Theraflu^® LAR Menthol (Tablets) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Healthcare, JSC (Russia)

Manufactured By

Novartis Saglik Gida Ve Tarim Urunleri Sanayi Ve Ticaret A.Ş. (Turkey)

Trademark Owner

GlaxoSmithKline Group of Companies

ATC Code

R02A (Preparations for the treatment of throat diseases)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Cetylpyridinium chloride (Rec.INN registered by WHO)

Dosage Form

Theraflu® LAR Menthol

Lozenges (menthol) 1 mg+2 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges (menthol) white, rectangular, with beveled edges.

Excipients: black peppermint leaf oil – 0.5 mg, Shimmel peppermint leaf oil – 0.5 mg, levomenthol – 6 mg, acesulfame potassium – 6 mg, corn starch – 55 mg, citric acid monohydrate – 5 mg, macrogol 6000 – 25 mg, microcrystalline cellulose (Avicel PH-105) – 20 mg, magnesium stearate – 2 mg, sorbitol (Karion 3140) – 1107 mg.

10 pcs. – blisters (2) – carton packs.

The secondary packaging may have a first-opening control.

Clinical-Pharmacological Group

Drug with antimicrobial and local anesthetic action for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic + local anesthetic

Pharmacological Action

Combined preparation for topical use, contains an antiseptic agent and a local anesthetic agent.

Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, has bactericidal activity against gram-positive and, to a lesser extent, gram-negative bacteria. It alters the permeability of the bacterial cytoplasmic membrane, disrupts the internal oxidative mechanisms of bacterial respiration, which leads to their death. Cetylpyridinium chloride has antifungal and antiviral activity against enveloped viruses.

Lidocaine hydrochloride is a local anesthetic from the amide group, in inflammatory processes it relieves sore throat when swallowing. Lidocaine disrupts the permeability of the cell membrane to sodium ions, which leads to anesthesia as a result of blocking the conduction of nerve impulses.

Pharmacokinetics

Cetylpyridinium chloride is practically not absorbed through the oral mucosa.

Lidocaine hydrochloride is poorly absorbed through the oral mucosa. When taken orally, it is absorbed, undergoing metabolism during the “first pass” through the liver. When taken orally, its bioavailability is about 35%. Metabolites are excreted in the urine, less than 10% of the substance is excreted unchanged.

Indications

Infectious and inflammatory diseases of the oral cavity and throat

• Pharyngitis;
• Laryngitis;
• Catarrhal tonsillitis;
• Stomatitis;
• Ulcerative gingivitis;
• Tonsillitis (as an auxiliary agent).

ICD codes

Dosage Regimen

The tablet should be slowly dissolved in the mouth.

The tablet should not be chewed or swallowed. Theraflu^® LAR Menthol should not be taken during or immediately before meals.

Adults and children over 12 years 1 tab. every 1-2 hours for acute inflammation and severe pain. For milder conditions – 1 tab. every 2-3 hours. The maximum daily dose is no more than 6 tablets.

Children from 6 to 12 years 1 tab. every 3-4 hours as needed, maximum daily dose – no more than 3 tablets.

Theraflu^® LAR Menthol tablets should not be used for more than 5 days in a row. If symptoms persist or are accompanied by high fever, dizziness, or vomiting, it is necessary to stop taking the drug and consult a doctor.

Adverse Reactions

Definition of the frequency of adverse reactions: very common (≥10%); common (≥1%, but ≤10%), uncommon (≥0.1%, but ≤1%), rare (≥0.01%, but ≤0.1%), very rare (≤0.01%).

From the digestive system: rarely – nausea; very rarely – diarrhea.

From the skin and subcutaneous tissues: very rarely – skin rash, itching.

Local reactions rarely – local irritation of the oral and throat mucosa.

Contraindications

• First trimester of pregnancy;
• Breastfeeding period;
• Children under 6 years of age;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Hypersensitivity to the components of the drug.

With caution: open wounds of the oral mucosa.

Use in Pregnancy and Lactation

The use of the drug Theraflu^® LAR Menthol is contraindicated in the first trimester of pregnancy, since the drug crosses the placental barrier. Use in the II-III trimesters of pregnancy is possible under medical supervision, if the expected benefit to the mother outweighs the potential risk to the fetus.

The drug is excreted in breast milk, so it is not recommended for use during breastfeeding.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Special Precautions

The drug should not be taken immediately before meals and simultaneously with milk. Simultaneous intake of the drug with milk and food may reduce the local antiseptic and anesthetic effects.

Alcohol increases the absorption of cetylpyridinium chloride, so the consumption of alcoholic beverages should be avoided while taking the drug.

Cetylpyridinium chloride slows down wound healing.

1 tablet of the drug contains 1107 mg of sorbitol as a sweetener, therefore Theraflu^® LAR Menthol should not be taken by patients with congenital fructose intolerance.

Effect on the ability to drive vehicles and mechanisms

No effect.

Overdose

Symptoms with accidental intake of the drug (like other ammonium compounds) in high doses, nausea and vomiting are possible. The lidocaine content in the drug is insignificant and cannot cause serious symptoms of overdose.

Treatment immediately stop taking the drug; it is recommended to drink milk or eat egg white beaten in water.

Drug Interactions

No drug interactions of Theraflu^® LAR Menthol have been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.