Forlax, 4 g 20 pcs.

Forlax is a laxative.

Pharmacodynamics

The high molecular weight compound macrogoal 4000 is a linear polymer that retains water molecules through hydrogen bonds. This increases the volume of intestinal contents after oral administration.

The volume of unabsorbed fluid in the intestinal lumen supports the laxative effect of the solution.

Pharmacokinetics

Pharmacokinetic data confirm that macrogoal 4000 undergoes neither gastrointestinal resorption nor biotransformation when taken orally.

Indications

Symptomatic treatment of constipation in children aged 6 months to 8 years.

Pharmacological effect

Forlax is a laxative.

Pharmacodynamics

The high-molecular compound macrogol 4000 is a linear polymer that holds water molecules through hydrogen bonds. Due to this, after oral administration of the drug, the volume of intestinal contents increases.

The volume of unabsorbed fluid in the intestinal lumen supports the laxative effect of the solution.

Pharmacokinetics

Pharmacokinetic data confirm that macrogol 4000 undergoes neither gastrointestinal resorption nor biotransformation when taken orally.

Special instructions

Data on the effectiveness of therapy in children under 2 years of age are limited.

Treatment of constipation with medications is recommended only as an adjunct to a healthy lifestyle and diet, for example:

– increasing fluid and fiber intake,

– adequate physical activity, which helps restore motility of the digestive tract.

Organic gastrointestinal disorders should be excluded before starting therapy.

Due to insufficient clinical data, the duration of treatment should not exceed 3 months. If symptoms of constipation persist for more than 3 months, it is necessary to conduct a repeated extensive diagnostic examination.

The drug contains macrogol (polyethylene glycol). Cases of hypersensitivity (anaphylactic shock, angioedema, urticaria, rash, itching, erythema) have been reported when taking drugs containing macrogol (polyethylene glycol).

Due to the presence of sulfur dioxide, severe hypersensitivity reactions and bronchospasm may occur in rare cases.

Patients with hereditary fructose intolerance should not take this drug.

If diarrhea develops, extreme caution should be taken in patients predisposed to fluid and electrolyte imbalance (for example, patients with impaired liver or kidney function, or patients taking diuretics) and electrolyte monitoring should be performed.

Cases of aspiration have been reported when large volumes of macrogol and electrolytes were administered through a nasogastric tube. Children with neurological disorders who have difficulty swallowing are at risk for aspiration.

Caution when using.

Forlax® 4 g does not contain significant amounts of sugar or polyols and can be used in children with diabetes mellitus or in children whose diet has excluded galactose.

Active ingredient

Macrogol

Composition

1 packet of powder for oral solution contains:

active ingredient:

macrogol 4000 – 4 g,

Excipients:

Fragrance with the scent of orange and grapefruit* – 60.0

Sodium saccharinate (E954) – 6.8

* Orange oil, grapefruit oil, concentrated orange juice, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, cis-3-hexenol, maltodextrin, acacia gum, sorbitol (E420), sulfur dioxide (E220), butylhydroxyanisole (E320).

Pregnancy

Pregnancy Experiments on rats and rabbits have shown that Macrogol 4000 does not have a teratogenic effect.

When prescribing Forlax to pregnant women, caution should be exercised due to insufficient data on the use of Forlax in pregnant women.

Lactation It is not known whether the drug passes into mother’s milk. Since macrogol 4000 is not absorbed, Forlax can be taken during lactation.

Contraindications

Serious inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or toxic megacolon;
perforation or risk of perforation of the gastrointestinal tract;
complete or partial intestinal obstruction, as well as suspected intestinal obstruction or symptomatic stenosis;
abdominal pain of unknown etiology;
hypersensitivity to the active substance or to any other auxiliary components of the drug.

Side Effects

The adverse reactions listed in the table below were reported in clinical studies involving 147 children aged 6 months to 15 years and during post-marketing use.

In general, adverse reactions were mild and transient and mainly affected the gastrointestinal tract.

The frequency of adverse drug reactions was determined according to the following gradation: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), frequency not established (cannot be estimated from the available data).

Gastrointestinal disorders:

Common – Abdominal pain, Diarrhea*

Uncommon – Vomiting, Bloating, Nausea

Immune system disorders

Frequency not established – Hypersensitivity reactions (anaphylactic shock, angioedema, urticaria, rash, itching).

* Diarrhea may cause irritation of the perianal area.

Interaction

Slows down the absorption of concomitantly taken medications. Therefore, it is recommended to prescribe Forlax® at least 2 hours after prescribing other drugs.

Overdose

Diarrhea is possible, which stops when the dosage of the drug is reduced or discontinued.

Intense diarrhea or vomiting can cause an imbalance in the input-electrolyte balance, which will require its correction.

There are reports of inflammation and irritation of the perianal area and fecal incontinence when large volumes of polyethylene glycol (4 – 11 liters) are used to cleanse the intestines before colonoscopy.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Manufacturer

Bofur Ipsen Industry, France