DOCTOR MOM® WITH LEMON FLAVOR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DOCTOR MOM® WITH LEMON FLAVOR

Composition:

Active substances: dry extract of Glycyrrhiza glabra, dry extract of Zingiber officinale, dry extract of Emblica officinalis, menthol;

One lozenge contains: dry extract of Glycyrrhiza glabra (5:1) (extraction solvent: purified water) 3.0 mg; dry extract of Zingiber officinale (10:1) (extraction solvent: purified water) 1.0 mg; dry extract of Emblica officinalis (4:1) (extraction solvent: purified water) 2.5 mg; menthol 7.0 mg;

Excipients: sucrose, glucose solution, glycerin, citric acid monohydrate, peppermint flavor, lemon oil, Quinoline Yellow dye (E 104).

Pharmaceutical form. Lozenges.

Main physicochemical properties: round, biconvex lozenges ranging in color from greenish-yellow to yellow, with a lemon flavor.

Pharmacotherapeutic group. Preparations for cough and colds. ATC code R05X.

Pharmacological properties.

A combination medicinal product with expectorant and anti-inflammatory effects.

The pharmacological properties of the drug are determined by the components contained in its composition.

Licorice root extract (Glycyrrhiza glabra L.) exhibits anti-inflammatory, spasmolytic, and expectorant effects. Ginger root extract (Zingiber officinale Rosc.) has anti-inflammatory and analgesic effects. Indian gooseberry extract (Emblica officinalis Gaertn.) has anti-inflammatory and antipyretic effects. Menthol exerts spasmolytic and antiseptic effects.

Clinical characteristics.

Indications.

Symptomatic treatment of acute and chronic diseases of the upper respiratory tract accompanied by cough (pharyngitis, laryngitis including "lecturer's" laryngitis, tracheitis, bronchitis).

Contraindications.

• Hypersensitivity to any component of the drug;
• liver and kidney function disorders;
• diseases associated with impaired bile secretion (gallstone disease and obstruction of bile ducts);
• arterial hypertension;
• hypokalemia;
• severe obesity;
• spasms;
• bronchial asthma;
• diabetes mellitus;
• childhood.

Interaction with other medicinal products and other forms of interaction.

Dr. Mom® lozenges should not be used simultaneously with antitussive agents and drugs that suppress mucus production, as this may interfere with expectoration of liquefied mucus.

Hypokalemia (due to excessive use of licorice root) may be intensified when used concomitantly with cardiac glycosides, antiarrhythmic agents, and drugs affecting heart rhythm (e.g., quinidine). When used together with drugs that may cause hypokalemia (thiazide and loop diuretics, adrenocorticosteroids, and laxatives), disturbances in electrolyte balance may occur; therefore, prolonged concurrent use of the drug with the above-mentioned medicinal products should be avoided.

May enhance the absorption of sulfaguanidine.

Caution is required when used concomitantly with warfarin due to the potential risk of bleeding resulting from increased INR (International Normalized Ratio).

Special precautions for use

If symptoms persist for more than 2 days and are accompanied by headache, nausea, or vomiting, consult a physician.

Patients with gastroesophageal reflux (heartburn) should avoid using this product, as heartburn may worsen.

Lozenges may pose a choking hazard.

Use with caution in patients with swallowing difficulties or aspiration risks.

Keep out of reach of children.

Important information about excipients

This medicinal product contains 1.62 g of sucrose and 0.88 g of glucose per dose. Use with caution in patients with diabetes mellitus. As the medicinal product contains glucose and sucrose, its use is not recommended in patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency. May be harmful to teeth.

Use during pregnancy or breastfeeding

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

Ability to affect reaction speed when driving or operating machinery

When used at the recommended dose, this product does not impair the ability to drive or operate potentially hazardous machinery.

Method of Administration and Dosage.

Adults: take 1 lozenge every 2 hours (slowly dissolve in the mouth).

Maximum daily dose – 10 lozenges.

Duration of treatment – no more than 3 days without consulting a physician.

Children: not recommended for those under 18 years of age.

Overdose.

Prolonged use (more than 4 weeks) and/or excessive doses of licorice-containing preparations may lead to fluid retention, hypokalemia, hypertension; in individual cases, hypokalemic myopathy and myoglobinuria are possible. There may be chest pain, cardiac arrhythmias, hypertensive encephalopathy, and rarely, gastric mucosa damage.

In case of overdose, symptomatic treatment should be administered.

Side effects.

Allergic reactions, including rash, vesicular and papular eruptions, pruritus, skin hyperemia, urticaria, angioneurotic edema.

Possible side effects: disturbances in water-electrolyte balance (appearance of edema), increased arterial pressure, chest pain, cardiac arrhythmias (with concomitant use of several drugs containing licorice), dermatitis, dizziness.

Reporting of adverse reactions

Reporting of adverse reactions after drug registration is important. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 30 °C in the original packaging, in a place inaccessible to children.

Packaging.

4 lozenges per strip, 5 strips per cardboard box.

Category of supply.

Over-the-counter.

Manufacturer.

Uniq Pharmaceuticals Laboratories (a division of J. B. Chemicals and Pharmaceuticals Ltd.).

Manufacturer's address and location of operations.

Plot No. 101/2 and 102/1, Daman Industrial Estate, Airport Road, Village Kadayath, Daman – 396 210, India.

Marketing Authorization Holder.

LLC "Johnson & Johnson Ukraine", Ukraine.

Address of the Marketing Authorization Holder.

32/2 Ostrivs’kykh Knyaziv St., Kyiv, 01010, Ukraine.

+38 (044) 498 0888

+38 (044) 498 7392