INSTI WITH LEMON FLAVOR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT INSTE WITH LEMON FLAVOR

Composition:

Active substances: 1 sachet contains:

• White willow bark dry extract (Salix alba) (1:5) (extraction solvent: water) – 135 mg
• Vasaka leaf dry extract (Adhatoda vasica) (1:5) (extraction solvent: water) – 50 mg
• Sweet violet leaf and flower dry extract (Viola odorata) (1:5) (extraction solvent: water) – 15 mg
• Licorice root and rhizome dry extract (Glycyrrhiza glabra) (1:5) (extraction solvent: water) – 115 mg
• Chinese tea leaf dry extract (Thea sinensis) (1:5) (extraction solvent: water) – 30 mg
• Fennel fruit dry extract (Foeniculum vulgare) (1:5) (extraction solvent: water) – 15 mg
• Eucalyptus leaf dry extract (Eucalyptus globulus) (1:5) (extraction solvent: water) – 25 mg
• Valerian root and rhizome dry extract (Valeriana officinalis) (1:5) (extraction solvent: water) – 15 mg

Excipients: menthol, corn starch, sucrose, lemon flavor "Lime C-8946".

Pharmaceutical form. Granules.

Main physicochemical properties: brown granules with a faint lemon odor when rubbed.

Pharmacotherapeutic group.
Combined preparations used in cough and colds.
ATC code: R05X.

Pharmacological properties.

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

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.

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

Sweet violet (Viola odorata). Possesses antihistaminic, expectorant, and antipyretic properties.

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

Chinese tea (Tea leaf). Exerts a bronchodilating effect and exhibits astringent and stimulating properties.

Common fennel (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.

Medicinal valerian (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 the components of the medicinal product. Hypersensitivity to salicylates, plants of the Apiaceae (Umbelliferae) family, atenolol.

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 production is not recommended.

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

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

Special precautions.

Use with caution in glomerulonephritis, hepatitis, organic heart lesions,

arterial hypertension, coagulation disorders, hepatic and renal dysfunction, 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 appears in the lungs, purulent sputum develops, or if there is nasal discharge with purulent secretions or tonsillitis, 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 for patients on a low-calorie diet. Due to the sucrose content, the medicinal product should not be used in patients with rare hereditary conditions such as fructose intolerance or sucrase-isomaltase deficiency.

Use during pregnancy or breastfeeding.

If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued. The drug is contraindicated during pregnancy.

Ability to affect reaction speed when driving or operating machinery.

While taking this drug, patients should refrain from driving or operating complex machinery.

Method of Administration and Dosage

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 take in small portions.

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

Children.

The medicinal product is not prescribed for children under 12 years of age.

Overdose.

May result in an intensification of adverse effects.

Symptoms include: nausea, vomiting, diarrhea, allergic skin rashes, disturbances in water-electrolyte balance, which may lead 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.

Side effects.

Allergic reactions are possible, including skin rash, itching, skin hyperemia, urticaria, angioedema; 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 (onset of edema).

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

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.

5 or 10 sachets per cardboard box.

Availability.

Over-the-counter (without prescription).

Manufacturer.

Herbion Pakistan Private Limited.

Manufacturer's address and place of business.

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