SEPTOLETE TOTAL SPRAY 0.15MG + 0.5MG/DOSE 30ML

Tradename: 

Septolet&№174; Total

International non-proprietary or grouping name: 

benzydamine + cetylpyridinium chloride

Composition

1 spray dose contains:
Active ingredients:
Benzydamine hydrochloride 0.150 mg
Cetylpyridinium chloride monohydrate 0.526 mg, equivalent to cetylpyridinium chloride 0,500 mg
Excipients: ethanol 26.760 mg, glycerol 10.450 mg, macrogol glycerylhydroxystearate 0.250 mg, sodium saccharinate 0.092 mg, peppermint oil, 0.100 mg, purified water to 0.1 ml
1 ml of spray contains:
Active ingredients:
Benzydamine hydrochloride 1.50 mg
Cetylpyridinium chloride monohydrate 5.26 mg, equivalent to cetylpyridinium chloride 5.00 mg
Excipients: ethanol 267.60 mg, glycerol 104.50 mg, macrogol glycerylhydroxystearate 2.50 mg, sodium saccharinate 0.920 mg, peppermint oil, oil 1.00 mg, purified water to 1 ml
1 dose of the drug - about 0.1 ml of solution.
30 ml of the drug in the primary package contain 250 doses.

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.

Carefully

Hypersensitivity to Acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including a history), liver disease, alcoholism, brain injury, brain disease, pregnancy, breastfeeding period.

Use during pregnancy and during breastfeeding

Use of the drug Septolet ® total during pregnancy and during breastfeeding is possible only after consulting with your doctor if the intended benefit to the mother outweighs the potential risk to the fetus and child.

Dosage and administration

Locally.
Adults
To obtain a single dose, press the spray head 2 times.
It is recommended to apply every 2 hours, 5 times a day for 4 days.
Do not exceed the specified dose.
To achieve an optimal effect, it is not recommended to use the drug Septolet&№174; total immediately before or after brushing your teeth.
If there is no improvement after treatment or new symptoms appear, it is necessary to consult a doctor.
Use the drug only according to the method of use and in those doses that are indicated in the instructions.
If necessary, please consult a physician before using the drug.
You should see a doctor if symptoms worsen or do not improve after 4 days of treatment.

Mode of application

Before the first use of Septolete&№174;, the total should be pressed several times on the spray head of the dosing device until a uniform
spraying. If Septolet ® 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.
Before use, remove the colored protective cap

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

After each use of the preparation Septolet&№174; total, close the spray head with a colored protective cap.
When you press once on the spray head, 0.1 ml of the solution is dispensed as a spray, which contains 0.15 mg of benzydamine and 0.5 mg of cetylpyridinium chloride.

Side effect

The 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.
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 is unknown: angioedema, pruritus.
If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects that are not indicated in the instruction, inform your doctor.

Overdose

Symptoms: toxic manifestations 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, arterial hypotension and coma. Lethal dose for humans is about 1-3 g.Treatment: due to 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

Read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, consult your doctor.
The medication with which you are being treated is intended for you personally, and should not be passed on to others, since it can harm them even if you have the same symptoms as you.
When using the drug Septolet ® total, you may develop a hypersensitivity reaction to the drug. 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
Seek medical attention if symptoms persist for more than three days.
The use of the drug Septolet ® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
Septolete&№174; Total should not be used simultaneously with anionic compounds (for example, they are present in toothpaste). Therefore, it is not recommended to use the drug immediately before or after brushing your teeth.
Contact of Septolete&№174; Total with eye mucosa should be avoided.
Spray can not be inhaled.
Septolete&№174; Total contains a small amount of ethanol 96%: 26.760 mg / 1 dose spray.
After opening the bottle, the drug should be used within 6 months.

Influence on ability to steer vehicles, mechanisms
The preparation Septolete&№174; total does not affect the ability to drive and work with mechanisms.

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug + antiseptic.

Pharmacological properties

Pharmacodynamics
Benzydamine is a non-steroidal anti-inflammatory agent that has anti-inflammatory, analgesic and local anesthetic action. 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 interaction 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.
When using benzydamine in the dosage form, a spray for local use at the recommended doses, absorption is insignificant.
Distribution
The distribution of all dosage forms is the same.
Removal
Excretion occurs mainly by the kidneys, mostly in the form of inactive metabolites. The half-life and total clearance are similar for all dosage forms.

Storage conditions

At a temperature not higher than 25 ° С, in the original package.
Keep out of the reach of children.

Shelf life

2 years.
Do not use the drug after the expiration date.

Vacation conditions

Let go without a prescription.