Septotlet® Total (Septolete® total)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsplozenges
Composition:

1 tablet for resorption contains:

Active substances:

Benzidamine hydrochloride 3,000 mg

Cetylpyridinium chloride monohydrate 1.050 mg, equivalent to cetylpyridinium chloride 1,000 mg

Excipients: eucalyptus of the rosaceous leaf oil 1,200 mg, levomentol 5,000 mg, sucralose (E955) 3,500 mg, citric acid (E330) 15,000 mg, isomalt (type M) (E953) 2471.285 mg, brilliant blue dye (E133) 0.015 mg

Description:Round tablets with beveled edges with a rough surface from light blue to blue. Allowed white coating, uneven staining, the presence of air bubbles in the caramel mass and a slight uneven edges.
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. The absorption of benzidine is higher when using dosage forms that dissolve in the oral cavity compared with topical dosage forms (eg, oral spray).

    Distribution

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

    Excretion

    Excretion occurs mainly in the kidneys, to a greater extent, 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 12 years.
    Carefully:Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including in the anamnesis).
    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:

    Tablets should be slowly dissolved 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. Do not exceed the indicated dose.

    To achieve the optimum effect, do not use Sepethlet® total immediately before or after brushing your teeth.

    The drug Sepptethon® total should not be used concomitantly with other drugs from the group of antiseptics.The drug Sepptethon® Total should not be used for more than 7 days.

    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 lo <1/1000

    very rarely <1/10000

    the frequency of the unknown can not be estimated from the available data.

    Immune system disorders:

    rarely: hypersensitivity reactions;

    frequency unknown: anaphylactic reactions.

    Impaired 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 cavity

    Disturbances from the skin and subcutaneous tissues: rarely: urticaria, photosensitivity; frequency unknown: angioedema, skin itching.

    Overdose:

    Symptoms: toxic manifestations of benzodamine overdose include: agitation, convulsions, 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:
    The drug Sepotlet® Total should not be used more than 7 days. If there are no visible signs of improvement, you should consult your doctor.
    With the use of the drug Sepotlet® total, hypersensitivity reactions may develop. 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. Simultaneous reception with milk can reduce the antimicrobial effect of cetylpyridinium chloride, so the drug Sepotlet® Total should not be used simultaneously with milk.
    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:
    Tablets for resorption, 3 mg + 1 mg.
    Packaging:
    For 8 tablets in a blister of the combined material PVC / polyethylene / PVDH-aluminum flags.
    For 1, 2, 3 or 4 blisters are swept into a pack of cardboard along with instructions for use.
    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 years. Do not use the drug after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002981
    Date of registration:29.04.2015
    Expiration Date:29.04.2020
    The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO
    Information update date: & nbsp10.10.2015
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