Milistan faringo forte

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT MİLİSTANPHARYNGO FORTE (MILISTAN PHARYNGO FORTE)

Composition:

Active substance: benzydamine;

1 ml of spray contains 3.0 mg of benzidamine hydrochloride;

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 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 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 excreted primarily in the urine, mainly as 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.

For symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by 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.

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and a doctor should be consulted 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 to other nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication may cause bronchospasm in patients with bronchial asthma or a history of bronchial 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. The use of medicinal products containing ethanol may result in a positive doping test, depending on the threshold limits set by certain sports federations.

Use during pregnancy or breastfeeding

Pregnancy

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

Systemic use of prostaglandin synthetase inhibitors during the third trimester of pregnancy 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 systemic exposure to Milistan Pharyngo Forte following local administration could be harmful to the embryo/fetus.

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

Breastfeeding

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

Milistan Pharyngo Forte should not be used during breastfeeding.

Effect on ability to drive and use machines

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

Method of Administration and Dosage

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

Pressing the pump produces an aerosol containing 1 spray dose of 0.17 mL, corresponding to 0.51 mg of benzidamine hydrochloride.

Dosing

Adults: 2–4 sprays 2–6 times daily.

Do not exceed the recommended doses.

Children

The medicinal product is not intended for use in children (under 18 years of age).

Overdose

There have been no reports of benzidamine overdose following topical administration.

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

There have been reports that ingestion of a large dose of benzidamine (hundreds of times higher than the possible doses of this medicinal form), particularly in children, may cause excitement, seizures, tremor, nausea, excessive sweating, ataxia, and vomiting. Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, symptomatic therapy, and adequate hydration.

Adverse reactions

Adverse reactions are classified according to their 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 authorization of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, pharmacists, patients, and 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. 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 classification.

Over-the-counter (without prescription).

Manufacturer.

ICPA Health Products Limited.

Manufacturer's address and place of business.

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