Forlax, 4 g 20 pcs.

Interaction

Delays absorption of concomitantly taken drugs. Therefore, it is recommended to prescribe Forlax® at least 2 hours after other drugs.

Special Instructions

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

The treatment of constipation with medication is recommended only as an adjunct to a healthy lifestyle and diet, such as:

– increasing fluid and fiber intake,

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

Organic gastrointestinal disorders should be ruled out prior to initiation of therapy.

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

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

Patients with hereditary fructose intolerance should not take this drug.

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

In cases of aspiration have been reported 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.

Caution when administering.

Forlax® 4 g does not contain significant amounts of sugar or polyols and may be used in children with diabetes or in children whose diet is free of galactose.

Contraindications

• Serious inflammatory bowel disease (ulcerative colitis, Crohn’s disease) or toxic megacolon;
• perforation or risk of perforation of the gastrointestinal tract;
• abdominal pain of unclear etiology;
• hypersensitivity to the active substance or to any other excipients of the drug.

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Side effects

The adverse reactions listed in the table below have been reported in clinical trials involving 147 children aged 6 months to 15 years and during post-registration use.

In general, adverse reactions were mild and transient and mostly involved the gastrointestinal systems.

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

Gastrointestinal disorders:

Often – Abdominal pain, Diarrhea*

Infrequent – Vomiting , Bloating, Nausea

Immune system disorders

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

* Diarrhea may cause perianal irritation.

Overdose

Diarrhea may occur, which stops when the dose of the drug is reduced or cancelled.

Intensive diarrhea or vomiting may cause an imbalance of the electrolyte balance, which will require correction.

There have been reports of perianal inflammation and irritation and fecal incontinence when large volumes (4-11 liters) of polyethylene glycol have been used for colon cleansing prior to colonoscopy.

Pregnancy use

Pregnancy Experiments in rats and rabbits have shown that Macrogol 4000 has no teratogenic effect.

Pregnant women should exercise caution when prescribing Forlax to pregnant women because of the paucity of data on the use of Forlax in pregnant women.

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

Similarities

Fortrans, Lavacol