Suprima-Lor (Tablets) Instructions for Use

Marketing Authorization Holder

Shreya Life Sciences, Pvt.Ltd. (India)

Contact Information

Shreya Life Sciences Pvt. Ltd. (India)

ATC Code

R02AA20 (Other antiseptics)

Dosage Forms

	Suprima-Lor	Lozenges (with eucalyptus scent): strips or blisters of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (raspberry): blisters or strips of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (pineapple): blisters or strips of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (with orange flavor): strips or blisters of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (with lemon flavor): strips or blisters of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (with honey and lemon flavor): strips or blisters of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (with strawberry flavor): strips or blisters of 1, 2, 4, 6, 8, 10 or 12 pcs.
		Lozenges (menthol): 16 pcs.

Dosage Form, Packaging, and Composition

Lozenges (pineapple) yellow, round, with a pineapple scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, dextrose 84%, anhydrous citric acid, menthol, sunset yellow FCF color, quinoline yellow color, pineapple flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (raspberry) red-raspberry color, round, with a raspberry scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, dextrose 84%, anhydrous citric acid, menthol, azorubine, raspberry flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (menthol) light blue, round, with a menthol scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, dextrose 84%, anhydrous citric acid, menthol, brilliant blue FCF, peppermint oil.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (with orange flavor) orange, round, with an orange scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, liquid dextrose 84%, anhydrous citric acid, menthol, sunset yellow FCF color, orange flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (with strawberry flavor) red, round, with a strawberry scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, liquid dextrose 84%, anhydrous citric acid, menthol, Ponceau 4R color, strawberry flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (with lemon flavor) yellow, round, with a lemon scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, liquid dextrose 84%, anhydrous citric acid, menthol, sunset yellow FCF color, quinoline yellow color, lemon flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (with honey and lemon flavor) light yellow, round, with a honey and lemon scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, liquid dextrose 84%, anhydrous citric acid, menthol, quinoline yellow color, honey flavor, lemon flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Lozenges (with eucalyptus scent) light blue, round, with a menthol and eucalyptus scent; uneven coloring, the presence of air bubbles in the caramel mass, and slight unevenness of the surface and edges of the tablets are allowed; the appearance of a white coating is possible.

Excipients: sugar S/30 base, liquid dextrose 84%, anhydrous citric acid, menthol, brilliant blue FCF color, eucalyptus flavor.

4 pcs. – aluminum strips (4) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

A combined antiseptic drug for topical use in the oral cavity and pharynx. It has an antimicrobial effect. It is active against gram-positive and gram-negative microorganisms.

The efficacy of the drug is due to the presence of two broad-spectrum antibacterial components.

Pharmacokinetics

Due to low systemic absorption, data on the pharmacokinetics of Suprima-LOR are not available.

Indications

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

ICD codes

Dosage Regimen

Use this medication for the symptomatic relief of infectious and inflammatory conditions of the oral cavity and pharynx.

Initiate treatment at the first sign of throat discomfort or inflammation.

Dissolve one lozenge slowly in the mouth. Allow it to dissolve completely; do not chew or swallow whole.

For adults and children 12 years and older, administer one lozenge every two hours.

The maximum daily dosage for adults and children 12 years and older is eight lozenges within a 24-hour period.

For children aged 6 to 11 years, administer one lozenge every four hours.

The maximum daily dosage for children aged 6 to 11 years is six lozenges within a 24-hour period.

Do not use this medication in children under 6 years of age due to the risk of choking.

Do not exceed the recommended daily dosage under any circumstances.

The total duration of self-treatment should not exceed three consecutive days.

Discontinue use and consult a physician if symptoms persist, worsen, or are accompanied by high fever, headache, nausea, or vomiting.

Patients with diabetes mellitus should consider the sugar content of each lozenge.

Adverse Reactions

Possible allergic reactions.

When used according to the indications in the recommended doses, no side effects of the drug have been noted.

Contraindications

• Hypersensitivity to the components of the drug.

Pediatric Use

Recommended for children over 6 years of age.

Special Precautions

Do not exceed the indicated dose.

When prescribing to patients with diabetes, it is necessary to take into account that the tablets contain sugar.

Overdose

Symptoms: nausea, vomiting, diarrhea.

Treatment: symptomatic.

Drug Interactions

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

Storage Conditions

Store in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use the drug after the expiration date printed on the package.

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.