Forlax powder for preparation of oral solution 10g, No. 20
Expiration Date: 05/2027
Russian Pharmacy name:
Форлакс порошок для приготовления р-ра для приема внутрь 10г, №20
Symptomatic treatment of constipation in adults and children from 8 years of age and older.
Inside, the contents of 1 - 2 packets (preferably as a single dose in the morning) or 1 packet (morning and evening) in the case of taking 2 packets per day.
The daily dosage must be adapted according to the clinical effect and can range from 1 sachet every day (especially in children) to 2 sachets per day.
The contents of each packet should be dissolved in a glass of water immediately before taking
The effect of taking ForlaxЃ is expressed within 24 - 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.
The maintenance of the effect after the restoration of normal bowel function should be carried out with an active lifestyle and a diet rich in plant fiber.
If the symptoms of constipation persist for more than 3 months, it is necessary to re-conduct an extended diagnostic examination.
Composition for one package:
Active substance:
Macrogol 4000 - 10.00 g
Excipients:
Orange-grapefruit flavor * - 0.15 g
Sodium saccharinate - 0.017 g
* Orange oil, grapefruit oil, orange juice concentrated, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, cis-3-hexenol, maltodextrin, acacia gum, sorbitol (E420), sulfur dioxide (E220), butaniline E320).
- serious inflammatory bowel disease (ulcerative colitis, Crohn's disease) or toxic enlargement 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 under 8 years old.
Carefully
Pregnancy
The results of animal studies have shown that
Macrogol 4000 does not have a teratogenic effect.
Since the systemic effect of ForlaxЃ is insignificant, negative effects on the mother and fetus are not expected. ForlaxЃ can be taken during pregnancy.
Lactation
The systemic effect of macrogol 4000 on the body of lactating women is negligible, therefore a negative effect on the body of a newborn / infant is not expected. ForlaxЃ can be taken during lactation.
Active substance
Macrogol
Dosage form
powder for oral solution
Composition:
Composition for one package:
Active substance:
Macrogol 4000 - 10.00 g
Excipients:
Orange-grapefruit flavor * - 0.15 g
Sodium saccharinate - 0.017 g
* Orange oil, grapefruit oil, orange juice concentrated, citral, acetaldehyde, linalol, ethyl butyrate, alpha terpineol, octanal, cis-3-hexenol, maltodextrin, acacia gum, sorbitol (E420), sulfur dioxide (E220), butaniline E320).
Description
Powder of white or almost white color with the smell of orange and grapefruit, readily soluble in water, with the formation of a white translucent solution.
Pharmacotherapeutic group
Laxative
Pharmacodynamics
The large molecular weight of macrogol 4000 is due to the 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 intestinal lumen maintains the laxative effect of the solution.
Pharmacokinetics
Pharmacokinetic data confirm that
macrogol 4000 does not undergo either gastrointestinal resorption or biotransformation when taken orally.
Indications for use
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 enlargement 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 under 8 years old.
Carefully
Pregnancy
The results of animal studies have shown that
Macrogol 4000 does not have a teratogenic effect.
Since the systemic effect of ForlaxЃ is insignificant, negative effects on the mother and fetus are not expected. ForlaxЃ can be taken during pregnancy.
Lactation
The systemic effect of macrogol 4000 on the body of lactating women is negligible, therefore a negative effect on the body of a newborn / infant is not expected. ForlaxЃ can be taken during lactation.
Method of administration and dosage
Inside, the contents of 1 - 2 packets (preferably as a single dose in the morning) or 1 packet (morning and evening) in the case of taking 2 packets per day.
The daily dosage must be adapted according to the clinical effect and can range from 1 sachet every day (especially in children) to 2 sachets per day.
The contents of each packet should be dissolved in a glass of water immediately before taking
The effect of taking ForlaxЃ is expressed within 24 - 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.
The maintenance of the effect after the restoration of normal bowel function should be carried out with an active lifestyle and a diet rich in plant fiber.
If the symptoms of constipation persist for more than 3 months, it is necessary to re-conduct an extended diagnostic examination.
Side effect
In adults.
Side effects observed during clinical trials on 600 patients were transient in nature, were observed with the following frequency and concerned mainly the gastrointestinal tract:
- frequent side effects (more than 1/100, less than 1/10): bloating and / or pain, nausea, diarrhea;
- rare side effects (more than 1/1000, less than 1/100): vomiting, an urgent urge to defecate and fecal incontinence.
Additional information obtained from post-marketing observations included: very rare (less than 1/10000) cases of hypersensitivity: pruritus, urticaria, transient (transient) rash, facial edema, Quincke's edema and isolated cases of anaphylactic shock.
The incidence of diarrhea leading to electrolyte imbalance (hyponatremia, hypokalemia) and / or dehydration is unknown, especially in adult patients.
In children.
Side effects related to the gastrointestinal tract were minimal and transient in clinical trials involving 147 children aged 6 months to 15 years, were detected with the following frequency:
Disorders of the gastrointestinal tract:
- frequent side effects (more than 1/100, less than 1/10): diarrhea and abdominal pain,
- rare side effects (more than 1/1000, less than 1/100): flatulence, nausea and vomiting.
- side effects that cannot be estimated on the basis of the available data: hypersensitivity reactions.
Diarrhea can cause pain in the perianal area.
Overdose
An overdose of the drug leads to diarrhea, followed by disappearance after dose reduction or discontinuation of treatment.
Excessive fluid loss from diarrhea or vomiting may require correction of electrolyte disturbances.
Interaction
Not described. It is possible to slow down the absorption of drugs taken simultaneously with Forlax. Therefore, it is recommended to prescribe ForlaxЃ at least 2 hours after prescribing other drugs.
special instructions
Organic disorders of the gastrointestinal tract should be excluded before starting therapy.
Warning.
Treatment of constipation with medications is recommended only as an adjunct to a healthy lifestyle and diet, for example:
- increased intake of fluids and fiber,
- adequate physical activity, which helps to restore the motility of the digestive tract.
If diarrhea develops, special caution should be exercised in patients who are prone to imbalance in water and electrolyte balance (for example, in elderly patients, in patients with impaired liver or kidney function, or in patients taking diuretics) and electrolyte monitoring should be performed.
ForlaxЃ 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 from
galactose.
Special warnings.
Very rare cases of hypersensitivity (including rash, urticaria, edema) have been reported when taking drugs containing
macrogol (polyethylene glycol). In exceptional cases, anaphylactic shock was observed.
Due to the presence of sorbitol, patients with congenital fructose intolerance should not take this drug.
Due to the presence of sulfur dioxide, in rare cases, serious allergic reactions and bronchospasm may occur.
Cases of aspiration have been reported when large volumes of macrogol and electrolytes were administered via a nasogastric tube.
Children with neurological impairments who have swallowing problems are at risk of aspiration.
Impact on the ability to drive a vehicle
Does not affect the ability to drive vehicles and mechanisms.
Release form
Powder for preparation of oral solution 10 g.
Packaging
10.167 g of the drug in bags made of paper laminated with aluminum foil and polyethylene.
10 or 20 bags, together with instructions for use, are placed in a cardboard box.
Storage conditions
At a temperature not exceeding 30 ? C, out of the reach of children.
Shelf life
3 years.
Do not use after the expiration date printed on the package.
Conditions of dispensing from pharmacies
Without recipe