Pektolvane® phyto iceland moss

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PECTOLVAN® PHYTO ICELANDIC MOSS (PECTOLVANPHYTOICELANDMOSS)

Composition:

Active substances: complex expectorant extract;

1 ml of the preparation contains:
alcoholic extract of elecampane root (Extractum Inulae fluidum) (1:(6–7)) 0.27 g;
alcoholic extract of Iceland moss (Extractum Cetrariae fluidum) (1:20) 0.18 g;
tincture of soapwort root (Tinctura Saponariae) (1:5) 0.09 g;
tincture of hyssop herb (Tinctura Hyssopi) (1:5) 0.18 g;
tincture of thyme herb (Tinctura Thymi) (1:5) 0.18 g;

Excipient: glycerin.

Pharmaceutical form. Liquid extract.

Main physicochemical properties: transparent yellowish-brown liquid with a characteristic odor. Formation of flaky sediment or turbidity may occur during storage.

Pharmacotherapeutic group.
Agents used for cough and colds. Expectorants. Combinations. ATC code: R05CA10.

Pharmacological properties.

Pharmacodynamics.

The pharmacological activity of the drug is due to the combined effect of physiologically active substances contained in individual components of the herbal raw materials. Extracts from the root of Ligusticum, herb of hyssop, and herb of thyme contain essential oils that stimulate ciliary movement of the respiratory tract epithelium, exert expectorant effects, and also possess anti-inflammatory and antimicrobial properties. In addition, the extract of thyme herb exerts a spasmolytic effect on bronchial smooth muscles. The extract of Cetraria islandica exerts demulcent, fluidifying, anti-inflammatory, and antimicrobial actions. The extract of the root of soapwort contains saponins, which exert an expectorant effect.

Pharmacokinetics.

After oral administration, the essential oils contained in the drug are almost completely absorbed in the small intestine and, via the bloodstream, reach the lungs, thereby producing the pharmacological effect. Elimination of essential oils occurs predominantly through the lungs by exhalation.

Clinical characteristics.

Indications.

As part of complex therapy for acute respiratory diseases, bronchitis, and lung diseases accompanied by difficult expectoration of sputum, cough—including dry, painful cough.

Contraindications.

Inflammatory diseases of the stomach and intestines, gastrointestinal bleeding, postoperative condition following surgery on gastrointestinal organs, including liver and urinary tract; severe cardiovascular and kidney diseases; hypersensitivity to the components of the drug and to plants of the Lamiaceae family, as well as to celery and birch pollen (cross-reactivity possible); children under 12 years of age.

Interaction with other medicinal products and other forms of interaction.

Not described.

Special precautions for use.

If symptoms worsen and/or dyspnea, fever, or purulent sputum occur during treatment with this medicinal product, medical advice must be sought. If symptoms persist after one week of treatment, a physician should be consulted.

This medicinal product contains 60 vol. % ethanol (alcohol), i.e. 189.6 mg/dose (for a dose of 10 drops), which is equivalent to 4.8 ml of beer or 1.66 ml of wine per dose. It is harmful for patients suffering from alcoholism. Caution is advised when used in children aged 12 years and older, and in patients with liver disease or epilepsy.

Use during pregnancy or breastfeeding.

There are no current clinical data on the use of the active substances during pregnancy or breastfeeding. Therefore, use of the medicinal product during these periods is not recommended (the medicinal product contains 60 vol. % ethanol).

Ability to affect reaction speed when driving or operating machinery.

When used at therapeutic doses, it does not affect reaction speed when driving or operating machinery.

Method of administration and dosage.

The medication should be taken orally, after meals, 3 times daily, previously dissolved in 20–50 ml of water.

Children aged 12–13 years – 10–15 drops per dose.

Children aged 14–16 years – 15–20 drops per dose.

Adults and children aged 16 years and older – 20–30 drops per dose.

The duration of treatment depends on the form and severity of the disease, concomitant complex therapy, and achieved effect, and averages 10–15 days.

Children.
The safety and efficacy of the medication in children under 12 years of age have not been established; therefore, it is not recommended for use in this patient group.

Overdose.

In case of overdose, an increased incidence of adverse drug reactions may occur.

Treatment: symptomatic therapy.

Side effects.

Possible gastrointestinal disorders (including cramps, nausea, vomiting, diarrhea); cardiovascular disturbances (bradycardia, hypotension) in patients with heart failure. Allergic reactions (including rash, skin hyperemia, urticaria, angioedema, allergic dermatitis, anaphylactic shock).

Shelf life.

3 years.

Do not use the medication after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

25 ml or 50 ml in a bottle. 1 bottle per carton (packaging, packing, and labeling done in bulk by the manufacturer "Phytopharm Klenka S.A.", Poland).

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC "Farmak".

Manufacturer's address.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.