Instructions for Septolete Total Eucalyptus Lozenges No. 16
Composition
active ingredients: benzydamine hydrochloride, cetylpyridinium chloride;
1 lollipop contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride;
excipients: eucalyptus oil, levomenthol, sucralose, citric acid anhydrous, isomalt (type M), diamond blue FCF (E 133).
Dosage form
Lollipops.
Main physicochemical properties: round lollipops with beveled edges and an uneven surface from blue to blue in color with possible white spots, uneven coloring, air bubbles and slightly jagged edges.
Pharmacotherapeutic group
Throat preparations. Antiseptics. ATX code R02A A20.
Pharmacological properties
Pharmacodynamics
Mechanism of action
Benzydamine hydrochloride is a nonsteroidal anti-inflammatory and analgesic agent. The mechanism of action is believed to be related to the inhibition of prostaglandin synthesis and, therefore, to the reduction of signs of inflammation (such as pain, redness, swelling, heat). Benzydamine hydrochloride also has a moderate local analgesic effect.
Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds. It acts as a cationic detergent. Quaternary ammonium compounds bind to the surface of bacterial cells, penetrate through it and bind to the cytoplasmic membrane of the microorganism. As a result of binding, the cytoplasmic membrane of microbes increases its permeability to low-molecular ingredients, mainly potassium ions. The quaternary ammonium compounds then penetrate the cell, disrupting the functions of the cell and thus destroying it. Cetylpyridinium chloride has a broad spectrum of antimicrobial activity, as well as antifungal activity (for example, against Candida and Saccharomyces) and antiviral activity against some enveloped viruses. The most pronounced is the bactericidal effect on gram-positive bacteria (in particular, Staphylococcus). Gram-negative bacteria are moderately sensitive to cetylpyridinium chloride, while some strains of Pseudomonas are relatively insensitive.
Pharmacokinetics
Absorption
Of the two active substances, only benzydamine is absorbed, so no pharmacokinetic interaction at the systemic level occurs.
The absorption of benzydamine through the mucous membrane of the oral cavity and pharynx is indicated by the amounts found in serum, which are insufficient to produce a systemic effect.
Distribution
The volume of distribution of the drug in the form of lozenges and spray is the same.
Breeding
Excretion occurs mainly in the urine, mostly as inactive metabolites. The half-life and systemic clearance are similar for all dosage forms of the drug.
Indication
Symptomatic treatment of throat and oral cavity infections (pharyngitis, laryngitis, gingivitis, conditions before and after tooth extraction, etc.).
Contraindication
Hypersensitivity to the active substances or to any of the excipients.
Children's age up to 6 years.
Interaction with other medicinal products and other types of interactions
Septolete Total Eucalyptus should not be used simultaneously with other antiseptics.
Lozenges should not be dissolved with milk due to its ability to reduce the antiseptic activity of cetylpyridinium chloride.
Application features
Septolete Total Eucalyptus should not be used for more than 7 days. If there is no improvement within 3 days, consult a doctor.
Septolete Total Eucalyptus should not be used in combination with anionic compounds present in toothpastes (reduces the effectiveness of cetylpyridinium), therefore it is not recommended to suck the lozenge immediately before or after brushing your teeth.
It is not recommended for use in the presence of wounds in the mouth due to the slowing of healing due to the action of cetylpyridinium chloride.
In severe infections accompanied by high fever, headache, and vomiting, the patient should consult a doctor, especially if the condition does not improve within three days.
If the patient suffers from chronic cough or hoarseness, a doctor should be consulted.
Septolete Total Eucalyptus does not contain sugar.
Septolete Total Eucalyptus contains isomalt (E 953). This medicine should not be taken by patients with rare hereditary problems of galactose or fructose intolerance.
Ability to influence reaction speed when driving vehicles or other mechanisms
Septolete Total Eucalyptus has no or negligible influence on the speed of reaction when driving or using other mechanisms.
Use during pregnancy or breastfeeding
Pregnancy
Due to the lack of sufficient data, the use of Septolete Total Eucalyptus is not recommended for pregnant women.
Breastfeeding period
It is not known whether the drug is excreted in human milk, but a risk to the newborn or infant cannot be excluded. A decision on whether to discontinue breast-feeding or to discontinue/abstain from Septolete Total Eucalyptus should be made taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Method of administration and doses
Adults and children over 12 years of age are recommended to use 3-4 lozenges per day by slowly dissolving them in the mouth every 3-6 hours.
For the elderly, the recommended dose is the adult dose.
Children aged 6 to 12 years are recommended to use 3 lozenges per day by slowly dissolving them in the mouth every 3-6 hours.
Do not exceed recommended doses.
Septolete Total Eucalyptus can be used for 7 days.
Method of application
The lollipop should be slowly dissolved in the mouth.
For optimal results, do not suck on the lollipop immediately before or after brushing your teeth.
Children
Use in children under 6 years of age is contraindicated, which is due to the dosage form.
Children aged 6-11 years use this medicine under adult supervision.
Overdose
Due to the low concentrations of both active substances in the composition of the drug Septolete® total eucalyptus, overdose is impossible when used in recommended doses.
Symptoms
Toxic manifestations of benzydamine overdose include agitation, convulsions, sweating, ataxia, tremors, and vomiting.
Signs and symptoms of intoxication after ingestion of significant doses of cetylpyridinium chloride are nausea, vomiting, shortness of breath, cyanosis, asphyxia due to paralysis of the respiratory muscles, CNS depression, hypotension and coma. The lethal dose for humans is approximately 1-3 g (which exceeds the maximum daily dose of Septolete® Total Eucalyptus lozenges by 250-750 times).
Treatment
Since there is no specific antidote, treatment of acute overdose is symptomatic.
Adverse reactions
Very common ≥ 1/10;
often ≥ 1/100 - < 1/10;
uncommon ≥ 1/1000 - < 1/100;
rare ≥ 1/10,000 - < 1/1,000;
very rare < 1/10,000.
unknown (cannot be estimated from available data)
| Organ system | Rarely | Very rare | Unknown |
| On the part of the immune system | hypersensitivity reactions | | |
| Respiratory system | bronchospasm | laryngospasm | |
| Gastrointestinal tract | burning sensation in the mouth, dry mouth | irritation in the oral cavity | loss of sensitivity of the oral mucosa |
| Skin and subcutaneous tissue disorders | urticaria, photosensitivity | | |
If any adverse reactions occur, treatment should be discontinued and a doctor should be consulted.
Expiration date
3 years.
Storage conditions
This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light. Keep out of the reach of children.
Packaging
8 lollipops in a blister, 2 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, d.d., Novo mesto, Slovenia.
Location of the manufacturer and its business address
Šmarješka cesta 6, 8501 Novo mesto, Slovenia.
