Forlax

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FORLAX® (FORLAX®)

Composition:

Active ingredient: macrogol 4000

1 sachet contains 4 g of macrogol 4000;

Excipients: orange-grapefruit flavor (essential oils of orange and grapefruit, concentrated orange juice, citral, acetaldehyde, linalool, ethyl butyrate, alpha-terpineol, octanal, beta- and gamma-hexenol, maltodextrin, acacia gum (E 414), sorbitol (E 420), butylated hydroxyanisole (E 320), and sulfur dioxide (E 220)); sodium saccharin.

Pharmaceutical form. Powder for oral solution.

Main physicochemical properties: the sachets contain a white or almost white powder, freely soluble in water, with an odor resembling orange and grapefruit.

Pharmacotherapeutic group.

Osmotic laxatives. Macrogol.

ATC code A06AD15.

Pharmacological properties.

Pharmacodynamics.

Macrogols with high molecular weight (4000) are long linear polymers that retain water molecules via hydrogen bonds. After oral administration, they increase the fluid volume in the intestine.

The volume of non-absorbed fluid in the intestine determines the laxative properties of the solution.

Pharmacokinetics.

Pharmacokinetic studies confirm that macrogol 4000 is not absorbed in the gastrointestinal tract and is not metabolized following oral administration.

Clinical characteristics.

Indications.

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

Contraindications.

• Severe inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or toxic megacolon.
• Perforation or risk of gastrointestinal tract perforation.
• Ileus or suspicion of intestinal obstruction, symptomatic strictures.
• Abdominal pain of unknown origin.
• Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other types of interactions.

There is a possibility that absorption of other medicinal products may be temporarily reduced when administered concomitantly with FORLAX®, particularly affecting medicinal products with a narrow therapeutic index or short elimination half-life, such as digoxin, antiepileptic agents, coumarins, and immunosuppressants, leading to reduced efficacy.

A potential interaction between the medicinal product FORLAX® and starch-based food thickeners is possible. Polyethylene glycol (PEG) counteracts the thickening effect of starch, effectively liquefying preparations that should remain thick for individuals with swallowing difficulties.

Special precautions for use

Before initiating treatment, the physician must ensure the absence of organic disorders, especially in patients under 2 years of age. FORLAX® (4 g) is indicated for the temporary treatment of constipation as an adjunctive therapy along with appropriate dietary and hygienic measures; the maximum duration of treatment is 3 months. If symptoms persist despite dietary recommendations, the underlying cause should be identified and addressed.

Warnings

Data on efficacy in children under 2 years of age are limited to a small number of patients.

Treatment of constipation with any medicinal product is only an adjunctive therapy and should be accompanied by a healthy lifestyle and dietary habits, including:

• increased fluid intake and dietary fiber,
• maintenance of adequate physical activity and restoration of normal bowel function.

Before initiating treatment, the absence of organic disorders must be confirmed.

After a 3-month treatment period, a complete clinical evaluation for constipation is recommended.

The medicinal product contains macrogol (polyethylene glycol). Hypersensitivity reactions (anaphylactic shock, angioneurotic edema, urticaria, rash, pruritus, erythema) to medicinal products containing macrogol have been reported (see section "Adverse reactions").

The medicinal product contains sulfur dioxide, which may rarely cause severe hypersensitivity reactions and bronchospasm.

The medicinal product contains sorbitol. It is not recommended for patients with hereditary fructose intolerance (a rare genetic disorder).

Sorbitol and sulfur dioxide are components of the orange-grapefruit flavoring:

sorbitol (E 420) – 0.72 mg per sachet;

sulfur dioxide (E 220) – 9.6 × 10⁻⁴ mg per sachet.

Cases of aspiration have been reported during administration of large volumes of polyethylene glycol and electrolytes via nasogastric tube. The risk of aspiration is particularly increased in children with neurological disorders affecting speech and motor function.

For patients with swallowing difficulties who require addition of a thickening agent to solutions to improve ease of swallowing, this interaction should be taken into account (see section "Interaction with other medicinal products and other forms of interaction").

Special precautions for use

FORLAX® (4 g) does not contain a significant amount of sugar or polyols and can be used by patients with diabetes or by patients on a galactose-free diet.

Use during pregnancy or breastfeeding

Pregnancy

Animal studies do not indicate any direct or indirect toxic effect on reproductive function.

Data on the use of FORLAX® in pregnant women are limited (fewer than 300 cases of pregnancy).

No adverse effects during pregnancy are expected, as systemic exposure to FORLAX® is negligible. FORLAX® may be used during pregnancy.

Lactation

There are no data on the excretion of FORLAX® in breast milk.

No effects on newborns/infants who are breastfed are expected, as systemic exposure to FORLAX® in breastfeeding women is negligible. FORLAX® may be used during breastfeeding.

Fertility

No studies on the effect on fertility have been conducted with FORLAX®; however, since macrogol 4000 is not significantly absorbed, no effect on fertility is expected.

Ability to influence the reaction rate while driving or operating machinery

Not established.

Dosage and Administration.

For oral use.

Dosage for children by age:

from 6 months to 1 year: 1 sachet (4 g) per day.

from 1 to 4 years: 1–2 sachets (4–8 g) per day.

from 4 to 8 years: 2–4 sachets (8–16 g) per day.

The daily dose should be adjusted according to the expected clinical response.

The first effect of FORLAX® occurs within 24–48 hours after administration.

Children

The treatment duration in children should not exceed 3 months due to lack of clinical data on use beyond 3 months. Restoration of intestinal motility during treatment should be supported by adherence to hygienic and dietary recommendations.

Administration

The contents of each sachet should be dissolved in approximately 50 mL of water immediately before use. Treatment should be administered in the morning if one sachet per day is prescribed, or in the morning and evening if more than one sachet per day is prescribed.

Children.

The medicinal product can be used in children aged from 6 months to 8 years.

Overdose.

Cases of diarrhea, abdominal pain, and vomiting have been reported. Diarrhea caused by overdose of this drug resolves when treatment is temporarily discontinued or the dose is reduced.

Excessive fluid loss due to diarrhea or vomiting may require correction of electrolyte imbalances.

Adverse reactions.

Adverse reactions listed below have been reported during clinical trials involving 147 children aged 6 months to 15 years, as well as during post-marketing use. Overall, adverse reactions were mild and transient, and primarily involved the gastrointestinal system.

Adverse drug reactions are classified by frequency of occurrence as follows: 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), unknown (cannot be estimated from available data).

*Diarrhea may cause painful sensations in the perianal area.

In addition, the following adverse reactions have been observed in adults during clinical trials and in the post-marketing period.

Gastrointestinal disorders

Uncommon: urgent need for defecation, involuntary bowel evacuation.

Metabolism and nutrition disorders

Not known: disturbances of water-electrolyte balance (hyponatremia, hypokalemia) and/or dehydration, especially in elderly patients.

Immune system disorders

Not known: erythema.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after marketing authorization of the medicinal product. This allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions through the national reporting system.

Shelf life.

3 years.

Storage conditions.

The medicinal product does not require special storage conditions. Keep out of the reach of children.

Packaging.

4.0668 g of powder in a sachet; 10, 20, 30, or 50 sachets in a cardboard box.

Prescription status.

Over-the-counter.

Manufacturer.

BOUHOURS IPSEN INDUSTRIE

Manufacturer's address and location of operations.

Rue Hte Viron, DREUX, 28100, France

Marketing authorization holder.

IPSEN CONSUMER HEALTHCARE

Simplified joint-stock company

Address of the marketing authorization holder.

65 Quai Georges Gorse, 92100 Boulogne-Billancourt, France