Форлакс

General characteristics. Structure:

Active agent: macrogoal of 4000 10 g

Excipients: a fragrance with a smell of orange and grapefruit (orange oil, grapefruit oil, the orange juice concentrated, citral, acetic aldehyde, linalol, ethyl butyrate, α-terpineol, octanal, cis-3 - гексенол, maltodextrin, acacias gum, sorbitol) - 150 mg, sodium saccharinate - 17 mg.

Pharmacological properties:

Osmotic laxative drug. The big molecular mass of a macrogoal 4000 is caused by long linear polymers which hold water molecules by means of hydrogen bindings. Thanks to it after oral administration of drug the volume of intestinal contents increases. The volume of not absorbed liquid which is in an intestines gleam supports laxative action of solution.
Laxative action of Forlaks comes in 24-48 h after reception.

Pharmacokinetics. Pharmacokinetic data confirm that at intake the macrogoal 4000 is not exposed to either gastrointestinal absorption, or biotransformation.

Indications to use:

— the symptomatic treatment of locks at adults and children at the age of 8 years is also more senior.

Route of administration and doses:

Accept inside, about 1-2 packages of 1 time/days in the morning or on 1 package of 2 times/days - in the morning and are preferable in the evening.
The daily dose is adjusted according to clinical effect.
Contents of each package should be dissolved in a glass of water just before reception.
The recommended course of treatment for adults and children at the age of 8 years is also more senior - 3 months. At children treatment should not exceed 3 months in connection with insufficiency of clinical data.
After recovery of normal work of intestines the patient has to support effect: to lead active lifestyle and to include the products rich with a cellulose in a diet.
If symptoms of a lock remain more than 3 months, it is necessary to conduct repeated expanded diagnostic examination.

Features of use:

Prior to therapy it is necessary to exclude organic gastrointestinal diseases.

Treatment of locks by means of medicines is recommended only as addition to a healthy lifestyle and a diet, for example: increase in consumption of liquids and cellulose; adequate physical activity which promotes recovery of motility of a GIT.

In case of development of diarrhea with extra care it is necessary to treat the patients predisposed to disturbances of water and electrolytic balance (for example, at patients with an abnormal liver function or kidneys, or the patients accepting diuretics); in such cases it is necessary to control the content of electrolytes.

There are messages on aspiration cases at introduction of large volumes of polyethyleneglycol with electrolytes via the nazogastralny probe. The children suffering from neurologic frustration with swallowing disturbance are especially subject to risk of aspiration.

Very exceptional cases of hypersensitivity (including rash, urticaria, hypostasis) at administration of drugs were registered, containing a macrogoal (polyethyleneglycol). The acute anaphylaxis was in exceptional cases observed.

Форлакс® contains sorbitol therefore drug should not be used at patients with inborn intolerance of fructose.

Форлакс® does not contain a large amount of sugar or polyol therefore it is possible to appoint drug a sick diabetes mellitus, and also to patients whose of diet the galactose is excluded.

Influence on ability to driving of motor transport and to control of mechanisms
Drug does not influence ability to control of motor transport and work with mechanisms.

Side effects:

Adults
Side effects which were observed at conduct of clinical trials with participation of 600 patients had tranzitorny character:
From the alimentary system: often (> 1/100, <1/10) - abdominal distention and/or pain, nausea, diarrhea; seldom (> 1/1000, <1/100) - vomiting, an urgent desire on defecation and an incontience a calla.
The additional information obtained at post-marketing observations:
Allergic reactions: very seldom (<1/10 000) - a skin itch, a small tortoiseshell, tranzitorny rash, a face edema, a Quincke's edema; in some cases - an acute anaphylaxis.
From the alimentary system: frequency is unknown - the diarrhea leading to disturbance of electrolytic balance (a hyponatremia, a hypopotassemia) and/or dehydration, especially at adults.

Children
Side effects which were observed at conduct of clinical trials with participation of 147 children aged from 6 months up to 15 years were minimum and had passing character:
From the alimentary system: often (> 1/100, <1/10) - diarrhea and abdominal pains; seldom (> 1/1000, <1/100) - a meteorism, nausea, vomiting.
Additional information at post-marketing observations is not obtained.
The allergic reactions noted at adults are not found.
Diarrhea can be the cause of painful feelings in perianal area.

Interaction with other medicines:

Interaction of the drug Forlaks® with other medicines is not described.

Форлакс® slows down absorption of at the same time accepted medicines. Therefore it is recommended to appoint it not earlier than in 2 h after reception of other drugs.

Contraindications:

— serious inflammatory diseases of intestines (ulcer colitis, disease Krone);
— toxic megacolon in combination with a symptomatic stenosis;
— perforation or threat of a perforation of a GIT;
— intestinal impassability or suspicion on intestinal impassability;
— abdominal pains of not clear etiology;
— children's age up to 8 years;
— hypersensitivity to a macrogoal (polyethyleneglycol) or other components of drug.

Use of the drug FORLAKS® at pregnancy and feeding by a breast
At purpose of the drug Forlaks® pregnant women should be careful in view of the insufficient number of data on use of drug for this category of patients.
It is unknown whether the macrogoal 4000 with breast milk at the person is allocated. As the macrogoal 4000 is not exposed to absorption, Forlaks® can be applied in the period of a lactation (breastfeeding).
In pilot studies it is shown that the macrogoal 4000 did not cause teratogenic effects in rats and rabbits.

Use for children
Use for children aged up to 8 years is contraindicated.

Overdose:

Symptoms: diarrhea which stops at reduction of a dose of drug or the termination of treatment.
Treatment: excess loss of liquid at diarrhea or vomiting can demand correction of electrolytic disturbances.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging:

Powder for пригот. solution for intake of 10 g: pack ice. 10 or 20 pieces.