Hexaspray

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEXASPRAY

Composition:

Active substance: bicalutamol;

1 bottle contains bicalutamol 750 mg;

Excipients: benzyl alcohol, disodium edetate, ammonium glycyrrhizinate, star anise oil, sodium saccharin, microcrystalline cellulose, soybean lecithin, glycerin, 95% ethanol, purified water, methylparahydroxybenzoate (E 218).

Propellant gas: nitrogen.

Pharmaceutical form. Oromucosal spray.

Main physicochemical properties: a homogeneous beige-colored suspension with a characteristic anise odor.

Pharmacotherapeutic group. Preparations used in throat diseases. ATC code R02A.

Pharmacological properties.

Pharmacodynamics.

An antiseptic, analgesic, and anti-inflammatory agent.

Biklotimol is a phenol derivative with antibacterial activity against staphylococci, streptococci, micrococci, and corynebacteria. It causes coagulation of microbial cell proteins. It also exerts anti-inflammatory and analgesic effects.

The drug is very slowly absorbed through the mucous membranes, ensuring its prolonged presence in the oral cavity.

Clinical characteristics.

Indications.

Local symptomatic treatment of infectious and inflammatory diseases of the oral cavity and nasopharynx: angina, pharyngitis, aphthous stomatitis, gingivitis, periodontitis.

Contraindications.

Hypersensitivity to any component of the drug. Children under 2.5 years of age (due to the risk of laryngospasm development). Because of the presence of soy lecithin in the formulation, Hexaspray is contraindicated in patients with peanut or soy allergy.

Interaction with other medicinal products and other forms of interaction.

Current available data do not indicate clinically significant interactions.

Special precautions for use.

Use of the drug for more than 5 days may disrupt the homeostasis of normal oral cavity microflora, increasing the risk of bacterial or fungal infection spread. Concomitant use of other antiseptic agents should be avoided, as undesirable interactions (antagonism, inactivation) may occur.

If the patient's condition worsens, particularly if fever develops, or if there is no improvement within 5 days, the patient should be re-examined and the treatment strategy revised.

This medicinal product contains methylparahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

This medicinal product contains soy lecithin and may cause hypersensitivity reactions (urticaria, anaphylactic shock).

This medicinal product contains 35 mg of benzyl alcohol per dose (2 sprays). Benzyl alcohol may cause allergic reactions and mild local irritation.

This medicinal product contains less than 1 mmol (23 mg)/dose of sodium, i.e., it is practically sodium-free.

Use during pregnancy or breastfeeding.

Pregnancy

Data on the use of biquanidyl (biklotimol) during pregnancy are lacking or limited.

Animal studies are insufficient to determine reproductive toxicity.

Hexaspray is not recommended for use during pregnancy and in women of childbearing potential who are not using contraceptive methods.

Breastfeeding

There is insufficient data on the excretion of biquanidyl (biklotimol) or its metabolites in breast milk.

Hexaspray should not be used during breastfeeding.

Fertility

Clinical studies have not been conducted.

Effect on ability to drive or operate machinery.

No effect.

Method of Administration and Dosage

For topical use. Intended for application in the oropharynx. The bottle should be shaken before use. The bottle should be held vertically during spraying.

For adults and children aged 2.5 years and older.

Adults and children aged 2.5 years and older: 2 sprays, 3 times daily.

Treatment should not exceed 5 days.

Children.

This medication is not recommended for children under 2.5 years of age.

Overdose.

Not reported.

Adverse reactions

The adverse reactions listed below are classified by system organ class and frequency according to the MEdDRA classification. Frequency 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), and frequency not known (cannot be estimated from the available data).

Immune system disorders:

Very rare: Lip swelling.

Skin and subcutaneous tissue disorders:

Very rare: Angioneurotic edema, erythema, skin rashes, urticaria.

Due to the presence of methylparahydroxybenzoate and soy lecithin in the formulation, allergic reactions are possible in certain patient populations.

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare 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. 5 years.

Storage conditions. Store in a light-protected place, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 30 g aerosol bottle in a cardboard box.

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

Manufacturer.

Laboratoires Dubois Recordati.

Manufacturer's location and address of the place of business.

Parc Mécatronic, 03410, Saint-Victor, France.

Marketing authorization holder.

Laboratoires Dubois Recordati.