Forlax, 10 g 20 pcs.

Osmotic laxative drug. The large molecular weight of macrogoal 4000 is due to the long linear polymers that retain the water molecules through hydrogen bonds. Due to this, the volume of intestinal contents increases after oral administration of the drug. The volume of unabsorbed fluid that is in the intestinal lumen supports the laxative effect of the solution.

The laxative effect of Forlax occurs 24-48 hours after administration.

Indications

Active ingredient

Composition

1 bag of powder for the preparation of oral solution contains:

the active ingredient:

macrogol 4000 – 4 g,

Excipients:

Orange and grapefruit fragrance* – 60.0

Sodium saccharinate (E954) – 6.8

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

How to take, the dosage

Overly, 1-2 sachets (preferably as a single dose in the morning) or 1 sachet in the morning and evening if taking 2 sachets per day.

The daily dose should be adjusted according to clinical effect and may range from 1 sachet each day (especially in children) to 2 sachets per day.

The contents of each packet should be dissolved in a glass of water immediately before intake.

The effect of taking Forlax® is seen within 24-48 hours after taking the drug.

The recommended course of 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 restoration of normal bowel function should be done with an active lifestyle and a diet rich in vegetable fiber.

If symptoms of constipation persist for more than 3 months, an extended diagnostic evaluation should be repeated.

Interaction

Special Instructions

Warning. Treatment of constipation with medication is recommended only as an adjunct to a healthy lifestyle and diet, such as:

Patients with a predisposition to poor water-electrolyte balance (e.g., elderly patients, patients with impaired hepatic or renal function, or patients taking diuretics) should be treated with extreme caution if diarrhea develops, and electrolyte control should be performed.

Forlax® does not contain significant amounts of carbohydrates and/or polyols (sugar alcohols) and may be used in diabetic patients or in patients whose diet is free of galactose.

Special warnings. Very rare cases of hypersensitivity reactions (including rash, urticaria, edema) have been reported when taking preparations containing macrogoal (polyethylene glycol). In exceptional cases anaphylactic shock has been observed.

Because of the presence of sorbitol, patients with congenital fructose intolerance should not take this drug.

Because of the presence of sulfur dioxide, serious allergic reactions and bronchospasm may occur in rare cases.

There have been reported cases of aspiration when large volumes of macrogoal and electrolytes have been administered using a nasogastric tube.

Children with neurological disorders who have a swallowing disorder are at risk for aspiration.

Impact on the ability to drive vehicles and operate machinery. Does not affect ability to drive vehicles and operate machinery.

Contraindications

Side effects

Gastrointestinal disorders: common (greater than 1/100, less than 1/10) – diarrhea and abdominal pain; rare (greater than 1/1000, less than 1/100) – flatulence, nausea and vomiting; frequency unknown – hypersensitivity reactions.

Diarrhea may be a cause of pain in the perianal area.

Adults Side effects observed in clinical trials in 600 patients were transient in nature, observed with the following frequency.

Gastrointestinal side effects: frequently (greater than 1/100, less than 1/10) – abdominal bloating and/or pain, nausea, diarrhea; rarely (greater than 1/1000, less than 1/100) – vomiting, urgent urge to defecate and fecal incontinence.

Additional information from post-marketing observations. Very rare (less than 1/10000) – cases of hypersensitivity: skin itching, urticaria, transient (transient) rash, facial edema, Quincke’s edema and in some cases – anaphylactic shock; frequency is unknown – occurrence of diarrhea leading to electrolyte balance disorder (hyponatremia, hypokalemia) and/or dehydration, especially in adult patients.

Overdose

Pregnancy use

The results of animal studies have shown that macrogoal 4000 has no teratogenic effect.

There are no expected negative effects on the mother and the fetus because the systemic effect of Forlax® is negligible. Forlax® can be taken during pregnancy.

The systemic effects of macrogoal 4000 on lactating women are negligible and therefore no adverse effects on the newborn/infant are expected. Forlax® can be taken during lactation.

Similarities