Rinza^® Lorsept (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 registered by WHO)

Dosage Forms

	Rinza® Lorsept	Lozenges (Blackcurrant): 8, 12, or 16 pcs.
		Lozenges (Orange): 8, 12, 16, or 24 pcs.
		Lozenges (Lemon): 8, 12, 16, or 24 pcs.
		Lozenges (Honey-Lemon): 8, 12, or 16 pcs.

Dosage Form, Packaging, and Composition

Lozenges (Orange) are orange in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose, dextrose, citric acid monohydrate, orange oil, anise seed oil, cornmint oil, sunset yellow dye.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – laminated multilayer bags (1) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – laminated multilayer bags (1) – cardboard packs.

Lozenges (Lemon) are yellow in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose, dextrose, citric acid monohydrate, anise seed oil, cornmint oil, lemon oil concentrate, quinoline yellow dye.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – laminated multilayer bags (1) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – laminated multilayer bags (1) – cardboard packs.

Lozenges (Honey-Lemon) are from brownish-yellow to brown in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose, dextrose, cornmint oil, lemon oil, honey flavor, caramel dye, sunset yellow dye.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – laminated multilayer bags (1) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – laminated multilayer bags (1) – cardboard packs.

Lozenges (Blackcurrant) are purple in color, round, biconvex, with a rough surface; uneven coloring, the presence of air bubbles, and slight edge irregularities are allowed.

Excipients: sucrose, dextrose, citric acid monohydrate, cornmint oil, blackcurrant flavor, azorubine dye, brilliant blue dye.

4 pcs. – aluminum strips (2) – cardboard packs.
4 pcs. – aluminum strips (3) – cardboard packs.
4 pcs. – aluminum strips (4) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – cardboard packs.
8 pcs. – Al/PVC blisters (2) – laminated multilayer bags (1) – cardboard packs.
8 pcs. – Al/PVC blisters (3) – laminated multilayer bags (1) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The drug has an antiseptic effect, is active against gram-positive and gram-negative microorganisms in vitro, and has an antimycotic effect.

Indications

• Symptomatic treatment of infectious and inflammatory diseases of the oral cavity and pharynx.

ICD codes

Dosage Regimen

Administer by topical use only. Dissolve one lozenge slowly in the mouth.

For adults and children over 6 years, administer one lozenge every two to three hours.

Do not exceed the maximum daily dose of eight lozenges.

Continue the treatment course for five to seven days, or as directed by a physician.

Allow each lozenge to dissolve completely; do not chew or swallow whole.

Adhere strictly to the recommended dosing interval to maintain therapeutic effect.

Discontinue use and consult a physician if symptoms persist beyond the treatment period.

For patients with diabetes, note that each lozenge contains sucrose and dextrose, equivalent to 0.20 bread units.

Adverse Reactions

Allergic reactions (burning sensation in the oral cavity) are possible.

If reactions not described in the instructions for use occur, you should consult a doctor about the advisability of further use of the drug.

Contraindications

• Hypersensitivity to the components of the drug;
• Sucrase/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption;
• Children’s age (under 6 years).

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is possible according to indications under medical supervision.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

Do not exceed the indicated doses.

The drug should not be used in case of increased individual sensitivity to any component of the drug.

When prescribing the drug to patients with diabetes, it should be taken into account that 1 tablet contains 0.20 bread units (BU).

If the medicine is spoiled or the expiration date has passed – do not throw it into the sewage system or on the street! Place the medicine in a bag and put it in a trash container.

Effect on the ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: nausea, vomiting, diarrhea.

Treatment: symptomatic.

Drug Interactions

No clinically significant interaction with drugs of other groups has been identified.

Storage Conditions

Store the drug in a dry place, out of reach of children, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 4 years. Do not use after the expiration date.

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.