Septollete Total Eucalyptus, tablets 3 mg+1 mg 16 pcs

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.

Indications

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

Pharmacological effect

non-steroidal anti-inflammatory drug + antiseptic

Special instructions

Hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, bronchial asthma (including a history).

Children over 12 years old

The recommended dose is 3-4 tablets per day.

Children from 6 to 12 years old

The recommended dose is 3 tablets per day.

Contraindicated for children under 6 years of age.

Use with caution in patients with bronchial asthma (including a history of asthma).

Elderly patients

The recommended dose is 3-4 tablets per day.

Septolete® total should not be used for more than 7 days. If there are no noticeable signs of improvement, you should consult a doctor.

When using Septolete® total, hypersensitivity reactions may develop. In this case, it is recommended to stop treatment and consult a doctor to prescribe appropriate therapy.

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

The use of Septolete® 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 (for example, present in toothpaste). To achieve optimal results, Septolete® total should not be used immediately before or after brushing your teeth.

Concomitant use with milk may reduce the antimicrobial effect of cetylpyridinium chloride, therefore Septolete® total should not be used simultaneously with milk.

The drug Septolete® total does not affect the ability to drive vehicles or operate machinery.

Active ingredient

Benzidamine, Cetylpyridinium chloride

Composition

1 lemon and honey lozenge contains:

Active ingredients:

Benzydamine hydrochloride 3,000 mg

Cetylpyridinium chloride monohydrate 1.050 mg, equivalent to cetylpyridinium chloride 1.000 mg

Excipients: isomalt (type M) (E953), citric acid (E330), sucralose (E955), honey flavor, lemon flavor, levomenthol, curcumin dye (E100)1), peppermint leaf oil

1) Curcumin dye (E100): curcumin (E100), maltodextrin, acacia gum (E414), emulsifier (E472c), citric acid (E330), potassium sorbate (E202), sodium benzoate (E211), purified water.

Pregnancy

Pregnancy

Before using Septolete® total, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.

Breastfeeding period

During breastfeeding, you should consult your doctor before using Septolete® total.

Contraindications

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

Children’s age up to 6 years.

Side Effects

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

very common ≥ 1/10

often ≥ 1/100 to < 1/10

uncommon ≥ 1/1000 to < 1/100

rarely from ≥ 1/10000 to < 1/1000

very rare <1/10000

frequency unknown cannot be estimated from available data.

Immune system disorders:

frequency unknown: hypersensitivity reactions, anaphylactic reactions.

Nervous system disorders:

frequency unknown: numbness of the oral mucosa.

Disorders of the respiratory system, chest and mediastinal organs:

rarely: bronchospasm.

Gastrointestinal disorders:

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

Disorders of the skin and subcutaneous tissues:

rarely: urticaria, photosensitivity;

frequency unknown: angioedema, skin itching.

Interaction

Not studied. Simultaneous use with other drugs from the group of antiseptics should be avoided.

Overdose

Symptoms: Toxic manifestations of benzydamine overdose include: agitation, convulsions, increased sweating, ataxia, chills and vomiting. Signs and symptoms of intoxication when ingesting significant quantities of cetylpyridinium chloride: nausea, vomiting, edema, cyanosis, asphyxia with subsequent paralysis of the respiratory muscles, depression of the central nervous system, arterial hypotension and coma. The lethal dose for humans is about 1-3 g.

Treatment: due to the lack of a specific antidote, treatment of acute benzydamine intoxication is symptomatic. Treatment of cetylpyridinium chloride overdose is also symptomatic. In case of overdose, consult a doctor.

Clinical pharmacology

Pharmacodynamics

Benzydamine is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and local anesthetic effects. Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, has antimicrobial, antifungal, and virucidal effects.

Pharmacokinetics

Suction

Of the two active ingredients – cetylpyridinium chloride and benzydamine – only benzydamine is absorbed through the mucous membranes. Therefore, cetylpyridinium chloride does not interact pharmacokinetically with benzydamine at the systemic level.

The absorption of benzydamine through the mucous membranes of the oral cavity and pharynx was shown by detecting the active substance in the blood serum, the amount of which, however, was insufficient to provide a systemic effect. Absorption of benzydamine is greater with dosage forms that dissolve in the mouth compared to topical dosage forms (eg, oral spray).

Distribution

The volume of 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 exceeding 25 °C, in the original packaging (blister in a pack).

Keep out of the reach of children.

Shelf life

3 years.

Do not use the drug after the expiration date.

Manufacturer

KRKA dd Novo Mesto, Slovenia