Septolete total lozenges 3 mg+1 mg No. 16 (eucalyptus)

Septolete total lozenges 3 mg+1 mg No. 16 (eucalyptus)

Compound

One lozenge contains:
active ingredients: benzydamine hydrochloride - 3 mg; cetylpyridinium chloride monohydrate - 1.05 mg, which corresponds to the content of cetylpyridinium chloride 1 mg.

excipients: eucalyptus leaf oil, levomenthol, sucralose (E955), citric acid (E330), isomalt (type M) (E953), brilliant blue dye (E133).

Description

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

Pharmacodynamics

Combined drug for local use.

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

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. It is excreted mainly by the kidneys, mostly in the form of inactive metabolites.

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.

Directions for use and doses

The tablets should be dissolved slowly in the mouth every 3-6 hours.

Adults, elderly patients and children over 12 years of age - the recommended dose is 3-4 tablets per day.

Children from 6 to 12 years old - the recommended dose is 3 tablets per day. Do not exceed the indicated dose.

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

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.

Contraindications

Children under 6 years of age; 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.

Use during pregnancy and breastfeeding

Should not be used during pregnancy and breastfeeding.

special instructions

• 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.

Drug interactions

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.

Impact on the ability to drive vehicles and machinery

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

Release form

Lozenges, 3 mg + 1 mg. 8 tablets in a blister made of combined material PVC/polyethylene/PVDC - aluminum foil. 2 blisters are placed in a cardboard pack along with instructions for use.

Storage conditions

Store at a temperature not exceeding 25 °C, in the original packaging. Keep out of the reach of children.

Best before date

2 years. Do not use the drug after the expiration date.

Vacation conditions

Over the counter.

Overdose

Toxic manifestations of benzydamine overdose include agitation, convulsions, sweating, ataxia, tremor and vomiting.

Signs and symptoms of intoxication after taking significant doses of cetylpyridinium chloride are nausea, vomiting, shortness of breath, cyanosis, asphyxia due to paralysis of the respiratory muscles, central nervous system depression, arterial hypotension and coma. The lethal dose for humans is approximately 1-3 g (exceeding the maximum daily dose of Septolete Total lozenges by 250-750 times).

Since there is no specific antidote, treatment of acute overdose is symptomatic.

Note!

Description of the drug Septolete Total Eucalyptus ice. 3mg/1mg No. 16 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.

Septolete Total 0.15mg+0.5mg/dose throat spray doser 250doses 30ml

Dosage

0.15 mg+0.5 mg/dose

Amount in a package

250

Active substance

Benzidamine + Cetylpyridinium chloride

Manufacturer

KRKA d.d. Novo Mesto JSC (Slovenia)

Shelf life

2 years

Storage conditions

At a temperature not exceeding 25 °C, in original packaging

Registration certificate number

LP-003914 dated 10/20/2016

Compound

Characteristic

Description of the dosage form

Transparent solution from colorless to yellowish.

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. When benzydamine is administered as a topical spray at recommended doses, absorption is negligible.

Distribution.

Vd of all dosage forms is the same.

Excretion.

Excretion occurs mainly by the kidneys, mostly in the form of inactive metabolites. T1/2 and total clearance are similar for all dosage forms.

Pharmacodynamics

Benzidamine is an NSAID 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.

Contraindications

hypersensitivity to the active substances or any auxiliary components of the drug;

children under 18 years of age.

Carefully:

hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history); liver diseases; alcoholism; traumatic brain injury; brain diseases; pregnancy; breastfeeding period.

Use during pregnancy and breastfeeding

The use of Septolete® total during pregnancy and breastfeeding is possible only after consultation with your doctor, if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Directions for use and doses

Locally.

Adults are recommended to use every 2 hours, 5 times a day for 4 days.

To receive a single dose, press the spray head 2 times. Do not exceed the indicated dose.

To achieve optimal results, it is not recommended to use Septolete® total immediately before or after brushing your teeth.

If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

It is necessary to use the drug only according to the method of application and in the doses indicated in the instructions. If necessary, consult a doctor before using the drug.

You should consult a doctor if symptoms worsen or do not improve after 4 days of treatment.

Before using Septolete® total for the first time, press the spray head of the dosing device several times until a uniform spray is obtained. If Septolete® total has not been used for a long time (for at least 1 week), press the spray head of the dosing device once until a uniform spray is obtained.

Before use, remove the colored protective cap. Then open your mouth wide, direct the applicator tube into the oral cavity, hold your breath and press the spray head 2 times.

After each use of Septolete® total, close the spray head with a colored protective cap.

By pressing the spray head once, 0.1 ml of solution is released in the form of a spray, which contains 0.15 mg of benzydamine and 0.5 mg of cetylpyridinium chloride. 30 ml of the drug in the primary package contains 250 doses.

Side effects

Classification of the incidence of side effects recommended by WHO: very often ≥1/10; often from ≥1/100 to <1/10; infrequently from ≥1/1000 to <1/100; rarely from ≥1/10000 to <1/1000; very rarely <1/10000; 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, chest and mediastinal organs:

rarely - bronchospasm.

From the gastrointestinal tract:

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

For 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; symptoms of intoxication when ingesting significant amounts of cetylpyridinium chloride are nausea, vomiting, edema, cyanosis, asphyxia with subsequent paralysis of the respiratory muscles, central nervous system depression, 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.

special instructions

You must carefully read the instructions before you start using the drug, and also save them, because it may be needed again. If you have any questions, you should consult your doctor.

The medicine is intended for the patient personally and should not be shared with others as it may cause harm to them even if they have the same symptoms.

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 oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than 3 days.

The use of Septolete® total is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

The drug Septolete® total should not be used simultaneously with anionic compounds (for example, present in toothpaste). Therefore, it is not recommended to use the drug immediately before or after brushing your teeth.

Contact of Septolete® total with the mucous membrane of the eyes should be avoided.

The spray should not be inhaled.

The drug Septolete® total contains a small amount of ethanol 96% - 26.760 mg/1 spray dose.

After opening the bottle, the drug should be used within 6 months.

Impact on the ability to drive vehicles and machinery

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

Conditions for dispensing from pharmacies

Over the counter.

Pharmaceutical actions

local anti-inflammatory, local anesthetic, local anesthetic, local antibacterial, local antifungal