Dulcolax tablets p / o 5mg, No. 30

1 tablet contains:

Active substance: bisacodyl 5 mg

Excipients: corn starch, glycerol 85%, soluble corn starch, lactose, magnesium stearate

Enteric coating: sucrose, talc, acacia gum, titanium dioxide, methacrylic acid and methyl methacrylate copolymer (1: 2) (Eudragit S100), methacrylic acid and methyl methacrylate copolymer (1: 1) (Eudragit L100), castor bean seed oil (castor oil ), magnesium stearate, macrogol (polyethylene glycol) 6000, iron dye yellow oxide (E172), white beeswax, carnauba wax, shellac.

Inside. The tablets must be taken with a sufficient amount of liquid.

For constipation

Unless otherwise prescribed by a physician, the following dosing regimen is recommended:

adults and children over 10 years old: 1 - 2 tablets (5-10 mg)

children aged 4-10 years: 1 tablet (5 mg)

To obtain a laxative effect in the morning, it is recommended to take the drug the night before.

The drug should not be taken with products that lower acidity in the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the enteric membrane.

In preparation for research and preoperatively

In preparation for research, pre- and postoperative treatment, medical conditions that require relief of bowel movements, DULCOLAXЃ should be used under medical supervision.

It is recommended to use 2 tablets at night the day before the study and 2 tablets at night on the eve of the operation or study. Can be used in combination with suppositories. For adults, in addition to 2-4 tablets taken the day before, one suppository in the morning is recommended.

1 tablet contains:

Active substance: bisacodyl 5 mg

Excipients: corn starch, glycerol 85%, soluble corn starch, lactose, magnesium stearate

Enteric coating: sucrose, talc, acacia gum, titanium dioxide, methacrylic acid and methyl methacrylate copolymer (1: 2) (Eudragit S100), methacrylic acid and methyl methacrylate copolymer (1: 1) (Eudragit L100), castor bean seed oil (castor oil ), magnesium stearate, macrogol (polyethylene glycol) 6000, iron dye yellow oxide (E172), white beeswax, carnauba wax, shellac.

The use of the drug is contraindicated in the following cases:

Х hypersensitivity to the active ingredient or excipients,

Х intestinal obstruction,

Х obstructive bowel disease,

Х acute diseases of the abdominal organs, including appendicitis,

Х acute inflammatory bowel disease,

Х severe abdominal pain associated with nausea and vomiting, which may be a sign of a more severe condition,

Х severe dehydration,

Х children under 4 years of age.

One tablet (5 mg) contains 33.2 mg of lactose. The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for X-ray examination contains 66.4 mg and 132.8 mg of lactose, respectively. Patients with a rare hereditary galactose intolerance, such as galactosemia, should not take the drug.

One tablet (5 mg) contains 23.4 mg of sucrose. The maximum recommended daily dose of tablets for adults and children over 10 years old for the treatment of constipation and for X-ray examination contains 46.8 mg and 93.6 mg of sucrose, respectively. Patients with rare hereditary fructose intolerance should not take the drug.

With caution DULKOLAXЃ, like other laxatives, should be used with caution in patients with hepatic and / or renal insufficiency.

Trade name of the drug: Dulcolax Ѓ

International non-proprietary name: bisacodyl

Dosage form:

enteric-coated tablets

Composition
1 tablet contains:

Active substance: bisacodyl 5 mg

Excipients: corn starch, glycerol 85%, soluble corn starch, lactose, magnesium stearate

Enteric coating: sucrose, talc, acacia gum, titanium dioxide, methacrylic acid and methyl methacrylate copolymer (1: 2) (Eudragit S100), methacrylic acid and methyl methacrylate copolymer (1: 1) (Eudragit L100), castor bean seed oil (castor oil ), magnesium stearate, macrogol (polyethylene glycol) 6000, iron dye yellow oxide (E172), white beeswax, carnauba wax, shellac.

Description: Round, beige-yellow, biconvex sugar enteric-coated tablets with a smooth, shiny surface and a white core

Pharmacotherapeutic group: laxative

Pharmacological properties

Bisacodyl is a topically acting laxative from the group of diphenylmethane derivatives. As a local laxative with antiresorptive effect, bisacodyl, after hydrolysis in the large intestine, increases the secretion of water and electrolytes in the large intestine, accelerates and increases its peristalsis. This leads to stimulation of the act of defecation, a decrease in evacuation time and softening of the stool. The time for the development of the laxative effect of the drug is 6-12 hours.

Pharmacokinetics

DULKOLAXЃ enteric-coated tablets are resistant to the action of gastrointestinal juice. Bisacodyl is released mainly in the large intestine to form an active metabolite that irritates the gastrointestinal mucosa. Absorption of the active metabolite does not occur.

A small part of the drug (from 3% to 17%) is excreted in the urine. In the systemic circulation and urine, mainly inactive forms of metabolites (glucuronides) are found. There is no relationship between the laxative effect of bisacodyl and the concentration of glucuronides in plasma or urine.

