Instructions for Septolete Total Lemon and Elderberry Lollipops Blister No. 16
Composition
active ingredients: benzydamine hydrochloride, cetylpyridinium chloride;
1 lollipop contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride;
excipients: peppermint oil, levomenthol, sucralose, citric acid, isomalt (type M) (E 953), lemon flavoring (contains butylhydroxyanisole (E 320)), elderberry flavoring (contains propylene glycol), dye Curcumin (contains sodium benzoate (E 211)), dye copper chlorophyllin complex (contains propylene glycol).
Dosage form
Lollipops.
Main physicochemical properties: round lollipops with beveled edges and an uneven surface from pale green to green with possible white spots, uneven coloring, air bubbles and slightly jagged edges.
Pharmacotherapeutic group
Throat preparations. Antiseptics. Other throat preparations. ATX code R02AX03.
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). In vivo studies with cetylpyridinium chloride have demonstrated antiviral activity, but the clinical relevance has not been determined. 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 evidenced by the amounts found in the blood serum, which are not sufficient to produce a systemic effect.
Distribution
When applied topically, benzydamine accumulates in inflamed tissues, where it reaches effective concentrations due to its ability to penetrate the epithelium.
Breeding
Excretion occurs mainly in the urine, mostly in the form of inactive metabolites.
Indication
Symptomatic treatment of throat and oral cavity infections (pharyngitis, laryngitis, gingivitis).
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 Lemon and Elderberry 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 Lemon and Elderberry should not be used for more than 7 days. If there is no improvement within 3 days of treatment, consult a doctor.
The use of topical preparations, especially over a long period of time, may lead to sensitization, in which case treatment should be discontinued and appropriate therapy should be prescribed.
Septolete® total lemon and elderberry 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 lollipop immediately before or after brushing your teeth.
The use of preparations containing benzydamine is not advisable in patients with hypersensitivity to salicylates (e.g. acetylsalicylic acid and salicylic acid) or to other non-steroidal anti-inflammatory drugs.
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, vomiting, the patient should consult a doctor, especially in cases where the condition does not improve within 3 days.
Bronchospasm may occur in patients with a history of bronchial asthma. The drug should be used with caution in such patients.
If the patient suffers from chronic cough or hoarseness, a doctor should be consulted.
Septolete® total lemon and elderberry contains butylhydroxyanisole (E 320) and may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
Septolete® total lemon and elderberry contains sodium benzoate (E 211) and may be moderately irritating to the skin, eyes and mucous membranes.
Septolete® total lemon and elderberry contains propylene glycol and may cause skin irritation.
Use during pregnancy or breastfeeding
Pregnancy
Due to the lack of sufficient data on the use of the active ingredients, the drug Septolete® total lemon and elderberry is not recommended for pregnant women.
Breastfeeding period
It is not known whether benzydamine and its metabolites are excreted in human milk, but a risk to the newborn or infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Septolete® Total Lemon and Elderberry taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Ability to influence reaction speed when driving vehicles or other mechanisms
Septolete® total lemon and elderberry has no or negligible effect on the speed of reaction when driving or operating machinery.
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 Lemon and Elderberry 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 due to the dosage form. Children aged 6-11 years should use the drug under adult supervision.
Overdose
Due to the low concentrations of both active substances in the preparation Septolete® Total Lemon and Elderberry, overdose is impossible when used in recommended doses.
Symptoms
Toxic manifestations of benzydamine overdose include agitation, convulsions, sweating, ataxia, tremors, and vomiting. Since there is no specific antidote, treatment of acute overdose is symptomatic.
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, central nervous system depression, hypotension and coma. The lethal dose for humans is approximately 1-3 g (which exceeds the maximum daily dose of Septolete® Total Lemon and Elderberry 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 | | | anaphylactic shock, hypersensitivity reactions |
| From the nervous system | | | burning sensation of the mucous membrane |
| Respiratory system | bronchospasm | laryngospasm | |
| Gastrointestinal tract | burning sensation in the 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.
Report of expected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Pharmacovigilance System at the link: https://aisf.dec.gov.ua.
Expiration date
4 years.
Storage conditions
This medicinal product does not require any special temperature 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, 1 or 2, or 3, or 4, or 5 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
KRKA, dd, Novo mesto/KRKA, dd, Novo mesto.
Location of the manufacturer and address of its place of business
Smarjeska cesta 6, 8501 Novo mesto, Slovenia.
