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Septolete® NEO (Pastilles) Instructions for Use

ATC Code

R02AA06 (Cetylpyridinium chloride)

Active Substance

Cetylpyridinium chloride (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antiseptic agent. It is a quaternary ammonium compound and belongs to cationic surfactants.

It has antimicrobial activity against Gram-positive bacteria and, to a lesser extent, Gram-negative bacteria.

It does not affect bacterial spores.

It has variable antifungal activity and is effective against some viruses.

Indications

Use this medication for the local treatment of infectious and inflammatory conditions caused by susceptible microorganisms.

  • Infections of the oral cavity, including gingivitis, stomatitis, and other periodontal diseases.
  • Infections of the pharynx and larynx, such as acute and chronic pharyngitis, tonsillitis, and laryngitis.
  • Superficial skin infections, including impetigo, furuncles, carbuncles, pyoderma, and post-traumatic wound infections.

ICD codes

ICD-10 code Indication
J02 Acute pharyngitis
J03 Acute tonsillitis
J04.0 Acute laryngitis
J31.2 Chronic pharyngitis
J35.0 Chronic tonsillitis
J37.0 Chronic laryngitis
K05 Gingivitis and periodontal diseases
K12 Stomatitis and related lesions
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
CA02.Z Acute pharyngitis, unspecified
CA03.Z Acute tonsillitis, unspecified
CA05.0 Acute laryngitis
CA09.2 Chronic pharyngitis
CA0F.Y Other specified chronic diseases of the palatine tonsils and adenoids
CA0G Chronic laryngitis or laryngotracheitis
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
EA50.3 Staphylococcal scarlet fever
EB21 Pyoderma gangrenosum
NF0A.3 Posttraumatic wound infection, not elsewhere classified

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.

For pastilles, dissolve one pastille slowly in the mouth. The dosing frequency is individual and depends on the specific indication and clinical need.

Adhere to the dosing schedule prescribed by a healthcare professional. Do not exceed the recommended duration of use. For oral and pharyngeal infections, ensure the pastille is dissolved completely to maximize local contact time.

Adverse Reactions

Adverse reactions are typically local and infrequent. Local irritation at the application site, such as mucosal irritation or a burning sensation, may occur, particularly with prolonged use.

Allergic reactions, including skin rash or hypersensitivity, are possible. Discontinue use immediately if signs of a severe allergic reaction appear. Report any persistent or severe adverse effects to a healthcare provider.

Drug Interactions

This agent is incompatible with soaps, anionic detergents, and other anionic surfactants, as they can inactivate the antiseptic properties. Avoid concurrent use with such substances.

Be aware that other topical medications applied to the same area may alter the efficacy or absorption of this product. Inform your doctor about all other medicines you are using before starting this treatment.

Contraindications

Do not use this medication under the following conditions.

  • Known hypersensitivity or previous allergic reaction to cetylpyridinium chloride or any other component of the formulation.

Hypersensitivity reactions may include contact dermatitis, mucosal inflammation, or other signs of allergy. Select an alternative antiseptic therapy if a contraindication exists.

Overdose

Accidental ingestion of a large number of pastilles is unlikely to cause acute systemic toxicity due to low bioavailability. If overdose occurs, symptomatic and supportive care is recommended.

Ingestion may lead to gastrointestinal irritation, such as nausea or abdominal discomfort. In case of suspected overdose, seek medical attention or contact a poison control center for advice. Do not induce vomiting unless instructed by a medical professional.

Special Precautions

Incompatible with soaps and other anionic surfactants.

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

Krka, D.D. (Slovenia)

Dosage Form

Bottle OTC Icon Septolete® NEO Apple lozenges 1.2 mg: 18 pcs.

Dosage Form, Packaging, and Composition

Apple pastilles round, biconvex, green in color; the presence of minor inclusions of a lighter color is allowed.

1 pastille
Cetylpyridinium chloride monohydrate 1.26 mg,
   Equivalent to cetylpyridinium chloride 1.2 mg

Excipients : liquid maltitol (dry substance) – 476.64 mg, mannitol – 163.88 mg, levomenthol – 2 mg, lemon oil – 3 mg, apple flavor – 10 mg, yellow dye (E100) (curcumin dye (E100), citric acid, sodium benzoate, sucrose, water, acacia gum) – 0.65 mg, green dye (E141) (copper chlorophyll dye (E141), citric acid, gelatin, sucrose, water) – 1.95 mg, glycerol – 3.5 mg, castor oil – 1.1 mg, colloidal anhydrous silicon dioxide – 1 mg, magnesium stearate – 3 mg, titanium dioxide (E171) – 3 mg, povidone – 2.5 mg, capol 600 pharma (beeswax, carnauba wax, shellac) – 2.5 mg, maltitol – up to 1200 mg.

9 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Krka, D.D. (Slovenia)

Dosage Form

Bottle OTC Icon Septolete® NEO Lemon lozenges 1.2 mg: 18 pcs.

Dosage Form, Packaging, and Composition

Lemon pastilles round, biconvex, yellow in color; the presence of minor inclusions of a lighter color is allowed.

1 pastille
Cetylpyridinium chloride monohydrate 1.26 mg,
   Equivalent to cetylpyridinium chloride 1.2 mg

Excipients : liquid maltitol (dry substance) – 476.64 mg, mannitol – 163.88 mg, levomenthol – 2 mg, lemon oil – 3 mg, lemon flavor – 3 mg, citrus flavor – 3 mg, orange oil – 4 mg, yellow dye (E100) (curcumin dye (E100), citric acid, sodium benzoate, sucrose, water, acacia gum) – 2.6 mg, glycerol – 3.5 mg, castor oil – 1.1 mg, colloidal anhydrous silicon dioxide – 1 mg, magnesium stearate – 3 mg, titanium dioxide (E171) – 3 mg, povidone – 2.5 mg, capol 600 pharma (beeswax, carnauba wax, shellac) – 2.5 mg, maltitol – up to 1200 mg.

9 pcs. – blisters (2) – cardboard packs.

Marketing Authorization Holder

Krka, D.D. (Slovenia)

Dosage Form

Bottle OTC Icon Septolete® NEO Cherry lozenges 1.2 mg: 18 pcs.

Dosage Form, Packaging, and Composition

Cherry pastilles round, biconvex, from pink to pink with a lilac shade, the presence of minor inclusions of a lighter color is allowed.

1 pastille
Cetylpyridinium chloride monohydrate 1.26 mg,
   Equivalent to cetylpyridinium chloride 1.2 mg

Excipients : liquid maltitol (dry substance) – 476.64 mg, mannitol – 163.88 mg, levomenthol – 2 mg, lemon oil – 3 mg, cherry flavor – 10 mg, violet dye (E120) (carminic acid (E120), sodium hydroxide solution, citric acid) – 2.6 mg, glycerol – 3.5 mg, castor oil – 1.1 mg, colloidal anhydrous silicon dioxide – 1 mg, magnesium stearate – 3 mg, titanium dioxide (E171) – 3 mg, povidone – 2.5 mg, capol 600 pharma (beeswax, carnauba wax, shellac) – 2.5 mg, maltitol – up to 1200 mg.

9 pcs. – blisters (2) – cardboard packs.

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