IMUNO TYSS FORTE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMUNO TAIS FORTE

Composition:

Active ingredient: natural expressed juice from fresh flowering herb of purple coneflower (Herba Echinaceae purpureae);

100 ml of drops contain 75.6 ml of natural expressed juice from fresh flowering herb of purple coneflower (Herba Echinaceae purpureae) (ratio of fresh herb to expressed juice 1.5–2.5 : 1);

Excipient: ethanol 96%.

20 drops contain 1 ml of solution.

Pharmaceutical form. Oral drops.

Main physicochemical properties: cloudy reddish-brown or greenish-brown liquid with a characteristic odor and a characteristic pungent taste of echinacea.

Pharmacotherapeutic group. Immunostimulants.

ATC code L03A X.

Pharmacological properties.

Pharmacodynamics. The medicinal product exhibits immunostimulatory effects. It increases the number of leukocytes and spleen cells, and stimulates phagocytic activity of granulocytes.

Clinical characteristics.

Indications.

As part of combination therapy for respiratory tract infections (RTIs).

Supportive therapy for recurrent respiratory and urinary tract infections.

Contraindications.

"Immuno Teyss Forte" should not be used in progressive systemic diseases such as tuberculosis, leukemia or leukemia-like conditions (leukosis), connective tissue rheumatic diseases (collagen diseases), and other autoimmune disorders.

Hypersensitivity to the components of the medicinal product, agranulocytosis, oncological diseases, multiple sclerosis, AIDS, HIV infections, primary immunodeficiency, primary immunosuppression, chronic viral infections.

"Immuno Teyss Forte" must not be taken in case of hypersensitivity to plants of the Asteraceae (Compositae) family.

Interaction with other medicinal products and other forms of interaction.

Due to its immunostimulatory effect, echinacea may reduce the effectiveness of immunosuppressive drugs.

The medicinal product is not recommended to be used concomitantly with hepatotoxic drugs such as amiodarone, methotrexate, ketoconazole, and steroid preparations.

The medicinal product contains ethanol, which may enhance the absorption and pharmacological effect of certain sedative drugs and, indirectly, by altering the activity of the cytochrome P450 system, affect the elimination of drugs metabolized by enzymes of this system. Ethanol may cause a disulfiram-like reaction when used concomitantly with certain antibacterial agents.

Special precautions for use.

In case of recurrent respiratory tract infections, or if fever persists for more than 3 days, or in case of dyspnea or expectoration of purulent mucus, medical advice must be sought immediately. Recurrent discomfort in the urinary tract always requires medical examination. If blood is detected in the urine, as well as if fever or discomfort persists for more than 5 days, medical advice should be sought.

Patients with a history of allergies should consult a physician before taking this medicinal product, as there is a risk of anaphylactic reactions.

This medicinal product contains 23 vol. % ethanol (alcohol), i.e. 500 mg/dose, equivalent to 12.7 ml of beer or 5.3 ml of wine per dose. It may be harmful for patients suffering from alcoholism. Caution is advised when used in children, and in patients with liver disease, organic brain disorders, or epilepsy.

The effect of other medicinal products may be weakened or enhanced.

Use during pregnancy or breastfeeding.

Women should not use "Imuno Teyss forte" during pregnancy or breastfeeding.

Ability to affect reaction speed while driving or operating machinery.

"Imuno Teyss forte" contains approximately 23 vol. % ethanol. This should be taken into account when driving vehicles or operating complex machinery.

Dosage and Administration.

For adults and children aged 12 years and older: take 55 drops (2.75 ml) 3–4 times daily.

The drops may be taken undiluted or diluted in a cold liquid, regardless of food intake. After taking the medication, it is recommended to drink a glass of water.

For children, the medication should be diluted in a small amount of liquid (half a teaspoon).

The treatment duration for children should be determined by a physician.

The treatment duration in adults should not exceed 10 days.

Therapy should be initiated at the first signs of cold.

Children:

Do not use in children under 12 years of age.

Overdose.

No cases of overdose have been reported.

In case of overdose, a more pronounced manifestation of the described adverse effects is possible.

In the event of overdose, seek immediate medical attention.

Side effects.

Hypersensitivity reactions, including skin rash, pruritus, urticaria, facial swelling, dyspnea. Cases of severe hypersensitivity reactions have been reported, such as Stevens–Johnson syndrome, angioneurotic skin edema, Quincke's edema, bronchospasm with airway obstruction, asthma, and anaphylactic shock.

Cases of association with autoimmune diseases have been reported (disseminated encephalomyelitis, nodular erythema, immune thrombocytopenia, Evans syndrome, Sjögren–Larsson syndrome with impaired renal tubular function).

If these or other adverse reactions occur, inform your doctor immediately.

Shelf life. 3 years.

Shelf life after opening the bottle – 6 months.

Storage conditions.

Store at a temperature not exceeding 25 °C in a place inaccessible to children.

During storage, the solution may become cloudy or precipitate may form; this does not affect the drug's activity.

Packaging.

50 ml of solution in a bottle with a dropper, in a cardboard box.

Availability category. Over-the-counter.

Manufacturer/Applicant.

Dr. Theiss Naturwaren GmbH.

Manufacturer's address and place of business.

Michelinstrasse 10, 66424 Homburg, Germany.