Septolete Total 3mg + 1mg Eucalyptus, 16pcs

Composition

1 tablet for resorption of lemon and honey contains:

Active ingredients:

Benzydamine Hydrochloride 3,000 mg

Cetylpyridinium Chloride Monohydrate 1,050 mg, equivalent to Cetylpyridinium chloride 1,000 mg

Excipients: isomalt (type M) (E 953), citric acid (E 330), sucralose (E 955), honey flavor, lemon flavor, levomentol, curcumin dye (E 100)1), peppermint leaf oil

1) Dye curcumin (E 100): curcumin (E 100), maltodextrin, acacia gum (E 414), emulsifier (E 472 C), citric acid (E 330), potassium sorbate (E 202), sodium benzoate (E 211), purified water.

Pharmacological action

nonsteroidal anti-inflammatory drug + antiseptic agent

Clinical Pharmacology

Pharmacodynamics

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

Pharmacokinetics

Suction

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

The absorption of benzydamine through the mucous membranes of the oral cavity and pharynx was shown by detecting the Active ingredient in the blood serum, the amount of which, however, was not enough to have a systemic effect. The absorption of benzydamine is higher when using dosage forms that are dissolved in the oral cavity compared to topical dosage forms (for example, oral spray).

Distribution

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

Deduction

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

Indications

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

Use during pregnancy and lactation

Pregnancy

Before using Septolete total, if you are pregnant, or believe that you might be pregnant, or are planning to become pregnant, you should consult your doctor.

Breast-feeding period

During breastfeeding, you should consult your doctor before using Septolete total.

Contraindications

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

Children under 6 years of age.

Side effects

Classification of the incidence of side effects recommended by the World Health Organization (WHO):

very common ≥ 1/10

common ≥ 1/100 to < 1/10

uncommon ≥ 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, thoracic and mediastinal disorders:

rare: bronchospasm.

Disorders of the gastrointestinal tract:

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

Skin and subcutaneous tissue disorders:

rare: urticaria, photosensitization;

frequency unknown: angioedema, pruritus of the skin.

Interaction

Not studied. Simultaneous use with other drugs from the group of antiseptics should be avoided.

How to take, course of use and dosage

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

Adults, elderly patients, and children over 12 years of age

The recommended dose is 3-4 tablets per day.

Children from 6 to 12 years old

The recommended dose is 3 tablets per day.

Do not exceed the indicated dose.

Septolete Total should not be used concomitantly with other antiseptic medications.

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

Overdose

Symptoms: Toxic effects of benzydamine overdose include: agitation, convulsions, increased sweating, ataxia, chills, and vomiting. Signs and symptoms of intoxication with ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia followed by paralysis of the respiratory muscles, central nervous system depression, hypotension and coma. The lethal dose for a person is about 1-3 g.

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

Description

Round tablets with beveled edges with a rough surface from light yellow to yellow in color. White coating, uneven coloring, the presence of air bubbles in the caramel mass and slight unevenness of the edges are allowed.

Special instructions

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis).

Children over 12 years of age

The recommended dose is 3-4 tablets per day.

Children from 6 to 12 years old

The recommended dose is 3 tablets per day.

Contraindicated in children under 6 years of age.

Use with caution in patients with bronchial asthma (including in the anamnesis).

Elderly patients

The recommended dose is 3-4 tablets per day.

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

If there is an ulcerative lesion of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than three days.

Application of the drug Septolete® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

The drug Septolete® total should not be used simultaneously with anionic compounds (for example, present in toothpaste). To achieve an optimal effect, do not use Septolete® total immediately before or after brushing your teeth.

Concomitant use with milk may reduce the antimicrobial effect of cetylpyridinium chloride, so the drug Septolete® total should not be used simultaneously with milk.

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

Form of production

Tablets for resorption lemon and honey,3 mg + 1 mg.

8 tablets each in a blister of combined PVC / polyethylene material/PVDH-aluminum foil.

1,2,3 or 4 blisters are placed in a cardboard pack together with the instructions for use.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging (blister pack).

Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date.

Active ingredient

Benzydamine, Cetylpyridinium chloride

Dosage form

resorption tablets