White coal®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BILE VUGILLIA®

Composition:

Active substance: colloidal anhydrous silicon dioxide;

1 tablet contains 210 mg of colloidal anhydrous silicon dioxide (calculated as 100% dry substance);

Excipients: potato starch, microcrystalline cellulose, sorbitol (E 420), sodium croscarmellose, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white, round-shaped tablets with a biconvex surface, without a score line.

Pharmacotherapeutic group. Enterosorbents. ATC code A07BC.

Pharmacological Properties

Pharmacodynamics

White Coal® is an enterosorbent whose active ingredient is silicon dioxide. The high dispersion of silicon dioxide provides a large adsorption surface area and, consequently, high sorption capacity of the drug. The non-porous structure of silicon dioxide particles ensures a high rate of sorption. The absence of pores also explains the weak adsorption of low-molecular-weight compounds, particularly minerals and vitamins.

Silicon dioxide exhibits significant adsorption activity toward protein-based substances, promoting the elimination from the body of exo- and endotoxins, toxic products of incomplete degradation of large organic compounds, and pathogenic antigens and allergens of microbial or other origin. Due to the presence of various protein structures on the surface of microorganisms, highly dispersed silicon dioxide actively adsorbs pathogenic microflora in the intestine—up to 10¹⁰ microbial bodies per 1 gram of substance—providing a pronounced antimicrobial and antidiarrheal effect. Furthermore, the antidiarrheal effect of silicon dioxide is attributed to coating the intestinal mucosa, thereby preventing microbial adhesion and colonization, as well as blocking the action of intestinal fluid secretion stimulators (sodium deoxycholate, c-AMP, and serotonin) via effects on corresponding receptors. An additional mechanism of antidiarrheal action is structuring of intestinal contents due to the pronounced hydrophilic properties of silicon dioxide.

Silicon dioxide facilitates the transfer of various toxic substances—including medium-sized molecules, oligopeptides, amines, and other compounds—from the body's internal environment (blood, lymph, interstitium) into the gastrointestinal tract, driven by concentration and osmotic gradients, followed by binding and subsequent elimination from the body.

Silicon dioxide exhibits pronounced adsorption properties toward cholesterol, bile pigments (particularly bilirubin), phospholipids, monosaccharides, and proteins (300–600 mg per 1 g of sorbent) containing primary amino groups. Adsorption of bile pigments and cholesterol occurs directly from the gastrointestinal tract as components of micellar complexes with proteins and phospholipids and may amount to several milligrams per 1 g of sorbent.

Microcrystalline cellulose, included in the composition of White Coal®, complements the adsorption properties of silicon dioxide by binding cholesterol and heavy metals. Swollen microcrystalline cellulose fibers, as they move along the intestine, mechanically cleanse the mucosal surface.

Pharmacokinetics

Silicon dioxide demonstrates chemical and microbiological stability: it does not degrade in organic solvents or biological fluids, including gastric juice, and its particle structure remains unchanged under varying pH conditions. Silicon dioxide does not accumulate in the body.

Over 99% of silicon dioxide is excreted unchanged via the gastrointestinal tract in feces.

Following oral administration, less than 1% of silicon dioxide is absorbed into the systemic circulation and is excreted by the kidneys in urine.

Clinical characteristics.

Indications.

As monotherapy or in complex therapy:

• acute intestinal diseases (salmonellosis, foodborne toxicoinfections);
• acute diarrhea of various etiologies;
• exogenous intoxication with household and industrial toxins (alkaloids, heavy metal salts, and other substances), drugs, and in cases of alcohol- and food-related overloads.

As adjunctive therapy:

• in viral hepatitis;
• in allergic diseases;
• in dermatitis;
• in late gestosis during pregnancy.

Contraindications. Hypersensitivity to the active substance and excipients. Peptic ulcer of the stomach and duodenum in the acute phase. Ulcers and erosions of the intestinal mucosa. Gastric and intestinal bleeding. Intestinal obstruction.

Interaction with other medicinal products and other forms of interactions.

When White Charcoal® is used concomitantly with acetylsalicylic acid, platelet disaggregation processes may be enhanced.

In combined therapy with nicotinic acid and simvastatin, White Charcoal® exhibits a synergistic effect: it promotes reduction of atherogenic lipid fractions in the blood and increases high-density lipoprotein cholesterol levels.

