IMUPRET®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMUPRET® (IMUPRET®)

Composition:
Active ingredients: 100 g of drops contain 29 g of aqueous-alcoholic extract (extractant ethanol 59% v/v) from medicinal plants:

• Radix Althaeae (marshmallow root) 0.4 g;
• Flores Chamomillae (chamomile flowers) 0.3 g;
• Herba Equiseti (horsetail herb) 0.5 g;
• Folia Juglandis (walnut leaves) 0.4 g;
• Herba Millefolii (yarrow herb) 0.4 g;
• Cortex Quercus (oak bark) 0.2 g;
• Herba Taraxaci (dandelion herb) 0.4 g.

Excipients: ethanol 19% v/v, purified water.

Pharmaceutical form:
Oral drops.

Main physicochemical properties:
Clear or slightly cloudy yellowish-brown liquid with a chamomile odor. During storage, slight clouding or sedimentation may occur.

Name and address of the manufacturer:
Bionorica SE, Kerschensteinerstrasse, 11-15, 92318 Neumarkt, Germany.

Pharmacotherapeutic group:
Combined preparations used in cough and colds.
ATC code: R05X.

The components of this herbal medicinal product exhibit complex activity. Imupret® stimulates the non-specific immune response through enhanced phagocytosis by macrophages and granulocytes, due to the polysaccharides from chamomile and marshmallow. These active components also enhance intracellular bacterial destruction during phagocytosis by increasing the release of oxygen metabolites with bactericidal properties.

Polysaccharides, essential oils, and flavonoids (from chamomine, marshmallow, and yarrow) reduce edema of the mucous membranes during respiratory tract infections. In vitro studies have demonstrated that oak bark, rich in tannins, exhibits antiviral activity, including against influenza virus. Horsetail, another component of the preparation, enhances these effects due to its well-known healing and preventive properties.

Indications:
For the treatment of upper respiratory tract infections (tonsillitis, pharyngitis, laryngitis).
Prevention of complications and recurrences in respiratory viral infections due to reduced body defenses.

Contraindications:
Hypersensitivity to any of the active or excipient ingredients of the product or to plants of the Asteraceae (Compositae) family.

Safety precautions:
This medicinal product contains ethanol 19% v/v. Due to its ethanol content, Imupret® drops should not be administered to patients after successful anti-alcohol treatment. Patients with liver disease, epilepsy, or head injuries may take this product only after consultation with a physician.

During storage, clouding or sedimentation may occur; however, this does not affect the efficacy of the product. If symptoms persist beyond 1 week of treatment, or if dyspnea, fever, or purulent or bloody sputum develop, medical advice should be sought.

Note for diabetic patients:
A single dose of the product contains a negligible amount of carbohydrate units (bread units, BU).

Special precautions:
Use during pregnancy or breastfeeding:
Not recommended during pregnancy.

Effect on ability to drive or operate machinery:
There is no direct information on the influence of the product on the ability to drive or operate machinery; however, it should be noted that the product contains ethanol.

Children:
Should not be used in children under 1 year of age.

Method of administration and dosage:
Unless otherwise prescribed, the product should be administered in the following doses:

Before use, the solution should be shaken. The bottle should be held vertically when administering the drops. The drops are usually taken undiluted. The specified number of drops should be held briefly in the mouth and then swallowed. If necessary, the drops may be taken with a small amount of water. Children may be given the drops by adding them to juice or tea. Even after the acute symptoms have disappeared, it is advisable to continue treatment for another 1 week to prevent recurrence of the disease. The drug is well tolerated and therefore may be recommended for long-term use. For baseline therapy of chronic respiratory diseases (especially tonsillitis), the drug should be used for at least 6 weeks.

Overdose. Cases of poisoning due to overdose have not been reported. Treatment: symptomatic therapy.

Side effects. Gastrointestinal disorders (e.g., abdominal pain, nausea, vomiting) may rarely occur. Allergic reactions (e.g., rash, itching, dyspnea) may also occur. When used in combination with preparations containing chamomile flowers, allergic reactions may occur, as well as in patients with increased sensitivity to other plants of the Asteraceae family (e.g., yarrow (Achillea millefolium)). If any adverse reactions occur, administration of the drug should be discontinued and medical advice must be sought immediately.

Interaction with other medicinal products and other forms of interaction. No interactions with other medicinal products have been observed. Preparations containing oak bark may reduce or block the absorption of alkaloids and other basic medicinal substances when used simultaneously.

Shelf life. 2 years. Do not use after the expiry date stated on the packaging. The shelf life refers to use up to the last day of the specified month. The opened bottle is suitable for use for 6 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging. 100 ml in a bottle in a cardboard pack.

Classification. Over-the-counter (without prescription).