Lincas pastilles

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINKUS LOZENGES

Composition:

Active substances: each lozenge contains:
Extract of Adhatoda vasica leaf, dry (Adhatoda vasica Ness.) (4–5:1) (extraction solvent – water) – 30.0 mg;
Extract of Glycyrrhiza glabra root, dry (Glycyrrhiza glabra L.) (4–5:1) (extraction solvent – water) – 7.0 mg;
Extract of long pepper fruit, dry (Piper longum L.) (4–5:1) (extraction solvent – water) – 6.0 mg;
Extract of sweet violet flowers, dry (Viola odorata L.) (4–5:1) (extraction solvent – water) – 2.0 mg;
Extract of hyssop herb, dry (Hyssopus officinalis L.) (4–5:1) (extraction solvent – water) – 3.0 mg;
Extract of greater galangal rhizome, dry (Alpinia galanga (L.) Willd.) (4–5:1) (extraction solvent – water) – 3.0 mg.

Excipients: menthol, eucalyptus oil, sucrose, glucose solution, anhydrous citric acid, orange tablet essence or honey-lemon tablet essence, talc, paraffin, yellow wax, lanolin, soft white paraffin, mineral oil.

Pharmaceutical form. Lozenges with orange, honey, or lemon flavor.

Main physicochemical characteristics: round brown lozenges with orange flavor or honey-lemon flavor. The upper and lower surfaces of the lozenges are uneven. Small air bubbles may be present in the caramel mass. A slight white coating may appear on the surface of the lozenges.

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

Pharmacological properties.

Pharmacodynamics.

A complex herbal preparation with anti-inflammatory, expectorant, mucolytic, spasmolytic, and antipyretic properties. Activates the secretory function of the respiratory epithelium, alters the surface activity of pulmonary surfactant, stimulates epithelial ciliary function, thereby exerting a positive effect on the exudative and proliferative phases of inflammation. Liquefies thick mucus and facilitates the removal of sputum from the respiratory tract. Acts on the mucous membranes of the pharynx and bronchi as a local antiseptic, protecting them from the action of pathogenic microorganisms. The use of the medicinal product reduces the tone of smooth muscles of the bronchioles and trachea, increases the diameter of bronchioles and alveolar sacs, and reduces edema of mucous membranes. Changes in cough intensity are observed within 3–4 days of using the medicinal product.

Adhatoda vasica – contains the alkaloid vasicine, which has antiseptic properties and exerts an expectorant effect.

Glycyrrhiza glabra – exerts expectorant, spasmolytic, and broad anti-inflammatory effects.

Piper longum – effective in the treatment of cough, bronchial asthma, and whooping cough.

Viola odorata – exerts expectorant, anti-inflammatory, antimicrobial, diuretic, analgesic, and sedative effects.

Hyssopus officinalis – exerts antiseptic and antitussive effects. Stimulates digestion and relieves spasm of the smooth musculature of the gastrointestinal tract.

Pharmacokinetics.

Pharmacokinetic data are not available.

Clinical characteristics.

Indications.

Symptomatic therapy of inflammatory diseases of the respiratory tract accompanied by dry irritating cough and sore throat, namely: bronchitis (acute and chronic); pharyngitis, tracheitis, tracheobronchitis.

Contraindications.

The medicinal product is contraindicated in case of hypersensitivity to its components, diabetes mellitus, organic heart diseases (myocarditis, pericarditis, myocardial infarction), arterial hypertension, hepatic and renal function disorders, hypokalemia, and severe obesity. The medicinal product is contraindicated in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of this medicinal product with antitussive agents (e.g., codeine) that reduce sputum expectoration is not recommended. If it is necessary to use any other medicinal products, a physician should be informed.

Special precautions for use.

Important information about excipients.

The medicinal product contains sugar, which should be taken into account for patients with diabetes mellitus and those on a low-calorie diet. If you have an intolerance to certain sugars, consult your doctor before taking this medicinal product. May be harmful to teeth.

Use during pregnancy or breastfeeding.

Use during pregnancy and breastfeeding is contraindicated, as the medicinal product exerts an estrogen-like effect; licorice root, which is part of the medicinal product, increases estrogen levels, thereby disrupting hormonal balance. If it is necessary to take this medicinal product, breastfeeding should be discontinued.

Ability to influence reaction rate when driving or operating machinery.

Does not affect the reaction rate when driving or operating machinery.

Dosage and Administration.

For adults: slowly suck one tablet until completely dissolved every 2–3 hours. Children aged 6 years and older: one tablet four times daily. Maximum daily dose – 8 tablets.

Duration of treatment – 3–5 days.

Children. The medicinal product is contraindicated in children under 6 years of age.

Overdose.

Overdose and prolonged use (more than 2 months) may cause disturbances in water-electrolyte balance, potentially leading to hypokalemic myopathy and myoglobinuria. Exacerbation of adverse effects is possible.

No cases of accidental overdose have been reported.

Side effects.

Weakness, increased blood pressure, hypokalemia, and allergic reactions (including rash (macular eruption), skin hyperemia, annular erythema, pruritus, urticaria, angioneurotic edema) may occur during administration of the medicinal product.

If any unusual reactions occur, discontinue use of the medicinal product and consult a physician.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product authorization is an important procedure. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national pharmacovigilance system.

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

8 pastilles in a blister, 2 blisters in a cardboard box.

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

Manufacturer.

Herbion Pakistan Private Limited.

Address of the manufacturer and its place of business.

LF-37/A-3, Landhi Industrial area, Karachi, Pakistan.