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Faringosept® (Tablets) Instructions for Use

ATC Code

R02AA01 (Ambazone)

Active Substance

Ambazone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic agent for topical use in ENT practice and dentistry. It has a bacteriostatic effect.

It is active against Streptococcus haemoliticus, Streptococcus viridans, and Pneumococcus.

Indications

Use for the prevention and treatment of acute infectious and inflammatory diseases affecting the oral cavity and larynx.

  • Acute and chronic tonsillitis.
  • Stomatitis and gingivitis.

Employ for the prevention of infectious and inflammatory complications following dental procedures.

Specifically, use after tooth extraction to reduce the risk of local infection.

ICD codes

ICD-10 code Indication
J03 Acute tonsillitis
J35.0 Chronic tonsillitis
K05 Gingivitis and periodontal diseases
K12 Stomatitis and related lesions
Z29.8 Other specified prophylactic measures
ICD-11 code Indication
CA03.Z Acute tonsillitis, unspecified
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
DA01.Z Diseases of the oral mucosa, unspecified
DA0B.Z Gingival diseases, unspecified
DA0C.Z Periodontal diseases, unspecified
DA0Z Diseases or disorders of the orofacial complex, unspecified
QC05.Z Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer tablets by slow dissolution in the mouth. Do not chew or swallow whole.

For adults, use 30-50 mg per day, divided into 3-4 doses, for a duration of 3-4 days.

For children from 3 to 7 years old, use 30 mg per day, divided into several doses. Do not use in children under 3 years of age.

Refrain from eating and drinking for 3 hours after administration to ensure optimal local effect.

Adverse Reactions

Adverse reactions are uncommon and typically mild.

Monitor for signs of allergic reactions, which may include skin rash, itching, or urticaria.

Discontinue use immediately and consult a physician if any signs of hypersensitivity appear.

Drug Interactions

Formal drug interaction studies have not been conducted.

Due to the topical mechanism of action and minimal systemic absorption, clinically significant drug interactions are considered unlikely.

Concomitant use with other locally applied oral preparations is not recommended to avoid potential inactivation of the active substance.

Contraindications

Do not use under any circumstances in patients with a known hypersensitivity to the active substance or any excipient.

  • Confirmed allergy to ambazone.

Contraindicated in children under 3 years of age due to the risk of choking and the inability to use the dosage form correctly.

Overdose

Overdose is unlikely due to topical application and minimal systemic absorption.

In case of accidental ingestion of a large number of tablets, symptomatic and supportive measures are recommended.

Gastric lavage is not indicated. Monitor the patient and consult a poison control center or physician if concerned.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is used in cases where the expected benefit of therapy for the mother outweighs the possible risk to the fetus or infant.

Use in Hepatic Impairment

No special precautions.

Use in Renal Impairment

No special precautions.

Pediatric Use

Used in children over 3 years of age.

Geriatric Use

No special precautions.

Special Precautions

After taking ambazone, it is recommended to refrain from eating and drinking for 3 hours.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Manufactured By

Terapia, S.C. S.A. (Romania)

Dosage Form

Bottle OTC Icon Faringosept® Lozenges 10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 729 mg, lactose monohydrate – 150 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, vanillin – 1 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Manufactured By

Terapia, S.C. S.A. (Romania)

Dosage Forms

Bottle OTC Icon Faringosept® Lemon-flavored lozenges 10 mg: 10 or 20 pcs.
Lozenges (cinnamon flavor) 10 mg: 10 or 20 pcs.
Lozenges (wild berry flavor) 10 mg: 10 or 20 pcs.
Lozenges (honey and lemon flavor) 10 mg: 10 or 20 pcs.
Mint-flavored lozenges 10 mg: 10 or 20 pcs.

Dosage Form, Packaging, and Composition

Lemon-flavored lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges and an engraving “L” on one side; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 745 mg, lactose monohydrate – 150 mg, cocoa bean powder – 25 mg, povidone K30 – 50 mg, lemon flavor – 10 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Cinnamon-flavored lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges and an engraving “C” on one side; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 729 mg, lactose monohydrate – 143 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, cinnamon flavor – 8 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Wild berry-flavored lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges and an engraving “F” on one side; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 729 mg, lactose monohydrate – 148.5 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, mixed berry flavor – 2.5 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Honey and lemon-flavored lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges and an engraving “H” on one side; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 729 mg, lactose monohydrate – 135 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, lemon flavor – 12 mg, honey flavor – 4 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

Mint-flavored lozenges round, flat-cylindrical, beveled to the edge, brown in color with intact edges and an engraving “M” on one side; the presence of light and dark inclusions is allowed.

1 tab.
Ambazone monohydrate 10 mg

Excipients: sucrose – 729 mg, lactose monohydrate – 139 mg, cocoa bean powder – 50 mg, povidone K30 – 50 mg, peppermint flavor – 12 mg, stearic acid – 10 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.

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