Septollete Total, spray 0.15 mg+0.5 mg/dose 250 doses 30 ml

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

Active ingredient

Benzidamine, Cetylpyridinium chloride

Composition

1 dose of spray/1 ml of spray

Active substances:

Benzidamine 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

Auxiliaries: ethanol, glycerol, macrogol glyceryl hydroxystearate, sodium saccharinate, peppermint leaf oil, purified water

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

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

How to take, the dosage

Locally.

Badults and children over the age of 12

Press the spray head 1-2 times for a single dose.

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

Children ages 6 to 12

Press the spray head once for a single dose. It is recommended to use every 2 hours, 3-5 times a day for 4 days.

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

Do not exceed the indicated dose.

For optimal effect, do not use Septollete® Total immediately before or after brushing teeth.

If there is no improvement after treatment or new symptoms appear, a doctor should be consulted.

Use the drug only as directed and in the doses indicated.

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

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

Method of Use

Before the first use of Septollete^® Total, press the spray head of the dispenser several times until an even spray is obtained. If Septollete® Total has not been used for a long time (for at least 1 week), press the spraying head of the dispenser once to obtain a uniform spray pattern.

Please remove the colored protective cap before use.

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

After each use of Septollete^® total, close the spray head with the colored protective cap.

A single press of the spray head produces 0.1 ml of a spray solution that contains 0.15 mg of benzidamine and 0.5 mg of cetylpyridinium chloride.

Interaction

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

Special Instructions

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including anamnesis), liver disease, alcoholism, craniocerebral trauma, brain disease.

Dchildren over age 12

Press the nebulizer head 1-2 times for a single dose.

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

Children ages 6 to 12

Press the spray head once for a single dose. It is recommended to use every 2 hours, 3-5 times a day for 4 days.

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

Contraindicated in children under 6 years of age.

Take with caution in patients with bronchial asthma (including anamnesis), liver disease, brain disease, alcoholism.

Read the instructions carefully before you begin using the drug. Keep the instructions; you may need them again. If you have any questions, ask your doctor.

The medicine you are taking is for you personally and should not be given to others because it could cause them harm even if you have the same symptoms.

When using Septoleta^® Total you may develop a hypersensitivity reaction to the drug. In this case it is recommended to stop the treatment and consult the doctor in order to prescribe an appropriate therapy.

In case of oropharyngeal ulceration, the patient should consult a physician if symptoms persist for more than three days.

The use of Septollete^® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

The drug Septollete^® 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 teeth.

Contact of Septollete^® total with the eye mucosa should be avoided.

The spray should not be inhaled.

A single dose of Septollete^® total contains 0.0264 g of absolute ethyl alcohol, the maximum daily dose of Septollete^® 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 within 6 months.

When using the drug, care must be taken when performing potentially hazardous activities requiring high concentration and quick psychomotor reactions (driving vehicles, operating moving machinery, operator’s work).

Synopsis

Transparent solution is colorless to yellowish in color.

Contraindications

– Hypersensitivity to the active substances, or to any excipients of the drug.

– Children under 6 years of age.

– Pregnancy, breastfeeding period.

Side effects

World Health Organization (WHO) recommended side effect frequency classification:

very frequently ≥1/10

often ≥ 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 cannot be estimated from available data.

Immune system disorders:

frequency unknown: hypersensitivity reactions, anaphylactic reactions.

Nervous system disorders:

frequency unknown: oral mucosa numbness.

Respiratory system, thoracic and mediastinal organs:

Rare: bronchospasm.

Gastrointestinal tract disorders:

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

Dermal and subcutaneous tissue disorders:

Rarely: urticaria, photosensitivity;

frequency unknown: angioedema, skin itching.

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

Overdose

Symptoms

Intoxication is possible only if significant amounts of benzidamine (> 300 mg) are accidentally ingested. In overdose of benzidamine, symptoms are observed mainly on 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 when ingested in significant amounts of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, dyspnea, asphyxia with subsequent paralysis of respiratory muscles, central nervous system depression, arterial hypotension and coma. The lethal dose for a human is about 1-3 grams.

Treatment

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

Treatment of cetylpyridinium chloride overdose is also symptomatic. In case of overdose it is necessary to consult a doctor.

Pregnancy use

The use of Septollete^® total is contraindicated in pregnancy and during breastfeeding. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Similarities

Septolete, Septolete Total