Septefril verde for sore throat

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Septefril Verde from a sore throat (Septefril Verde from a sore throat)

Composition:

Active substance: benzidamine hydrochloride;

1 ml of solution contains benzidamine hydrochloride 1.5 mg;

Excipients: ethanol (96 %), glycerol, methylparaben (E 218), saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear green liquid with a characteristic odour.

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 in the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic actions, producing a local anesthetic effect on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by measurable amounts of benzidamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs predominantly via 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.

Studies on interaction have not been conducted.

Special precautions for use

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

In some patients, oral or pharyngeal mucosal ulcers 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, where appropriate, a dentist.

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

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or a history of 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/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 solution, 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.

Dosage and Administration.

Measure 15 ml of Septefril Verde solution for sore throat using the measuring cup provided from the bottle. Gargle the oral cavity with the solution either undiluted or diluted (the measured 15 ml of solution may be diluted with 15 ml of water). Gargling should be performed 2–3 times daily. Do not exceed the recommended dose.

Children.

The product must not be used in children under 12 years of age due to the risk of swallowing the solution during mouth rinsing.

Overdose.

There have been no reports of overdose with topical application of benzydamine.

Following accidental ingestion of a large amount of benzydamine (> 300 mg), poisoning may occur. Characteristic signs of overdose after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitement, anxiety, and irritability).

Very rarely, ingestion of high doses of benzydamine by children (hundreds of times higher than the recommended dose for this dosage form) has been associated with excitement, convulsions, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, 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 – < 1/10), uncommon (≥ 1/1,000 – < 1/100), rare (≥ 1/10,000 – < 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 (including delayed reactions).

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report any suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: 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. 100 ml in a bottle; 1 bottle with a measuring cup 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.