Septefril verde for sore throat

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEPTEFRIL VERDE FOR SORE THROAT (SEPTEFRIL VERDE FROM A SORE THROAT)

Composition:

Active substance: benzidamine hydrochloride;

1 ml of spray contains benzidamine hydrochloride 1.5 mg;

Excipients: ethanol (96%), glycerol, methylparahydroxybenzoate (E 218), saccharin, sodium hydrogencarbonate, polysorbate 20, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical properties: clear, colorless liquid with a characteristic odor.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local use in the oral cavity. ATC code A01AD02.

Pharmacological properties.

Pharmacodynamics.

Benzidamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzidamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membrane of the oral cavity and pharynx has been confirmed by the presence of measurable concentrations of benzidamine in human plasma. However, these concentrations are insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via the urine, mainly as inactive metabolites or conjugated compounds.

It has been shown that with local application, an effective concentration of benzidamine accumulates in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

If hypersensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought to determine appropriate management.

In some patients, ulcers of the buccal or pharyngeal mucosa may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should consult a physician or dentist, as appropriate.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

Important information about excipients.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

For athletes: the use of medicinal products containing ethyl alcohol may result in a positive anti-doping test, depending on the thresholds established by certain sports federations.

Septefril Verde for sore throat, oral spray contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

There are currently insufficient available data on the use of benzidamine in pregnant or breastfeeding women. It is not known whether this product is excreted in breast milk. Animal studies are insufficient to draw conclusions regarding the effects of this product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Septefril Verde for sore throat should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

When used at recommended doses, this medicinal product has no influence on the ability to drive or operate machinery.

Method of Administration and Dosage.

Attach the spray nozzle into the working position.

Pressing the pump produces an aerosol containing 1 dose of spray – 0.17 mL, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosing.

Adults: 4–8 sprays 2–6 times daily.

Children (6–12 years): 4 sprays 2–6 times daily.

Children (4–6 years): 1 spray per 4 kg of body weight, up to a maximum dose equivalent to 4 sprays, 2–6 times daily.

Do not exceed the recommended dosage.

Children.

The medication may be used in children aged 4 years and older.

Overdose.

There have been no reports of overdose with topical benzidamine administration.

However, accidental ingestion of a large amount of benzidamine (> 300 mg), especially in children, may lead to poisoning. Characteristic signs of overdose following ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as dizziness, hallucinations, excitement, seizures, tremor, excessive sweating, ataxia, anxiety, and irritability).

In cases of such acute overdose, immediate gastric lavage is required, along with treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse Reactions

All adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

Within each frequency grouping, adverse effects are listed in order of decreasing severity.

Gastrointestinal disorders:
Rare – burning sensation in the mouth, dry mouth;
Frequency not known – oral hypoaesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste alteration.

Immune system disorders:
Rare – hypersensitivity reaction;
Frequency not known – anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders:
Very rare – laryngospasm;
Frequency not known – bronchospasm.

Skin and subcutaneous tissue disorders:
Uncommon – photosensitivity;
Very rare – angioneurotic oedema;
Frequency not known – rash, pruritus, urticaria.

Nervous system disorders:
Frequency not known – dizziness, headache.

Septefril Verde for sore throat contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at: https://aisf.dec.gov.ua.

Shelf life. 1.5 years.

Shelf life after first opening of the bottle – 30 days.

Storage conditions. Store in the original packaging at a temperature not exceeding 25°C. Do not freeze. Keep out of reach of children.

Packaging. 30 ml in a bottle, 1 bottle with a metered spray nozzle in a carton.

Supply category. Over-the-counter.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and location of its business activities.
13, Boryspylska Street, Kyiv, 02093, Ukraine.