Linkas plus expectorant

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LINKUS PLUS EXPECTORANT

Composition:

Active substances: 5 ml of syrup contains: extract of Solanum xanthocarpum fruit, dry (1:5) (extraction solvent – water) 15 mg; extract of Adhatoda vasica leaves, dry (1:5) (extraction solvent – water) 35 mg; extract of Glycyrrhiza glabra roots and rhizomes, dry (1:5) (extraction solvent – water) 7.5 mg; extract of Ocimum basilicum flowers and leaves, dry (1:5) (extraction solvent – water) 15 mg; extract of Cordia latifolia fruit, dry (1:5) (extraction solvent – water) 5 mg; extract of Piper longum fruit, dry (1:5) (extraction solvent – water) 5 mg; extract of Althea officinalis seeds, dry (1:5) (extraction solvent – water) 7.5 mg; extract of Illicium verum fruit, dry (1:5) (extraction solvent – water) 25 mg.

Excipients: sucrose, anhydrous citric acid, methylparaben E 218, propylparaben E 216, eucalyptus oil, peppermint oil, "Chewing gum" flavouring, ammonium chloride, propylene glycol, purified water.

Pharmaceutical form. Syrup.

Main physicochemical characteristics: brown syrup with a specific odour. Sediment formation may occur, which dissolves upon shaking.

Pharmacotherapeutic group. Medicinal products used in cough and common cold. Expectorants. Combinations. ATC code: R05CA10.

Pharmacological properties.

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-active properties of pulmonary surfactant, and stimulates 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. Acts locally on the mucous membranes of the pharynx and bronchi as an antiseptic. Administration of the drug reduces the tone of smooth muscles of the bronchioles and decreases edema of the respiratory mucosa. Changes in cough intensity are observed within 3–4 days of taking the medication.

Clinical characteristics.

Indications.

As part of complex therapy for inflammatory diseases of the upper and lower respiratory tract:

• bronchitis, pneumonia, bronchial asthma, and tuberculosis;
• common cold, smoker's cough;
• inflammatory diseases of the upper respiratory tract (laryngopharyngitis, tracheitis, tracheobronchitis).

Contraindications.

Hypersensitivity to the components of the drug; diabetes mellitus; organic heart lesions (myocarditis, pericarditis, myocardial infarction); arterial hypertension; liver and kidney dysfunction; hypokalemia; severe obesity.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of this medicinal product with antitussive agents that reduce sputum expectoration (e.g., codeine) is not recommended.

If simultaneous use of any other medicinal products is required, a physician should be informed.

Special precautions for use.

Important information about excipients.

Since the medicinal product contains methylparaben and propylparaben, it may cause allergic reactions (possibly delayed).

The medicinal product contains sucrose, which may be harmful to teeth.

If intolerance to certain sugars has been diagnosed, consult a physician before taking this medicinal product.

Use during pregnancy or breastfeeding.

Use during pregnancy or breastfeeding is contraindicated, because the liquorice root contained in the medicinal product increases estrogen levels, thereby disrupting hormonal balance. If use of the medicinal product is necessary, breastfeeding should be discontinued.

Effect on the ability to drive vehicles or operate machinery.

The effect on the ability to drive vehicles or operate machinery has not been studied.

Dosage and Administration.

For adults and children aged 12 years and older: 2 teaspoons (10 ml) of syrup 3–4 times daily; for children aged 7 to 11 years: 1 teaspoon (5 ml) of syrup 3–4 times daily; for children aged 2 to 6 years: ½–1 teaspoon (5 ml) of syrup 3–4 times daily.

Duration of treatment: 3 to 7 days.

Shake well before use.

Children. The medicinal product must not be administered to children under 2 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 reports of accidental overdose have been received.

Side effects.

Weakness, increased blood pressure, hypokalemia, allergic reactions (including rash, itching, skin hyperemia, urticaria, swelling formation); increased salivation, irritation of gastric mucosa may occur during the use of the medicinal product.

If any adverse 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 allows continuous monitoring of the benefit-risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Storage conditions.

Store in a dry place at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 120 ml in a bottle, in a cardboard box.

Supply classification. Over-the-counter (without prescription).

Manufacturer.

Herbion Pakistan Private Limited, Pakistan / Herbion Pakistan Private Limited, Pakistan.

Manufacturer's address and place of business.

Plot №30 Sector 28, Industrial Area Korangi, Karachi, Pakistan / Plot №30 Sector 28, Industrial Area Korangi, Karachi, Pakistan.