FORLAKS® (Powder for oral solution (for children))

Active material: Macrogol
When ATH: A06AD15
CCF: Laxatives osmotic properties
ICD-10 codes (testimony): K59.0
When CSF: 11.08.03
Manufacturer: BEAUFOUR IPSEN PHARMA (France)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Powder for oral solution (for children) white or nearly white, with the smell of orange and grapefruit, easily soluble in water.

Excipients: orange-grapefruit flavor (60 mg), sodium saccharin (6.8 mg).

4.0668 g – single-dose sachets (10) – packs cardboard.
4.0668 g – single-dose sachets (20) – packs cardboard.
4.0668 g – single-dose sachets (30) – packs cardboard.
4.0668 g – single-dose sachets (50) – packs cardboard.

Pharmacological action

Osmotic laxatives. Macrogol 4000 – high-molecular compound, is a linear polymer, which by means of hydrogen bonds holding the water molecules. Due to this, after oral administration increases the amount of intestinal contents. Not absorbed liquid, which is located in the intestinal lumen, It supports the laxative effect of the drug.

The pharmacological data confirm the lack of gastro-intestinal absorption and biotransformation macrogol 4000 upon oral administration.

Laxative effect Forlaks^® It comes through 24-48 h after administration.

Pharmacokinetics

If ingestion macrogoal 4000 It is not absorbed from the digestive tract and metabolized.

Testimony

- Symptomatic treatment of constipation in children between the ages of 6 months before 8 years.

Dosage regimen

Children aged 6 months before 1 year appointed 1 Package / day; from 1 Year to 4 years – 1-2 Package / day; from 4 to 8 years – 2-4 Package / day.

Contents 1 packet to be dissolved in about 50 ml of water and taken orally morning (at a dose 1 Package / day) either in the morning and evening (at a dose of 1 Package / day).

Duration of treatment – no more 3 months.

Drug treatment of constipation is advantageous to maintain a diet, rich in vegetable fiber, and adequate physical activity.

Side effect

From the digestive system: while taking the drug in high doses may develop diarrhea, which stops after 24-48 h after drug withdrawal, after that you can continue receiving Forlaks^® a lesser dosage; diarrhea due to possible irritation of the perianal area, stomach ache (especially in patients with irritable bowel syndrome), flatulence, nausea, borborygmus; rarely – vomiting.

Allergic reactions: rarely – rash, hives, angioedema.

Contraindications

- Inflammatory bowel disease (incl. yazvennыy colitis, Crohn's disease);

- Toxic megacolon;

- The risk of perforation or bowel perforation;

- Partial or complete intestinal obstruction;

- Abdominal pain of unknown etiology;

- Hypersensitivity to polyethylene glycol or other ingredients.

Cautions

Forlaks^® It does not contain large amounts of sugar or polyol, so the drug can be administered to patients with diabetes, and patients, which is excluded from the diet of galactose.

There have been reports of cases of aspiration with the introduction of large volumes of polyethylene glycol and electrolytes through a nasogastric tube. Children, suffering from neurological disorders with swallowing disorders, They are particularly at risk of aspiration.

Overdose

Symptoms: possible diarrhea, which terminates at reducing the dose or repeal; intense diarrhea or vomiting may cause a violation of water-electrolyte balance, that require its correction; there are reports of the appearance of inflammation and irritation of the perianal region and anal incontinence in cases of large volumes of polyethylene glycol (4-11 l) to clean bowel prior to colonoscopy.

Drug Interactions

Interaction Forlaks^® with other drugs is not disclosed.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 5 years.