RESPERO MYRTOL FORTE

Instructions for Medical Use of Respero Myrtol forte

Composition:

Active substance: 1 capsule contains 300 mg of a distilled mixture of rectified essential oils of eucalyptus, sweet orange, myrtle, and lemon;

Excipients: refined rapeseed oil;

Capsule shell composition: gelatin; glycerol 85%, sorbitol solution non-crystallizing (E 420); hydrochloric acid 13% (prepared from hydrochloric acid 25% and purified water); hypromellose acetate succinate; triethyl citrate; sodium lauryl sulfate; talc; dextrin; ammonium glycyrrhizinate.

Pharmaceutical form. Enteric-coated capsules.

Main physicochemical characteristics: transparent soft gelatin capsule (elongated shape) with a natural yellowish color. Contents of the capsules: clear liquid with a characteristic odor.

Pharmacotherapeutic group. Expectorants, excluding combination products containing antitussives.

ATC code R05C.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of Respere Myrtol forte is a distilled mixture of rectified essential oils of eucalyptus, sweet orange, myrtle, and lemon.

The distilled mixture of rectified essential oils of eucalyptus, sweet orange, myrtle, and lemon exerts secretomotor and secretolytic effects, resulting in liquefaction of sputum, activation of the mucociliary epithelium, and consequently, enhanced sputum expulsion. When used at high doses, it also exhibits antimicrobial, immunomodulatory, spasmolytic, and vasodilatory effects.

Clinical characteristics.

Indications.

As part of complex therapy for acute and chronic bronchitis, and inflammation of the paranasal sinuses (sinusitis).

Contraindications.

Hypersensitivity to the components of the drug; inflammatory diseases of the stomach, intestines, and biliary tract; severe impairment of liver function.

Special precautions.

If disease symptoms do not resolve or the patient's condition worsens, or if dyspnea occurs, body temperature rises, or blood or pus appears in the sputum, immediate medical consultation is required.

Patients with bronchial asthma or whooping cough should consult a physician before using the medication.

Interaction with other medicinal products and other forms of interaction.

Currently, interactions between Respero Myrtol forte and other medicinal products are unknown.

Special precautions for use.

Use during pregnancy or breastfeeding.

Although there is no evidence of harmful effects of the drug Respero Myrtol forte on the fetus, during pregnancy (especially in the first trimester) or breastfeeding, the drug should be used only under medical supervision.

Ability to influence reaction rate while driving or operating machinery.

There are no data regarding the effect of the drug on reaction rate while driving or operating machinery.

Method of administration and dosage.

Respero Myrtol forte capsules are recommended to be taken 30 minutes before meals, with a large amount of cool water or other beverages.

For adults and children aged 10 years and older with acute inflammatory conditions: take 1 capsule 3–4 times daily. To promote better sleep, the last dose should be taken before bedtime.

For chronic conditions: take 1 capsule twice daily. The same dosage is recommended for long-term therapy.

To facilitate morning expectoration in chronic bronchitis, an additional 1 capsule of Respero Myrtol forte is recommended in the evening before bedtime.

For children aged 6 to 10 years (this medication should be prescribed only during the period when children are able to swallow capsules independently): administer 1 capsule twice daily.

The medication should be used during the symptomatic phase of the disease and for 2–4 days after symptoms have resolved.

Children.

This medicinal formulation may be prescribed to children aged 6 years and older.

Overdose.

No cases of overdose have been reported.

Side effects.

Rarely (from 1 to 10 cases per 1000) gastrointestinal pain and discomfort may occur. Very rarely (from 1 to 10 cases per 10,000) nausea, vomiting, and diarrhea may occur. Isolated cases of allergic reactions have also been observed, including skin rash, itching, redness, facial swelling, dyspnea, and circulatory disturbances. In 1 case per 10,000, exacerbation of gallstone or kidney stone disease may occur.

Shelf life.

3 years.

Storage conditions. Store in a dry place out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 10 capsules per blister, 2 blisters per cardboard box.

Pharmaceutical category. Over-the-counter (without prescription).

Manufacturer. G. Pohl-Boskamp GmbH & Co. KG

Manufacturer's address and place of business. Kieler Strasse 11, 25551 Hohenlockstedt, Germany