DOCTOR MOM® WITH ORANGE FLAVOR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DR. MOM® WITH ORANGE FLAVOR

Composition:

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

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

Excipients: sucrose, glucose solution, glycerin, citric acid monohydrate, peppermint flavor, orange flavor, colorant Yellow Sunset FCF (E 110).

Pharmaceutical form. Lozenges.

Main physicochemical properties: round, biconvex, orange-colored lozenges with orange flavor.

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

Pharmacological properties.

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

The pharmacological properties of the drug are determined by the components included 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 associated with cough (pharyngitis, laryngitis, including "lecturer's" laryngitis, tracheitis, bronchitis).

Contraindications.

• Hypersensitivity to any component of the drug;
• Impaired liver or kidney function;
• Conditions associated with impaired bile secretion (gallstone disease and obstruction of bile ducts);
• Arterial hypertension;
• Hypokalemia;
• Severe obesity;
• Spasmophilia;
• Bronchial asthma;
• Diabetes mellitus;
• Pediatric age.

Interaction with other medicinal products and other types of interactions.

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 potentiated when used concomitantly with cardiac glycosides, antiarrhythmic agents, and drugs affecting cardiac rhythm (e.g., quinidine). Concomitant use with drugs that may cause hypokalemia (thiazide and loop diuretics, adrenocorticosteroids, and laxatives) may lead to electrolyte imbalance; therefore, prolonged concurrent use of this drug with the aforementioned medicinal products should be avoided.

May enhance 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 individuals with swallowing difficulties or aspiration problems.

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. Since the medicinal product contains glucose and sucrose, it is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency. May be harmful to teeth.

This medicinal product contains the colouring agent Sunset Yellow FCF (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding

The product is contraindicated during pregnancy. If treatment requires use during breastfeeding, breastfeeding should be discontinued.

Ability to influence reaction rate while driving or operating machinery

Use of the product at the recommended dose does not affect 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 dosing of licorice 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 (including vesicular, papular), pruritus, skin hyperemia, urticaria, angioedema.

Possible side effects: electrolyte imbalance (edema), increased blood pressure, chest pain, cardiac arrhythmias (when using multiple licorice-containing preparations simultaneously), dermatitis, dizziness.

Reporting of adverse reactions

Reporting of adverse reactions after marketing authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as 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.

Availability.

Over-the-counter.

Manufacturer.

Unique 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 Kaday, Daman – 396 210, India.

Marketing Authorization Holder.

LLC "Johnson & Johnson Ukraine", Ukraine.

Address of the Marketing Authorization Holder.

32/2 Ostrizkykh Knyaziv St., Kyiv, 01010, Ukraine.

+38 (044) 498 0888

+38 (044) 498 7392