Guttalax drops for oral administration 7.5mg/ml 15ml №1

Name:
Guttalax. Release form Drops. MNN sodium picosulfate. FTHS Laxative. Ingredients: 1 ml (=14 drops) contains the active substance sodium picosulfate 7.5 mg. Excipients: sodium benzoate (E 211), liquid sorbitol (non-crystallizing) (E 420), sodium citrate dihydrate (E 331), citric acid monohydrate (E 330), purified water.
Description:
Transparent solution, slightly viscous, colorless to yellowish or slightly yellowish brown. Pharmacotherapeutic group Laxatives of contact action. Sodium picosulfate. ATX code: A06AB08. Pharmacological propertiesPharmacodynamics Sodium picosulfate, the active substance of the drug GUTTALAX, belongs to the contact laxatives from the triarylmethane group, which, after metabolism under the influence of microorganisms of the colon mucosa, stimulate peristalsis and contribute to the accumulation of water and electrolytes in the lumen of the colon. As a result, defecation is stimulated, the passage of intestinal contents is accelerated and the stool softens. Sodium picosulfate acts at the level of the large intestine and stimulates the evacuation of intestinal contents. Thus, this drug does not affect the absorption of essential nutrients in the small intestine. Pharmacokinetics Absorption and distribution After oral administration, sodium picosulfate enters the large intestine without any significant absorption. Biotransformation As a result of bacterial cleavage of sodium picosulfate in the distal segment of the intestine, its active metabolite, bis-(p-hydroxyphenyl)-pyridyl-2-methane, is formed. Withdrawal After transformation, only a small amount of the active metabolite is absorbed. After oral administration of 10 mg sodium picosulfate, 10.4% of the dose was excreted as the active metabolite glucuronide in the urine after 48 hours. Relationship between pharmacokinetics and pharmacodynamics The effect of the drug occurs after 6-12 hours, depending on the release of the active metabolite. There is no relationship between the laxative effect and the concentration of the active metabolite in plasma. Indications for useFor use in case of constipation, as well as in the need to facilitate defecation. As with other laxatives, GUTTALAX oral drops should not be taken regularly every day or for a long time without a diagnostic examination. Dosage and administration Dosage Unless otherwise prescribed, the adult dose is 10-18 drops (corresponding to 5-10 mg sodium picosulfate). For children 4 years of age and older who should take this medicine only on prescription, the dose is 5-9 drops (corresponding to 2.5-5 mg sodium picosulfate). It is recommended to start taking the drug with the lowest dose. To achieve regular bowel movements, the dose may be adjusted to the maximum recommended dose. Do not exceed the maximum daily dose, which is 18 drops for adults and 9 drops for children 4 years of age and older. GUTTALAX drops for oral administration should not be taken regularly every day or for a long time without finding out the cause of constipation. How to use GUTTALAX drops for oral administration is best taken in the evening with or without liquid. After taking the action usually occurs within 6-12 hours. Side effect The frequency of side effects is indicated as: very often (≥1/10), often (from ≥1/100 to <1/10), infrequently (from ≥1/1000 to <1/100), rarely (from ≥1 /10000 to <1/1000), very rare (<1/10000), or not known (cannot be estimated from the available data). From the immune system Not known: allergic reactions. Nervous system disorders Uncommon: dizziness. Unknown: fainting. Dizziness and/or fainting that occurs after taking the drug may be associated with straining during bowel movements (Valsalva effect) or a vasovagal reaction to abdominal pain. Gastrointestinal disorders Very common: diarrhea. Often: discomfort and pain in the abdomen, spastic pain in the abdomen. Uncommon: nausea, vomiting. From the skin and subcutaneous tissues Not known: skin reactions, for example, angioedema, drug rash, rash, itching. Prolonged and excessive use of GUTTALAX may cause loss of fluid, potassium and other electrolytes. This can lead to muscle weakness, cardiac dysfunction, especially if GUTTALAX is taken simultaneously with diuretics or corticosteroids. In the event of adverse reactions, including those not listed in this leaflet, you should stop using the drug and consult a doctor. Contraindications - Hypersensitivity to the active substance, other triarylmethanes or any of