Forlax^® (Solution, Powder) Instructions for Use

ATC Code

A06AD15 (Macrogol)

Active Substance

Macrogol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Osmotic laxative (macrogol)

Pharmacological Action

The large molecular weight of macrogol 4000 is due to long linear polymers that hold water molecules through hydrogen bonds. This results in an increase in the volume of intestinal contents after oral administration of the drug. The volume of non-absorbed fluid present in the intestinal lumen maintains the laxative effect of the solution.

Pharmacokinetics

Pharmacokinetic data confirm that Macrogol 4000 undergoes neither gastrointestinal absorption nor biotransformation upon oral administration.

Indications

• Symptomatic treatment of constipation in adults and children aged 8 years and older.

ICD codes

Dosage Regimen

Solution

Administered orally or via a nasogastric tube. The dose, method, and regimen of administration are determined individually, depending on the indications, the patient’s age, and the dosage form used.

In children, it is used strictly in the doses and dosage forms recommended for the respective age category.

Powder

Take orally.

Adults and children aged 8 years and older: 1-2 sachets preferably once/day in the morning or 1 sachet twice/day – in the morning and in the evening.

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

The contents of each sachet should be dissolved in 50 ml of water immediately before administration.

The effect of taking Forlax^® is manifested within 24-48 hours after administration.

The recommended course of treatment for adults and children aged 8 years and older is 3 months.

In children, the course of treatment should not exceed 3 months due to insufficient clinical data. Organic gastrointestinal disorders must be excluded before starting therapy. Treatment with Forlax^® should remain a temporary aid for the treatment of constipation in addition to an appropriate lifestyle and diet. If constipation symptoms persist for more than 3 months despite following hygiene measures and diet, the underlying cause must be identified and treated.

Maintenance of the effect after restoration of normal bowel function should be achieved through an active lifestyle and a diet rich in plant fiber.

Adverse Reactions

Adverse effects from the use of the drug are presented in the tables below with the frequency: very common (≥1/10); common (≥1/100 to < 1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000); frequency unknown (cannot be estimated from the available data).

Adults

Adverse effects presented in Table 1 were observed in clinical trials (including 600 adult patients) and were collected during post-registration use. In general, adverse reactions were mostly mild, transient, and mainly concerned the gastrointestinal tract.

Table 1

Pediatric population

Adverse effects presented in Table 2 were observed in clinical trials involving 147 children aged from 6 months to 15 years, and during post-registration use. In general, adverse reactions were mostly mild, transient, and mainly concerned the gastrointestinal tract.

Table 2

*Diarrhea may cause painful sensations in the perianal area.

Contraindications

• Hypersensitivity to macrogol (polyethylene glycol) or any component of the drug;
• Serious inflammatory bowel diseases (ulcerative colitis, Crohn’s disease) or toxic megacolon;
• Perforation or threat of gastrointestinal perforation;
• Intestinal obstruction or suspicion of intestinal obstruction; symptomatic stenosis;
• Abdominal pain of unclear etiology;
• Children under 8 years of age.

Use in Pregnancy and Lactation

Pregnancy

Experimental animal studies have not shown any direct or indirect harmful effects of toxic action on reproductive function.

There is limited data (less than 300 pregnancy outcomes) on the use of Forlax^® in pregnant women.

Since the systemic exposure to Forlax^® is negligible, no effect on the course of pregnancy is expected. Forlax^® can be taken during pregnancy.

Breastfeeding period

There are no data on the excretion of Forlax^® into breast milk.

Systemic exposure to macrogol 4000 in breastfeeding women is negligible, so no effect on the newborn/infant is expected. Forlax^® can be taken during breastfeeding.

Fertility

Studies on the effect of Forlax^® on fertility have not been conducted, however, since Macrogol 4000 is minimally absorbed, its effect on fertility is not expected.

Pediatric Use

Contraindicated for use in children under 8 years of age.

Special Precautions

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

• Increased intake of fluids and fiber;
• Adequate physical activity, which helps restore digestive tract motility.

Organic gastrointestinal disorders must be excluded before starting therapy.

In case of diarrhea, special caution should be exercised in patients predisposed to water-electrolyte imbalance (e.g., elderly patients, patients with impaired liver or kidney function, or patients taking diuretics) and electrolyte levels should be monitored.

Forlax^® does not contain significant amounts of carbohydrates and/or polyols (sugar alcohols) and can be used in patients with diabetes or in patients on a galactose-free diet.

Special warnings

Cases of hypersensitivity (anaphylactic shock, urticaria, angioedema, rash, pruritus, erythema) have been reported with the use of drugs containing Macrogol.

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

The drug contains 1.7 mg of sorbitol in each sachet.

The drug contains less than 1 mmol sodium (23 mg) in one sachet, thus it can be stated that the drug is essentially sodium-free.

Caution should be exercised when using the drug in patients with impaired gag reflex, as well as in patients prone to regurgitation or aspiration. Cases of aspiration have been reported when a large volume of macrogol and electrolytes was administered via a nasogastric tube. Children with neurological disorders who have impaired swallowing are at risk of aspiration.

Effect on ability to drive vehicles and operate machinery

No studies have been conducted on the effect of the drug on the ability to drive vehicles and operate machinery.

Overdose

Diarrhea, abdominal pain, and vomiting have been reported. In case of severe diarrhea, weight loss and water-electrolyte imbalance may occur. Diarrhea resulting from overdose subsides after reducing the dose or by temporarily discontinuing the drug.

Excessive fluid loss due to diarrhea or vomiting can cause water-electrolyte imbalance requiring correction.

Drug Interactions

There is a possibility that the absorption of other drugs may be temporarily reduced during concomitant use with Forlax^®, especially drugs with a narrow therapeutic index or short half-life, such as digoxin, antiepileptic drugs, coumarins, and immunosuppressants, leading to a decrease in their effectiveness.

It is recommended to take Forlax^® at least 2 hours after taking other drugs.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date stated on the packaging.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.