Forlax - instructions for use, dose, side effects, contraindications

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

Description:

Powder white or almost white with the smell of orange and grapefruit, easily soluble in water, to form a white translucent solution.

Pharmacotherapeutic group:Laxative

ATX: & nbsp

A.06.A.D.15 Macrogol

Pharmacodynamics:

The large molecular weight of macrogol 4000 is due to long linear polymers that hold 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 lumen of the intestine supports the laxative action of the solution.

Pharmacokinetics:

Pharmacokinetic data confirm that macrogol 4000 is not subjected to either gastrointestinal resorption or bioreactivation by oral administration.

Indications:

Symptomatic treatment of constipation in adults and children from 8 years of age and older.

Contraindications:

- Serious inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic expansion of the colon, combined with symptomatic stenosis;

- perforation or threat of perforation of the gastrointestinal tract;

- intestinal obstruction or suspicion of intestinal obstruction;

- abdominal pain of unclear etiology;

- hypersensitivity to macrogol (polyethylene glycol) or any of the components of the drug;

- Children's age till 8 years.

Pregnancy and lactation:

Pregnancy

The results of studies in animals showed that Macrogol 4000 does not have a teratogenic effect.

Since the systemic effect of Forlax® is negligible, no adverse effects on the body of the mother and fetus are expected. Forlax® can be taken during pregnancy.

Lactation

The systemic effect of macrogol 4000 on the organism of lactating women is negligible, so no negative impact on the body of the newborn / baby is expected. Forlax® can be taken during lactation.

Dosing and Administration:

Inside, the contents of 1 - 2 packages (preferably in the form of a single dose in the morning) or 1 packet (morning and evening) in the case of taking 2 packages a day.

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

The contents of each package should be dissolved in a glass of water immediately before taking.

The effect of taking Forlax® is expressed within 24 to 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 the restoration of normal bowel function should be carried out with the help of an active lifestyle and a diet rich in vegetable fiber.

If the symptoms of constipation persist for more than 3 months, it is necessary to conduct a repeated extended diagnostic examination.

Side effects:

In adults.

Side effects observed during clinical trials in 600 patients were transient, were observed at the following frequency and were mainly in the gastrointestinal tract:

- frequent side effects (more than 1/100, less than 1/10): bloating and / or pain, nausea, diarrhea;

- rarely occurring side effects (more than 1/1000, less than 1/100): vomiting, urgent urge to stool and stool incontinence.

Additional information obtained from post-marketing observations included: very rarely (less than 1/10000) cases of hypersensitivity: skin itching, urticaria, transient rash, facial edema, Quincke's edema and isolated cases of anaphylactic shock.

The incidence of diarrhea leading to an electrolyte balance disorder (hyponatremia, hypokalemia) and / or dehydration is unknown, especially in adult patients.

Children.

Side effects related to the gastrointestinal tract were minimal and transient in clinical studies with the participation of 147 children aged 6 months to 15 years were detected at the following frequency:

Disorders of the gastrointestinal tract:

- frequent side effects (more than 1/100, less than 1/10): diarrhea and abdominal pain,

- rarely occurring side effects (more than 1/1000, less than 1/100): flatulence, nausea and vomiting.

- side effects that can not be assessed on the basis of available data: hypersensitivity reactions.

Diarrhea can be the cause of pain in the perianal area.

Overdose:

An overdose of the drug leads to diarrhea with a subsequent disappearance after a dose reduction or discontinuation of treatment.

Excess fluid loss with diarrhea or vomiting may require correction of electrolyte disorders.

Interaction:

Not described. It is possible to slow the absorption of drugs taken simultaneously with Forlax. Therefore, it is recommended to prescribe Forlax® after at least 2 hours after the administration of other drugs.

Special instructions:

Organic disorders of the gastrointestinal tract should be excluded before the start of therapy.

A warning.

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

- increased consumption of liquids and fiber,

- adequate physical activity, which contributes to the restoration of the motility of the digestive tract.

If diarrhea develops with extreme caution, patients who are predisposed to a disturbance of the electrolyte balance (for example, in elderly patients, in patients with impaired liver or kidney function, or patients taking diuretics) should be treated with caution and electrolyte monitoring should be performed.

Forlax® does not contain significant amounts of carbohydrates and / or polyols (sugar alcohols) and can be used in patients with diabetes mellitus or in patients whose diet is excluded galactose.

Special warnings.

Very rare cases of hypersensitivity have been reported (including rashes, urticaria, edema) with medications containing macrogol (polyethylene glycol). In exceptional cases, anaphylactic shock was observed.

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

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

Aspiration cases were reported when a large volume of macrogol and electrolytes was injected with a nasogastric tube.

Children with neurologic disorders who have impaired swallowing are at risk of aspiration.

Effect on the ability to drive transp. cf. and fur:

Does not affect the ability to drive vehicles and machinery.

Form release / dosage:

Powder for solution for oral administration 10 g.

Packaging:

By 10,167 g of the drug in bags made of paper, laminated aluminum foil and polyethylene.

For 10 or 20 packs, together with the instructions for use are placed in a cardboard box.

Storage conditions:

At temperatures not higher than 30 ° C, out of reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N014670 / 01

Date of registration:17.11.2008 / 30.07.2013

The owner of the registration certificate:IPSEN PHARMA IPSEN PHARMA France

Manufacturer: & nbsp

BEAUFOUR IPSEN INDUSTRIE France

Representation: & nbspIPSEN PHARMA IPSEN PHARMA France

Information update date: & nbsp29.02.2016

Illustrated instructions

Instructions

Forlax® (Forlax®)