Milistan pharyngo

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MĪLĪSTANFARĪNGO (MILISTANPHARYNGO)

Composition:

Active substance: benzydamine;

1 ml of solution contains 1.5 mg of benzydamine hydrochloride;

Excipients: glycerol, propylene glycol, polyoxyl 40 hydrogenated castor oil, menthol, flavour enhancer SC 364174*, caraway flavour SC 092777**, sodium benzoate (E 211), sodium saccharin, brilliant blue FCF (E 133), tartrazine (E 102), purified water.

* Propylene glycol, water, nature-identical flavouring, natural flavouring.

** Propylene glycol, nature-identical flavouring.

Pharmaceutical form. Oral solution.

Main physicochemical properties: clear green liquid with a characteristic fennel taste and odour.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local use 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 demonstrated that benzydamine is effective in relieving symptoms associated with localized inflammatory conditions of the oral cavity and pharynx. In addition, benzydamine 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 measurable concentrations of benzydamine in human plasma. However, these concentrations are insufficient to produce systemic pharmacological effects. Benzydamine 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 benzydamine 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.

Studies on the investigation of interactions have not been conducted.

Special precautions for use

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

In some patients, ulcers of the buccal mucosa/pharynx may be caused by serious pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other symptoms, should seek medical advice from a physician or, where appropriate, a dentist.

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

The use of this medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains tartrazine (E 102), which may cause allergic reactions.

This medicinal product contains sodium benzoate (E 211), which may moderately irritate the skin, eyes, and mucous membranes upon external application.

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 a delay in the onset of labor is possible.

It is unknown whether systemic exposure to Milistan Faringo following topical application could be harmful to the embryo/fetus.

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

Breastfeeding

Currently, there are no adequate data available on the use of benzidamine in women who are breastfeeding. The ability of this product to pass into breast milk has not been studied. Animal studies are insufficient to draw conclusions regarding the use of this product during breastfeeding. The potential risk to humans is unknown.

Milistan Faringo should not be used during breastfeeding.

Effect on ability to drive and use machines

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

Method of Administration and Dosage

Measure 15 ml of Milistan Pharingo solution from the bottle using the measuring cup provided and rinse the oral cavity with the undiluted solution or diluted solution (15 ml of the solution can be diluted with 15 ml of water). Rinse 2–3 times daily. Do not exceed the recommended dose.

Children

The medicinal product should not be used in children under 12 years of age due to the risk of swallowing the solution during mouth rinsing.

Overdose

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

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

There have been reports that ingestion of a large dose of benzidamine (hundreds of times higher than the possible dose of this medicinal form), especially in children, may cause agitation, 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.

Side effects

Adverse reactions are classified according to frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from the available data).

Within each frequency category, 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, pruritus, urticaria.

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

Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows ongoing 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 through 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.

100 ml in a bottle with a measuring cup; 1 bottle per cardboard box.

Supply category.

Over-the-counter.

Manufacturer.

ICPA Health Products Limited.

Manufacturer's address.

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