Each sachet of 10.167 g contains Macrogol 4000 10 g, saccharin sodium 0.017 g and orange-grapefruit flavour 0.15 g.
Excipients/Inactive Ingredients: Orange and grapefruit oils, concentrated orange juice, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, beta gamma hexenol, maltodextrine, gum arabic, sorbitol (E420), BHA (E320) and sulphur dioxide (E220).
Pharmacology: Macrogols of high molecular weight are long linear polymers which retain water molecules by means of hydrogen bonds. Administered by oral route, they give rise to an increase in the volume of intestinal liquids. The volume of unabsorbed intestinal liquid accounts for the laxative properties of the solution.
Pharmacokinetics: The pharmacokinetic data confirms that Macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation following oral ingestion.
FORLAX 10 g is indicated in symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. FORLAX 10 g should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-months treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated.
The dosage is 1 to 2 sachets per day.
The content of each sachet must be dissolved in a glass of water for oral consumption.
The effect of FORLAX becomes apparent within 24 to 48 hours after its administration.
In children, treatment should not exceed 3 months. Treatment-induced restoration of bowel movement will be maintained by lifestyle and dietary measures.
In all cases, patient must strictly comply with the physician's prescription or pharmacist's advice.
Leads to diarrhoea which disappears when treatment is temporarily interrupted or the dosage is reduced. Cases of aspiration have been reported when extensive volumes of polyethylene glycol and electrolytes were administered with nasogastric tube. Neurologically impaired children having oromotor dysfunction are particularly at risk of aspiration.
Severe inflammatory bowel disease (ulcerative colitis, Crohn’s disease), toxic mega colon, perforation or risk of perforation, ileus or suspicion of intestinal obstruction or symptomatic stenosis, painful abdominal syndromes of undetermined reason, and known hypersensitivity to FORLAX or to on of the components. Due to the presence of sorbitol (traces), this medicine is contraindicated in persons who are intolerant to fructose.
The treatment of constipation with any medicinal product in only an adjuvant to a healthy lifestyle and diet, for example: Increase intake of liquids and dietary fiber; advice on appropriate physical activity and rehabilitation of the bowel reflex.
Patients with hereditary problems of fructose intolerance should not take this medicinal product.
Due to the presence of sulphur dioxide, it may rarely cause severe hypersensitivity reactions and bronchospasm.
In case of diarrhoea, caution should be exercised in patients prone for disturbances of water-electrolyte balance (e.g. elderly, patients with impaired hepatic or renal function or patients taken diuretics) and electrolyte control considered.
FORLAX 10 g contains polyethylene glycol.
Very rare cases of hypersensitivity reactions (rash, urticaria, oedema) have been reported with drugs containing polyethylene glycol. Exceptional cases of anaphylactic shock have been reported.
The medicinal product does not contain a significant quantity of sugar or polyol and can be prescribed to diabetic patients or patients on a galactose-free diet.
Use in Pregnancy: Macrogol 4000 was not teratogenic in rats or rabbits. There are no adequate data from use of FORLAX in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to FORLAX is negligible. FORLAX can be used with caution during pregnancy.
Use in Lactation: No data exists on the excretion of Macrogol 4000 in breast milk. No effects on the breast feeding newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to macrogol 4000 is negligible. FORLAX can be used during breast feeding.
Adverse Drug Reactions are listed under headings of frequency using the following categories: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from the available data).
The undesirable effects listed in the Table 1 have been reported during clinical trials (including 600 adult patients) and post-marketing use. Generally, adverse reactions have been minor and transitory and have mainly concerned the gastrointestinal system: (see Table 1.)
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The undesirable effects listed in the Table 2 have been reported during clinical trials including 147 children aged from 6 months to 15 years and post-marketing use. As in adult population, adverse reactions have generally been minor and transitory and have mainly concerned the gastrointestinal system: (see Table 2.)
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FORLAX may interfere with the absorption of other drugs if administered simultaneously. Generally, it is better to take FORLAX at least 2 hours apart from other products.
A06AD15 - macrogol ; Belongs to the class of osmotically acting laxatives.
Powd for oral soln (sachet) 10 g x 20's.