Septolete Total lemon and honey lozenges 3mg/1mg No. 8x2


Septolete total

Septolete total is a combined two-component drug in the form of tablets for resorption in the oral cavity, which includes the NSAID benzydamine and the disinfectant cetylpyridinium chloride. Benzidamine has an anti-inflammatory, analgesic effect and causes local loss of sensitivity. Cetylpyridinium chloride exhibits antibacterial, antimycotic and antiviral effects. Of the two components of the drug, only one has the ability to penetrate mucous membranes - benzydamine. In this regard, the second component of the drug, cetylpyridinium chloride, does not pharmacokinetically interact with benzydamine at the level of systemic circulation. The ability of benzydamine to be absorbed upon contact with mucous membranes is confirmed by its detection in the blood plasma in quantities that, however, are not enough to cause systemic effects. Elimination of both substances from the body is carried out primarily by the kidneys. Septolete total is indicated for symptomatic (directed not at the cause of the disease, but at eliminating its symptoms) treatment of pain that occurs against the background of an inflammatory process in the oropharynx. In pediatric practice, the drug is used after the patient reaches 12 years of age. Septolete total should not be used if there is an individual intolerance to any of the active or auxiliary components of the drug. Pregnancy and breastfeeding are not direct contraindications to the use of the drug, however, when prescribing the drug to women during this period, all possible risks must be carefully weighed. Directions for use: slow absorption in the mouth. Frequency of application – 3-4 times a day with intervals of 3-6 hours between doses. It is not recommended to take the medicine before or after brushing your teeth.

because in this case its effectiveness decreases (the toothpaste may contain anionic compounds that enter into undesirable interactions with the components of the drug). Septolete total should not be combined with other local disinfectants. The maximum duration of taking the drug is seven days. Septolete total has a favorable safety profile and is well tolerated by patients. In rare cases, reactions of individual intolerance, bronchospasm, urticaria, increased sensitivity to light, and itching of the skin are possible. The possibility and characteristics of the pharmacological interaction of Septolete total with other drugs have not been studied. If, after a seven-day medication course, the patient’s condition has not improved or there are signs of deterioration, you should stop taking the drug and seek medical advice to adjust the diagnosis and treatment regimen. When using the drug, hypersensitivity reactions are possible. In this case, pharmacotherapy should be interrupted and medical advice should be sought. If ulcers form on the mucous membrane of the mouth or pharynx that do not go away within three or more days, you should seek medical help. Individual intolerance to aspirin and other NSAIDs is a reason to refuse to prescribe Septolete total and to search for alternative pharmacotherapy options. Consumption of milk during the course of medication may weaken the antibacterial effect of the drug (undesirable interaction with cetylpyridinium chloride). Septolete total does not affect attention, concentration, reactivity of the nervous system and does not interfere with activities that require quick response, such as driving. Working with dangerous machinery in production, etc.

Septolete Total 16 lozenges

Registration Certificate Holder

KRKA (Slovenia)

Dosage form

Medicine - Septolete® Total

Description

Lozenges

from light blue to blue, round, with beveled edges, with a rough surface; A white coating, uneven coloring, the presence of air bubbles in the caramel mass and slight unevenness of the edges are allowed.

1 tab.

benzydamine hydrochloride 3 mg cetylpyridinium chloride monohydrate 1.05 mg, which corresponds to the content of cetylpyridinium chloride 1 mg

Excipients

: eucalyptus leaf oil - 1.2 mg, levomenthol - 5 mg, sucralose (E955) - 3.5 mg, citric acid (E330) - 15 mg, isomalt (type M) (E953) - 2471.285 mg, brilliant blue dye (E133) - 0.015 mg.

8 pcs. - blisters (1) - cardboard packs. 8 pcs. - blisters (2) - cardboard packs. 8 pcs. - blisters (3) - cardboard packs. 8 pcs. - blisters (4) - cardboard packs.

Indications

Symptomatic treatment of pain syndrome of inflammatory diseases of the oral cavity and ENT organs (of various etiologies): gingivitis, glossitis, stomatitis (including after radiation and chemotherapy); pharyngitis, laryngitis, tonsillitis; candidiasis of the oral mucosa (as part of combination therapy); calculous inflammation of the salivary glands; after surgical interventions and injuries (tonsillectomy, jaw fractures); after treatment and tooth extraction; periodontal disease.

Contraindications for use

Children under 6 years of age;
children under 12 years of age (for spray); hypersensitivity to benzydamine or cetylpyridinium chloride. With caution
Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including a history), liver disease, alcoholism, traumatic brain injury, brain disease, pregnancy, breastfeeding.

pharmachologic effect

Combined drug for local use.

Benzydamine

- NSAIDs from the indazoles group. It has an anti-inflammatory and local analgesic effect, and has an antiseptic effect against a wide range of microorganisms. The mechanism of action of the drug is associated with the stabilization of cell membranes and inhibition of prostaglandin synthesis.

Benzidamine has an antibacterial and specific antimicrobial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and cell lysosomes.

