Doctor mom® with pineapple flavor

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DOCTOR MOM® WITH PINEAPPLE 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 (Glycyrrhiza glabra) (5:1) (extraction solvent: purified water) 3.0 mg; dry extract of Zingiber officinale (Zingiber officinale) (10:1) (extraction solvent: purified water) 1.0 mg; dry extract of Emblica officinalis (Emblica officinalis) (4:1) (extraction solvent: purified water) 2.5 mg; menthol 7.0 mg;

Excipients: sucrose, glucose syrup, glycerin, citric acid monohydrate, peppermint flavor, pineapple flavor, colorant Diamond Blue (E 133), colorant Quinoline Yellow (E 104).

Pharmaceutical form. Lozenges.

Main physicochemical properties: green-colored, round, biconvex lozenges with pineapple 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 its constituent components.

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.) possesses 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 biliary tract obstruction);
• arterial hypertension;
• hypokalemia;
• severe obesity;
• spasophilia;
• bronchial asthma;
• diabetes mellitus;
• childhood 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 formation, 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 cardiac rhythm (e.g., quinidine). When used together with drugs that may cause hypokalemia (thiazide and loop diuretics, adrenocorticosteroids, and laxatives), electrolyte imbalance 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.

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 medicine, as heartburn may increase.

Lozenges may pose a choking hazard.

Use with caution in patients 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, 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 drug is contraindicated during pregnancy. If drug use is required during treatment, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery

When used at the recommended dose, this medicine 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 preparations may lead to water retention, hypokalemia, hypertension; in individual cases, hypokalemic myopathy and myoglobinuria are possible. Symptoms may include chest pain, cardiac arrhythmias, hypertensive encephalopathy, and rarely, damage to the gastric mucosa.

In case of overdose, symptomatic treatment should be administered.

Adverse reactions.

Allergic reactions, including rash (including vesicular, papular), pruritus, skin hyperemia, urticaria, angioedema.

Possible adverse reactions: water-electrolyte imbalance (edema), increased blood pressure, chest pain, cardiac arrhythmias (with concomitant use of several drugs containing licorice), dermatitis, dizziness.

Reporting of adverse reactions

Reporting of adverse reactions following drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of drug 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.

Supply category.

Over-the-counter (without prescription).

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 Kadaiya, 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