EXTRATERM

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT EXTRATERM®

Composition:

Active substances:

1 tablet contains dry extract of Thermopsis lanceolata herb (extractant – ethanol 25%) 0.043 g, sodium hydrogencarbonate 0.2 g;

Excipients: sodium benzoate (E 211), ammonium chloride, potato starch, talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets from light-yellow, light-brown to yellow-brown in colour; greyish tinge is acceptable; with speckles, with a score line.

Pharmacotherapeutic group.

Combined preparations used in cough and colds.

ATC code R05X.

Pharmacological properties.

Extraterm**®** is a combination drug that has expectorant, antitussive, and anti-inflammatory effects.

Thermopsis enhances secretion of the bronchial glands. Alkaloids (cytisine, methylcytisine, pachycarpine, anagyrine, thermopsine, and thermopsidine) contained in thermopsis exert a stimulating effect on the respiratory center.

Sodium hydrocarbonate stimulates secretion of the bronchial glands, promoting a reduction in sputum viscosity.

Clinical characteristics.

Indications.

Symptomatic treatment of cough (especially with difficult expectoration) in respiratory tract diseases such as: tracheitis, bronchitis, bronchopneumonia.

Contraindications.

Hypersensitivity to the components of the drug. Acute glomerulonephritis, acute pyelonephritis; duodenal ulcer, gastric ulcer, hemoptysis. Age under 12 years.

Interaction with other medicinal products and other types of interactions.

Adsorbents, astringents, and demulcent agents may reduce the absorption of alkaloids from Thermopsis herb in the gastrointestinal tract. Cough suppressant tablets should not be used simultaneously with preparations containing codeine and with other cough-suppressing agents.

Special precautions for use.

To improve sputum liquefaction and expectoration, it is recommended to use large amounts of warm fluid.

This medicinal product contains 3.8 mmol/dose of sodium. Caution should be exercised when administering to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding. Use during pregnancy or breastfeeding is contraindicated.

Ability to affect reaction speed when driving or operating machinery. The drug does not affect the ability to drive or operate machinery.

Dosage and Administration.

For adults and children aged 12 years and older: take 1 tablet orally 3–4 times daily.

Before administration, it is recommended to dissolve the tablet in 1/4 glass of boiled water at a temperature of approximately 40 °C, stirring thoroughly, or to swallow the tablet with the same amount of water. The duration of treatment depends on the course of the disease and the therapeutic effect achieved, and should be determined by a physician.

Children. Do not use this medicinal product in children under 12 years of age.

Overdose.

Nausea, vomiting, weakness, diarrhea, dizziness, cold sweat, pallor, cyanosis of mucous membranes; in severe poisoning, disturbances of consciousness, excitement, hallucinations, and convulsions may occur.

Treatment: gastric lavage, saline laxatives, activated charcoal, symptomatic therapy.

Adverse reactions.

Allergic reactions, including hyperemia, rash, itching, and swelling of the skin.

Gastrointestinal disorders: nausea, gastritis, vomiting, diarrhea.

Reporting of adverse reactions following registration of the medicinal product 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, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

12 tablets per blister, 1 blister without a carton or 2 blisters per carton.

Availability. Over-the-counter (without prescription).

Manufacturer. JSC "FITOFARM".

Manufacturer's address and location of business activity.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7 Verkhovnoi Rady Avenue, Kyiv, 02100, Ukraine, 3rd floor, room 18.

In case of adverse reactions or questions regarding safety, quality, and efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOFARM" at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the "Pharmacovigilance" section, and choose your preferred method of communication.

INSTRUCTIONS

for medical use of the medicinal product

EXTRATERM®

Composition:

Active substances:

Each tablet contains dry extract of Thermopsis lanceolata herb (extractant – ethanol 25%) 0.043 g, sodium bicarbonate 0.2 g;

Excipients: sodium benzoate (E 211), ammonium chloride, potato starch, talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets are light-yellow, light-brown to yellow-brown in colour, a greyish tint may be present, with speckles, and a score line for dividing.

Pharmacotherapeutic group.

Combined preparations used for cough and colds.

ATC code R05X.

Pharmacological properties.

Extraterm**®** is a combination medication that has expectorant, antitussive, and anti-inflammatory effects.

Thermopsis enhances bronchial gland secretion. Alkaloids (cytisine, methylcytisine, pachicarpine, anagyrine, thermopsine, and thermopsidine) contained in thermopsis exert a stimulating effect on the respiratory center.

Sodium bicarbonate stimulates bronchial gland secretion, promoting a reduction in sputum viscosity.

Clinical characteristics.

Indications.

Symptomatic treatment of cough (especially with difficult expectoration of sputum) in respiratory tract diseases such as: tracheitis, bronchitis, bronchopneumonia.

Contraindications.

Increased individual sensitivity to the components of the medicinal product. Acute glomerulonephritis, acute pyelonephritis; peptic ulcer of the duodenum, peptic ulcer of the stomach, hemoptysis. Age under 12 years.

Interaction with other medicinal products and other forms of interaction.

Adsorbents, astringents, and demulcents may reduce the absorption of alkaloids from Thermopsis herb in the gastrointestinal tract. Cough tablets should not be used simultaneously with codeine-containing preparations and with other cough-suppressant drugs.

Special precautions for use.

To improve the liquefaction and expectoration of sputum, it is recommended to use large amounts of warm fluid.

This medicinal product contains 3.8 mmol/dose of sodium. Caution is advised when administered to patients on a sodium-restricted diet.

Use during pregnancy or breastfeeding. Use during pregnancy or breastfeeding is contraindicated.

Effect on the ability to drive or operate machinery. The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage.

For adults and children aged 12 years and older: take 1 tablet internally 3–4 times a day.

Before administration, it is recommended to dissolve the tablet in 1/4 glass of boiled water at a temperature of approximately 40 °C, stirring thoroughly, or to swallow the tablet with the same amount of water. The duration of treatment depends on the course of the disease and the therapeutic effect achieved, and is determined by a physician.

Children. Do not use this medicinal product in children under 12 years of age.

Overdose.

Nausea, vomiting, weakness, diarrhea, dizziness, cold sweat, pallor, cyanosis of mucous membranes; in severe poisoning, disturbances of consciousness, excitement, hallucinations, and convulsions may occur.

Treatment: gastric lavage, saline laxatives, activated charcoal, symptomatic therapy.

Side effects.

Allergic reactions, including hyperemia, rash, itching, and skin swelling.

Gastrointestinal disorders: nausea, gastritis, vomiting, diarrhea.

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

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

12 tablets per blister, 1 blister without a carton or 2 blisters per carton.

Prescription status. Over-the-counter.

Manufacturer. JSC «FITOFARM» (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of operations.

17, Chumatska Street, city of Boryspil, Kyiv region, 08303, Ukraine.

Marketing Authorization Holder. JSC «FITOFARM».

Address of the Marketing Authorization Holder.

7, Verkhovnoi Rady Boulevard, premises 18, 3rd floor, city of Kyiv, 02100, Ukraine.

In case of adverse reactions or questions regarding the safety, quality, or efficacy of this medicinal product, please contact the Pharmacovigilance Department of JSC «FITOFARM» at +38 (044) 390 52 96 or visit https://fitofarm.ua, go to the «Pharmacovigilance» section, and choose your preferred method of communication.