Expiration date: 01/2025

Form of production, composition and packaging

Tablets for resorption from light blue to blue, round, with beveled edges, with a rough surface; allowed white plaque, uneven coloring, the presence of air bubbles in the caramel mass and slight irregularity of the edges.

1 tablet contains:

of benzydamine hydrochloride 3 mg

cetylpyridinium chloride monohydrate 1.05 mg, 

that corresponds to the content of cetylpyridinium chloride 1 mg

Auxiliary substances: oil of eucalyptus leaves promovideo - 1.2 mg, levomenthol 5 mg, Sucralose (E955) - 3.5 mg, citric acid (E330) - 15 mg, isomalt (type M) (E953) - 2471.285 mg, colorant brilliant blue (E133) - 0.015 mg.

Pharmaco-therapeutic group: antiseptic+local anesthetic .

Indications:

• symptomatic therapy of pain of inflammatory diseases of the oral cavity and ENT organs (various etiologies).
  

Dosage regimen

Tablets should be slowly dissolve in the mouth every 3-6 hours

Adults, elderly patients.

The recommended dose is 3-4 tab./ day. Do not exceed the specified dose.

To achieve the optimal effect should not be used medication Septolete® total immediately before or after brushing.

The drug Septolete® total should not be used simultaneously with other drugs from the group of antiseptics.

Septolete® total should not be used for more than 7 days.

Side effect

Classification of incidence of side effects recommended by the world health organization (who): very often ?1/10, often from ?1/100 to <1 10="" 1="" 1000="" 100="" 10000="" span="">

Immune system disorders: rarely-hypersensitivity reactions; unknown frequency-anaphylactic reactions.

Disorders of the nervous system: the frequency is unknown-numbness of the oral mucosa.

Disorders of the respiratory system, chest and mediastinum: rarely-bronchospasm.

Violations by the gastrointestinal tract: rarely - irritation of the mucous membrane of the mouth, burning sensation in the mouth.

Disorders of the skin and subcutaneous tissues: rarely - urticaria, photosensitization; the frequency is unknown - angioedema, skin itching.

Contraindications to use:

• hypersensitivity to the active substances or to any auxiliary components of the drug;
  
• children under 18 years of age.
  

With caution

Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, asthma (including history).

Use during pregnancy and breast-feeding

The use of Septolete® total during pregnancy and breastfeeding is possible only after consultation with the doctor, if the expected benefit to the mother exceeds the potential risk to the fetus and child.

Use in children

The use of the drug in children and adolescents under the age of 18 years is contraindicated.

Special instruction

Septolete® total should not be used for more than 7 days. If there are no visible signs of improvement, consult a doctor.

When using the drug Septolete ® total possible development of hypersensitivity reactions. In this case, it is recommended to stop treatment and consult a doctor for appropriate therapy.

In the presence of ulcerative lesions of the mucous membrane of the oropharynx, the patient should consult a doctor if the symptoms persist for more than three days.

The use of Septolete total is not recommended in patients with increased sensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

The drug Septolete total should not be used simultaneously with anionic compounds (for example, present in toothpaste). Therefore, it is not recommended to use the drug directly before or after brushing your teeth.

Simultaneous administration with milk can reduce the antimicrobial effect of cetylpyridinium chloride, so the drug Septolete total should not be used simultaneously with milk.

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (e.g., vehicle management, work with moving machinery)

The drug Septolete total has no effect on the ability to drive vehicles and work with mechanisms.

Overdose

Symptoms: toxic manifestations of benzidamine overdose include: arousal, seizures, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia, followed by paralysis of the respiratory muscles, CNS oppression, hypotension and coma.

The lethal dose for humans is about 1-3 g.

Treatment: due to the lack of a specific antidote, treatment of acute intoxication with benzidamine is symptomatic. Treatment of overdose of cetylpyridinium chloride is also symptomatic. In case of overdose, consult a doctor.

Drug interaction

Has not been studied. Avoid concomitant use with other drugs from the group of antiseptics.

Pharmacy leave conditions

The drug is allowed to use as a means of non-prescription.

Storage conditions and terms

The drug should be stored in its original packaging, out of reach of children at a temperature not exceeding 25°C. 

Shelf life-2 years.

Do not use the drug after the expiration date.