Immunal plus with 50ml oral solution

Compound

general information

Registration number

P N013458/01

Tradename

Immunal®

Dosage form

Oral solution

Description

Transparent to cloudy brown solution. During storage, the formation of flaky sediment is acceptable.

Compound

1 ml of oral solution contains the active substance: Echinacea purpurea (L.) Moench juice - 0.80 ml; excipients: ethanol, sorbitol.

Release form

Oral solution, 50 ml of the drug in a dark glass bottle, 1 bottle complete with a dosage pipette and instructions for medical use in a cardboard box.

Storage conditions

At a temperature not exceeding 25° C. Keep out of the reach of children.

best before date

2 years. Do not use the drug after the expiration date.

Conditions for dispensing from pharmacies

Over the counter.

Manufacturer

Sandoz d.d. Verovškova 57, 1000, Ljubljana, Slovenia

Produced by: Lek d.d. Verovškova 57, 1526, Ljubljana, Slovenia

Consumer complaints should be sent to Sandoz CJSC:

125315, Moscow, Leningradsky Prospekt, 72, bldg. 3; Tel. Fax (495) 660-75-10

Immunal, drops fl 50ml (Lek, SLOVENIA)

Compound.

Description of the dosage form.

Oral solution:

A clear to cloudy brown solution. During storage, the formation of flaky sediment is acceptable.

Pills:

round, flat-cylindrical, light brown in color with inclusions, with the smell of vanilla.
Pharmachologic effect. Immunostimulating.

Pharmacodynamics.

Immunal® is an immunostimulating drug made from medicinal plant materials.

Echinacea purpurea (L.) Moench

contains active substances that enhance the body's natural defenses and act as immune stimulants.

By increasing the number of leukocytes (granulocytes) and activating phagocytosis, the active ingredients of the drug suppress the proliferation of microorganisms in the human body and contribute to the destruction of pathogenic bacteria. In addition, the antiviral effect of the herb Echinacea purpurea against pathogens of influenza and herpes has been established.

Indications.

Immunal® is recommended for use:

● to strengthen the immune system in patients with uncomplicated acute infectious diseases and a predisposition to frequent colds;

● for the prevention of colds and flu;

● as an auxiliary drug for long-term antibiotic therapy of chronic infectious diseases accompanied by decreased immunity.

Contraindications.

● increased sensitivity to the components of the drug and plants of the Asteraceae family;

● progressive systemic and autoimmune diseases such as tuberculosis, leukemia, collagenosis, multiple sclerosis, AIDS or HIV infection;

● children under 1 year of age (for oral solution) or up to 4 years of age (for tablets).

Use during pregnancy and breastfeeding.

There are no data on the negative effects of the drug Immunal®. Before using the drug during pregnancy and breastfeeding, you should consult your doctor.

Side effects.

, hypersensitivity reactions may develop

skin rash, itching, dizziness, bronchospasm, angioedema, Stevens-Johnson syndrome, anaphylactic shock.

Other:

leukopenia (with continuous use for more than 8 weeks).

Interaction.

Oral solution.

Immunal® contains alcohol, and therefore the drug may enhance or change the effect of other medications. Clinically significant interactions have been observed with the simultaneous use of each of the following five cephalosporin derivatives (cefamandole, cefotetan, cefmenoxime, cefaperazone and moxalactam) and alcohol (even in small quantities). The patient's response was characterized by facial flushing, nausea, sweating, headache and rapid heartbeat. In this regard, Immunal® oral solution should not be used when treating a patient with these antibiotics. Taking Immunal® is allowed only three days after the end of the course of treatment with the above cephalosporin derivatives.

Pills.

When taken simultaneously with immunosuppressants, the effect is mutually weakened.

There are no reports of any clinically significant interactions with other drugs.

Method of administration and dose.

Inside.

Oral solution

To facilitate correct dosing, a graduated dosage pipette is included in each package.

Before taking, the required amount of the drug should be diluted in a small volume of water.

Adults and adolescents over 12 years of age: 2.5 ml of solution for oral administration 3 times a day. Children aged 6 to 12 years - 1.5 ml of solution for oral administration 3 times a day; children aged 1 to 6 years: 1 ml of solution for oral administration 3 times a day.

Pills

For young children, it is recommended to crush the tablet and mix with a small amount of liquid. Adults and adolescents over 12 years of age: 1 tablet. 3–4 times a day; children aged 6 to 12 years: 1 tablet. 1–3 times a day; children aged 4 to 6 years: 1 tablet. 1–2 times a day.

To achieve a therapeutic effect, Immunal® should be taken for at least 1 week. The duration of the continuous course of treatment should not exceed 8 weeks.

Overdose.

Symptoms of intoxication due to an overdose of the drug were not noted.

Special instructions.

Before using the drug Immunal® in children under 12 years of age and patients with a history of allergic diseases and bronchial asthma, you should consult your doctor.

If side effects occur, you should stop taking Immunal® and consult a doctor.

If symptoms of the disease persist for more than 10 days, you should consult your doctor.

Immunal® oral solution contains 20% ethanol (i.e. the alcohol content in the maximum single dose is equivalent to 1 teaspoon of dry wine). During storage, flaky sediment consisting of active polysaccharides may form. Shake the bottle thoroughly before use.

Effect on the ability to concentrate.

When taking the drug in recommended doses, no special precautions are required.

