FRINOL

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FREENOL (FREENOLOL)

Composition:

Active substance:

100 g of oral drops contains: Freenol, liquid extract (1:11) from a mixture of herbal drugs: gentian roots (Gentianae Radix), primrose flowers with calyx (Primulae Flores cum Calycibus), sorrel herb (Rumicis Herba), elder flowers (Sambuci Flores), verbena herb (Verbenae Herba) (1:3:3:3:3) [extraction agent — ethanol 59% (v/v)] — 29.0 g;

Excipients: purified water.

Pharmaceutical form. Oral drops.

Main physicochemical properties: clear or slightly cloudy yellow-brown liquid. Slight cloudiness or sediment formation may occur during storage.

Pharmacotherapeutic group.

Preparations used for cough and colds. ATC code R05X.

Pharmacological properties.

The components contained in the herbal medicinal product have complex activity, manifested through secretolytic, anti-edematous, anti-inflammatory, immunostimulatory, and antiviral effects.

The active components of the medicinal product Frinol inhibit the replication of various respiratory viruses, such as influenza virus A, parainfluenza virus, and RSV (respiratory syncytial viruses).

Under the influence of the drug, secretion is regulated and tissue edema is reduced. Drainage and ventilation of the paranasal sinuses are restored, nasal congestion is relieved, and the protective function of the respiratory epithelium is normalized. The efficacy of antibiotic therapy is enhanced.

Frinol is a traditional herbal medicinal product used according to indications supported by long-standing use.

Clinical characteristics.

Indications. Acute and chronic inflammation of the paranasal sinuses.

Contraindications. Hypersensitivity to any of the active or excipient ingredients of the medicinal product or to other species of primrose. Peptic ulcer.

Interaction with other medicinal products and other forms of interaction. No interaction with other medicinal products has been observed. Combination with antibiotics is possible and advisable.

Special precautions for use

Medical advice is recommended if the patient experiences pronounced symptoms of severe rhinosinusitis such as nasal bleeding, fever, severe pain, purulent nasal discharge, visual disturbances, facial asymmetry involving the midfacial region or eyes, or facial numbness, as emergency medical treatment may be required.

If symptoms persist for more than 7–14 days, worsen, or recur periodically during treatment, the patient should consult a physician.

Particular caution is required when administering the medicinal product to patients with gastritis or functional dyspepsia (so-called "sensitive stomach"). The medicine should be taken after meals.

The medicinal product contains 19% (v/v) ethanol, i.e. 410 mg per dose; therefore, it should not be used in patients suffering from alcoholism or who have successfully completed treatment for alcoholism.

Caution is advised when using the product in pregnant women, breastfeeding women, children, patients with liver disorders, and patients with epilepsy.

During storage, the preparation may become cloudy or a precipitate may form; however, this does not affect the efficacy of the medicine. Shake well before use.

Use during pregnancy or breastfeeding. The medicinal product may be used during pregnancy or breastfeeding only after consulting a physician and only if the expected benefit outweighs the potential risk to the fetus/infant.

Ability to affect reaction speed when driving or operating machinery. At recommended doses, the medicinal product does not impair the ability to drive or operate machinery. However, it should be noted that the product contains ethanol.

Method of administration and dosage.

If the physician has not prescribed otherwise, administer the medicinal product in the following doses:

Adults usually take the drops undiluted, but if desired, a certain amount of liquid may be added. Children should take the drops diluted, and to mask the bitter taste, they may be added to juice or tea.

The usual recommended treatment course is 7–14 days, unless otherwise prescribed by a physician. The recommendations in the "Instructions for Use" section "Special Precautions" should be followed.

The patient should consult a physician if symptoms of the disease do not disappear during the use of the medicinal product or if any adverse reactions occur.

Children. Due to insufficient experience with use, the medicinal product should not be administered to children under 2 years of age.

Overdose. Cases of overdose are currently unknown. If the dose is exceeded, the indicated adverse reactions may be intensified.

Treatment: symptomatic therapy is required in case of poisoning or overdose symptoms.

Side effects.

Gastrointestinal disorders are observed infrequently, including stomach pain, nausea, diarrhea, vomiting, and abdominal discomfort. Hypersensitivity reactions are possible, including rash, skin redness, itching, urticaria, angioedema, dyspnea, and facial swelling.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Shelf life: 3 years.

Shelf life after opening the package: 6 months.

Storage conditions: Store in the original packaging at a temperature not exceeding 25 ℃.

Keep out of reach of children.

Packaging: 50 ml in a bottle, 1 bottle per pack.

Availability: Over-the-counter.

Manufacturer:

JSC "Halychpharm".

Manufacturer's address and location of business activity:

6/8 Opryshkovska Street, Lviv, 79024, Ukraine.