Immunorm-Teva (Tablets) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Echinacea (BP British Pharmacopoeia)

Dosage Form

Immunorm-Teva

Tablets 100 mg: 20 or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets are round, biconvex, light yellow in color with a slight brownish tint; marbling, lighter and darker inclusions are allowed.

Excipients: colloidal silicon dioxide – 7 mg, sorbitol – 570 mg, sodium cyclamate – 2 mg, magnesium stearate – 7 mg.

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

Herbal remedy. Echinacea purpurea herb contains water-soluble immunostimulating polysaccharides (4-O-methylglucuronylarabinoxylans, acidic arabinorhamno-galactans); essential oils (components include germacrene alcohol, borneol, bornyl acetate, pentadeca-8-en-2-one, germacrene D, caryophyllene, caryophyllene epoxide); flavonoids (ferulic acid and its derivatives, including cichoric acid, methyl ester of cichoric acid, 2-O-caffeoyl-3-O-feruloyl-tartaric acid, 2,3-O-diferuloyl-tartaric acid, 2-O-caffeoyl-tartaric acid); alkamides; polyenes.

It has immunomodulatory and anti-inflammatory effects. Polysaccharides increase the phagocytic activity of neutrophils and macrophages and stimulate the production of interleukin-1. The complex of active substances induces the transformation of B-lymphocytes into plasma cells and improves the functions of T-helpers. Due to inulin, levulose, and betaine, it improves metabolic processes, especially in the liver and kidneys. It increases the body’s nonspecific resistance (including to influenza and herpes pathogens). It has a capillary-protective effect.

Indications

Enhancement of nonspecific defense factors in uncomplicated acute infectious diseases and in predisposition to frequent colds; for immune stimulation in patients with uncomplicated acute infectious diseases (as an auxiliary treatment); prevention of ARVI and influenza; as an auxiliary drug during prolonged antibiotic therapy of chronic infectious diseases. Prevention and as part of complex therapy of recurrent infectious diseases of the respiratory tract and urinary tract.

ICD codes

Dosage Regimen

Take tablets orally with a sufficient amount of liquid.

For treatment of acute conditions at the first signs of a cold: take 1 tablet up to 5 times daily.

After symptom improvement, reduce the dose to 1 tablet 3 times daily.

The total continuous treatment course should not exceed 8 weeks.

For prevention: take 1 tablet 3 times daily.

Initiate prophylactic use at the start of the cold and flu season.

The prophylactic course should last for a maximum of 10 days.

A break of at least two weeks is mandatory before initiating a new course.

Do not exceed the recommended daily dose.

Discontinue use immediately if signs of hypersensitivity appear.

Consult a physician if no improvement is observed within 10 days.

Adverse Reactions

From the digestive system: nausea, vomiting, stool disorders.

From the hematopoietic system: leukopenia (with continuous use for more than 8 weeks).

From the immune system: skin rash, itching, angioedema, Quincke’s edema, Stevens-Johnson syndrome, anaphylactic shock. Allergic reactions are possible in patients with atopy. A relationship between the occurrence of adverse events and autoimmune diseases (diffuse encephalitis, erythema nodosum, immunothrombocytopenia, Evans syndrome, Sjögren’s syndrome with renal tubular dysfunction) has been reported.

From the cardiovascular system: dizziness, decreased blood pressure.

From the respiratory system: bronchospasm with obstruction and asthma attacks as manifestations of hypersensitivity reactions.

Allergic reactions: hyperemia, swelling.

Other: chills.

Contraindications

Hypersensitivity to echinacea and plants of the Asteraceae family; progressive systemic and autoimmune diseases (including tuberculosis, sarcoidosis, collagenosis, multiple sclerosis); immunodeficiency (AIDS or HIV infection) and immunosuppression (including cytostatic anticancer therapy; history of organ or bone marrow transplantation); blood diseases (agranulocytosis, leukemia); allergic diseases (urticaria, atopic dermatitis, bronchial asthma); children under 12 years of age; pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 12 years of age.

Special Precautions

Patients with recurrent infectious diseases of the respiratory tract require regular medical supervision.

Patients with atopy have an increased risk of developing anaphylactic shock.

Drug Interactions

With simultaneous use of echinacea preparations with immunosuppressants, a mutual weakening of the effect occurs.

Simultaneous use with antibiotics and other antimicrobial agents is possible.

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.