Release form.

Oral solution.

50 ml of the drug in a dark glass bottle, 1 fl. complete with dosing pipette in a cardboard box.

Pills.

10 or 20 tablets. in a blister, 2 blisters (10 tablets each) or 1 blister (20 tablets each) in a cardboard box.

Manufacturer.

Lek d.d. Verovškova 57, Ljubljana, Slovenia.

Consumer complaints should be sent to Sandoz CJSC: 125317, Moscow, Presnenskaya embankment, 8, building 1.

Tel.; Fax.

Conditions for dispensing from pharmacies.

Over the counter.

Pharmacokinetics

Pharmacotherapeutic group

Immunostimulating agent of plant origin. ATX code: L03AX

Pharmacological properties

Immunal® is an immunostimulating drug made from medicinal plant materials.

Echinacea purpurea (L.) Moench) contains active substances that enhance the body's natural defenses and act as immune stimulants. By increasing the number of leukocytes (granulocytes) and activating phagocytosis, the active ingredients of the drug suppress the proliferation of microorganisms in the human body and contribute to the destruction of pathogenic bacteria. In addition, the antiviral effect of the herb Echinacea purpurea against pathogens of influenza and herpes has been established.

Application

Indications for use

Immunal® is recommended for use to strengthen the immune system in patients with uncomplicated acute infectious diseases, a predisposition to frequent colds, for the prevention of colds and flu, and also as an adjuvant drug for long-term antibiotic therapy of chronic infectious diseases accompanied by decreased immunity.

Contraindications

• hypersensitivity to the components of the drug and plants of the Asteraceae family;
• progressive systemic and autoimmune diseases (such as tuberculosis, sarcoidosis, collagenosis, multiple sclerosis);
• immunodeficiency (AIDS or HIV infection) and immunosuppression (for example, cytostatic antitumor therapy; history of organ or bone marrow transplantation);
• blood diseases (agranulocytosis, leukemia);
• allergic diseases (urticaria, atopic dermatitis, bronchial asthma);
• age up to 12 years (insufficient data on effectiveness);
• pregnancy and breastfeeding period.

Carefully

Liver diseases, alcoholism, traumatic brain injury, brain diseases, children over 12 years of age (the drug contains ethyl alcohol).

Use during pregnancy and breastfeeding

Data on the use of Echinacea during pregnancy and during breastfeeding are limited, therefore the use of the drug during pregnancy and during breastfeeding is contraindicated.

Directions for use and doses

Use internally regardless of meals. Before taking, the required amount of the drug must be measured using the supplied graduated dosage syringe and diluted in a small amount of water. Adults and adolescents over 12 years of age, take 2.5 ml of oral solution 3 times a day. For prevention during seasonal diseases and treatment of colds, it is recommended to take the drug continuously for 10 days. Repeated courses are possible on the recommendation of a doctor after a 14-day break. For treatment, the drug should be started at the first sign of a cold.

Side effect

According to the World Health Organization (WHO), adverse effects are classified according to their frequency as follows: very common (≥1/10), common (≥1/100 to Blood and lymphatic system disorders frequency unknown: leukopenia (with continuous use for more than 8 weeks).Immune system disorders, frequency unknown: hypersensitivity reactions (skin rash, itching), angioedema, Quincke's edema, Stevens-Johnson syndrome, anaphylactic shock. Echinacea may provoke allergic reactions in patients with atopy. Also the relationship between the occurrence of adverse events and autoimmune diseases has been reported (diffuse encephalitis, erythema nodosum, immunothrombocytopenia, Evans syndrome, Sjögren's syndrome with renal tubular dysfunction).Disorders from the cardiovascular system, frequency unknown: dizziness, decreased blood pressure. Disorders from the respiratory system and chest organs, the frequency is unknown: bronchospasm with obstruction and attacks of bronchial asthma as manifestations of hypersensitivity reactions. If side effects occur, you should stop taking the drug and consult your doctor.

Overdose

Symptoms of intoxication due to an overdose of the drug were not noted.

Interaction with other drugs

No studies have been conducted on the interaction of Echinacea purpurea preparations with other drugs. Immunal® oral solution contains alcohol, and therefore the drug may enhance or change the effect of other medications. Clinically significant interactions have been observed with simultaneous use of ethyl alcohol, even in small quantities, with one of the following five cephalosporin derivatives: cefamandole, cefotetan, cefmenoxime, cefoperazone and moxalactam. The patient's response was characterized by facial flushing, nausea, sweating, headache and rapid heartbeat. In this regard, Immunal® oral solution should not be used when treating a patient with these antibiotics. Taking Immunal® in the form of an oral solution is permitted only three days after the end of the course of treatment with the above cephalosporin derivatives.

Directions

special instructions

If side effects occur, you should stop taking Immunal® and consult a doctor. If your condition worsens or a high temperature appears while using the drug, or symptoms of the disease persist for more than 10 days, you should consult your doctor. Immunal® oral solution contains 20% ethanol. The content of absolute ethyl alcohol in the maximum single dose of the drug is 0.38 g, the content of absolute ethyl alcohol in the maximum daily dose of the drug is 1.14 g. During storage, the formation of a flaky sediment consisting of active polysaccharides is acceptable. Shake the bottle thoroughly before use.

Effect on ability to concentrate

When taking the drug in recommended doses, no special precautions are required.