Instructions for use White Coal tablets No. 30
Composition
active ingredient: colloidal anhydrous silicon dioxide;
1 tablet contains 210 mg of colloidal anhydrous silicon dioxide (calculated on 100% dry matter);
excipients: potato starch, microcrystalline cellulose, sorbitol (E 420), croscarmellose sodium, magnesium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets are white or almost white, round in shape, with a biconvex surface, without a score.
Pharmacotherapeutic group
Enterosorbents. Code ATX A07B C.
Pharmacological properties
Pharmacodynamics
White Coal® is an enterosorbent, the active substance of which is silicon dioxide. The high dispersion of silicon dioxide provides a large active sorption surface and, therefore, the sorption capacity of the drug. The non-porous structure of silicon dioxide particles provides a high rate of sorption. The absence of pores also explains the weak sorption of low-molecular compounds, in particular minerals and vitamins.
Silicon dioxide has a significant adsorption activity towards substances of protein nature, which contributes to the removal of exo- and endotoxins, toxic products of incomplete decomposition of large organic compounds, pathogenic antigens and allergens of microbial or other origin from the body. 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, which provides pronounced antimicrobial and antidiarrheal effects. In addition, the antidiarrheal effect of silicon dioxide consists in enveloping the intestinal mucosa, which prevents the adhesion of microorganisms and their colonization, and also blocks the action of stimulants of fluid secretion in the intestine (sodium deoxycholate, c-AMP and serotonin) through the effect on the corresponding receptors. An additional mechanism of antidiarrheal action is the structuring of intestinal contents due to the pronounced hydrophilic properties of silicon dioxide.
Silicon dioxide promotes the movement of various toxic products, including medium molecules, oligopeptides, amines, and other substances, from the internal environment of the body (blood, lymph, interstitium) to the digestive tract, due to concentration and osmotic gradients, with subsequent binding and excretion from the body.
Silicon dioxide has pronounced adsorption properties for cholesterol, bile pigments (in particular bilirubin), phospholipids, monosaccharides and proteins (300-600 mg per 1 g of sorbent), which contain a primary amino group. Sorption of bile pigments and cholesterol occurs directly from the gastrointestinal tract as part of micellar complexes with proteins and phospholipids and can be several milligrams per 1 g of sorbent.
Microcrystalline cellulose, which is part of the drug White Coal®, complements the adsorption properties of silicon dioxide, binding cholesterol and heavy metals. The swollen fibers of microcrystalline cellulose, moving along the intestine, mechanically cleanse the surface of its mucosa.
Pharmacokinetics
Silicon dioxide exhibits chemical and microbiological stability: it does not decompose in organic solvents and biological fluids, including gastric juice, and the structure of its particles does not change when the pH changes. Silicon dioxide does not accumulate in the body.
More than 99% of silicon dioxide is excreted unchanged through the gastrointestinal tract in the feces.
When taken orally, less than 1% of silicon dioxide enters the systemic bloodstream and is excreted by the kidneys in the urine.
Indication
As monotherapy or in combination therapy:
acute intestinal diseases (salmonellosis, food poisoning);
acute diarrhea of various etiologies;
exogenous intoxication with household and industrial toxins (alkaloids, heavy metal salts, other substances), medications, and alcohol and food overloads.
As adjunctive therapy:
with viral hepatitis;
for allergic diseases;
for dermatitis;
with late gestosis of pregnant women.
Contraindication
Hypersensitivity to the active substance and to excipients. Gastric and duodenal ulcer in the acute stage. Ulcers and erosions of the intestinal mucosa. Gastric and intestinal bleeding. Intestinal obstruction.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of White Coal® and acetylsalicylic acid, platelet disaggregation processes may be enhanced.
In complex therapy with nicotinic acid and simvastatin, White Coal® exhibits a synergistic effect: it helps reduce the level of atherogenic fractions of the blood lipid spectrum and increase the level of high-density lipoprotein cholesterol.
Application features
White Coal®, when used in complex therapy, should be taken 1 hour before taking other oral medications to prevent a decrease in their effectiveness.
The medicine contains sorbitol, so it should not be used in patients with rare hereditary diseases such as fructose intolerance syndrome.
Use during pregnancy or breastfeeding
The decision to take the drug White Coal® during pregnancy or breastfeeding is made by a doctor, taking into account the benefit/risk ratio.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
Take between meals, washed down with drinking water:
adults and children over 7 years old - 3-5 tablets 3-4 times a day;
children aged 5-6 years - 3 tablets 3 times a day;
Children aged 3-4 years - 2 tablets 3 times a day.
In severe cases, if necessary, a single dose can be increased to 10-14 tablets.
In acute intestinal diseases, the course of treatment is 3-5 days. In severe cases, the treatment period can be extended to 10-15 days.
The course of treatment for viral hepatitis depends on the severity of the disease and is 10-14 days.
The duration of treatment depends on the course of the disease.
Children
The drug should not be prescribed to children under 3 years of age.
Overdose
There were no reports of overdose.
Side effects
No cases of adverse reactions were recorded when the method of administration was followed.
If the recommended doses are exceeded, isolated cases of constipation are possible.
Expiration date
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 in a cardboard pack.
12 tablets in a blister; 2 blisters in a cardboard pack.
100 tablets in a container; 1 container in a cardboard pack.
Vacation category
Without a prescription.
Producer
LLC "PHARMEX GROUP".
or
PJSC SVC "Borshchagovskyi KhPF".
Location of the manufacturer and address of its place of business.
LLC "PHARMEX GROUP".
Ukraine, 08301, Kyiv region, Boryspil city, Shevchenko st., building 100.
or
PJSC SVC "Borshchagovskyi KhPF"
Ukraine, 03134, Kyiv, Myru St., 17.
Applicant
LLC "ACTIPHARM".
Location of the applicant.
Ukraine, 02141, Kyiv, O. Myshugy St., building 10, office 212.
