Forlax powder for preparation of oral solution 10 pcs.
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Active ingredients
Macrogol
Release form
Powder
Composition
Ingredients for one package: Active substance: Macrogol 4000 - 10.00 gActivities: Orange-grapefruit flavoring * - 0.15 g Sodium saccharinate - 0.017 g * Orange oil, grapefruit oil, orange juice concentrated, citral, acetic acetaldehyde, lignal oil, aldehyde, lidallol, linall oil, orange juice, orange juice; butyrate, alpha terpineol, octanal, cis-3-hexenol, maltodextrin, acacia gum, sorbitol (E420), sulfur dioxide (E220), butylhydroxyanisole (E320).
Pharmacological effect
The large molecular weight of macrogol 4000 is due to long linear polymers that retain water molecules through hydrogen bonds. Due to this, the amount of intestinal contents increases after oral administration of the drug. The volume of unabsorbed fluid in the intestinal lumen supports the laxative effect of the solution.
Pharmacokinetics
Pharmacokinetic data confirm that macrogol 4000 is not exposed to either gastrointestinal resorption or biotransformation when taken orally.
Indications
Symptomatic treatment of constipation in adults and children 8 years and older.
Contraindications
serious inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic enlargement of the colon, combined with symptomatic stenosis; - perforation or perforation of the gastrointestinal tract; - intestinal obstruction or suspected intestinal obstruction; - abdominal pain of unclear etiology; - hypersensitivity to macrogol (polyethylene glycol) or any of the components of the drug; - children's age up to 8 years.
Precautionary measures
Organic disorders of the gastrointestinal tract should be eliminated before starting therapy. Prevention. The treatment of constipation with medications is recommended only as an aid to a healthy lifestyle and diet, for example: - increased consumption of fluids and fiber, - adequate physical activity that helps restore motility of the digestive tract. In the case of diarrhea with extreme caution should be treated patients who are prone to disruption of water-electrolyte o balance (for example, in elderly patients, in patients with impaired liver or kidney function, or in patientsreceiving diuretics) and it is necessary to carry out electrolyte control. Forlax does not contain significant amounts of carbohydrates and / or polyols (sugar alcohols) and can be used in patients with diabetes mellitus or in patients whose ration does not allow galactose.
Use during pregnancy and lactation
Pregnancy The results of animal studies have shown that Macrogol 4000 does not have a teratogenic effect. Since the systemic effect of the Forlax drug is insignificant, a negative impact on the mother’s body and the fetus is not expected. Forlax can be taken during pregnancy. Lactation The systemic effect of macrogol 4000 on the body of nursing women is insignificant, so a negative impact on the body of the newborn / baby is not expected. Forlax can be taken during lactation.
Dosage and administration
Inside, the contents of 1 - 2 packages (preferably in the form of a single dose in the morning) or 1 package (in the morning and evening) in the case of receiving 2 packages per day. The daily dose should be adapted according to the clinical effect and can vary from 1 packet each day (especially in children) to 2 packets per day. The contents of each package should be dissolved in a glass of water just before taking. The effect of taking Forlax is expressed within 24 to 48 hours after taking the drug. The recommended treatment for children and adults is 3 months. In children, treatment should not exceed 3 months due to insufficient clinical data. Maintaining the effect after the restoration of normal bowel should be carried out using an active lifestyle and a diet rich in plant fiber. If the symptoms of constipation persist for more than 3 months, it is necessary to conduct a re-extended diagnostic examination.
Side effects
In adults. Side effects observed during clinical studies on 600 patients were transient in nature, were observed with the following frequency, mainly in the gastrointestinal tract: - frequent side effects (more than 1/100, less than 1/10): bloating and / or pain, nausea, diarrhea; - rare side effects (more than 1/1000, less than 1/100): vomiting, urgent urge to have a bowel movement and fecal incontinence.Additional information obtained from post-marketing observations included: very rarely (less than 1/10000) cases of hypersensitivity: pruritus, urticaria, transient (transient) rash, swelling of the face, angioedema, and individual cases of diarrhea causing disorder electrolyte balance (hyponatremia, hypokalemia) and / or dehydration, especially in adult patients. In children. Side effects concerning the gastrointestinal tract were minimal and were transient in clinical studies involving 147 children aged 6 months to 15 years, were detected with the following frequency: Disorders of the gastrointestinal tract: - frequent side effects (more 1/100, less than 1/10): diarrhea and abdominal pain. - rarely encountered side effects (more than 1/1000, less than 1/100): flatulence, nausea and vomiting. - side effects that cannot be assessed based on available Data: hypersensitivity reactions.Diar it can be a cause of pain in the perianal region.
Overdose
An overdose of the drug leads to diarrhea followed by disappearance after dose reduction or cessation of treatment. Excessive fluid loss during diarrhea or vomiting may require correction of electrolyte disturbances.
Interaction with other drugs
Not described. Possible slowdown in the absorption of drugs taken simultaneously with Forlax. Therefore, it is recommended that Forlax be prescribed later, at least 2 hours after other drugs are prescribed.
special instructions
Special warnings. Very rare cases of hypersensitivity (including rashes, urticaria, edema) were reported when taking medications containing macrogol (polyethylene glycol). In exceptional cases, anaphylactic shock was observed. Due to the presence of sorbitol, patients with congenital fructose intolerance should not take this drug. Due to the presence of sulfur dioxide in rare cases, serious allergic reactions and bronchospasm can occur. Aspiration cases have been reported when large amounts of macrogol and electrolytes were injected with a nasogastric probe. Children with neurological disorders who have a violation of swallowing are at risk of aspiration.