Septefril verde for sore throat

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT SEPTIFRIL VERDE FOR SORE THROAT

Composition:

Active substance: benzydamine hydrochloride;

1 lozenge contains 3 mg of benzydamine hydrochloride, equivalent to 2.68 mg of benzydamine;

Excipients: isomalt (E 953), citric acid monohydrate (E 330), aspartame (E 951), quinoline yellow (E 104), honey flavor, orange flavor, peppermint oil, cochineal red (E 120).

Pharmaceutical form. Lozenges.

Main physicochemical properties: orange-colored, round lozenges with honey and orange flavor.

Pharmacotherapeutic group. Agents acting on the respiratory system. Preparations used in throat disorders. Other preparations used in throat disorders. Benzydamine. ATC code R02A X03.

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 moderate-intensity anti-inflammatory and local analgesic effects on the mucous membranes of the oral cavity.

Pharmacokinetics.

Absorption

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzidamine in human plasma.

Distribution

Approximately 2 hours after administration of a 3 mg lozenge, the maximum plasma concentration of benzidamine reaches 37.8 ng/mL, and the AUC value is 367 ng/mL∗h. However, these concentrations are too low to produce systemic pharmacological effects.

It has been shown that with local application, benzidamine accumulates in inflamed tissues, where effective concentrations are achieved due to its ability to penetrate through the mucous membrane.

Elimination

Excretion occurs primarily via the urine, mainly in the form of inactive metabolites or conjugated compounds.

Clinical characteristics.

Indications.

For symptomatic treatment of pain, irritation, and inflammation of the oral cavity and throat.

Contraindications.

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

Interaction with other medicinal products and other forms of interactions.

Interaction studies have not been conducted.

Special precautions for use

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

Septefril Verde for sore throat should be used with caution in patients with bronchial asthma, particularly in those with a history of asthma, due to the potential risk of bronchospasm.

In some patients, oral 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.

Important information on excipients

Septefril Verde for sore throat, lozenges, contains aspartame, a source of phenylalanine synthesis. It may be harmful to patients with phenylketonuria.

The medicinal product contains isomalt and therefore should not be used in patients with rare hereditary fructose intolerance disorders.

Septefril Verde for sore throat contains carmine red, which may cause allergic reactions.

Use during pregnancy or breastfeeding

Currently, there are no adequate data available on the use of benzidamine in pregnant or breastfeeding women. The ability of this drug to pass into breast milk has not been studied. Animal study data are insufficient to draw conclusions regarding the effects of this drug on pregnancy and lactation. There is a lack of data on the potential risk during pregnancy or breastfeeding.

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

Ability to affect reaction speed when driving or operating machinery

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

Method of Administration and Dosage

The lozenge should be slowly dissolved by sucking until it completely dissolves in the oral cavity. Lozenges should not be swallowed or chewed.

For adults and children aged 6 years and older: 1 lozenge 3 times daily. The duration of treatment should not exceed 7 days.

Children

This medicinal form is intended for children aged 6 years and older.

Children aged 6–11 years should use Septefril Verde for sore throat under adult supervision.

Overdose

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

However, it is known that benzidamine, if ingested in large quantities (hundreds of times higher than the possible doses of this medicinal form), especially in children, may cause excitation, seizures, tremor, nausea, increased sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of water-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).

Respiratory, thoracic and mediastinal disorders: very rare — laryngospasm.

Gastrointestinal disorders: rare — burning sensation in the mouth, dry mouth; frequency not known — oral hypoaesthesia.

Immune system disorders: rare — hypersensitivity reactions; frequency not known — anaphylactic reactions.

Skin and subcutaneous tissue disorders: uncommon — photosensitivity; very rare — angioneurotic edema.

Reporting of suspected adverse reactions.

Reporting of suspected adverse reactions after marketing authorization is of vital importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients are encouraged to report any suspected adverse reactions and/or lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 pastilles in a blister; 2 blisters in a carton.

Supply classification. Over-the-counter (without prescription).

Manufacturer. LOZI’S PHARMACEUTICALS S.L.

Manufacturer's address and place of business.

Cámpus Empresarial, Lecarroce, Navarra, 31795, Spain.

Marketing Authorization Holder. JSC "Pharmaceutical Company "Darnytsia".

Address of the Marketing Authorization Holder. 13, Boryspilska Street, Kyiv, 02093, Ukraine.