Instruction for use: Septolete total

Active substance Benzydamine + Cetylpyridinium chloride

ATX code R02A Throat preparations

Pharmacological group

Antiseptics and disinfectants in combinations

Nosological classification (ICD-10)

J02 Acute pharyngitis

Inflammation of the nasopharynx, Inflammatory disease of the oropharynx, Inflammatory process of pharynx, Infectious diseases of ENT organs, Sore Throat Infection ,Exacerbation of inflammatory diseases of the pharynx and oral cavity, Pharyngitis, Pharyngitis acute, Pharyngitis, Pharyngolaringitis

J03 Acute tonsillitis [sore throat]

J04.0 Acute laryngitis

Lektorsky laryngitis, Acute catarrhal Laryngitis,Laryngitis is an acute abscess

J31.2 Chronic pharyngitis

Pharyngitis chronic, Exacerbation of inflammatory diseases of the pharynx and oral cavityHypertrophic pharyngitis, Inflammatory process of pharynx, Sore Throat Infection, Infectious-inflammatory diseases of the pharynx, Infectious-inflammatory diseases of the oral cavity and pharynx, Atrophic pharyngitis

J37.0 Chronic laryngitis

Chronic atrophic laryngitis

K05 Gingivitis and periodontal disease

Gingivitis, Inflammatory Gum Disease, Inflammatory diseases of the oral cavity, Hyperplastic gingivitis, Diseases of the mouth, Catarrhal gingivitis, Erythematous gingivitis, Ulcerative gingivitis, Exacerbation of inflammatory diseases of the pharynx and oral cavity, Bleeding from the gums, Epstein cysts

K12 Stomatitis and Related Lesions

Bacterial stomatitis, Inflammatory diseases of the oral cavity, Inflammatory diseases of tissues of the oral cavity, Inflammatory processes in the oral cavity, Fungal diseases of the mouth, Fungal infections of the oral cavity, Fungal infections and inflammatory diseases of the mouth, Diseases of the mouth, Infectious-inflammatory disease of the oral cavity, Exacerbation of inflammatory diseases of the pharynx and oral cavity, Stomatitis, Angular stomatitis, Chronic recurrent stomatitis, Ulcerative necrotic diseases of the oral mucosa, Ulcerative necrotic gingivostomatitis, Ulcerative stomatitis, Erosive-ulcerative lesion of the oral mucosa, Erosive-ulcerative lesions of the mucous membrane of the oral cavity, Erotic mucous membrane of the oral cavity, Recurrent ulcerative stomatitis

Composition

Tablets for absorption 1 table.

active substances:

benzidamine hydrochloride 3 mg

cetylpyridinium chloride monohydrate 1.05 mg

equivalent to cetylpyridinium chloride - 1 mg

auxiliary substances: eucalyptus of the leaf-shaped leaf oil - 1.2 mg; levomenthol - 5 mg; sucralose (E955) 3.5 mg; citric acid (E330) - 15 mg; isomalt (type M) (E953) - 2471.285 mg; dye diamond blue (E133) - 0.015 mg

Description of dosage form

Round with beveled edges tablets with a rough surface from light blue to blue. Allowed white coating, uneven staining, the presence of air bubbles in the caramel mass and a slight uneven edges.

pharmachologic effect

Pharmacological action - local anesthetic, anti-inflammatory local, antifungal local, antibacterial local, local anesthetic.

Pharmacodynamics

Benzidamine is an NSAID with anti-inflammatory, analgesic and local anesthetic action.

Cetylpyridinium chloride - an antiseptic from the group of quaternary ammonium compounds, has an antimicrobial, antifungal, virucidal effect.

Pharmacokinetics

Suction. Of the two active substances - cetylpyridinium chloride and benzidamine - only benzydamine is absorbed through the mucous membranes. Therefore, cetylpyridinium chloride does not enter into a pharmacokinetic interaction with benzidamine at the systemic level. The absorption of benzidamine through the mucous membranes of the oral cavity and pharynx has been shown by identifying the active substance in the blood serum, the amount of which, nevertheless, was not sufficient to provide systemic action. The absorption of benzidine is higher when using dosage forms that dissolve in the oral cavity in comparison with topical dosage forms (eg, oral spray).

