Ribomunyl^® (Granules) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Medicament Production (France)

ATC Code

L03AX (Other immunostimulants)

Dosage Forms

	Ribomunyl®	Granules for oral solution 750 mcg+1.125 mg: sachets 4 pcs.
		Tablets 250 mcg+375 mcg: 12 pcs.
		Tablets 750 mcg+1.125 mg: 4 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, white or almost white, odorless.

Excipients: colloidal hydrophobic silicon, magnesium stearate, sorbitol.

12 pcs. – blisters (1) – cardboard packs.

Tablets round, biconvex, white or almost white, odorless.

Excipients: colloidal hydrophobic silicon, magnesium stearate, sorbitol.

4 pcs. – blisters (1) – cardboard packs.

Granules for oral solution white, odorless.

Excipients: povidone, mannitol (D-mannitol).

Sachets made of combined material (4) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug of bacterial origin

Pharmacotherapeutic Group

MIBP

Pharmacological Action

Immunomodulator of bacterial origin. Ribomunyl^® is a ribosomal-proteoglycan complex that includes the most common pathogens of ENT organ and respiratory tract infections and belongs to stimulants of specific and nonspecific immunity.

The ribosomes included in the drug contain antigens identical to the surface antigens of bacteria and, when entering the body, cause the production of specific antibodies to these pathogens (vaccine effect). Membrane proteoglycans stimulate nonspecific immunity, which is manifested by increased phagocytic activity of macrophages and polymorphonuclear leukocytes, and increased factors of nonspecific resistance. The drug stimulates the function of T- and B-lymphocytes, the production of serum and secretory immunoglobulins type IgA, interleukin-1, as well as alpha- and gamma-interferons. This explains the preventive effect of Ribomunyl^® against respiratory viral infections.

The use of Ribomunyl^® in complex therapy can increase the effectiveness and reduce the duration of treatment, significantly reduce the need for antibiotics and bronchodilators, and increase the remission period.

Pharmacokinetics

Pharmacokinetic data for Ribomunyl^® are not available.

Indications

• Prevention and treatment of recurrent infections of the ENT organs (otitis, rhinitis, sinusitis, pharyngitis, laryngitis, tonsillitis) and respiratory tract (chronic bronchitis, tracheitis, pneumonia, infection-dependent bronchial asthma) in patients over 6 months of age;
• Prevention of recurrent infections in at-risk patients (frequently and long-term ill patients, before the start of the autumn-winter season, especially in environmentally unfavorable regions, patients with chronic diseases of the ENT organs, chronic bronchitis, bronchial asthma, including children over 6 months of age and elderly persons).

ICD codes

Dosage Regimen

Adults and children over 6 months the drug is prescribed 1 time/day in the morning on an empty stomach.

A single dose (regardless of age) is 3 tablets of 0.25 mg (with 1/3 of a single dose), 1 tablet of 0.75 mg (with one dose), or granules from 1 sachet, previously dissolved in boiled water at room temperature.

In the first month of treatment and/or for prophylactic purposes, Ribomunyl^® is taken daily for the first 4 days of each week for 3 weeks. In the next 2-5 months – the first 4 days of each month.

For young children, the drug is recommended to be prescribed in the form of granules.

It is recommended to conduct three-month preventive courses of treatment 2 times a year, six-month preventive courses – 1 time per year.

Adverse Reactions

Rarely observed, does not require drug withdrawal, characterized by

• Transient hypersalivation at the beginning of treatment, nausea, vomiting, diarrhea.
• Allergic reactions (urticaria, angioedema).

Contraindications

• Autoimmune diseases;
• Hypersensitivity to the drug.

Use in Pregnancy and Lactation

No specific studies on the safety and efficacy of Ribomunyl^® use during pregnancy and lactation have been conducted.

The use of Ribomunyl^® during pregnancy and lactation (breastfeeding) is possible only after assessing the expected benefit for the mother and the potential risk to the fetus and child.

Pediatric Use

Used in children over 6 months of age.

Special Precautions

Patients should be warned about the possibility of a transient increase in body temperature on days 2-3, which is a manifestation of the therapeutic effect of the drug and, as a rule, does not require discontinuation of treatment. The increase in temperature may sometimes be accompanied by minor and transient symptoms of ENT infections.

Overdose

There have been no reports of Ribomunyl^® overdose to date.

Drug Interactions

To date, clinically significant drug interactions of Ribomunyl^® have not been described.

Ribomunyl^® can be combined with other drugs (antibiotics, bronchodilators, anti-inflammatory drugs).

Storage Conditions

The drug should be stored out of the reach of children and transported (by all types of covered transport) at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by 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.