Expiration date: 01/2028

Composition

of the active ingredient: psyllium oval seed shell (Plantain ovata Forssk) – 3.53 g; auxiliary components: sucrose – 0.527 g, sodium alginate – 0.276 g, sodium citrate – 0.247 g, maltodextrin – 0.193 g, citric acid monohydrate – 0.137 g, aspartame – 0.030 g, orange flavor (natural) [multicomponent mixture of aromatic substances, maltodextrin, gum arabic, alpha-tocopherol] – 0.060 g.

Dosage form

powder for preparation of suspension for oral administration

Description

A powder consisting of various shapes from yellowish-white to light brown brittle pieces of the seed coat of plantain, from inclusions of various shapes of brown color of other parts of the seed and from inclusions of auxiliary components. The smell, which increases when the powder is rubbed, is specific - orange.

Action

The complex action of Fibralaxa Softens stools, facilitating bowel movement in case of constipation, Restores normal bowel function, and alleviates unpleasant symptoms of hemorrhoids and anorectal lesions. Soluble dietary fiber in Fibralax: Promotes the growth of beneficial microflora as a prebiotic.

Pharmacodynamics

The hydrophilic fibers contained in the shell of psyllium ovalis seeds increase in volume due to the absorption of water and cause a reflex increase in motility, restoring the normal activity of the large intestine. The gel-forming fraction helps to soften stools and acts as a lubricant, facilitating bowel movement in patients with constipation and painful bowel movements in patients with perianal lesions.

Indications for use

Acute and chronic constipation, anal fissures, hemorrhoids, and the postoperative period during interventions in the anorectal area (in order to create a softer stool consistency).

Contraindications

Known hypersensitivity to psyllium (psyllium major or psyllium) or to any component of the drug, sudden changes in bowel movements lasting more than 2 weeks, rectal bleeding of unknown etiology, inability to defecate after using a laxative, difficulty swallowing, stenosis of the esophagus, cardiac stomach or gastrointestinal tract, potential or existing intestinal obstruction (ileus), intestinal paralysis or megacolon syndrome, fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption syndrome, phenylketonuria, age up to 12 years (due to the lack of data on efficacy and safety in this population). With caution, Coprostasis or symptoms such as abdominal pain, nausea and vomiting, which may be a sign of a potential or existing intestinal obstruction. If you have one of the above diseases/conditions or risk factors, it is necessary to consult a doctor before using the drug.

Use during pregnancy and lactation

There are no contraindications to taking the drug during pregnancy and breastfeeding. There are limited data (less than 300 pregnancies) regarding the use of the drug during pregnancy. The data obtained in animal studies for the purpose of determining reproductive toxicity are limited. The use of the drug during pregnancy and breast-feeding may be considered if necessary and if dietary changes have not produced positive results. Volume-forming laxatives should be taken before using other laxatives. Before using the drug, if you are pregnant, or assume that you could be pregnant, or are planning pregnancy, you should consult your doctor. During breastfeeding, consult your doctor before using the drug.

Side effects

Allergic reactions are possible (including rhinitis, conjunctivitis, skin reactions (exanthema, itching), bronchospasm, anaphylactic shock). In the first days of using the drug, there may be increased flatulence and a feeling of fullness in the abdomen. Bloating and coprostasis may develop. Intestinal obstruction or esophageal obstruction may develop, especially when taking the drug without sufficient fluid. If any of the adverse reactions listed in the instructions worsen, or you notice any other adverse reactions not listed in the instructions, inform your doctor.

Interaction

If you are using the following or other medications (including over-the-counter ones), consult your doctor before using Fibralax. When the drug is combined with drugs such as minerals, vitamins (vitamin B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium preparations, their absorption in the small intestine may slow down. For this reason, Fibralax should be taken 30-60 minutes before taking other medications or 30-60 minutes after taking them. In order to reduce the risk of obstruction, treatment with Fibralax when combined with medications that inhibit intestinal motility (such as opiates, loperamide) should be carried out under medical supervision. It is impossible to exclude the possibility of weakening the effect of thyroid hormones, even if their intake is not simultaneous with the intake of Fibralax.

Method of administration and dosage

For the treatment of chronic constipation and conditions that require a soft stool consistency (for example, in the presence of anal fissures, hemorrhoids): adults and children over 12 years of age — 1 sachet 1-3 times a day 30 minutes before meals or 2 hours after meals. Before use, pour the contents of 1 sachet with a glass of cold water, stir and drink immediately, then wash down with another glass of liquid. As maintenance therapy in patients with functional diarrhea, irritable bowel syndrome or hypercholesterolemia: adults and children over 12 years of age — 1 sachet 2-6 times a day 30 minutes before meals or 2 hours after meals. Before use, pour the contents of 1 sachet with a glass of cold water, stir and drink immediately, then wash down with another glass of liquid. With elevated cholesterol levels (from mild to moderate), the drug is recommended to be taken with meals. Course of treatment: for acute constipation — until the constipation disappears (1-2 days); for chronic constipation — up to 4 weeks, after a one-week break, it is possible to repeat the course; for anal fissures and hemorrhoids – until there is no discomfort during defecation (up to 4 weeks, after a one-week break, it is possible to repeat the course); in the postoperative period, with interventions in the anorectal area – on the recommendation of a doctor (up to 4 weeksx weeks). The drug should not be taken lying down or just before bedtime. If the patient has prolonged constipation and irregular stools for more than 3 days, or diarrhea that lasts for more than 2 days or is accompanied by blood or fever, it is necessary to consult a doctor. In the absence of a positive effect from the therapy, deterioration of the condition or the appearance of new symptoms, you should consult a doctor. Use the drug only according to the indications, the method of use and in the doses specified in the instructions.

Overdose

To date, no cases of overdose have been reported.In case of overdose, abdominal discomfort, flatulence, intestinal obstruction are possible. In case of overdose of the drug, you should immediately consult a doctor. Treatment: symptomatic.

Special instructions

During treatment with the drug, you should drink at least 1.5 liters of liquid per day. In the absence of a sufficient amount of fluid, taking volume-forming drugs can lead to obstruction of the respiratory tract and esophagus, accompanied by suffocation, and intestinal obstruction. If abdominal pain or irregular stools appear during the treatment of chronic constipation, it is necessary to stop using the drug and consult a doctor. Separate studies have shown that psyllium seed shells cause a decrease in blood glucose concentration. Patients with diabetes mellitus receiving treatment with Fibralax may need to adjust the dose of antidiabetic drugs. Treatment of debilitated and/or elderly patients requires medical supervision.

Influence on the ability to drive motor vehicles and manage mechanisms

The drug does not affect the ability to drive vehicles and mechanisms.

Form of release

Cardboard packaging, sachet No. 20

Conditions of release from pharmacies

Without a prescription

Storage conditions

Store at a temperature not exceeding 25 C. Keep out of reach of children.

Expiration date

3 years. Do not use after the expiration date.