INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MАLІPІN® (MALIPIN)

Composition:

Active substance: 5 ml of syrup contains dry extract of lime flowers (Tiliae flores) (16:1) (extractant – ethanol 40%) – 97 mg (with 2% maltodextrin);

Excipients: confectioner's sugar, sodium benzoate, anhydrous citric acid, xanthan gum, "Raspberry" flavoring, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: viscous brown-orange liquid with raspberry flavor and odor. Sediment formation during storage is permissible.

Pharmacotherapeutic group. Cough and cold remedies. ATC code R05X.

Pharmacological properties.

Pharmacodynamics.

Malipin® is a herbal preparation containing dry extract of lime flowers (Tiliae flores). The medicinal product exerts a pronounced diaphoretic effect.

Pharmacokinetics. Data are lacking.

Clinical characteristics.

Indications. An adjunctive agent in acute respiratory viral infections (ARVI), sore throat, cough, accompanied by elevated body temperature.

Contraindications. Hypersensitivity to the components of the medicinal product. Pollinosis.

Interaction with other medicinal products and other forms of interactions. Not known.

Special precautions for use.

If fever persists for more than 3 days during treatment, or if dyspnea or purulent sputum develops, a doctor should be consulted.

Malipin® should not be administered to patients with rare hereditary disorders related to fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency. The medicinal product contains sugar and therefore may be harmful to teeth.

10 ml of syrup contains 8 g of confectioner's sugar; hence, the medicinal product should be used with caution in patients with diabetes mellitus.

Malipin® contains "Raspberry" flavoring ("Ponceau 4R"), which may cause allergic reactions.

Use during pregnancy or breastfeeding. Not recommended during pregnancy or breastfeeding due to lack of data on the use of the medicinal product during these periods.

Ability to affect reaction rate while driving or operating machinery. The effect on reaction rate while driving or operating machinery has not been studied.

Dosage and Administration.

The medicinal product is administered orally.

Children aged 1 to 3 years: after consultation with a physician, the recommended dose is 5 ml of syrup 2–3 times daily.

Children aged 3 to 12 years: 5 ml of syrup 4–5 times daily.

Children aged 12 years and adults: 10 ml of syrup 3–4 times daily.

The duration of treatment is determined individually by a physician.

Children.

The medicinal product may be used in children aged 1 year and older.

Children aged 1 to 3 years should use the product only after consultation with a physician.

Overdose.

No reports available.

In individuals who poorly tolerate high doses of sucrose, nausea may occur.

Side effects

Allergic reactions (including rash, itching, skin swelling).

If side effects occur, discontinue use of the medicinal product and consult a physician.

Reporting of adverse reactions after registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Shelf life after opening — 12 months.

Storage conditions. Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 125 g in a bottle; 1 bottle with a measuring cup in a carton.

Supply category. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity. 4, Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.