Hexalis

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEXALIS

Composition:

Active substances: one tablet contains bicitolol 5 mg, lysozyme hydrochloride 5 mg, enoxolone 5 mg;

Excipients: lemon oil, citric acid monohydrate, colouring agent "Orange-Yellow S" (E 110), magnesium stearate, gum arabic, sucrose.

Pharmaceutical form. Effervescent tablets.

Main physicochemical properties: light orange tablets with slight speckles, lemon-flavoured, round-shaped with flat surface and bevelled edges.

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

Pharmacological properties.

Pharmacodynamics.

A combination drug exhibiting prolonged local action. The antiseptic, analgesic, anti-inflammatory, and cleansing effects of the drug are due to its three active ingredients.

Bacitracin exerts a bactericidal effect against staphylococci, streptococci, and corynebacteria. It causes coagulation of microbial cell proteins.

Bacitracin and enoxolone provide the anti-inflammatory and analgesic actions of the drug.

Lysozyme—a natural polymucosaccharide—exerts antibacterial activity against Gram-positive bacteria and demonstrates antiviral activity. In addition, it enhances humoral immunity and local cellular defense. By inhibiting histamine, lysozyme participates in the anti-inflammatory response and also promotes rapid removal of metabolic byproducts from damaged tissues.

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

Clinical characteristics.

Indications.

Local treatment of infectious-inflammatory diseases of the mucous membrane of the oral cavity, pharynx, and larynx: tonsillitis, pharyngitis, laryngitis, stomatitis, gingivitis, periodontosis. Inflammation of the gingival margin.

Contraindications.

• Hypersensitivity to any component of the drug;
• children under 6 years of age.

Special precautions.

Prolonged use of the drug (more than 5 days) should be avoided.

When prescribing to patients with diabetes mellitus or those on a sugar-restricted diet, the amount of sugar powder in each tablet should be taken into account: 1.054 g.

Since the drug contains sucrose, its use should be avoided in patients with fructose intolerance, glucose/galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

The drug contains the dye sunset yellow S (E 110), which may cause allergic reactions.

If symptoms such as severe pain or ulcers in the throat, headache, nausea, vomiting, or significant fever occur, the patient should consult a physician for re-evaluation and reassessment of the treatment regimen.

Interaction with other medicinal products and other forms of interaction.

Concomitant or sequential use of local antiseptics should be avoided, as undesirable interactions (antagonism, inactivation) may occur.

Usage characteristics.

Use during pregnancy or breastfeeding.

There are no reliable data on teratogenic effects from animal studies.

To date, clinical experience with the medicinal product has not demonstrated any developmental abnormalities or fetotoxic effects.

There is insufficient information from observations of pregnant women exposed to the active substances to exclude any risk; therefore, it is advisable to avoid using the medicinal product in this patient category.

There are no reliable data on the use of the medicinal product during breastfeeding; therefore, it is advisable to avoid using the medicinal product in this patient category.

Ability to influence reaction rate while driving or operating machinery.

No effect on driving or operating machinery has been observed.

Method of administration and dosage.

Slowly dissolve the tablet in the mouth without chewing. Hold the tablet in the mouth until it is completely dissolved.

For adults and children aged 6 years and older, use 6 to 8 tablets per day.

Children.

Do not administer the drug to children under 6 years of age.

Overdose.

No data available.

Side effects.

Hypersensitivity to bicalutamol or to any of the substances in the tablet.

In individual cases, allergic reactions may occur, including lip swelling, urticaria, skin rash, erythema, angioneurotic edema.

Shelf life.

2 years.

Storage conditions.

Store in a light-protected and child-resistant place, at a temperature not exceeding 25 °C.

Packaging.

10 tablets per blister. 3 blisters per cardboard box.

Availability.

Over-the-counter.

Manufacturer.

Laboratoires Bouchard Recordati.

Manufacturer's address.

Mécatronic Park, 03410, Saint-Victor, France.

Marketing authorization holder.

Laboratoires Bouchard Recordati.