Special precautions for use.

White Coal® should be taken 1 hour before other oral medicinal products when used as part of combination therapy to prevent reduced efficacy of the latter.

Since the medicinal product White Coal® does not contain sugar, it can be used by patients with diabetes mellitus.

The medicinal product contains sorbitol and therefore should not be administered to patients with rare hereditary disorders such as fructose intolerance.

Use during pregnancy or breastfeeding.

The decision to use the medicinal product White Coal® during pregnancy or breastfeeding should be made by a physician, taking into account the benefit-risk ratio.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Dosage and Administration.

Take between meals with drinking water:

for adults and children aged 7 years and older — 3–5 tablets 3–4 times daily;

for children aged 5–6 years — 3 tablets 3 times daily;

for children aged 3–4 years — 2 tablets 3 times daily.

In severe cases, if necessary, the single dose may be increased to 10–14 tablets.

In acute intestinal diseases, the treatment course lasts 3–5 days. In severe cases, the treatment duration may be extended to 10–15 days.

The treatment course for viral hepatitis depends on the severity of the disease and lasts 10–14 days.

The duration of treatment depends on the course of the disease.

Children.

The drug is contraindicated for children under 3 years of age.

Overdose.

There have been no reports of overdose.

Side effects.

No cases of adverse reactions have been reported when the recommended dosage regimen was followed.

In case of exceeding the recommended doses, isolated cases of constipation are possible.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets per blister; 1 or 3 blisters per cardboard box.

100 tablets in a container; 1 container per cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

LLC "AKTIFARM".

Manufacturer's address and place of business.

11, Pryozerna St., village Horenka, Bucha district, Kyiv region, Ukraine, 08150.

Marketing authorization holder.

LLC "AKTIFARM".

Address of the marketing authorization holder.

10, O. Myshuhy St., office 212, Kyiv, Ukraine, 02141.

INSTRUCTION

for medical use of the medicinal product

WHITE CHARCOAL®

Composition:

Active substance: anhydrous colloidal silicon dioxide;

1 tablet contains 210 mg of anhydrous colloidal silicon dioxide (recalculated to 100% dry substance);

Excipients: potato starch, microcrystalline cellulose, sorbitol (E 420), sodium croscarmellose, magnesium stearate.

Pharmaceutical form. Tablets.

Main physicochemical characteristics: white or almost white, round-shaped tablets with a biconvex surface, without a score line.

Pharmacotherapeutic group. Enter sorbents. ATC code A07B C.

Pharmacological Properties.

Pharmacodynamics.

White Coal® is an enterosorbent whose active ingredient is silicon dioxide. The high dispersion of silicon dioxide provides a large adsorption surface area and, consequently, high sorption capacity of the drug. The non-porous structure of silicon dioxide particles ensures a high rate of adsorption. The absence of pores also explains the weak adsorption of low-molecular-weight compounds, particularly minerals and vitamins.

Silicon dioxide exhibits significant adsorption activity towards protein substances, promoting the elimination from the body of exo- and endotoxins, toxic products of incomplete degradation of large organic compounds, and pathogenic antigens and allergens of microbial or other origin. Due to the presence of various protein structures on the surface of microorganisms, highly dispersed silicon dioxide actively adsorbs pathogenic microflora in the intestine—up to 10^10 microbial bodies per 1 gram of substance—providing a pronounced antimicrobial and antidiarrheal effect. Additionally, the antidiarrheal effect of silicon dioxide is attributed to coating the intestinal mucosa, thereby preventing microbial adhesion and colonization, as well as blocking the action of intestinal fluid secretion stimulators (sodium deoxycholate, c-AMP, and serotonin) via effects on corresponding receptors. An additional mechanism of antidiarrheal action is structuring of intestinal contents due to the pronounced hydrophilic properties of silicon dioxide.

Silicon dioxide promotes the transfer of various toxic substances—including medium-sized molecules, oligopeptides, amines, and other compounds—from the body's internal environment (blood, lymph, interstitium) into the gastrointestinal tract, driven by concentration and osmotic gradients, followed by binding and subsequent elimination from the body.

Sil combustus exhibits strong adsorption properties towards cholesterol, bile pigments (particularly bilirubin), phospholipids, monosaccharides, and proteins (300–600 mg per 1 g of sorbent) containing primary amino groups. Adsorption of bile pigments and cholesterol occurs directly from the gastrointestinal tract, where they are present as micellar complexes with proteins and phospholipids, and may amount to several milligrams per 1 g of sorbent.

