Septolete Total for children, tablets 3 mg+1 mg 8 pcs

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug + antiseptic agent

ATX code: R02AA20

Pharmacological properties

Pharmacodynamics

Benzidamine is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and local anesthetic effects. Cetylpyridinium chloride is an antiseptic of the group of quaternary ammonium compounds with antimicrobial, antifungal and virulicidal action.

Pharmacokinetics

absorption

. Of the two active substances, cetylpyridinium chloride and benzidamine, only benzidamine is absorbed through the mucous membranes. Therefore, cetylpyridinium chloride does not interact pharmacokinetically with benzidamine at the systemic level.

The absorption of benzidamine through the oral and pharyngeal mucous membranes has been demonstrated by detecting the active ingredient in serum, the amount of which, however, was insufficient to exert systemic action. Absorption of benzidamine is higher when using dosage forms that dissolve in the mouth compared to topical dosage forms (e.g., oral spray).

Distribution

The volume of distribution of all dosage forms is the same.

Extraction

Extraction occurs mainly by the kidneys, to a greater extent, in the form of inactive metabolites. The elimination half-life and total clearance are similar for all dosage forms.

Indications

Symptomatic treatment of pain syndrome of inflammatory diseases of the oral cavity and ENT-organs (various etiologies), including tonsillitis, pharyngitis, as part of the treatment.

Active ingredient

Benzidamine, Cetylpyridinium chloride

Composition

1 lemon and elderberry snuff tablet contains:

Active ingredients:

Benzidamine hydrochloride 3.000 mg

Cetylpyridinium chloride monohydrate 1.050 mg, equivalent to cetylpyridinium chloride 1.000 mg

Associates: isomalt (type M) (E953), citric acid (E330), Elderberry flavoring, sucralose (E955), citrus flavoring, levomenthol, curcumin dye (E100)¹⁾, chlorophyllin copper complex dye (E141), peppermint leaf oil

¹⁾ Curcumin dye (E100): curcumin (E100), maltodextrin, acacia gum (E414), emulsifier (E472c), citric acid (E330), potassium sorbate (E202), sodium benzoate (E211), purified water.

How to take, the dosage

Children use

Children over 12 years

The recommended dose is 3 to 4 tablets per day.

Children 6 to 12 years

The recommended dose is 3 tablets per day.

Do not exceed the stated dose.

It is contraindicated children under 6 years of age.

Applications in chronic conditions

Take with caution in patients with bronchial asthma (including history).

Elderly patients

The recommended dose is 3-4 tablets daily.

Method of Use and Dosage

The tablets should be slowly crumbled in the mouth every 3-6 hours.

Adults, elderly patients and children over 12 years

The recommended dose is 3-4 tablets daily.

Children 6 to 12 years

The recommended dose is 3 tablets per day.

Do not exceed the stated dose.

The drug Septoleta^® Total should not be used simultaneously with other drugs from the antiseptic group.

The drug Septoleta^® total should not be used for more than 7 days.

Interaction

Not studied. Concomitant use with other drugs from the antiseptic group should be avoided.

Special Instructions

The drug Septoleta^® total should not be used for more than 7 days. If there are no noticeable signs of improvement, you should consult a doctor.

When using the drug Septoleta^® total it is possible to develop hypersensitivity reactions. In this case it is recommended to stop the treatment and consult a physician for prescribing appropriate therapy.

In the presence of ulcerative lesions of the oropharyngeal mucosa, the patient should consult a physician if symptoms persist for more than three days.

The use of the drug Septoleta^® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

The drug Septollete® total should not be used simultaneously with anionic compounds (e.g., present in toothpaste). For optimal effect, do not use Septollete® Total immediately before or after brushing your teeth.

The concomitant administration with milk may decrease the antimicrobial action of cetylpyridinium chloride, therefore Septolete^® total should not be used simultaneously with milk.

Influence on driving and operating machinery

The drug Septolete^® total has no effect on the ability to drive vehicles and operate mechanisms.

Synopsis

Round tablets with beveled edges with a rough surface from pale green to green. Allowed a white coating, uneven color, the presence of air bubbles in the caramel mass and slight roughness of the edges.

Contraindications

Hypersensitivity to the active ingredients or any excipients of the drug.

Children under 6 years of age.

Cautions

High sensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including history).

Side effects

World Health Organization (WHO) recommended frequency of side effects:
very common ≥ 1/10
common ≥ 1/100 to < 1/10
infrequent ≥ 1/1000 to < 1/100
rare ≥ 1/10000 to < 1/1000
very rare < 1/10000
frequency unknown cannot be estimated based on available data.
Immune system disorders:
frequency unknown: hypersensitivity reactions, anaphylactic reactions.
Nervous system disorders:
frequency unknown: numbness of the oral mucosa.
Respiratory system, thoracic and mediastinal organs:
rarely: bronchospasm.
Gastrointestinal tract disorders:
very rare: irritation of the oral mucosa, burning sensation in the mouth.
Skin and subcutaneous tissue disorders:
rare: urticaria, photosensitization;
frequency unknown: angioedema, skin itching.

Overdose

Symptoms:Toxic manifestations of benzidamine overdose include: agitation, seizures, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when ingested in significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia with subsequent respiratory muscle paralysis, central nervous system depression, arterial hypotension and coma. Lethal dose for humans is about 1-3 grams.

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

Pregnancy use

Pregnancy

Consult your doctor before using Septoleta^® Total if you are pregnant or think you may be pregnant or are planning a pregnancy.

Breastfeeding period

In the period of breastfeeding, you should consult your doctor before using Septoleta^® total.

Similarities

Septolete, Septolete Total