Glandum

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLANDUM (GLANDUM)

Composition:

Active ingredient: benzidamine hydrochloride;

1 ml of solution contains benzidamine hydrochloride 1.5 mg;

Excipients: ethanol 96 %, glycerol, methylparahydroxybenzoate (E 218), menthol (levomenthol), sodium saccharin, sodium hydrogencarbonate, polysorbate 20, purified water.

Pharmaceutical form. Oral spray.

Main physicochemical characteristics: colorless clear or slightly opalescent liquid with a menthol aroma.

Pharmacotherapeutic group.
Medicaments for use in dentistry. Other local preparations for use 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 irritative conditions in the oral cavity and pharynx. In addition, benzidamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics

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

It has been shown that topical application leads to accumulation of an effective concentration of benzidamine 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 caused by pharyngitis, gingivitis, stomatitis; 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.

Studies on drug interactions have not been conducted.

Special precautions for use

In cases of sensitivity occurring during prolonged use, treatment should be discontinued and medical advice should be sought for appropriate management.

In some patients, ulcers of the buccal mucosa/throat may be due to serious 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 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 suffering from bronchial asthma or with a history of bronchial asthma. Such patients must be warned accordingly.

The 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 thresholds established by certain sports federations.

Glandum oral spray contains the flavoring agent menthol (levomenthol), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are currently insufficient available data on the use of benzidamine in pregnant or breastfeeding women. The ability of this product to pass into breast milk has not been studied. Animal studies are insufficient to allow any conclusions regarding the effects of this medicinal product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Glandum should not be used during pregnancy or breastfeeding.

Effect on ability to drive and use machines.

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

Administration and Dosage

When the spray pump is pressed, an aerosol is produced containing 1 dose of spray – 0.17 ml, corresponding to 0.255 mcg 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 dosage.

Children

The drug 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 after ingestion include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitement, convulsions, tremor, excessive 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

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

Adverse reactions are classified according to the frequency of their occurrence: 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).

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.

Glandum contains methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed).

Reporting of adverse reactions after marketing authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as 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. 2 years.

Do not use after the expiry date.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

30 ml in a bottle with a spray pump and rotating nozzle. One bottle per carton.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "CHEMICAL PHARMACEUTICAL PLANT "CHERVONA ZIRKA".

Manufacturer's address.

1, Gordienkovska Street, Kharkiv, Kharkiv region, 61010, Ukraine.