Instin

Ukraine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INSTI

Composition:

Active substances: 1 sachet contains: extract of white willow bark, dry (Salix alba) (1:5) (extraction solvent: water) 135 mg; extract of Malabar nut leaf, dry (Adhatoda vasica) (1:5) (extraction solvent: water) 50 mg; extract of sweet violet leaf and flower, dry (Viola odorata) (1:5) (extraction solvent: water) 15 mg; extract of licorice root and rhizome, dry (Glycyrrhiza glabra) (1:5) (extraction solvent: water) 115 mg; extract of Chinese tea leaf, dry (Thea sinensis) (1:5) (extraction solvent: water) 30 mg; extract of common fennel fruit, dry (Foeniculum vulgare) (1:5) (extraction solvent: water) 15 mg; extract of globulus eucalyptus leaf, dry (Eucalyptus globulus) (1:5) (extraction solvent: water) 25 mg; extract of valerian root and rhizome, dry (Valeriana officinalis) (1:5) (extraction solvent: water) 15 mg;

Excipients: menthol, corn starch, sucrose.

Pharmaceutical form. Granules.

Main physicochemical properties: brown granules with a faint odour of menthol upon rubbing.

Pharmacotherapeutic group.

Combined preparations used in cough and colds.

ATC Code: R05X.

Pharmacological properties.

A complex natural preparation based on medicinal herbs that collectively possess a broad spectrum of antimicrobial activity (disinfectant, antiseptic, and anti-inflammatory properties).

Salix alba (White willow). The bark of white willow contains salicin and is used for pain and elevated body temperature. Salicin enhances the analgesic, antipyretic, disinfectant, and antiseptic properties of the preparation.

Adhatoda vasica. Contains the bitter non-volatile alkaloid vasicine, which provides antiseptic properties and exerts an expectorant effect.

Viola odorata. Has antihistaminic, expectorant, and antipyretic properties.

Glycyrrhiza glabra. Reduces irritation and exerts expectorant and spasmolytic effects due to stimulation of tracheal mucus secretion.

Camellia sinensis (tea leaf). Exerts bronchodilating effects and exhibits astringent and stimulant properties.

Foeniculum vulgare. Helps in respiratory diseases such as bronchial asthma and bronchitis due to its secretolytic and spasmolytic properties.

Eucalyptus globulus. Exerts antiseptic and expectorant effects.

Valeriana officinalis. Exerts a sedative effect and helps with headache, cough, and fever.

Clinical characteristics.

Indications.

Symptomatic treatment of influenza, colds, and viral respiratory tract infections accompanied by cough, sore throat, throat irritation, nasal congestion, and headache.

Contraindications.

Hypersensitivity to salicylates, plants of the Apiaceae (umbelliferous) family, anethole, or to any other components of the medicinal product.

Severe impairment of liver or kidney function.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of this product with other antitussive agents or with medicinal products that reduce mucus formation is not recommended.

Simultaneous use with cardiac glycosides, antiarrhythmic agents (quinidine), thiazide and loop diuretics, adrenocorticosteroids, and laxatives may enhance hypokalemia. Excessive doses of products containing fennel, due to their estrogenic activity, may interfere with hormonal therapy outcomes, including oral contraceptives. The product enhances the effects of alcohol, sedatives, hypnotics, antihypertensives, anxiolytics, and spasmolytic agents.

If concomitant use with any other medicinal products is necessary, consult a physician.

Special precautions.

Use with caution in glomerulonephritis, hepatitis, organic heart diseases, arterial hypertension, coagulation disorders, hepatic and renal function impairment, hypokalemia, severe obesity, bronchial asthma, bronchospasm, whooping cough, croup; in depression.

Prolonged use and high doses of the drug may impair digestion, cause headache, stimulate the nervous system, and worsen cardiac function.

If body temperature rises above 38 °C, cough intensifies, wheezing in the lungs appears, purulent sputum, rhinorrhea with purulent discharge, or sore throat develops, discontinue use of the drug and consult a physician.

The granules contain sucrose, which should be taken into account for patients with diabetes mellitus and those on a low-calorie diet. Also, due to the presence of sucrose in the formulation, the drug should not be used in patients with rare hereditary conditions such as fructose intolerance or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding.

It is recommended to discontinue breastfeeding if use of the drug becomes necessary. The drug is contraindicated during pregnancy.

Ability to affect reaction rate when driving or operating machinery.

During treatment with this drug, patients should refrain from driving or operating complex machinery.

Dosage and Administration

Before using the medication, consult a physician.

Administer 1 sachet 2–3 times daily. Dissolve the contents of the sachet in a cup of hot water or tea and drink in small portions.

The treatment duration is determined individually by a physician and usually lasts from 5 to 7 days. Maximum dose: 1 sachet 3 times daily.

Children. The drug is not prescribed for children under 12 years of age.

Overdose. May result in an intensification of adverse effects.

Symptoms include: nausea, vomiting, diarrhea, skin allergic rash, disturbances in water-electrolyte balance, possibly leading to the development of hypokalemic myopathy and myoglobinuria; feelings of depression, increased fatigue, drowsiness, dizziness, headache, bradycardia, increased blood coagulation.

Treatment: gastric lavage, symptomatic therapy.

Adverse Reactions.

Possible allergic reactions, including skin rash, itching, skin hyperemia, urticaria, angioneurotic edema; gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea, abdominal spasms, intestinal dysfunction); increased blood pressure, hypokalemia; respiratory disorders; sleep disturbances and paradoxical stimulant effects, headache, bradycardia, arrhythmia, weakness, drowsiness, depression, reduced work capacity; water-electrolyte imbalance (appearance of edema).

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

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

5 or 10 sachets per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Herbion Pakistan Private Limited.

Manufacturer's address.

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