Bisacodyl enteric tablets p/o 5mg №10×3

Name:
] Bisacodyl. [Forms of release] Tablets. [INN] Bisacodyl. [FTG] Laxative. [
Description:
] Film-coated tablets, round, light brown with a pink tint, with a biconvex surface. The cross section shows two layers. [Composition] Active ingredient – bisacodyl – 5 mg; excipients – lactose monohydrate, sucrose, potato starch, microcrystalline cellulose, talc, calcium stearate, acrylic-from (including methacrylic acid and ethyl acrylate copolymer, talc, triethyl citrate, anhydrous colloidal silicon dioxide, sodium carbonate, sodium lauryl sulfate, coloring pigment ( contains titanium dioxide E 171, iron oxide yellow E 172, iron oxide red E 172)). [Pharmacotherapeutic group] Contact laxatives. ATX code – A06AB02. [Pharmacological properties] Bisacodyl is a locally acting laxative from the group of diphenylmethane derivatives. As a local laxative with an 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, reduction of evacuation time and softening of the stool. The effect of the drug develops after 5-10 hours. [Indications for use] Short-term symptomatic treatment of occasional constipation. [Contraindications] Absolute contraindications: – hypersensitivity to Bisacodyl or to any of the excipients; – severe dehydration with electrolyte disturbances; – inflammatory bowel disease, ulcerative colitis, Crohn’s disease; – Acute abdomen syndrome, severe abdominal pain accompanied by nausea and vomiting; – intestinal obstruction of various origins; – children’s age up to 6 years; – congenital galactosemia, hereditary fructose intolerance, malabsorption of glucose and galactose, deficiency of lactase or sucrase-isomaltase (see section “Precautions”). Relative contraindications: – taking drugs that can cause the development of arrhythmias such as torsades de pointes. [Method of application and dose] Inside. Adults: 1 or 2 tablets per day (5-10 mg). Children 6 to 12 years old: 1 tablet (5 mg) daily. Children from 6 to 12 years of age with chronic constipation should take the drug only under medical supervision. To obtain a laxative effect in the morning, it is recommended to take the drug the night before. The tablets are swallowed with a sufficient amount of liquid. Tablets should be swallowed without chewing. The drug should not be taken with products that reduce acidity in the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the enteric coating. The duration of taking the drug is determined by the doctor. [Side effect] Adverse reactions are listed by organ system class with frequency of occurrence according to the following classification: very common (≥ 1/10), common (≥ 1/100 to <1/10), infrequent (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to <1/1000), very rare (< 1/10,000), not known (frequency cannot be estimated from the available data). The most commonly reported occurrences were abdominal pain and diarrhea. From the immune system: rarely: anaphylactic reactions, Quincke's edema. On the part of the skin and subcutaneous tissue: rarely: generalized itching. From the side of metabolism: rarely: dehydration; not known: hypokalemia. From the nervous system: infrequently: dizziness; rarely: fainting. Dizziness and fainting that occur after taking Bisacodyl appear in conjunction with a parasympathetic vascular reaction (eg, abdominal cramps, defecation). From the gastrointestinal tract: often: abdominal pain, diarrhea; infrequently: bleeding from the rectum, anorectal discomfort, burning and pain in the anorectal region; rarely: colitis. Reporting suspected adverse reactions If you experience any of the symptoms described or not described in this leaflet, be sure to tell your doctor! [Precautions] Patients with unstable fluid balance (eg, patients with impaired renal function, elderly patients) have an increased risk of dehydration, the symptoms of which are oliguria and thirst. Before prescribing laxatives, it is necessary to restore the water balance, ensure the intake of a sufficient amount of fluid. Drug treatment of constipation should be preceded by the following measures: adequate physical activity and drinking regimen, the use of a sufficient amount of dietary fiber. The use of laxatives for more than 10 days is not recommended. With prolonged use, the development of dependence is possible (the need to increase the dosage and the development of severe constipation after discontinuation of the drug). After taking Bisacodyl, there have been reports of cases of dizziness and fainting during bowel movements. Children should be given laxatives with extreme caution due to the risk of impaired bowel release reflex. In case of bleeding from the rectum or lack of bowel movements after taking a laxative, you should consult a doctor. Take with caution in diabetic patients. [Interaction with other drugs] The simultaneous use of Bisacodyl with drugs that can cause the development of torsades de pointes arrhythmias is not recommended: 1) antiarrhythmic drugs: Amiodarone, Bretilium, Disopyramide, Quinidine, Sotalol, 2) other drugs: Astemizol, Bepridil, Erythromycin for intravenous administration, Halofantrine, Pentamidine, Sultopride, Terfenadine, Vincamine. Risk factors for the development of torsades de pointes arrhythmia are hypokalemia, bradycardia, and prolongation of the QT interval. Drug combinations that require caution: 1. Cardiac glycosides. Hypokalemia increases the toxic effects of digitalis preparations. It is necessary to monitor the level of potassium in the blood serum and, if necessary, ECG control. 2. Other drugs leading to the excretion of potassium: kaliuretic diuretics (alone or in combination), amphotericin B for intravenous administration, corticosteroids, tetracosactide. It is required to control the level of potassium in the blood serum, and if necessary - correction. [Pregnancy and lactation] The use of Bisacodyl is not recommended during pregnancy due to insufficient data from clinical and preclinical studies. Bisacodyl passes into breast milk. The use of Bisacodyl is not recommended during breastfeeding. [Influence on the ability to drive vehicles and control mechanisms] Studies to assess the effect of taking the drug on the ability to drive a car and work with machinery have not been conducted. However, patients should be informed that they may experience dizziness and/or syncope during a parasympathetic vascular reaction (eg, abdominal cramps). If patients experience abdominal cramps, they should avoid potentially hazardous activities such as driving or operating machinery. [Overdose] Acute overdose may cause diarrhea, abdominal cramps, loss of fluid, potassium and other electrolytes. Chronic overdose can lead to the development of diarrhea, abdominal pain, hypokalemia, muscle weakness. In case of overdose symptoms, stop taking the medicine and consult a doctor. Correction of electrolyte disturbances and replenishment of fluid loss is necessary. These measures are especially important in elderly patients and children. Symptomatic treatment is also carried out. [Packaging] 10 tablets in a blister pack made of PVC film and aluminum foil. 3 blister packs, together with the leaflet, are placed in a pack of cardboard (No. 10 × 3). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25°C. Keep out of the reach of children. [Shelf life] 3 years. The medicinal product must not be used after the expiration date indicated on the label. [Terms of dispensing from pharmacies] Without a prescription. Buy Bisacodyl enteric tablets p/o 5mg №10x3 Bisacodyl enteric tablets p/o 5mg №10x3