Immunorm (Tablets) Instructions for Use

Marketing Authorization Holder

Ratiopharm, GmbH (Germany)

Manufactured By

Merckle, GmbH (Germany)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Echinacea (BP British Pharmacopoeia)

Dosage Forms

	Immunorm	Tablets 100 mg: 20 or 50 pcs.
		Oral solution 50 ml: 1 fl. in a set with a measuring cup

Dosage Form, Packaging, and Composition

Tablets are round, biconvex, beige in color with brown spots (inclusions).

10 pcs. – blister packs (2) – cardboard packs.

Oral solution is clear, brown or reddish-brown in color, with a characteristic odor.

50 ml – dark glass bottles (1) in a set with a measuring cup – cardboard packs.
100 ml – dark glass bottles (1) in a set with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent of plant origin

Pharmacological Action

An immunostimulating drug of plant origin. The active components of Echinacea purpurea juice are caffeic acid derivatives (chicoric acid and its esters) and polysaccharides (4-O-methyl-glucurono-arabinoxylan and arabinorhamno-galactan), which increase the activity of the body’s nonspecific defense factors.

The drug stimulates the phagocytic activity of granulocytes and macrophages and also causes an increase in the number of lymphocytes in the human body, thereby suppressing the reproduction and promoting the destruction of microorganisms.

It has an anti-inflammatory effect.

Pharmacokinetics

The action of Echinacea purpurea herb juice is the combined action of its components, so conducting pharmacokinetic studies is not possible.

Indications

• Prevention and treatment of recurrent infectious diseases of the respiratory tract;
• Prevention and treatment of recurrent infectious diseases of the urinary tract.

ICD codes

Dosage Regimen

For adults and children over 12 years Immunorm is prescribed at a dose of 100 mg (1 tab.) or 2.5 ml of oral solution 3 times/day. The duration of the course is no more than 8 weeks.

The time of administration of the drug does not depend on the time of food intake.

Before use, the solution should be diluted in a sufficient amount of liquid (water, juice).

For accurate dosing of the solution, the supplied measuring cup should be used. The tablets can be sucked, chewed, or swallowed with water.

Adverse Reactions

Allergic reactions skin rash, itching; rarely – facial swelling, shortness of breath.

Other increased sweating.

Contraindications

• Tuberculosis;
• Collagenoses;
• Multiple sclerosis;
• HIV infection;
• Autoimmune diseases;
• Malignant neoplasms of lymphoid and hematopoietic tissue;
• Pregnancy;
• Lactation (breastfeeding);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Immunorm is contraindicated for use during pregnancy and lactation.

Special Precautions

Constant medical supervision is necessary in case of recurrent infectious diseases of the respiratory tract accompanied by prolonged persistence of complaints: shortness of breath, hyperthermia, production of purulent or bloody sputum.

Medical supervision is necessary if complaints from the urinary tract reappear during therapy with Immunorm. Other immunostimulating drugs should not be used during the period of taking Immunorm.

Immunorm in the form of an oral solution should not be prescribed to patients with impaired liver function and patients with chronic alcoholism.

Immunorm in the form of tablets should be prescribed with caution to patients with congenital fructose intolerance.

Patients should be warned that in case of side effects, it is necessary to stop taking Immunorm and consult a doctor.

The drug does not cause dependence.

The appearance of cloudiness or flocculent sediment in the solution does not have a noticeable effect on the effectiveness of the drug.

Use in pediatrics

Clinical data on the efficacy and safety of Immunorm in children under 12 years of age are lacking, therefore the use of the drug in this category of patients is contraindicated.

Overdose

To date, no cases of overdose of Immunorm have been reported.

Drug Interactions

No clinically significant interaction of Immunorm with other drugs has been established.

Storage Conditions

Tablets should be stored at room temperature; shelf life – 2 years.

The solution should be stored in a place protected from light in a tightly closed bottle at a temperature not exceeding 25°C (77°F). After opening the bottle, the solution can be used within 4 weeks; shelf life – 5 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.