Septollete Total lemon and honey, tablets 3 mg+1 mg 16 pcs

Pharmacotherapeutic group: nonsteroidal anti-inflammatory drug + antiseptic

ATX code: R02AA20
Pharmacological properties

Pharmacodynamics

Benzidamine is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and local anesthetic action.

Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, has antimicrobial, antifungal, virulicidal action.

Pharmacokinetics

Intake

From the two active substances – cetylpyridinium chloride and benzidamine – only benzidamine is absorbed through the mucous membranes. Therefore, cetylpyridinium chloride does not interact pharmacokinetically with benzidamine at the systemic level. Absorption of benzidamine through the oral and pharyngeal mucous membranes was demonstrated by detecting the active ingredient in serum, the amount of which, however, was insufficient to exert systemic action. Absorption of benzidamine is higher when using dosage forms that dissolve in the mouth compared to topical dosage forms (e.g., oral spray).

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

Excretion. Excretion occurs mainly by the kidneys, to a greater extent in the form of inactive metabolites. The elimination half-life and the total clearance are similar for all dosage forms.

Indications

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

Active ingredient

Benzidamine, Cetylpyridinium chloride

Composition

1 tablet for dissolving contains:

active ingredient:

Benzidamine hydrochloride 3,000 mg

Cetylpyridinium chloride monohydrate 1,050 mg, equivalent to cetylpyridinium chloride 1,000 mg

excipients: Eucalyptus twig leaf oil 1,200 mg, levomenthol 5,000 mg, sucralose (E955) 3,500 mg, citric acid (E330) 15,000 mg, isomalt (type M) (E953) 2471,285 mg, diamond blue dye (E133) 0,015 mg.

How to take, the dosage

Adults, elderly patients and children over 12 years

The recommended dose is 3-4 tablets per day.

Do not exceed the specified dose. For optimal effect the drug Septolete® total should not be used immediately before or after brushing teeth.

Septolete® total should not be used simultaneously with other drugs from antiseptic group. The drug Septolete® total should not be used for more than 7 days.

Interaction

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

Special Instructions

The drug Septolete® Total should not be used for more than 7 days. In the absence of noticeable signs of improvement the condition should consult a physician.

When using Septolete® total it is possible to develop hypersensitivity reactions. In this case it is recommended to discontinue the treatment and consult a physician in order to prescribe an appropriate therapy. In the presence of ulcerative lesions of oropharyngeal mucosa, the patient should consult a physician if the symptoms persist for more than three days.

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

The drug Septolete® total should not be used simultaneously with anionic compounds (e.g., present in toothpaste).

Therefore, it is not recommended to use the product immediately before or after brushing your teeth.

Simultaneous use with milk may decrease the antimicrobial activity of cetylpyridinium chloride, so Septolate® Total should not be used with milk.

Impact on the ability to perform potentially hazardous activities requiring particular attention and quick reactions (e.g., driving, operating moving machinery)

The drug Septolete® total has no effect on the ability to drive vehicles and operate machinery.

Contraindications

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

With caution

Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, bronchial asthma (including anamnesis).

Side effects

World Health Organization (WHO) recommended frequency of side effects:

• very frequently >1/10
• often from >1/100 to <1/10
• frequently from >1/1000 to <1/100
• often from >1/10000 to < 1/1000
• very rarely <1/10000
• frequency unknown cannot be estimated from available data.

Immune system disorders: rare: hypersensitivity reactions; frequency unknown: anaphylactic reactions.

Nervous system disorders: frequency unknown: numbness of the oral mucosa.

Respiratory system, thoracic and mediastinal organs: rare: bronchospasm.

Gastrointestinal tract disorders very rare: irritation of the oral mucosa, burning sensation in the cavity

Skin and subcutaneous tissue disorders: rare: urticaria, photosensitization; frequency unknown: angioedema, skin itching.

Overdose

Symptoms: toxic manifestations of benzidamine overdose include: agitation, seizures, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when significant amounts of cetylpyridinium chloride are ingested: nausea, vomiting, edema, cyanosis, asphyxia followed by respiratory muscle paralysis, central nervous system depression, arterial hypotension and coma. The lethal dose for a human is about 1-3 grams.

Treatment: Since there is no specific antidote the treatment of acute intoxication with benzidamine is symptomatic. Treatment of cetylpyridinium chloride overdose is also symptomatic. In case of overdose it is necessary to consult a physician.

Pregnancy use

Application of Septolete® total during pregnancy and lactation is possible only after consultation with the attending physician in case if the expected benefits to the mother exceed the potential risk to the fetus and child.

Similarities

Septolete, Septolete Total