Fibralax (Powder) Instructions for Use

Marketing Authorization Holder

Evalar, CJSC (Russia)

Contact Information

EVALAR CJSC (Russia)

ATC Code

A06AC01 (Isfagula (oval or psyllium plantain seeds))

Active Substance

Plantago ovata (BHP British Herbal Pharmacopoeia)

Dosage Form

Fibralax

Powder for oral suspension: sachets 5 g 20 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral suspension consisting of variously shaped, yellowish-white to light brown, brittle pieces of Plantago ovata seed coat, inclusions of variously shaped brown fragments of other seed parts, and inclusions of excipients. The odor, which intensifies when the powder is rubbed, is specific – orange.

Excipients: sucrose – 0.527 g, sodium alginate – 0.276 g, sodium acetate – 0.247 g, maltodextrin – 0.193 g, citric acid monohydrate – 0.137 g, aspartame – 0.03 g, orange flavor (natural) [multicomponent mixture of flavoring substances, maltodextrin, gum arabic, alpha-tocopherol] – 0.06 g.

5 g – sachets made of composite material (20) – cardboard packs.

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Laxative of plant origin

Pharmacological Action

The active ingredient of the plantain seed coat consists of the episperm and adjacent layers of the dried, mature seeds of Plantago ovata Forssk. (Plantago ispaghula Roxb.). Plantain seed coats are particularly rich in dietary fiber and plant mucilage; their content is much higher than in other plantain species. Plantain seed coats are capable of absorbing a volume of water up to 40 times their own mass. They consist of 85% water-soluble fiber, which is partially fermentable (in vitro non-fermentable residue is 72%) and promotes stool hydration.

Intestinal peristalsis and the transit rate of its contents can be altered by the action of plantain seed coats through mechanical expansion of the intestinal wall. This occurs as a result of an increase in the mass of the large intestine contents and a decrease in its viscosity due to water absorption.

When plantain seed coats are taken with plenty of fluid, the volume of intestinal contents increases due to their high bulking capacity, consequently stimulating the stretching of the anal sphincter, which induces defecation. Simultaneously, the swollen mass of mucilaginous substance forms a lubricating layer that facilitates the passage of intestinal contents. The preparation restores normal bowel function.

Onset of action: plantain seed coats usually act as a laxative within 12-24 hours after a single dose. Sometimes the maximum effect is achieved only after 2-3 days.

In mild to moderate hypercholesterolemia, a reduction in LDL cholesterol of approximately 7% was observed. Studies on the effect of plantain seed coats on the frequency of cardiovascular complications and overall mortality have not been conducted.

Pharmacokinetics

No data available.

Indications

For adults and children over 12 years of age

• Constipation;
• Anal fissures;
• Hemorrhoids;
• Postoperative period after interventions in the anorectal area (to create a softer stool consistency);
• Functional diarrhea;
• Irritable bowel syndrome;
• As an adjunct to diet for hypercholesterolemia.

ICD codes

Dosage Regimen

Adults

For the treatment of chronic constipation and conditions requiring a soft stool consistency (for example, in the presence of anal fissures, hemorrhoids): adults – 1 sachet 1-3 times/day 30 minutes before meals or 2 hours after meals.

As maintenance therapy in patients with functional diarrhea and irritable bowel syndrome or hypercholesterolemia: adults – 1 sachet 2-6 times/day 30 minutes before meals or 2 hours after meals.

For elevated cholesterol levels (mild to moderate), the preparation is recommended to be taken with meals.

Treatment course for acute constipation – until constipation resolves (1-2 days); for chronic constipation – up to 4 weeks, after a one-week break the course can be repeated; for anal fissures and hemorrhoids – until discomfort during defecation is absent (up to 4 weeks, after a one-week break the course can be repeated); in the postoperative period after interventions in the anorectal area – as recommended by a doctor (up to 4 weeks).

If the patient has prolonged constipation and irregular stools for more than 3 days, or diarrhea that lasts more than 2 days or is accompanied by blood or fever, it is necessary to consult a doctor.

The safety and efficacy of the drug Fibralax in special patient groups have not been established.

