PHARYCILL THROAT PAIN SPRAY

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHARYSIL SPRAY FOR SORE THROAT

Composition:

Active substance: benzidamine hydrochloride;

1 ml of oral spray contains 1.5 mg of benzidamine hydrochloride;

Excipients: saccharin, sodium hydrogen carbonate, polysorbate 20, mint or lemon flavouring, methylparahydroxybenzoate (E 218), glycerin, ethanol 96%, purified water.

Pharmaceutical form. Oral spray with mint or lemon flavour.

Main physicochemical properties: clear, colourless liquid with a characteristic mint or lemon odour and taste.

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local application 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 effects, producing a local anesthetic action on the mucous membranes of the oral cavity.

Pharmacokinetics.

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

With topical 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 associated with 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 sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought to determine appropriate further management.

In some patients, ulcers of the mucous membranes of the cheeks/throat 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 symptoms, should consult a physician or, where appropriate, a dentist.

Benzidamine is not recommended for 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.

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.

The product contains methyl 4-hydroxybenzoate (methylparaben), which may cause allergic reactions (possibly delayed), and in rare cases, bronchospasm.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of benzidamine during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiopulmonary and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both mother and child, and the onset of labor may be delayed.

It is unknown whether the systemic effects of benzidamine achieved after local application could be harmful to the embryo/fetus.

Therefore, benzidamine should not be used during pregnancy unless absolutely necessary. If used, the dose should be as low as possible and the duration of treatment as short as possible.

Breastfeeding period

Currently, there are insufficient data available on the use of benzidamine in breastfeeding women. The ability of this medicinal product to pass into breast milk has not been studied. Animal studies are insufficient to draw any conclusions regarding the effects of this medicinal product during breastfeeding. The potential risk to humans is unknown.

FARISIL THROAT SPRAY should not be used during breastfeeding.

Ability to influence the speed of reactions when driving or operating machinery

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

Method of Administration and Dosage

Before use, the spray device must be primed.

Pressing the spray device produces a spray containing 1 dose – 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 can be used in children aged 4 years and older.

Overdose

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

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

Such acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse reactions.

Within each frequency group, adverse reactions are listed in order of decreasing severity.

Adverse reactions are classified according to the frequency of occurrence: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1,000 to < 1/100); rare (from ≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known (cannot be estimated from the available data).

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

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 edema; frequency not known – rash, pruritus, urticaria.

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicinal product registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report any suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life.

3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging.

30 ml in a polyethylene container with a cap, supplied with a nebulizer device, or 30 ml in a polyethylene container with a cap and cap, supplied with a nebulizer device, in a carton.

Availability category.

Over-the-counter.

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

21027, Vinnytsia, vul. 600-richchia, 25, Ukraine.

Tel.: + 38 (0432) 52-30-36. E-mail: [email protected]

www.sperco.ua