Septolete total pills 3mg + 1mg №16

Qualitative and quantitative composition

1 lozenge contains:

Active ingredients:

Benzydamine hydrochloride 3,000 mg

Cetylpyridinium chloride monohydrate 1,050 mg, equivalent to cetylpyridinium chloride 1,000 mg

Excipients: eucalyptus leaf leaves oil 1,200 mg, levomenthol 5,000 mg, sucralose (E955) 3,500 mg, citric acid (E330) 15,000 mg, isomalt (type M) (E953) 2471.285 mg, dye brilliant blue (E133) 0.015 mg

Pharmaceutical form

Round pills with beveled edges with a rough surface from light blue to blue. White bloom, uneven coloring, the presence of air bubbles in the caramel mass and a slight unevenness of the edges.

Clinical data

Indications for use

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

Contraindications

Hypersensitivity to the active substances, or to any auxiliary components of the drug.

Children's age up to 12 years.

Hypersensitivity to Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including a history of). Use during pregnancy and during breastfeeding

Pregnancy

The use of the drug Septoleta total during pregnancy and during breastfeeding is possible only after consulting with the attending physician, if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Dosage and administration

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

Adults and Elderly Patients

The recommended dose is 3-4 pills a day.

Do not exceed the specified dose.

To achieve an optimal effect, do not use Septolet Total just before or after brushing your teeth.

Side effect

Classification of the incidence of side effects recommended by the World Health Organization (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 unknown cannot be estimated based on available data.

Immune system disorders:

rarely: hypersensitivity reactions.

Frequency unknown: Anaphylactic reactions.

Nervous system disorders:

frequency unknown: numbness of the oral mucosa.

Disorders of the respiratory system, organs of the chest and mediastinum:

rarely: bronchospasm.

Violations of the gastrointestinal tract:

very rarely: irritation of the oral mucosa, burning sensation in the mouth.

Violations of the skin and subcutaneous tissues:

seldom: urticaria, photosensitivity.

Frequency unknown: angioedema, pruritus.

Overdose

Symptoms: toxic manifestations of benzydamine overdose include: agitation, convulsions, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when ingesting significant amounts of cetylpyridinium chloride include: nausea, vomiting, swelling, cyanosis, asphyxia followed by paralysis of the respiratory muscles, depression of the central nervous system, hypotension and coma.

Lethal dose for humans is about 1-3 g.

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

Interaction with other drugs

Not studied. It is necessary to avoid simultaneous use with other drugs from the group of antiseptics.

special instructions

The drug Septoleta total should not be used for more than 7 days. In the absence of noticeable signs of improvement, you should consult a doctor.

With the use of the drug Septoleta, the development of hypersensitivity reactions is possible. In this case, it is recommended to discontinue treatment and consult a physician for appropriate therapy.

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

The use of Septolete Total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. The drug Septoleta total should not be used simultaneously with anionic compounds (for example, are present in toothpaste). Therefore, it is not recommended to use the drug immediately before or after brushing your teeth.

Simultaneous intake with milk can reduce the antimicrobial effect of cetylpyridinium chloride, therefore, 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 (for example, driving, working with moving machinery)

The preparation Septolete total does not affect the ability to drive vehicles and work with mechanisms.

Pharmacological properties

Pharmacodynamics

Mechanism of action

Benzydamine is a non-steroidal anti-inflammatory agent that has anti-inflammatory, analgesic and local anesthetic effects. Cetylpyridinium chloride - an antiseptic from the group of quaternary ammonium compounds, has an antimicrobial, antifungal, virucidal effect.

Pharmacokinetics

Suction

Of the two active ingredients, cetylpyridinium chloride and benzydamine, only benzydamine is absorbed through the mucous membranes.Therefore, cetylpyridinium chloride does not enter into pharmacokinetic interactions with benzydamine at the system level.

The absorption of benzydamine through the mucous membranes of the oral cavity and pharynx was shown by identifying the active substance in blood serum, the amount of which, however, was not enough to provide a systemic effect.

Benzydamine absorption is higher when using dosage forms that dissolve in the oral cavity compared to topical dosage forms (for example, oral spray).

Distribution

The distribution of all dosage forms is the same.

Removal

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

Pharmaceutical data

Release form

Tablets for sucking, 3 mg + 1 mg.

Storage conditions

At a temperature not higher than 25 ° С, in the original package

Keep out of the reach of children.