LINCAS PASTILLES

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINKUS LOZENGES

Composition:

Active substances: each lozenge contains: Adhatoda vasica leaf extract, dry (4~5:1) (extraction solvent: water) – 30.0 mg; Glycyrrhiza glabra root extract, dry (4~5:1) (extraction solvent: water) – 7.0 mg; Piper longum fruit extract, dry (4~5:1) (extraction solvent: water) – 6.0 mg; Viola odorata flower extract, dry (4~5:1) (extraction solvent: water) – 2.0 mg; Hyssopus officinalis leaf extract, dry (4~5:1) (extraction solvent: water) – 3.0 mg; Alpinia galanga rhizome extract, dry (4~5:1) (extraction solvent: water) – 3.0 mg; Mentha piperita leaf extract, dry (4~5:1) (extraction solvent: water) – 2.0 mg.

Excipients: menthol, eucalyptus oil, sucrose, glucose syrup, talc, paraffin, yellow wax, lanolin, soft white paraffin, mineral oil.

Pharmaceutical form. Lozenges.

Main physicochemical properties: round brown lozenges with a mint flavor. The upper and lower surfaces have irregularities. 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. Expectorant preparations. Combinations. ATC code R05C A10.

Pharmacological Properties

Pharmacodynamics

A complex herbal-based preparation with anti-inflammatory, expectorant, mucolytic, spasmolytic, and antipyretic properties. It activates the secretory function of the respiratory epithelium, alters the surface activity of pulmonary surfactant, and stimulates the ciliary epithelial function, thereby exerting a positive effect on the exudative and proliferative phases of inflammation. It liquefies thick mucus and facilitates the elimination of sputum from the respiratory tract. On the mucous membranes of the pharynx and bronchi, it acts 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 bronchioles and trachea, increases the diameter of bronchioles and alveolar sacs, and reduces swelling 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. It stimulates digestion and relieves spasms of the smooth musculature of the gastrointestinal tract.

Pharmacokinetics

Pharmacokinetic data are not available.

Clinical characteristics.

Indications.

Symptomatic treatment 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 cases of hypersensitivity to its components, diabetes mellitus, organic heart diseases (myocarditis, pericarditis, myocardial infarction), arterial hypertension; hepatic and renal dysfunction; hypokalemia; severe obesity; bronchial asthma.

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 suppress expectoration is not recommended. If it is necessary to use any other medicinal products, a physician should be informed.

Special precautions for use.

Patients with gastroesophageal reflux (heartburn) should avoid using the medicinal product due to the presence of peppermint leaf, as it may exacerbate heartburn.

Important information about excipients.

The medicinal product contains sugar, which should be taken into account by patients with diabetes mellitus and those on a low-calorie diet.

If you have been diagnosed with 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, because licorice root contained in 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 affect reaction speed when driving or operating machinery.

Does not affect reaction speed when driving or operating machinery.

Method of Administration and Dosage.

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

Duration of treatment – 3–5 days.

Children.

The medicinal product should not be administered to 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 the development of hypokalemic myopathy and myoglobinuria. Improper use of peppermint leaf may cause chest pain. Possible increase in adverse effects.

No reports of accidental overdose have been received.

Side effects.

Weakness, increased blood pressure, hypokalemia, allergic reactions (including rash (macular eruption), skin hyperemia, annular erythema, pruritus, urticaria, angioneurotic edema) may occur during use 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 of suspected adverse reactions after medicinal product registration is an important procedure. It enables continuous monitoring of the benefit-risk ratio 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 and sight of children.

Packaging. 8 pastilles in a blister pack, 2 blisters per cardboard box.

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

Manufacturer.

Herbion Pakistan Private Limited /
Herbion Pakistan Private Limited.

Manufacturer's address.

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