ACETILKA

INSTRUCTIONS for medical use of the medicinal product MILISTAN PHARYNGO FORTE (MILISTAN PHARYNGO FORTE)

Composition

active substance: benzydamine; 1 ml of spray contains benzydamine hydrochloride 3.0 mg; excipients: ethanol 96%, glycerin, methylparaben (E 218), sodium saccharin, polysorbate 20, sodium bicarbonate, peppermint oil, purified water.

Pharmaceutical form

Spray for the oral cavity.

Main physical and chemical properties

Clear colorless liquid with a characteristic taste and smell of mint.

Pharmacotherapeutic group

Agents for use in stomatology. Other agents for local application in the oral cavity.

ATC code A01AD02.

Pharmacological properties

Pharmacodynamics

Benzydamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have shown that benzydamine is effective in relieving symptoms accompanying localized irritating pathological processes in the oral cavity and pharynx. Additionally, benzydamine has anti-inflammatory and local analgesic effects on the mucous membrane of the oral cavity.

Pharmacokinetics

The fact of absorption through the mucous membrane of the oral cavity and pharynx has been proven by the presence of measurable amounts of benzydamine in human plasma. However, this is not sufficient for a systemic pharmacological effect. Benzydamine is excreted mainly with urine, predominantly in the form of inactive metabolites or conjugated compounds.

It has been shown that with local application, an effective concentration of benzydamine is achieved in inflamed tissues due to its ability to penetrate the mucous membrane.

Clinical characteristics

Indications

For symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in stomatology, apply after tooth extraction or for prophylactic purposes.

Contraindications

Increased sensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other types of interactions

No interaction studies have been conducted.

Special warnings and precautions for use

In case of sensitivity during prolonged use, treatment should be discontinued and a doctor consulted to prescribe appropriate treatment.

In some patients, ulcers of the mucous membrane of the cheeks/pharynx may be caused by serious pathological processes. In this regard, patients whose symptoms have worsened or have not decreased within 3 days, or who have an increased body temperature or other symptoms, should consult a therapist or dentist.

It is not recommended to apply benzydamine to patients with hypersensitivity to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs.

The use of the drug may cause bronchospasm in patients with bronchial asthma or with a history of bronchial asthma. Such patients should be warned about this.

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

For athletes: this medicinal product contains a small amount of ethanol (alcohol) - less than 100 mg/dose. The use of medicinal products containing ethyl alcohol may give a positive result in anti-doping tests, considering the limit values established by some sports federations.

Use during pregnancy or breastfeeding

Currently, there are no adequate available data on the use of benzydamine in pregnant women and breastfeeding women. The ability of this agent to penetrate into breast milk has not been studied. The data from animal studies are insufficient to draw any conclusions about the effect of this agent during pregnancy or breastfeeding. The potential risk to humans is unknown.

The medicinal product Milistan Pharyngo Forte should not be used during pregnancy or breastfeeding.

Ability to influence the reaction rate when driving vehicles or working with other mechanisms

When used in recommended doses, the medicinal product does not affect the ability to drive vehicles and work with other mechanisms.

Method of administration and dosage

Before using the medicinal product, it is necessary to install the nebulizer.

When pressing the pump, an aerosol is formed, which contains 1 dose of spray - 0.17 ml, which corresponds to 0.51 mg of benzydamine hydrochloride.

Dosage

For adults: 2-4 sprays 2-6 times a day.

Do not exceed the recommended doses.

Children

The medicinal product is not used in children (under 18 years of age).

Overdose

There have been no reports of benzydamine overdose when used locally.

In case of accidental ingestion of a large amount of benzydamine (> 300 mg), poisoning is possible. Characteristic signs of overdose after ingestion are gastroenterological symptoms (most often nausea, vomiting, abdominal pain, irritation of the esophagus) and symptoms from the central nervous system (dizziness, hallucinations, excitement, anxiety, and irritability).

It has been reported that benzydamine, when ingested in large doses (which is hundreds of times higher than the possible doses of this medicinal form), especially in children, caused excitement, convulsions, tremors, nausea, increased sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of disturbances of water-electrolyte balance, and symptomatic treatment, adequate hydration.

Side effects

Undesirable reactions are classified by frequency of occurrence: very often (≥ 1/10); often (from ≥ 1/100 to < 1/10); uncommon (from ≥ 1/1000 to < 1/100); rare (from ≥ 1/10 000 to < 1/1000); very rare (<1/10 000); frequency not known (cannot be estimated from available data).

In each group by frequency, undesirable reactions are listed in order of decreasing severity.

From the gastrointestinal tract

Rarely - sensation of burning in the mouth, dryness in the mouth; frequency not known - hypesthesia of the oral cavity, nausea, vomiting, swelling, and change in color of the tongue, change in taste.

From the immune system

Rarely - hypersensitivity reaction; frequency not known - anaphylactic reaction.

From the respiratory system, organs of the thorax, and mediastinum

Very rarely - laryngospasm; frequency not known - bronchospasm.

From the skin and subcutaneous tissue

Uncommonly - photosensitivity; very rarely - angioneurotic edema; frequency not known - rash, itching, urticaria.

From the nervous system

Frequency not known - dizziness, headache.

Reporting side effects after registration of the medicinal product is important. This allows monitoring the ratio of benefit/risk when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their legal representatives, should report all cases of suspected side effects and lack of efficacy of the medicinal product through the automated information system for pharmacovigilance at: 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 in a cardboard box.

Release category

Without a prescription.

Manufacturer

ICPA Health Products Limited.

Location of the manufacturer and its address

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