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INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARIVERDE (FARIVERDE)

Composition:

Active substance: benzidamine hydrochloride;

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

Excipients: saccharin, sodium bicarbonate, polysorbate 20, peppermint flavor, methylparaben (E 218), glycerin, ethanol 96%, purified water.

Pharmaceutical form. Oral spray.

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

Pharmacotherapeutic group. Agents used in dentistry. Other agents for local oral use.

ATC code A01AD02.

Pharmacological Properties

Pharmacodynamics

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

Clinical studies have demonstrated that benzydamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine 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 concentrations of benzydamine in human plasma. However, these levels are insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via urine, mainly in the form of inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of effective concentrations of benzydamine in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical characteristics.

Indications.

Symptomatic treatment of:

• oropharyngeal irritations and inflammations;
• pain caused by gingivitis, stomatitis, pharyngitis;
• in dentistry, after tooth extraction or for prophylactic purposes.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been performed.

Special precautions for use.

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

In some patients, mucosal ulcers of the cheek/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 to other nonsteroidal anti-inflammatory drugs.

The use of this medicinal product may cause bronchospasm in patients suffering from bronchial asthma or with 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/dose.

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

The product contains methylparahydroxybenzoate (methylparaben), which may cause allergic reactions (possibly delayed), and in individual 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 a delay in the onset of labor is possible.

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

Therefore, benzidamine should not be used during pregnancy unless clearly 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 no adequate 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 allow any conclusions regarding the use of this medicinal product during breastfeeding. The potential risk to humans is unknown.

The product should not be used during breastfeeding.

Ability to influence the speed of reactions while driving or operating machinery.

When used at recommended doses, this medicinal product does not affect 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 dosages.

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 following ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system effects (such as 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 effects are listed in decreasing order of severity.

Adverse reactions are classified by frequency: very common (≥ 1/10); common (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on 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 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 edema; frequency not known – rash, pruritus, urticaria.

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

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 of children.

Packaging.

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

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and place of business.

21027, Ukraine, Vinnytsia, 600-richchya St., 25.

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

www.sperco.ua