Lasolvan^® PHYTO (Syrup) Instructions for Use

Marketing Authorization Holder

A. Nattermann and Cie., GmbH (Germany)

ATC Code

R05CA (Expectorants)

Active Substance

Thymi herba (BP British Pharmacopoeia)

Dosage Form

Lasolvan® PHYTO

Syrup 150 mg/1 ml: 5 ml mini-sachets 20 pcs.; 100 ml bottle with dosing cup

Dosage Form, Packaging, and Composition

Syrup transparent or with slight opalescence, reddish-brown in color, sediment formation is possible.

* ratio of thyme herb to extractant 1:2-2.5.
Extractant 10% ammonia solution (mass/mass), glycerol 85%, ethanol (ethyl alcohol) 90% (vol/vol), water – in a ratio of 1:20:70:109.

Excipients : rose oil, honey flavor, sodium benzoate, cherry flavor, invert syrup 81/55, liquid dextrose (liquid glucose), liquid sucrose, citric acid monohydrate, purified water.

5 ml – aluminum foil mini-sachets (20) – cardboard packs.
100 ml – glass bottles (1) complete with a dosing cup – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with expectorant effect

Pharmacotherapeutic Group

Herbal expectorant

Pharmacological Action

The preparation has an expectorant, anti-inflammatory, bronchodilatory, antimicrobial effect, helps to reduce the viscosity of sputum and accelerate its evacuation.

The expectorant effect of the preparation is due both to an increase in the activity of the cilia of the bronchial ciliated epithelium, caused by reflex stimulation of the vagus nerve through the receptors of the gastric mucosa, and to direct stimulation of the cells of the bronchial glands.

Pharmacokinetics

In accordance with the International Convention (EMEAHMPWG11/99), isolated studies of pharmacokinetic parameters are not required when conducting clinical trials of herbal preparations.

Indications

• As an expectorant in the complex therapy of inflammatory diseases of the upper respiratory tract, accompanied by cough with difficult-to-discharge sputum.

ICD codes

Dosage Regimen

If the doctor has not prescribed another dosage regimen, adults and adolescents are prescribed orally after meals, 2 teaspoons of syrup (10 ml) or 2 mini-sachets (10 ml) 3 times/day;

children from 6 to 12 years – 1 teaspoon (5 ml) or 1 mini-sachet (5 ml) 3 times/day;

children from 2 to 6 years – 1 teaspoon (5 ml) or 1 mini-sachet (5 ml) 2 times/day;

children from 1 year to 2 years – 1/2 teaspoon (2.5 ml) 3 times/day;

The cough syrup should be taken at regular intervals throughout the day.

The duration of use of the preparation is determined by therapeutic necessity and the duration of the disease.

Since sediment formation is possible, it is necessary to shake the bottle or knead the mini-sachet between the fingers before use.

If no improvement occurs during treatment, or symptoms worsen, or new symptoms appear, it is necessary to consult a doctor.

The preparation should be used only according to those indications, method of application, and in those doses that are indicated in the instructions.

Adverse Reactions

According to WHO, adverse effects are classified according to their frequency of occurrence as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), frequency unknown (frequency of phenomena cannot be determined from the available data).

From the immune system frequency unknown – hypersensitivity reactions (including anaphylactic shock).

From the digestive system frequency unknown – gastritis, dyspepsia.

From the skin and subcutaneous tissues frequency unknown – angioedema, urticaria, skin rash.

If side effects indicated in the instructions are noted, or they worsen, or any other side effects not indicated in the instructions are noted, the patient must inform the doctor about this.

Contraindications

• Increased individual sensitivity to thyme or any other plant from the Lamiaceae family, as well as to other components of the preparation;
• Gastric and duodenal ulcer;
• Congenital fructose intolerance, glucose-fructose malabsorption, sucrase and isomaltase enzyme deficiency;
• Children under 1 year of age.

With caution and only after consultation with a doctor, the syrup should be taken by patients with liver diseases, brain diseases and injuries, epilepsy, patients with alcoholism, children over 1 year of age.

Use in Pregnancy and Lactation

The preparation is not recommended during pregnancy and breastfeeding.

Use in Hepatic Impairment

With caution and only after consultation with a doctor, the syrup should be taken by patients with liver diseases.

Pediatric Use

The use of the preparation is contraindicated in children under 1 year of age.

Special Precautions

If symptoms of the disease persist or the condition worsens during treatment for more than 1 week, if difficulty breathing occurs, in case of fever (increased temperature), in case of purulent sputum or sputum with an admixture of blood, you should immediately consult a doctor.

The preparation contains 4.9% by volume of ethyl alcohol or 0.039 g of ethanol/ml in a single dose of the preparation and 1.17 g of ethanol/30 ml in the maximum daily dose of the preparation.

Information for patients with diabetes: 5 ml contains up to 1.2 g of glucose and up to 1.5 g of sucrose (sugar). 1 ml corresponds to 0.07 XE (single dose of the preparation); 2.28 XE (bread units) corresponds to the maximum daily dose of the preparation.

This medicinal product contains glucose, sucrose, invert sugar syrup and 7.5 mg of sodium benzoate per 5 ml of syrup, which is equivalent to 1.5 mg/1 ml of syrup.

Lasolvan^® PHYTO cough syrup may be harmful to teeth (dental caries).

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

Influence on the ability to drive vehicles and mechanisms

During the period of taking the preparation, patients should exercise caution when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving vehicles, working with moving mechanisms).

Overdose

No cases of intoxication have been reported with the use of Lasolvan^® PHYTO, syrup.

Drug Interactions

Concomitant use with antitussive drugs, as well as with medicinal products that reduce sputum formation, is not recommended, as this makes it difficult to cough up liquefied sputum.

Storage Conditions

The preparation should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

After opening the bottle, the shelf life of the preparation is 6 months.

Dispensing Status

The preparation is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.