Distribution. Vd of all dosage forms is the same.

Excretion. Excretion occurs mainly in the kidneys, mostly in the form of inactive metabolites. T1 / 2 and overall clearance are similar for all dosage forms.

The readings of the drug Sepptetho® total

Symptomatic therapy of pain syndrome inflammatory diseases of the oral cavity and ENT organs (different etiology).

Contraindications

hypersensitivity to active substances or any auxiliary components of the drug;

children under 12 years.

With caution: hypersensitivity to acetylsalicylic acid or other NSAIDs, bronchial asthma (including in the anamnesis).

pregnancy and lactation

The use of the drug Septolete® Total during pregnancy and during breastfeeding is possible only after consultation with the attending physician, if the prospective benefit to the mother exceeds the potential risk to the fetus and the baby.

Side effects

Classification of the incidence of side effects recommended by WHO: very often ≥1 / 10; often from ≥1 / 100 to <1/10; infrequently from ≥1 / 1000 to <1/100; rarely from ≥1 / 10000 to <1/1000; very rarely <1/10000; frequency is unknown - can not be estimated from the available data.

From the side of the immune system: rarely - reactions of increased sensitivity; frequency unknown - anaphylactic reaction.

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

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

From the gastrointestinal tract: very rarely - irritation of the oral mucosa, burning sensation in the oral cavity.

From the skin and subcutaneous tissues: rarely - hives, photosensitization; frequency unknown - angioedema, skin itching.

Interaction

Not studied. Avoid simultaneous application with other drugs from the group of antiseptics.

Dosing and Administration

Locally. Tablets should be slowly dissolved in the mouth every 3-6 hours.

Adults, elderly patients and children over 12 years of age: the recommended dose is 3-4 tablets / day. Do not exceed the indicated dose.

To achieve the optimum effect, do not apply the drug Sepotelet® Total immediately before or after brushing your teeth.

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

The drug Septolete® Total should not be used for more than 7 days.

Overdose

Symptoms: toxic manifestations of benzodamine overdose include agitation, convulsions, increased sweating, ataxia, chills and vomiting; symptoms of intoxication when ingesting significant amounts of cetyl pyridinium chloride - nausea, vomiting, edema, cyanosis, asphyxia followed by paralysis of the respiratory muscles, CNS depression, hypotension and coma. The lethal dose for a person is about 1-3 g.

Treatment: in view of the absence of a specific antidote, the treatment of acute intoxication with benzydamine is symptomatic. Treatment of an overdose of cetylpyridinium chloride is also symptomatic. In case of overdose, see a doctor.

special instructions

The drug Septolete® Total should not be used for more than 7 days.

If there are no visible signs of improvement, you should consult your doctor.

With the use of the drug Septolete® total, hypersensitivity reactions may develop. In this case, it is recommended that you stop treatment and consult with your doctor to prescribe appropriate therapy. If there is a ulcerative lesion of the mucous membrane of the oropharynx, the patient should consult a doctor if the symptoms persist for more than 3 days.

The use of the drug Septolete® Total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug Septolete® Total should not be used simultaneously with anionic compounds (for example, present in toothpaste). Therefore, the use of the drug is not recommended immediately before or after brushing the teeth.

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

Influence on the ability to carry out potentially dangerous activities requiring special attention and quick reactions (for example, vehicle management, working with moving mechanisms)

The drug Septolete® Total does not affect the ability to drive vehicles and work with mechanisms.

Form of issue

Tablets for resorption, 3 mg + 1 mg. For 8 tables. in a blister of the combined material PVC / PE / PVDH-aluminum foil. By 1, 2, 3 or 4 bl. put in a pack of cardboard.

Conditions of leave from pharmacies

Without recipe.

storage conditions

At a temperature of no higher than 25 ° C, in the original packaging.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.