the excipients. - Intestinal stenosis or intestinal obstruction. - Severe abdominal pain, which may be accompanied by fever, nausea and vomiting (eg appendicitis). - Acute inflammatory diseases of the gastrointestinal tract. - Severe dehydration. - In case of hereditary intolerance to any of the excipients of the drug. GUTTALAX should not be administered to children under 4 years of age. GUTTALAX should be used in older children only after consulting a doctor. In diseases associated with a violation of the water and electrolyte balance (for example, severe renal failure), the drug can be used only under medical supervision. Overdose Overdose can result in loose stools (diarrhea), crampy abdominal pain, and clinically significant loss of fluid, potassium, and other electrolytes. In cases of acute overdose, the effect of GUTTALAX can be reduced or prevented by inducing vomiting and gastric lavage as soon as possible after ingestion. Fluid replenishment and electrolyte balance correction are recommended. In certain circumstances, the use of antispasmodics may be considered. There have been reports of individual cases of ischemia of the colonic mucosa in connection with the intake of sodium picosulfate in doses significantly higher than those recommended for the treatment of constipation. Chronic overdose of GUTTALAX, as with other laxatives, can cause chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, and urolithiasis. Long-term use of laxatives in excessive doses can lead to damage to the renal tubules, metabolic alkalosis, hypokalemia and muscle weakness. Precautions: Talk to your doctor before taking GUTTALAX. If the symptoms persist while taking the drug or if the condition worsens, stop taking the drug and consult a doctor. Bleeding from the rectum or not having a bowel movement after taking a laxative may indicate a serious illness. Patients with chronic constipation should undergo a complete diagnostic evaluation. Prolonged use of the drug GUTTALAX can lead to impaired water and electrolyte balance and hypokalemia. If GUTTALAX is discontinued, symptoms may recur. In chronic constipation after prolonged use of GUTTALAX, symptoms may recur and constipation may worsen. Dizziness and/or fainting have been reported in association with sodium picosulfate. Available information suggests that these events may be related to straining during defecation (Valsalva effect) or a vasovagal response to abdominal pain. This medicinal product contains about 450 mg of sorbitol per ml (equivalent to 600 mg at the maximum recommended daily dose for adults). Patients with hereditary fructose intolerance should not take GUTTALAX. Pregnancy and lactation Pregnancy Adequate clinical studies involving pregnant women have not been conducted. Animal studies have shown reproductive toxicity at daily doses of 10 mg/kg and above. For safety reasons, GUTTALAX should not be taken during pregnancy. Breastfeeding Clinical data indicate that neither the active metabolite sodium picosulfate nor its glucuronides are excreted into breast milk. Therefore, GUTTALAX can be used during lactation. Fertility Studies of the effect of the drug on human fertility have not been conducted. Preclinical studies have not revealed any effect of the drug on fertility. The effect of the drug on the ability to drive a car and mechanisms Studies of the effect of the drug on the ability to drive a car and mechanisms 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. Interaction with other medicinal products Concomitant use of diuretics or corticosteroids may increase the risk of electrolyte imbalance when taking GUTTALAX in excessive doses. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides. The simultaneous use of antibiotics may reduce the laxative effect of GUTTALAX. Packaging Drops for oral administration 7.5 mg/ml in white high-density polyethylene bottles of 15 or 30 ml. The bottle is sealed with a stopper-dropper and a screw cap, together with instructions for use, placed in a cardboard box. Storage conditions Store below 30°C. Keep out of the reach of children. Shelf life 3 years. Shelf life after the first opening of the vial: 12 months. Do not use after the expiry date stated on the packaging. Terms of dispensing from pharmacies Without a doctor's prescription. Buy Guttalax drops for oral administration 7.5 mg / ml 15 ml No. 1 Price for Guttalax drops for oral administration 7.5 mg / ml 15 ml No. 1 Instructions for use for Guttalax drops for oral administration 7.5 mg / ml 15 ml #1