Children

The dosage regimen for children from 12 to 18 years old does not differ from the dosage regimen for adults.

Safety and efficacy in children aged 0 to 12 years have not been established to date. No data available.

Method of administration

Orally. Before use, pour the contents of 1 sachet into a glass of cold water, stir and drink immediately, then drink another glass of fluid.

The preparation should not be taken while lying down or immediately before bedtime.

Adverse Reactions

Allergic reactions rhinitis, conjunctivitis, skin reactions (eczema, itching), bronchospasm, anaphylactic shock.

Gastrointestinal in the first days of treatment, increased flatulence and a feeling of abdominal fullness are possible; abdominal distension, coprostasis may develop; development of intestinal obstruction or esophageal obstruction is possible, especially when taking the preparation without sufficient fluid.

Laboratory data: possible decrease in blood glucose concentration.

Contraindications

• Hypersensitivity to Plantago ovata seed coat or to any of the excipients included in the preparation;
• Sudden changes in bowel habits persisting for more than 2 weeks;
• Rectal bleeding of unknown etiology;
• Inability to defecate after using a laxative;
• Difficulty swallowing, stenosis of the esophagus, cardia of the 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;
• Children under 12 years of age (due to lack of data on efficacy and safety in this population).

With caution

• Diabetes mellitus;
• Persons on a diet low in carbohydrates and sodium should consult a doctor before taking the preparation;
• Coprostasis or symptoms such as abdominal pain, nausea and vomiting, which may be a sign of potential or existing intestinal obstruction.

Use in Pregnancy and Lactation

There are no contraindications to taking the preparation during pregnancy and breastfeeding. There are limited data (less than 300 pregnancies) regarding the use of the preparation during pregnancy. Data obtained from animal studies to determine reproductive toxicity are limited.

The use of the preparation during pregnancy and breastfeeding may be considered if necessary and if dietary measures have not yielded positive results. Bulk-forming laxatives should be taken before starting other laxatives.

Fertility

Special studies on the effect of the preparation on fertility have not been conducted.

Pediatric Use

Contraindicated for use in children under 12 years of age (due to lack of data on efficacy and safety in this population).

Special Precautions

During treatment with the preparation, at least 1.5 liters of fluid should be consumed per day.

In the absence of sufficient fluid, intake of bulk-forming preparations can lead to obstruction of the airways and esophagus, accompanied by choking, and intestinal obstruction. If abdominal pain or irregular stools appear during the treatment of chronic constipation, it is necessary to discontinue the use of the preparation.

Some studies have shown that plantain seed coats cause a decrease in blood glucose concentration. Patients with diabetes mellitus receiving treatment with Fibralax may require dose adjustment of antidiabetic drugs.

Treatment of debilitated patients and/or elderly patients requires medical supervision.

Excipients

The preparation contains sucrose. Patients with hereditary fructose intolerance, glucose-galactose malabsorption, or congenital sucrase/isomaltase deficiency should not take this preparation.

A single dose of Fibralax contains 98.12 mg of sodium. This should be taken into account by persons on a diet with controlled sodium content (low sodium/sodium chloride).

Effect on ability to drive vehicles and operate machinery

Fibralax does not affect the ability to drive vehicles and operate machinery.

Overdose

Symptoms abdominal discomfort, flatulence, intestinal obstruction. In case of drug overdose, a doctor should be consulted immediately.

Treatment symptomatic.

Drug Interactions

When the preparation is used concomitantly with drugs such as minerals, vitamins (vitamin B₁₂), cardiac glycosides, coumarin derivatives, carbamazepine, and lithium preparations, their absorption in the small intestine may be slowed. For this reason, Fibralax should be taken 30-60 minutes before or 30-60 minutes after taking other medicines.

To reduce the risk of obstruction, treatment with Fibralax when taken concomitantly with drugs that inhibit intestinal peristalsis (such as opiates, loperamide) should be carried out under medical supervision.

The possibility of a weakening of the effect of thyroid hormones cannot be excluded, even if their intake is not simultaneous with the intake of Fibralax.

Storage Conditions

The preparation should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years.

Dispensing Status

Available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.