FARIDAMIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARIAMIN (FARIDAMIN)

Composition:

Active substance: benzidamine hydrochloride;

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

Excipients: saccharin, sodium hydrogencarbonate, polysorbate 20, mint or lemon flavouring, methylparahydroxybenzoate (E 218), glycerol, 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 locally acting products 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 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 amounts of benzidamine in human plasma. However, these concentrations are insufficient to produce a systemic pharmacological effect. Excretion occurs primarily via the urine, mainly in the form of 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. For symptomatic treatment of: irritation and inflammation of the oropharynx; pain associated with gingivitis, stomatitis, and pharyngitis; in dentistry — following 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 interactions. Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and a doctor should be consulted for appropriate 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 new symptoms, should consult a physician or a dentist, as appropriate.

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.

Athletes should be aware: the use of products containing ethyl alcohol may result in a positive doping test, depending on the thresholds established by certain sports federations.

This medicinal product contains methylparahydroxybenzoate (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 there may be a possible delay in the onset of labor.

It is unknown whether systemic exposure to 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 draw conclusions about the effects of this medicinal product during breastfeeding. The potential risk to humans is unknown.

The medicinal product FARIDAMIN should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.
When used at recommended doses, this medicinal product has no effect on the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

Before use, the spray device must be primed.

One actuation of the spray device produces a spray containing 1 dose — 0.17 mL, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosage

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 medicinal product can be used in children aged 4 years and older.

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

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

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

Adverse Reactions

The frequency of adverse reactions is defined as follows: 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 based on available data). Within each frequency grouping, adverse reactions 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 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 authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all 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 the reach and sight of children.

Packaging. 30 ml in a polyethylene container with a cap, supplied with a nebulizer device, in a cardboard box; or 30 ml in a polyethylene container with a cap and a cap, supplied with a nebulizer device, in a cardboard box.

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

Manufacturer. Ukrainian-Spanish joint enterprise "Sperco Ukraine".

Manufacturer's address and place of business. 25, 600-richchya St., Vinnytsia, 21027, Ukraine.

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

www.sperco.ua