Has antifungal effect against Candida albicans. Causes structural modifications of the cell wall of fungi and their metabolic chains, thus preventing their reproduction, which was the basis for the use of benzydamine for inflammatory processes in the oral cavity, including infectious etiology.

Cetylpyridinium chloride

- antiseptic, quaternary ammonium compound, belongs to cationic surfactants. It has antimicrobial activity against gram-positive and to a lesser extent gram-negative bacteria. Does not affect bacterial spores. It has variable antifungal activity and is effective against some viruses.

Drug interactions

Simultaneous use with other drugs from the group of antiseptics should be avoided.

Dosage regimen

The drug is used topically, after meals. The frequency of use depends on the age of the patient and the dosage form of the combination drug used.

Side effect

Determination of the frequency of adverse reactions: very often (≥1/10); often (from ≥1/100 to <1/10); uncommon (from ≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10,000); frequency unknown (cannot be estimated from available data).

From the immune system:

rarely - hypersensitivity reactions.

From the nervous system:

frequency unknown - numbness of the oral mucosa.

From the respiratory system:

rarely - bronchospasm.

From the digestive system:

very rarely - irritation of the oral mucosa, burning sensation in the mouth.
From the skin and subcutaneous tissues:
rarely - photosensitivity; frequency unknown - itchy skin.

Allergic reactions:

rarely - urticaria; frequency unknown - angioedema.

special instructions

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 3 days.

Should not be used simultaneously with anionic compounds (for example, they are present in toothpaste). Therefore, it is not recommended to use immediately before or after brushing your teeth.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - Contraindicated. Restrictions when breastfeeding - Contraindicated. Should not be used during pregnancy and breastfeeding.

Use in elderly patients

Restrictions for elderly patients - No restrictions. The drug is approved for use in elderly patients

Use in children

Restrictions for children - With caution.

Use is contraindicated in children under 6 years of age.

Septolete Total lemon and honey lozenges 3mg/1mg No. 8x2

Name

Septolete total lemon and honey.

Description

Lozenges 3mg/1mg N16.

Main active ingredient

Benzidamine + cetylpyridinium chloride.

Release form

Lozenges.

Dosage

3 mg+1 mg.

pharmachologic effect

Means for the treatment of diseases of the larynx and pharynx. Antiseptics.

Indications for use

Local treatment as part of complex therapy for infectious and inflammatory diseases of the oral cavity and pharynx (tonsillitis, pharyngitis, stomatitis, gingivitis).

Directions for use and doses

Dosage Children aged 6 to 12 years: The recommended dose is 3 tablets per day. In this age group, the drug is recommended to be used after consulting a doctor. The drug is contraindicated in children under 6 years of age. Children aged 12 years and older: The recommended dose is 3-4 tablets per day. Adults: The recommended dose is 3-4 tablets per day. Elderly patients. No dose adjustment is required. Do not exceed recommended doses. Do not take a double dose of the drug to make up for a missed dose. Directions for use The tablets should be dissolved slowly in the mouth every 3-6 hours. To achieve optimal results, do not use the drug immediately before or immediately after brushing your teeth. Course of treatment The drug should not be used for more than 7 days. If there are no noticeable signs of improvement (or if it worsens) after 3 days of treatment, you should consult your doctor.

Use during pregnancy and lactation

If you are pregnant or breastfeeding, you should consult your doctor before taking any medications. Use during pregnancy is not recommended. When prescribing a drug to a breastfeeding woman, the doctor will evaluate the advisability of stopping breastfeeding, taking into account its benefits for the child and the expected benefits of therapy for the mother.

Interaction with other drugs

Before you start taking it, you must tell your doctor that you are taking or have recently taken any medications. Simultaneous use with drugs from the antiseptic group is not recommended.

Contraindications

Hypersensitivity to the active substances or other components of the drug. The drug is contraindicated in children under 6 years of age.

Compound

1 lozenge contains. Active ingredients: 3 mg benzydamine hydrochloride and 1 mg cetylpyridinium chloride (in the form of monohydrate). Excipients: eucalyptus oil, levomenthol, sucralose (E955), anhydrous citric acid (E330), isomalt (E953), brilliant blue (E133).

Overdose

If you take doses higher than recommended, you should immediately inform your specialist.

Side effect

Like all medicines, Septolete total may in some cases cause undesirable effects. In rare cases (1 in 1000), the following are possible: - hypersensitivity reactions, - urticaria, increased sensitivity of the skin to sunlight, - bronchospasm. In very rare cases (1 in 10,000) the following are possible: - local irritation of the oral mucosa, a slight burning sensation in the mouth. In cases for which the frequency is unknown (cannot be established on the basis of available data), the following are possible: - a burning sensation or numbness (loss of sensitivity) of the oral mucosa. If any adverse reactions occur, including those not listed in this leaflet, you should stop using the drug and consult a doctor. By following the recommendations for use presented in this leaflet, you reduce the risk of adverse reactions.

Storage conditions

Store in original packaging to protect from light. Does not require special temperature storage conditions. Keep out of the reach of children.

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