Septolete Total external spray for external use, 30ml

Composition

1 dose of spray/1 ml of spray

Active ingredients:

Benzydamine Hydrochloride 0.150 mg / 1.50 mg

Cetylpyridinium chloride monohydrate 0.526 mg / 5.26 mg, equivalent to Cetylpyridinium chloride 0.500 mg/5.00 mg

Excipients: ethanol, glycerol, macrogol glycerylhydroxystearate, sodium saccharinate, peppermint leaf oil, purified water

1 dose of the drug – about 0.1 ml of solution.

30 ml of the drug in the primary package contains 250 doses.

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.

When using benzydamine in the dosage form of a topical spray at the recommended doses, absorption is insignificant.

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

Application of the drug Septolete® total is contraindicated during pregnancy and lactation. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Contraindications

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

* Children under 6 years of age.

* Pregnancy, breast-feeding period.

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, photosensitivity;

frequency unknown: angioedema, pruritus of the skin.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

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

How to take, course of use and dosage

Locally.

Adults and children over 12 years of age

To get a single dose, press the spray head 1-2 times.

It is recommended to apply every 2 hours,3-5 times a day for 4 days.

Children aged 6-12 years

To get a single dose, press the spray head 1 time. It is recommended to apply every 2 hours,3-5 times a day for 4 days.

In children aged 6-12 years, the drug should be used only after consulting a doctor.

Do not exceed the indicated dose.

To achieve an optimal effect, it is not recommended to use the drug Septolete® total immediately before or after brushing your teeth.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

Use the drug only according to the method of use and in the doses indicated in the instructions.

If necessary, please consult your doctor before using the medicine.

You should see your doctor if symptoms worsen or do not improve after 4 days of treatment.

Method of application

Before applying Septolete Total for the first time, press the spray head of the dispenser several times until a uniform spray pattern is obtained. If Septolete® total has not been used for a long time (for at least 1 week), you should press the spray head of the dosing device 1 time until a uniform spray is obtained.

Remove the colored protective cap before use.

Open your mouth wide, point the applicator tube into your mouth, hold your breath, and press the spray head 1-2 times.

After each application of Septolete total, cover the spray head with a colored protective cap.

When the spray head is pressed once,0.1 ml of the spray solution is released, which contains 0.15 mg of benzydamine and 0.5 mg of cetylpyridinium chloride.

Overdose

Symptoms

Intoxication is only possible if significant amounts of benzydamine (> 300 mg) are accidentally ingested. Benzydamine overdose is associated with symptoms, mainly from the gastrointestinal tract (GIT) and central nervous system (CNS). The most common gastrointestinal symptoms are nausea, vomiting, abdominal pain, and irritation of the esophageal mucosa. CNS symptoms include dizziness, hallucinations, agitation, restlessness, and irritability.

Signs and symptoms of intoxication with ingestion of significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, dyspnoea, 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

In acute benzydamine overdose, treatment is symptomatic. Medical supervision, supportive therapy, and adequate hydration should be provided.

Treatment of cetylpyridinium chloride overdose is also symptomatic. In case of overdose, you should consult a doctor.

Description

Clear solution from colorless to yellowish color.

Special instructions

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis), liver disease, alcoholism, traumatic brain injury, brain diseases.

Child over 12 years old

To get a single dose, press the spray head 1-2 times.

It is recommended to apply every 2 hours,3-5 times a day for 4 days.

Children aged 6-12 years

To get a single dose, press the spray head 1 time. It is recommended to apply every 2 hours,3-5 times a day for 4 days.

In children aged 6-12 years, the drug should be used only after consulting a doctor.

Contraindicated in children under 6 years of age.

Use with caution in patients with bronchial asthma (including:h. in the anamnesis), liver diseases, brain diseases, alcoholism.

Please read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, contact your doctor.

The medicine you are being treated with is intended for you personally, and it should not be passed on to others, as it can cause harm to them even if you have the same symptoms as you do.

When using the drug Septolete® total hypersensitivity reactions to the drug may occur. 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). Therefore, it is not recommended to use the drug immediately before or after brushing your teeth.

Avoid contact of Septolete total with the eye mucosa.

Do not inhale the spray.

Single dose of Septolete® total contains 0.0264 g of absolute ethyl alcohol, the maximum daily dose of Septolete® total for children 6-12 years old contains 0.132 g of absolute ethyl alcohol, for children 12 years and older and adults – 0.264 g.

After opening the bottle, the drug should be used for 6 months.

During the period of using the drug, care should be taken when performing potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, working as a dispatcher, operator).

Form of production

Spray for topical application dosed,0.15 mg + 0.5 mg / dose.

30 ml (250 doses) of the drug in a high-density polyethylene bottle equipped with a dosing device (pump), with a spray head with an applicator tube made of combined material and a colored protective cap made of polypropylene.

1 bottle together with the instructions for use is placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 °C, in the original packaging.

Keep out of reach of children.

Shelf

life is 2 years.

Do not use the drug after the expiration date.

Active ingredient

Benzydamine, Cetylpyridinium chloride

Dosage Form

Oral spray