Mikoflos (Powder) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

A06AC01 (Isfagula (oval or psyllium plantain seeds))

Active Substance

Plantago ovata (BHP British Herbal Pharmacopoeia)

Dosage Form

Mikoflos

Powder for oral suspension (orange): jars 150 g or 300 g or sachet 5 g 5, 10, 15, 20, or 25 pcs.

Dosage Form, Packaging, and Composition

Powder for the preparation of an oral suspension light brown in color with inclusions of lighter and darker brown particles of various shapes, coarse, with a faint characteristic odor or almost odorless. When 5 g of the drug is mixed with 150 ml of water, a gel-like suspension from yellowish-white to light brown in color with a characteristic orange odor is formed.

Excipients: sucrose – 0.0959 g, citric acid monohydrate – 0.087 g, dextrin – 0.0588 g, sodium alginate – 0.0503 g, sodium citrate dihydrate (calculated as sodium citrate) – 0.045 g, sodium chloride – 0.003 g, sodium saccharin – 0.002 g, orange flavor – 0.008 g.

5 g – sachets (5) – cardboard packs.
5 g – sachets (10) – cardboard packs.
5 g – sachets (15) – cardboard packs.
5 g – sachets (20) – cardboard packs.
5 g – sachets (25) – cardboard packs.
150 g – jars (1) – cardboard packs.
300 g – jars (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal laxative preparation

Pharmacotherapeutic Group

Drugs for the treatment of constipation; laxatives that increase the volume of intestinal contents

Pharmacological Action

The hydrophilic fibers contained in the seed coat of Plantago ovata increase in volume by absorbing water and cause a reflex enhancement of motility, restoring the normal activity of the large intestine. The gel-forming fraction helps to soften the stool and acts as a “lubricant”, facilitating bowel movements in constipation and painful defecation in patients with perianal lesions.

Indications

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

ICD codes

Dosage Regimen

Orally. Taken as an infusion 1-3 times/day 30 min before meals or 2 hours after meals.

Course of treatment: for acute constipation – until constipation disappears (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 the absence of discomfort during defecation is achieved (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).

Adverse Reactions

Possible allergic reactions.

In the first days of treatment, a feeling of fullness in the abdomen may appear.

Contraindications

Organic strictures of the gastrointestinal tract; intestinal obstruction; abdominal pain of unknown origin; age under 18 years; hypersensitivity to the drug.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible as prescribed by a doctor.

Special Precautions

During treatment, it is necessary to drink at least 1.5 liters of fluid per day. Incorrect administration procedure (with insufficient fluid) can lead to irritation of the esophagus or intestines, especially in elderly people.

Drug Interactions

Should not be prescribed simultaneously with antidiarrheal drugs, as well as with drugs that inhibit intestinal motility.

The drug may slow down the absorption of concurrently used drugs. An interval of 30-60 minutes between doses should be observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.