Lazophito

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Lasophyto (Lasophyto)

Composition:

Active substance: 100 ml of syrup contain 15 g of liquid extract of thyme /Thymus vulgaris L./ (1:2–2.5);

Extractant composition for liquid thyme extract: ammonium solution 10 %, glycerol 85 %, ethanol 90 % (v/v), water in the ratio (1:20:70:109);

Excipients: rose oil; honey flavor; concentrated sour cherry juice; invert syrup 81/55; glucose solution; 67 % sucrose solution; sodium benzoate (E 211); citric acid monohydrate; purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: a clear or slightly cloudy reddish-brown solution.

Pharmacotherapeutic group. Expectorant agent.

ATC Code: R05C A.

Pharmacological properties.

Pharmacodynamics.

Results of in vitro studies and animal studies indicate that due to the substances contained in thyme, particularly its essential oil and its main component thymol, the medicinal product Lazophyto, syrup, exerts broncholytic, expectorant, and antimicrobial effects. Viscous bronchial secretion becomes more fluid, facilitating its expulsion by coughing; bronchial spasm is reduced, and growth and proliferation of microorganisms are inhibited.

The expectorant effect is due to enhanced ciliary activity of bronchial epithelium, resulting from reflex stimulation of the vagus nerve in the gastric mucosa, as well as direct stimulation of serous gland cells by components of the preparation after their absorption and excretion via the lungs.

Pharmacokinetics.

No data available.

Clinical characteristics.

Indications. Symptomatic treatment of acute bronchitis and inflammation of the respiratory mucosa accompanied by the production of thick mucus.

Contraindications. Hypersensitivity to the components of the medicinal product or to other plants of the Lamiaceae family, as well as sensitivity to celery and birch pollen (possible cross-reaction); hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency.

Children under 4 years of age.

Interaction with other medicinal products and other forms of interaction. Unknown.

Please inform your doctor if you are taking or have recently taken any other medicinal products, including those obtained without a prescription.

Special precautions for use

Seek immediate medical advice if symptoms persist for more than one week or if the following symptoms occur: shortness of breath, body temperature above 39°C, or sputum containing pus or blood.

Information for diabetic patients

10 ml of the preparation contains 0.6 carbohydrate exchange units (CEU).

5 ml of syrup contains up to 1.2 g of glucose and up to 1.5 g of sucrose (sugar). This should be taken into account by patients with diabetes mellitus.

Lazophyto syrup may be harmful to teeth (caries).

Lazophyto syrup contains 4.9% v/v ethanol (ethyl alcohol). A single 10 ml dose of syrup contains 0.49 ml or 0.392 g of ethanol. When the entire content of a 100 ml bottle is consumed, 3.9 g of ethanol is ingested. This product should not be used by patients with alcohol dependence.

Special caution is required when using this product (do not exceed the recommended dosage) in children and patients in high-risk groups, particularly those with liver impairment, cerebral disorders, or epilepsy.

This medicinal product contains less than 1 mmol (or 23 mg) of sodium per 30 ml of syrup, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding

Due to lack of data on the use of thyme-containing preparations during pregnancy and breastfeeding, the use of Lazophyto is not recommended during these periods.

Ability to affect reaction speed when driving or operating machinery

Reaction speed when driving or operating machinery is not altered by the use of this product; however, it should be noted that the product contains ethanol.

Method of administration and dosage.

The product contains ethanol!

Children under 6 years of age must dilute the product in 50 ml of water.

Take during the day at regular intervals, as evenly spaced as possible. The bottle must be shaken before use.

The duration of treatment is determined by the physician depending on the severity and course of the disease. Also consider the information provided in the sections "Contraindications", "Special precautions", "Side effects".

Due to the presence of naturally derived components, the color and taste of Lazofito syrup may vary slightly. These differences do not affect the efficacy and quality of the medicinal product.

Children. For use in children aged 4 years and older.

Overdose. Symptoms of poisoning due to an overdose of thyme or thyme extracts are unknown.

Adverse Reactions.

Adverse reactions were assessed according to the following frequency of occurrence:

very common (≥ 1/10);

common (from ≥ 1/100 to < 1/10);

uncommon (from ≥ 1/1,000 to < 1/100);

rare (from ≥ 1/10,000 to < 1/1,000);

very rare (< 1/10,000);

frequency not known (cannot be estimated from available data).

In very rare cases (< 0.01%), allergic reactions may occur, including dyspnea, rash, urticaria, or Quincke's edema. Cases of anaphylactic shock and gastrointestinal disorders, including spasms, nausea, vomiting, and diarrhea, have been reported, but their frequency is unknown.

Information for the patient.

If you experience any adverse reactions, discontinue use of the medicinal product and seek immediate medical advice. If any of the adverse reactions become severe or if you experience any reaction not listed in this leaflet, please consult your doctor.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is an important procedure. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report all adverse reactions via the pharmacovigilance system.

Shelf life. 3 years.

After first opening of the bottle, do not store for longer than 6 months at a temperature not exceeding 25 ºC.

Storage conditions. Keep out of reach of children. Store in the original packaging at a temperature not exceeding 30 ºC.

Packaging. № 1: 100 ml in a glass bottle with a child-resistant plastic closure; 1 bottle with a plastic measuring cap in a cardboard box.

Prescription status. Over-the-counter.

Manufacturer. A. Nattermann und Cie. GmbH

Address of manufacturer.
Nattermannallee 1, 50829 Cologne, Germany.

Marketing Authorization Holder. LLC "Opella Health Ukraine", Ukraine.

Address of Marketing Authorization Holder and/or its representative.
48-50A Zhylianska St., Kyiv, 01033, Ukraine.