Indications for use
As a laxative in the following cases:

• constipation due to hypotension of the large intestine (including chronic),

• preoperative preparation, postoperative treatment, preparation for instrumental and X-ray examinations, medical conditions requiring easier bowel movements.

Contraindications The
use of the drug is contraindicated in the following cases:

Х hypersensitivity to the active ingredient or excipients,

Х intestinal obstruction,

Х obstructive bowel disease,

Х acute diseases of the abdominal organs, including appendicitis,

Х acute inflammatory bowel disease,

Х severe abdominal pain associated with nausea and vomiting, which may be a sign of a more severe condition,

Х severe dehydration,

Х children under 4 years of age.

One tablet (5 mg) contains 33.2 mg of lactose. The maximum recommended daily dose of tablets for adults and children over 10 years of age for the treatment of constipation and for X-ray examination contains 66.4 mg and 132.8 mg of lactose, respectively. Patients with a rare hereditary galactose intolerance, such as galactosemia, should not take the drug.

One tablet (5 mg) contains 23.4 mg of sucrose. The maximum recommended daily dose of tablets for adults and children over 10 years old for the treatment of constipation and for X-ray examination contains 46.8 mg and 93.6 mg of sucrose, respectively. Patients with rare hereditary fructose intolerance should not take the drug.

With caution DULKOLAXЃ, like other laxatives, should be used with caution in patients with hepatic and / or renal insufficiency.

Pregnancy and lactation

During the long-term experience of using the drug, no adverse events have been identified during pregnancy. However, due to the lack of research, the use of DULCOLAXЃ during pregnancy is recommended only in cases where the potential benefit to the mother outweighs the possible risk to the fetus. Bisacodyl does not pass into breast milk. Like other laxatives, during pregnancy and breastfeeding, the drug can only be used after consulting a specialist.

Method of administration and dosage

Inside. The tablets must be taken with a sufficient amount of liquid.

For constipation

Unless otherwise prescribed by a physician, the following dosing regimen is recommended:

adults and children over 10 years old: 1 - 2 tablets (5-10 mg)

children aged 4-10 years: 1 tablet (5 mg)

To obtain a laxative effect in the morning, it is recommended to take the drug the night before.

The drug should not be taken with products that lower acidity in the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the enteric membrane.

In preparation for research and preoperatively

In preparation for research, pre- and postoperative treatment, medical conditions that require relief of bowel movements, DULCOLAXЃ should be used under medical supervision.

It is recommended to use 2 tablets at night the day before the study and 2 tablets at night on the eve of the operation or study. Can be used in combination with suppositories. For adults, in addition to 2-4 tablets taken the day before, one suppository in the morning is recommended.

Side effect

• From the gastrointestinal tract, discomfort, nausea, vomiting, spastic pain in the abdomen, diarrhea, colitis are possible.

• Hypersensitivity reactions from the immune system are possible, including angioedema and anaphylaxis.

Overdose
In case of an acute overdose, the following are possible: diarrhea, dehydration, decreased blood pressure, imbalance in water and electrolyte balance, hypokalemia, convulsions. DULKOLAXЃ, like other laxatives, in chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, hyperaldosteronism, urolithiasis. Chronic laxative abuse can lead to renal tubular damage, metabolic alkalosis, and muscle weakness associated with hypokalemia.

Treatment should be symptomatic. There is no specific antidote. To reduce the absorption of the drug after ingestion, you can induce vomiting or gastric lavage. Fluid replenishment and electrolyte balance adjustments may be required, as well as antispasmodics.

Interaction with other medicinal products
Simultaneous administration of high doses of the drug and diuretics or glucocorticosteroids increases the risk of electrolyte imbalance (hypokalemia).

Electrolyte imbalance (hypokalemia) enhances the action of cardiac glycosides.

special instructions

You should not use the drug, like all laxatives, regularly or for a long period of time without establishing the cause of constipation. Long-term use of high doses of the drug can lead to fluid loss, electrolyte imbalance, hypokalemia.

Dizziness and / or fainting was observed in patients taking DULCOLAXЃ. Studies have shown that these cases were associated with fainting during bowel movements (or fainting caused by straining during bowel movements) or with a vasovagal response to abdominal pain, which could be due to constipation, which forced patients to take laxatives, and not necessarily associated with taking the drug.

One tablet (5 mg) contains 0.006 bread units (bread units). Children should only take this medicine as directed by a doctor.

Release form
Enteric-coated tablets, 5 mg.

10 tablets in a PVC / PVDC / Al blister.

3 blisters with instructions in a cardboard box.

Storage
conditions Store in a dry place at a temperature not exceeding + 25 ? —. Keep out of the reach of children.

Shelf life is
3 years.

Do not use after the expiration date.

Terms of dispensing from pharmacies
Without prescription.