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.

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 children aged 6 months to 8 years.

Contraindications:

- Serious inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic megacolon;

- perforation or perforation risk of the intestine;

- complete or partial intestinal obstruction, as well as suspected intestinal obstruction, symptomatic stenosis;

- abdominal pain of unclear etiology;

- Hypersensitivity to macrogol (polyethylene glycol) or to other components of the drug.

Pregnancy and lactation:

Not applicable.

Dosing and Administration:

Inside.

- from 6 months to 1 year: 1 packet per day.

- from 1 year to 4 years: from 1 to 2 bags per day.

- from 4 to 8 years: from 2 to 4 bags per day.

The contents of one sachet should be dissolved in about 50 ml of water and taken in the morning (if the dosage is 1 sachet per day)or take in the morning and in the evening (if the dosage is more than 1 sachet per day).

Duration of treatment - no more than 3 months.

Forlax action® manifested after 24 - 48 hours after admission.

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:

Data on adverse reactions are presented in accordance with the following classification: very often (≥1/10), often (≥1/100 - <1/10), infrequently (≥1 / 1,000 to <1/100), rarely (<1 / 1,000), very rarely (≥1/10,000).

In general, adverse reactions are of an easy transient nature and are most often associated with gastrointestinal disorders.

Often: abdominal pain, diarrhea *.

Diarrhea can cause irritation of the perianal area.

Infrequently: nausea, vomiting, swelling.

Experience in using the drug in routine practice (at a frequency that can not be estimated on the basis of available data): extremely rare cases of hypersensitivity ** in the form of rash, hives, and Quincke's edema.

** Information is provided on the basis of data collected for all drugs containing Macrogol in various dosages.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

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

Intensive diarrhea or vomiting can cause disturbance of the electrolyte electrolyte balance, which will require correction.

There are reports of inflammation and irritation of the perianal area and incontinence in cases of using polyethylene glycol in large volumes (4 - 11 liters) for the purpose of cleaning the intestine before colonoscopy.

Interaction:

Slows the absorption of concomitant medications. Therefore it is recommended to appoint Forlax® after at least 2 hours after the administration of other drugs.

Special instructions:

PRECAUTIONS FOR USE

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

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

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:

No information.

Form release / dosage:Powder for solution for oral administration (for children) 4 g.

Packaging:

By 4,0668 g of the drug in single-dose bags made of paper, laminated aluminum foil and polyethylene. For 20 bags are placed together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature not exceeding 30 °FROM.

Keep out of the 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:LS-002549

Date of registration:23.08.2010 / 10.01.2013

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® )