MILISTAN PHARYNGO

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MİLİSTAN PHARYNGO (MILISTANPHARYNGO)

Composition:

Active substance: benzydamine;

1 ml of spray contains benzidamine hydrochloride 1.5 mg;

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

Pharmaceutical form. Oral spray.

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

Pharmacotherapeutic group.

Agents for use in dentistry. Other agents for local application 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 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 concentrations of benzidamine in human plasma. However, these levels are insufficient to produce a systemic pharmacological effect. Benzidamine is primarily excreted in the urine, mainly as 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 irritations and inflammations of the oropharynx; pain associated with gingivitis, stomatitis, pharyngitis; in dentistry, to be used 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 interaction have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and the patient should consult a physician for appropriate management.

In some patients, oral/pharyngeal mucosal ulcers 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 seek medical advice from a physician or dentist.

Benzidamine is not recommended for patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs).

The use of this drug may cause bronchospasm in patients with bronchial asthma, including those with a history of asthma. Such patients must be warned accordingly.

This medicinal product contains methylparaben (E 218), which may cause allergic reactions (possibly delayed), and in rare cases, bronchospasm.

For athletes: this medicinal product contains a small amount of ethanol (alcohol) — less than 100 mg per dose. Medicinal products containing ethanol may result in a positive anti-doping test, depending on the threshold limits established by certain sports federations.

Use during pregnancy or breastfeeding

Pregnancy

There are no clinical data on the use of Milistan Faringo during pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiovascular and renal toxicity in the fetus. Towards the end of pregnancy, prolonged bleeding time may occur in both the mother and the newborn, and labor onset may be delayed.

It is unknown whether the systemic exposure to Milistan Faringo resulting from local application could be harmful to the embryo/fetus.

Therefore, Milistan Faringo should not be used during pregnancy unless the treatment is considered clinically justified. If used, the dose should be as low as possible and the duration of treatment kept to a minimum.

Breastfeeding

There are currently insufficient data available on the use of benzidamine in breastfeeding women. The ability of this drug to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding its effects during breastfeeding. The potential risk to humans is unknown.

The medicinal product Milistan Faringo should not be used during breastfeeding.

Ability to affect reaction speed when 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 using the medicinal product, a nebulizer must be assembled.

Pressing the pump produces an aerosol containing 1 dose of spray — 0.17 mL, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosing

Adults: 4–8 sprays 2–6 times daily.

Children aged 6–12 years: 4 sprays 2–6 times daily.

Children aged 4–6 years: 1 spray per every 4 kg of body weight. The maximum dose is equivalent to 4 sprays 2–6 times daily.

Do not exceed the recommended doses.

Children

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

Overdose

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

Following accidental ingestion of a large amount of benzidamine (> 300 mg), poisoning may occur. Characteristic signs of overdose after oral intake include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, excitement, anxiety, and irritability).

Cases have been reported where ingestion of high doses of benzidamine (hundreds of times higher than the possible doses of this medicinal form), especially in children, caused excitement, convulsions, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of water-electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse Reactions

Undesirable effects are classified according to frequency of 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).

Within each frequency group, 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, itching, urticaria.

Nervous system disorders:
Frequency not known — dizziness, headache.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are advised 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.

Storage conditions.

Store in the original packaging at a temperature not exceeding 30 °C, in a place inaccessible to children.

Packaging.

25 ml in a bottle with a nebulizer, 1 bottle per cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

ICPA Health Products Limited.

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

286/287/288, GIDC, Ankleshwar, Gujarat, 393002, India.