Instructions for Bisacodyl-Darnitsa enteric-coated tablets 0.005 g No. 30
Composition
active ingredient: bisacodyl;
1 tablet contains 5 mg bisacodyl;
Excipients: potato starch, lactose monohydrate, microcrystalline cellulose, povidone, calcium stearate, methacrylate copolymer dispersion, talc, titanium dioxide (E 171), polyethylene glycol, quinoline yellow (E 104).
Dosage form
The film-coated tablets are enteric-coated.
Main physicochemical properties: film-coated tablets, round, light yellow to greenish-yellow or yellow-orange in color, with a biconvex surface. Two layers are visible in cross section.
Pharmacotherapeutic group
Drugs used in case of constipation. Contact laxatives. Bisacodyl. ATX code A06A B02.
Pharmacological properties
Pharmacodynamics.
Bisacodyl has a laxative effect, which is manifested by softening or liquefaction of feces. The mechanism of laxative action is due to increased penetration of water into the intestinal cavity and reduced absorption, as well as acceleration of intestinal peristalsis.
An important place in the mechanism of action is occupied by the breakdown of bisacodyl in the alkaline contents of the intestine, which leads to the formation of substances that irritate the receptors of the mucous membrane. This leads to stimulation of intestinal peristalsis.
Pharmacokinetics.
Intestinal and bacterial enzymes rapidly convert bisacodyl to its active metabolite. Only 5% of an oral dose is absorbed into the systemic circulation, transformed in the liver, and excreted in the urine and bile as inactive metabolites (glucuronides).
Indication
Short-term symptomatic treatment of constipation.
Preparation of the intestine for diagnostic tests and before surgical interventions (under the supervision of a doctor).
Clinical need to facilitate defecation in hemorrhoids, anal fistulas and fissures.
Contraindication
Hypersensitivity to bisacodyl or any other component of the drug.
Acute proctitis, acute hemorrhoids, spastic constipation, intestinal obstruction, strangulated hernia.
Gastrointestinal bleeding, uterine bleeding.
Acute abdominal syndrome, including appendicitis, other acute inflammatory bowel diseases, peritonitis.
Severe abdominal pain accompanied by nausea and vomiting (these symptoms may be manifestations of the above serious conditions).
Crohn's disease, nonspecific ulcerative colitis.
Severe dehydration.
Interaction with other medicinal products and other types of interactions
It is not recommended to use the drug simultaneously with H2-histamine receptor blockers, dairy products and antacids (within 1 hour), as there is a risk of rapid dissolution of the outer coating of the tablet and, as a result, irritation of the gastric and duodenal mucosa, and impaired effectiveness of bisacodyl.
Do not consume alkaline foods while using the medicine and for 1 hour before and after taking it.
The laxative effect of bisacodyl can cause potassium deficiency, so caution should be exercised when using bisacodyl with the following drugs: diuretics, β-adrenomimetics, corticosteroids (mineralocorticoids and glucocorticoids), amphotericin B, tetracosactide, or drugs whose toxicity increases with potassium deficiency in the body (e.g., cardiac glycosides).
Astemizole, terfenadine, erythromycin, amiodarone, sotalol, and quinidine preparations are not recommended to be combined with bisacodyl.
When used with digitalis preparations (digitalis glycosides), the risk of developing hypokalemia and digitalis intoxication increases.
Application features
When using Bisacodyl-Darnitsa, it is worth remembering that the tablet is coated with an enteric coating, so it cannot be divided or chewed.
The medicine should not be taken with alkaline mineral water, or within 1 hour of taking it with milk, antacids, or H2 blockers.
Use with caution in patients with liver and kidney disease.
It is contraindicated for use in cases of abdominal pain of unknown origin, accompanied by nausea and vomiting.
Like all laxatives, bisacodyl should not be taken daily for more than 5 days without investigating the cause of constipation.
Prolonged, more than 7 days, and systematic use of the drug should be avoided, as this may lead to intestinal atony and the inability to defecate without the use of stronger laxatives.
Prolonged use of high doses may lead to electrolyte imbalance and hypokalemia.
