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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Apple lozenges 1.2 mg: 18 pcs.
Marketing Authorization Holder
Krka, D.D. (Slovenia)
Dosage Form
 |
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.
Lemon lozenges 1.2 mg: 18 pcs.
Marketing Authorization Holder
Krka, D.D. (Slovenia)
Dosage Form
|
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.
Cherry lozenges 1.2 mg: 18 pcs.
Marketing Authorization Holder
Krka, D.D. (Slovenia)
Dosage Form
|
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.
![Septolete® NEO [Pastilles] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Septolete® NEO [Pastilles] 2")