcavis® 120 mg tablets, 4 times daily, with tetracycline 500 mg 4 times daily, metronidazole 500 mg 3 times daily, and a proton pump inhibitor (omeprazole, lansoprazole, rabepazole, pantoprazole, or esomeprazole) at the standard therapeutic dose 2 times daily.

Duration of combination therapy: 10–14 days.

For improved healing of ulcer defects, further treatment with Ulcavis® may be continued: 1 tablet 4 times daily, 30 minutes before breakfast, lunch, dinner, and at bedtime. The total duration of Ulcavis® therapy should not exceed 6 weeks (maximum 8 weeks).

Method of Administration

The tablet should be swallowed whole and taken with sufficient amount of water.

Children.

Ulcavis® can be used in children aged 4 years and older.

Overdose.

Overdose may occur with frequent intake of large doses and may manifest after 10 days with symptoms typical of renal failure (elevated bismuth levels in blood plasma).

In cases of impaired renal function associated with high bismuth levels in plasma, chelation therapy with complex-forming agents—dimercaptosuccinic acid and dimercaptopropanesulfonic acid—should be administered.

Treatment includes gastric lavage followed by administration of activated charcoal and osmotic laxatives. Absorption of bismuth as additional treatment is not mandatory.

Bismuth concentrations in blood and urine should be measured in cases of acute or chronic intoxication to establish a link between any symptoms and elevated bismuth levels.

In cases of concomitant severe kidney disease, chelation therapy should be accompanied by hemodialysis.

Side effects.

Very common (≥ 1/10):

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

Uncommon (≥ 1/1,000 to < 1/100):

Gastrointestinal disorders: nausea, vomiting, constipation, diarrhea.

Skin and subcutaneous tissue disorders: rash, pruritus.

Very rare (< 1/10,000):

Immune system disorders: anaphylactic reaction.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Information on any suspected adverse reactions should be reported in accordance with the requirements of legislation.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging to protect from moisture and light.

Keep out of the reach and sight of children.

Packaging.

14 tablets in a blister; 2, 6, or 8 blisters in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. KRKA, d.d., Novo mesto, Slovenia / KRKA, d.d., Novo mesto, Slovenia.

Manufacturer's name and address of the place of business.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia / Smarjeska cesta 6, 8501 Novo mesto, Slovenia.