Septotlet® Total (Septolete® total)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspfromprey for topical application dosed
Composition:

1 dose of spray contains:

Active substances:

Benzodamine 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 glyceryl hydroxy stearate 0.250 mg, sodium saccharinate 0.092 mg, peppermint mint oil 0.100 mg, water purified to 0.1 ml

1 ml of spray contains:

Active substances:

Benzodamine 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 glyceryl hydroxy stearate 2.50 mg, sodium saccharinate 0.920 mg, peppermint mint oil 1.00 mg, water purified 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.

Description:

Transparent solution from colorless to yellowish color.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug + antiseptic
ATX: & nbsp
  • Other drugs
    • Pharmacodynamics:Benzidamine - a non-steroidal anti-inflammatory agent with anti-inflammatory, analgesic and local anesthetic action.
    Cetylpyridinium chloride - antiseptic from the group of quaternary ammonium compounds, has antimicrobial, antifungal, virucidal effect.
    Pharmacokinetics:

    Suction

    Of the two active substances - cetylpyridinium chloride and benzydamine - only mucous membranes are absorbed benzydamine. therefore cetylpyridinium chloride does not enter into a pharmacokinetic interaction with benzidamine at the systemic level.

    The absorption of benzidamine through the mucous membranes of the oral cavity and pharynx has been shown by identifying the active substance in the blood serum, the amount of which, nevertheless, was insufficient to provide systemic action.

    When using benzidamine in a dosage form, spray for topical use at recommended doses of absorption is insignificant.

    Distribution

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

    Excretion

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

    Indications:

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

    Contraindications:

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

    Children under 18 years.

    Carefully:

    Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including history), liver disease, alcoholism, traumatic brain injury, brain disease, pregnancy, the period of breastfeeding.

    Pregnancy and lactation:

    The use of the drug Sepotlet® Total during pregnancy and during breastfeeding is possible only after consultation with the attending physician, if the intended benefit to the mother exceeds the potential risk to the fetus and the baby.

    Dosing 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 indicated dose.

    To achieve the best effect, do not use Sepethlet® 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 administration and the doses specified in the instructions.

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

    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 the drug Sepotlet® Total, several times, press the spray head of the dosing device until a uniform
    spraying. If the drug Sepotlet® Total was not used for a long time (for at least 1 week), press the spray head of the dispenser 1 time to obtain a uniform spray.

    Before use, remove the colored protective cap.

    Widely open your mouth, direct the tube of the applicator into the mouth, hold your breath and press the spray head 2 times.

    After each use of the drug Sepotlet® Total, cover the spray head with a colored protective cap.

    With a single press on the spray head, 0.1 ml of a spray solution is dispensed, which contains 0.15 mg of benzidamine and 0.5 mg of cetylpyridinium chloride.

    Side effects:

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

    Often

    ≥1/10

    often

    from ≥ 1/100 to <1/10

    infrequently

    from ≥ 1/1000 to <1/100

    rarely

    from ≥ 1/10000 to <1/1000

    rarely

    < 1/10000

    frequency unknown

    can not be estimated from the available data.

    Immune system disorders:

    rarely: hypersensitivity reactions.

    Disturbances from the nervous system:

    frequency unknown: numbness of the oral mucosa.

    Disturbances from the respiratory system, chest and mediastinal organs:

    rarely: bronchospasm.

    Disorders from the gastrointestinal tract:

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

    Disturbances from the skin and subcutaneous tissues:

    rarely: hives, photosensitivity.

    frequency unknown: angioedema, skin itching.

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

    Overdose:

    Symptoms: toxic manifestations of benzodamine overdose include: agitation, seizures and, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when ingesting 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: in view of the absence of a specific antidote, the treatment of acute intoxication with benzydamine is symptomatic. Treatment of an overdose of cetylpyridinium chloride is also symptomatic. In case of overdose, see a doctor.

    Interaction:

    Not studied.

    Avoid simultaneous application with other drugs from the group of antiseptics.

    Special instructions:

    Read the instructions carefully before using the product. Keep the manual, it may be needed again. If you have any questions, contact your doctor.

    The medicine you are treating is intended for you personally and should not be transferred to others because it can harm them even if you have the same symptoms,as well as you.

    With the use of the drug Sepotlet ® total, the development of a hypersensitivity reaction to the drug is possible. In this case, it is recommended that you stop treatment and consult with your doctor to prescribe appropriate therapy.

    If there is a ulcerative lesion of the mucous membrane of the oropharynx, the patient should consult a doctor if the symptoms persist for more than three days.

    The use of the drug Sepotlet® Total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

    The drug Sepotlet® Total should not be used simultaneously with anionic compounds (for example, present in toothpaste). Therefore, the use of the drug is not recommended immediately before or after brushing the teeth.

    It is necessary to avoid the contact of the drug Septhlet® total with the mucous membrane of the eyes.

    Spray can not be inhaled.

    The drug Sepotlet® Total contains a small amount of ethanol 96%: 26,760 mg / 1 dose of spray.

    After opening the vial, the drug should be used within 6 months.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:

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

    Packaging:

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

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

    Storage conditions:

    At a temperature of no higher than 25 ° C, in the original packaging.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003914
    Date of registration:20.10.2016
    Expiration Date:20.10.2021
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA KRKA Slovenia
    Information update date: & nbsp11.11.2016
    Illustrated instructions
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