Vicalyn

I N S T R U C T I O N for medical use of the medicinal product VICALIN (VICALINUM)

Composition:

Active substances: bismuth nitrate basic, magnesium carbonate basic, sodium bicarbonate, cascara bark powder, calamus rhizome powder, rutin, quillin;

1 tablet contains: bismuth nitrate basic 350 mg, magnesium carbonate basic 400 mg, sodium bicarbonate 200 mg, cascara bark powder 25 mg, calamus rhizome powder 25 mg, rutin 5 mg, quillin 5 mg;

Excipients: potato starch, talc, stearic acid.

Medicinal form. Tablets.

Main physico-chemical properties: light brown tablets with barely noticeable specks, flat surface, beveled edges and a score line.

Pharmacotherapeutic group. Agents for treatment of peptic ulcer and gastroesophageal reflux disease. ATC code A02BX.

Pharmacological properties.

Pharmacodynamics.

The drug exerts a complex effect. Bismuth nitrate basic, sodium bicarbonate, and magnesium carbonate exert an antacid and astringent effects; cascara bark (although in a small dose) promotes a laxative effect; rutin reduces capillary permeability; and the rhizome of sweet flag (Acorus calamus) and chelidonium provide a spasmolytic effect.

Pharmacokinetics.

Data are lacking.

Clinical characteristics.

Indications.

As part of complex therapy for functional dyspepsia, hyperacid gastritis, peptic ulcer of the stomach and duodenum.

Contraindications.

Hypersensitivity to the components of the drug.

Severe impairment of kidney function.

Gastritis with reduced gastric secretory function.

Chronic inflammatory bowel diseases.

Chronic inflammatory conditions of the gallbladder.

Gastrointestinal bleeding.

Acute life-threatening conditions.

Cortex Frangulae (buckthorn bark): neurogenic and endocrine constipation, spastic constipation, intestinal obstruction, hemorrhages, acute abdomen syndrome, appendicitis, acute gastroenterocolitis.

Special precautions.

During treatment, a special diet should be followed. Alcohol consumption should be avoided during therapy. Renal function and bismuth concentration in blood and urine should be monitored during treatment. Stool may turn dark green or black during tablet intake. The drug should be taken 2 hours before or after other medicinal products.

Interaction with other medicinal products and other types of interactions.

During treatment with Vikalin, drugs containing bismuth should not be taken to avoid increased bismuth levels in the blood.

When Vikalin is used, the absorptive effect of tetracyclines is reduced, because complexes that are poorly absorbed are formed upon interaction of tetracyclines with drugs containing magnesium cations.

Concomitant use with alkaloids, glycosides, enzyme preparations, and antibiotics is not recommended.

The drug reduces absorption of coumarin derivatives.

Reduced absorption of other medicinal products taken concomitantly with Vikalin is possible. Therefore, the interval between administration of the drugs should be at least 2 hours.

Special precautions for use

Antacid preparations and milk should not be taken within half an hour before or after taking the drug, since 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 drug, concomitant use of other bismuth-containing preparations is not recommended.

Use during pregnancy or breastfeeding

The drug is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery

The effect of Vikalin on the ability to drive vehicles or operate machinery has not been studied.

Method of Administration and Dosage.

Adults should take 1–2 tablets 3 times daily after meals, swallowing with ½ glass of warm water. The tablets are recommended to be crushed before administration.

The duration of treatment is determined by the physician depending on the nature and severity of the disease.

Children.

There is no experience with the use of Vikalin in children.

Overdose.

Symptoms include nausea, vomiting, diarrhea, development of methemoglobinemia, eyelid swelling, and gums swelling.

Treatment: symptomatic.

Bismuth.

With frequent administration of large doses of the drug, bismuth overdose is possible, which may manifest after 10 days with symptoms characteristic of renal failure (increased bismuth levels in blood plasma).

Cortex Frangulae (Buckthorn bark).

Symptoms: colicky abdominal pain, tenesmus, sensation of discomfort.

Adverse reactions.

Gastrointestinal tract: increased frequency of defecation, which resolves with dose reduction; nausea, vomiting, tongue pigmentation. Stool may turn dark green or black during treatment.

Central nervous system: headache.

Blood and lymphatic system: hemoglobinemia.

General disorders: swelling of the gums and eyelids.

Other: allergic reactions, including urticaria, rash, itching, and edema.

Bismuth.

Skin and subcutaneous tissue: rash, itching.

Gastrointestinal tract: black or dark green discoloration of stools.

Cortex frangulae (Buckthorn bark).

Gastrointestinal tract: dehydration, reduced intestinal enzyme function, colonic atony, colic-like pain.

Rhizoma lepichis (Lepichis rhizome).

Immune system: urticaria, skin rash, itching, swelling.

Shelf life.

5 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in blisters or strips;

10 tablets per blister; 2 or 10 blisters per cardboard pack;

10 tablets per strip; 2 or 10 strips per cardboard pack.

Prescription status. Over-the-counter.

Manufacturer: JSC "Monfarm".

Manufacturer's address and location of business activity.

8, Zavodska St., Avramivka, Uman district, Cherkasy region, 19161, Ukraine.