Microcrystalline cellulose, included in the composition of the medicinal product White Coal®, complements the adsorption properties of silicon dioxide by binding cholesterol and heavy metals. Swollen fibers of microcrystalline cellulose, moving along the intestine, mechanically cleanse the mucosal surface.

Pharmacokinetics.

Silicon dioxide demonstrates chemical and microbiological stability: it does not degrade in organic solvents or biological fluids, including gastric juice, and its particle structure remains unchanged with variations in pH. Silicon dioxide does not accumulate in the body.

More than 99% of silicon dioxide is excreted unchanged via the gastrointestinal tract in feces.

Following oral administration, less than 1% of silicon dioxide penetrates into the systemic circulation and is excreted by the kidneys in urine.

Clinical characteristics.

Indications.

As monotherapy or in complex therapy:

• acute intestinal diseases (salmonellosis, food toxicoinfections);
• acute diarrhea of various etiologies;
• exogenous intoxication with household and industrial toxins (alkaloids, heavy metal salts, other substances), drugs, and in alcohol- and food-related overloads.

As adjunctive therapy:

• in viral hepatitis;
• in allergic diseases;
• in dermatitis;
• in late gestosis of pregnancy.

Contraindications. Hypersensitivity to the active substance and excipients. Peptic ulcer of the stomach and duodenum in the acute phase. Ulcers and erosions of the intestinal mucosa. Gastric and intestinal bleeding. Intestinal obstruction.

Interaction with other medicinal products and other types of interactions.

When used concomitantly, White Charcoal® and acetylsalicylic acid may enhance platelet disaggregation processes.

In combined therapy with nicotinic acid and simvastatin, White Charcoal® exhibits a synergistic effect: it promotes reduction of atherogenic lipid fractions in the blood and increases high-density lipoprotein cholesterol levels.

Special precautions for use.

White Coal® should be taken 1 hour before taking other oral medicinal products when used as part of combination therapy to prevent a reduction in their effectiveness.

Since the medicinal product White Coal® does not contain sugar, it can be used by patients with diabetes.

The medicinal product contains sorbitol and therefore should not be used in patients with rare hereditary disorders such as fructose intolerance.

Use during pregnancy or breastfeeding.

The decision to use the medicinal product White Coal® during pregnancy or breastfeeding should be made by a physician, taking into account the benefit-risk ratio.

Ability to influence reaction rate while driving or operating machinery.

Has no effect.

Dosage and Administration.

Take between meals, with drinking water:

for adults and children aged 7 years and older — 3–5 tablets 3–4 times daily;

for children aged 5–6 years — 3 tablets 3 times daily;

for children aged 3–4 years — 2 tablets 3 times daily.

In severe cases, if necessary, the single dose may be increased to 10–14 tablets.

In acute intestinal diseases, the treatment course lasts 3–5 days. In severe cases, the treatment duration may be extended to 10–15 days.

The treatment course for viral hepatitis depends on the severity of the disease and lasts 10–14 days.

The duration of treatment depends on the course of the disease.

Children.

The drug should not be administered to children under 3 years of age.

Overdose.

No cases of overdose have been reported.

Side effects.

No cases of side effects have been reported when the recommended dosage regimen is followed.

In cases of exceeding the recommended doses, isolated cases of constipation are possible.

Shelf life.

3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a blister; 1 or 3 blisters per cardboard pack.

12 tablets in a blister; 2 blisters per cardboard pack.

100 tablets in a container; 1 container per cardboard pack.

Classification of supply.

Over-the-counter (without prescription).

Manufacturer.

LLC "FARMEKS GROUP"

or

JSC NVC "Borshchahivskiy CHP".

Manufacturer's address and location of business activity.

LLC "FARMEKS GROUP"

Ukraine, 08301, Kyiv region, Borispol, Shevchenka St., 100.

or

JSC NVC "Borshchahivskiy CHP"

Ukraine, 03134, Kyiv, Miru St., 17.

Marketing Authorization Holder.

LLC "AKTIFARM"

Address of the Marketing Authorization Holder.

Ukraine, 02141, Kyiv, Mishugi St., 10, office 212.