Fluid loss in the gastrointestinal tract may cause dehydration, symptoms of which may include thirst and oliguria. In patients suffering from fluid loss and for whom dehydration may be harmful (e.g. patients with renal insufficiency, elderly patients), bisacodyl should be discontinued; use should only be resumed under medical supervision.
Cases of dizziness and/or fainting have been reported in patients taking bisacodyl. The available data on these cases suggest that these adverse reactions are related to irregular defecation (or difficulty in defecating) or to a neurovascular response to abdominal pain associated with constipation and not necessarily to bisacodyl.
There have been isolated reports of abdominal pain and bloody diarrhea following the administration of bisacodyl. Some cases have been associated with ischemia of the colonic mucosa.
Bisacodyl should not be given to children under 10 years of age without consulting a doctor.
In elderly people, frequent use of the drug may cause asthenia, orthostatic hypotension, and impaired coordination of movements.
The lack of stimulation of the act of defecation by a drug may indicate an organic cause of constipation.
Laxatives do not help with weight loss.
Along with the use of bisacodyl, it is recommended to follow a certain diet containing a lot of fiber: wholemeal bread, beans and other legumes (if tolerated), fruits and vegetables. It is also necessary to drink enough fluids per day and move more.
Important information about excipients.
The medicinal product contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take the medicinal product.
Use during pregnancy or breastfeeding
The use of the drug during pregnancy or breastfeeding is not recommended due to the lack of safety data for this group of patients.
Ability to influence reaction speed when driving vehicles or other mechanisms
Patients should be warned that dizziness and/or fainting may occur as a result of colic. During treatment, caution should be exercised when driving or operating machinery, and in case of dizziness, refrain from potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
For effective bowel movements in the morning, the medicine should be taken orally before bedtime, regardless of food intake. The tablet should be swallowed without chewing and washed down with a full glass of water.
For short-term treatment of constipation, facilitating defecation in hemorrhoids, anal fistulas and fissures.
Adults and children over 10 years of age: 1–2 tablets (5–10 mg) once a day.
Children aged 4 to 10 years: 1 tablet (5 mg) once a day.
To prepare for diagnostic procedures and before surgical interventions (under the supervision of a physician).
Adults and children over 10 years of age: 2–4 tablets (10–20 mg) once in the evening.
Children aged 4 to 10 years: 1 tablet (5 mg) in the evening.
It is not recommended to use the drug for more than 7 days, daily use of the drug is undesirable.
Children
Do not use the medicine in children under 4 years of age.
Children aged 4 to 10 years should use the medicine only as prescribed by a doctor.
Overdose
Symptoms: High doses may cause diarrhea, abdominal cramps, electrolyte imbalance (including symptoms of hypokalemia and functional atony of the colon). Chronic overdose may lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and nephrolithiasis.
Cases of renal tubular damage, metabolic alkalosis, and muscle weakness due to hypokalemia resulting from chronic laxative abuse have been described.
Treatment. Discontinue the drug and consult a doctor. It is necessary to wash the stomach or induce vomiting. Correction of water and electrolyte imbalance is recommended (especially important for elderly patients and children), the use of symptomatic agents, and in some cases, antispasmodics.
Adverse reactions
Gastrointestinal tract: abdominal discomfort, spastic abdominal pain, flatulence, vomiting, nausea, diarrhea, thirst, dry mouth, intestinal colic, rectal irritation, hematochezia (blood in the stool) may occur, prolonged use may lead to intestinal atony, melanosis of the large intestine, colitis.
From the side of metabolism: disturbances of water and electrolyte balance (metabolic acidosis/alkalosis, hypokalemia, hypocalcemia), especially in the elderly, dehydration (as a result of dehydration, muscle weakness, cramps, arterial hypotension may occur).
Nervous system: dizziness, weakness, loss of coordination, orthostatic hypotension, periodic cramps of the calf muscles (cramps), in severe cases - vasospasm. Dizziness and fainting that occur after the use of bisacodyl occur as a result of a vasovagal response (e.g., to colic, defecation).
Immune system disorders: anaphylactic reactions, hypersensitivity reactions including skin rashes, itching, angioedema.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of the medicinal product in question. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
10 tablets in a contour blister pack; 3 contour blister packs in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business
Ukraine, 02093, Kyiv, Boryspilska St., 13.
