Rinza^® Lorsept Anaesthetics (Tablets) Instructions for Use

Marketing Authorization Holder

Unique Pharmaceutical Laboratories (India)

Company Division

J. B. Chemicals & Pharmaceuticals, Ltd. (India)

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Dichlorobenzyl alcohol (Grouping name)

Amylmetacresol (Rec.INN)

Lidocaine (Rec.INN)

Dosage Form

Rinza® Lorsept Anaesthetics

Lozenges (orange, lemon, honey-lemon, blackcurrant): 16 pcs.

Dosage Form, Packaging, and Composition

Lozenges (orange, lemon, honey-lemon, blackcurrant).

8 pcs. – blister packs (2) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic + local anesthetic

Pharmacological Action

Combined antiseptic medicinal product.

The combination exhibits activity against gram-positive and gram-negative microorganisms in vitro; has an antifungal effect.

It also has a local anesthetic and anti-edema effect.

Indications

Symptomatic treatment of severe sore throat in infectious and inflammatory diseases.

ICD codes

Dosage Regimen

Administer one lozenge topically, allowing it to dissolve slowly in the mouth.

Repeat administration every 2 hours as needed for pain relief.

Do not exceed 8 lozenges within any 24-hour period.

The maximum duration of treatment is 3 days.

Discontinue use and consult a physician if symptoms persist beyond 3 days or if high fever, headache, or rash develops.

Avoid eating or drinking hot foods and beverages during treatment due to potential impaired oral sensation and risk of burns or biting injury.

Use the shortest possible course and the minimum effective dose to control symptoms.

Adverse Reactions

From the immune system frequency unknown – hypersensitivity reactions (including angioedema, urticaria).

From the cardiovascular system arterial hypotension with fainting.

From the digestive system frequency unknown – nausea, burning or tingling sensation, swelling in the oral cavity.

From the skin and subcutaneous tissues frequency unknown – rash.

Contraindications

Hypersensitivity to the components of the combination; history of allergy to local anesthetics; history or predisposition to methemoglobinemia; bronchial asthma, bronchospasm; children under 12 years of age.

With caution pregnancy, breastfeeding period, trauma to the oral mucosa.

Use in Pregnancy and Lactation

Use of the drug during pregnancy and breastfeeding is possible only on the recommendation of a doctor if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Pediatric Use

The use of the drug is contraindicated in children under 12 years of age.

Special Precautions

It is recommended to take the drug for the shortest possible course and at the minimum effective dose necessary to relieve symptoms.

If loss of tongue sensitivity is possible, it is recommended to be careful when consuming hot food and water, as biting of the tongue and lips is possible.

If symptoms persist or if body temperature rises, a headache appears, the patient should consult a doctor.

Drug Interactions

The effect of topically applied lidocaine may be enhanced when used concomitantly with erythromycin, itraconazole, cimetidine, fluvoxamine, beta-blockers, other antiarrhythmic drugs, for example, mexiletine.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.