RESPERO MYRTOL

Instructions for Medical Use of the Medicinal Product Respero Myrtol

Composition:

Active ingredient: 1 capsule contains 120 mg of a rectified mixture distillate of essential oils of eucalyptus, sweet orange, myrtle, and lemon;

Excipients: medium-chain triglycerides;

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

Pharmaceutical form. Enteric-coated capsules.

Main physicochemical properties: transparent soft gelatin capsules (elongated shape) with a natural yellowish color. Capsule contents: clear liquid with a characteristic odor.

Pharmacotherapeutic group. Expectorants, excluding combination preparations containing antitussives.

ATC Code R05C.

Pharmacological Properties.

Pharmacodynamics.

The active substance of 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 exhibits 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 demonstrates anti-infective, 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 hepatic dysfunction.***

Special precautions.

If disease symptoms do not disappear or the patient's condition worsens, if shortness of breath occurs, body temperature rises, or blood or pus appears in the sputum, immediate consultation with a physician 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 of Respero Myrtol with other medicinal products are unknown.

Special precautions for use.

Use during pregnancy or breastfeeding.

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

Ability to influence the speed of reactions when driving vehicles or operating machinery.

There are no data regarding the effect of the medicinal product on the speed of reactions when driving vehicles or operating machinery.

Dosage and Administration

Respero Myrtol 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, the recommended dose is 2 capsules 4–5 times daily during acute inflammatory episodes. For chronic conditions, the recommended dose is 2 capsules 3 times daily. The same dosage is recommended for long-term therapy. To facilitate morning expectoration in chronic bronchitis, an additional dose of 2 Respero Myrtol capsules is recommended to be taken in the evening before bedtime.

For children aged 3 to 10 years (this medication should be administered to children only during the period when they are able to swallow capsules independently):

• In acute inflammatory conditions, the recommended dose is 1 capsule 4–5 times daily. To improve sleep, the last dose should be taken before bedtime;
• In chronic conditions, the recommended dose is 1 capsule 3 times daily. The same dosage is recommended for long-term therapy;
• To facilitate morning expectoration in chronic bronchitis, an additional dose of 1 Respero Myrtol capsule is recommended to be taken in the evening before bedtime.

The medication should be used during symptomatic periods and continued for 2–4 days after symptoms have resolved.

Children.

This dosage form may be administered to children aged 3 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, shortness of breath, circulatory disturbances. In 1 case per 10,000, exacerbation of cholelithiasis or nephrolithiasis may occur.

Shelf life.

3 years.

Storage conditions.

Store in a dry place, protected from light, at a temperature not exceeding 25 °C, out of reach of children.

Packaging.

10 capsules per blister pack, 2 blister packs per cardboard box.

Availability.

Over-the-counter (without prescription).

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

Manufacturer's address. Kieler Strasse 11, 25551 Hohenlockstedt, Germany