Instructions for use Milistan Pharyngo oral solution 1.5 mg/ml bottle 120 ml
Composition
active ingredient: benzydamine;
1 ml of solution contains benzydamine hydrochloride 1.5 mg;
excipients: glycerin, propylene glycol, polyoxyl 40 hydrogenated castor oil, menthol, flavor enhancer SC 364174*, dill flavor SC 092777**, sodium benzoate (E 211), sodium saccharin, brilliant blue FCF (E 133), tartrazine (E 102), purified water.
* Propylene glycol, water, natural identical flavor, natural flavor.
** Propylene glycol, a flavoring identical to natural.
Dosage form
Oral solution.
Main physicochemical properties: transparent green liquid with a characteristic taste and smell of fennel.
Pharmacotherapeutic group
Means for use in dentistry. Other means for local use in the oral cavity.
ATX code A01A D02.
Pharmacological properties
Pharmacodynamics.
Benzydamine is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antiexudative properties.
In clinical studies, benzydamine has been shown to be effective in relieving symptoms associated with localized irritant pathologies in the oral cavity and pharynx. In addition, benzydamine has an anti-inflammatory and local analgesic effect on the oral mucosa.
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 blood plasma. However, this is not sufficient for a systemic pharmacological effect. Benzydamine is excreted mainly in the urine, mainly in the form of inactive metabolites or conjugated compounds.
It has been shown that topical application achieves the accumulation of effective concentrations of benzydamine in inflamed tissues due to its ability to penetrate the mucous membrane.
Indication
Use for symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry, use after tooth extraction or for preventive purposes.
Contraindication
Hypersensitivity 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.
Application features
If sensitivity occurs with prolonged use, treatment should be discontinued and a doctor should be consulted for appropriate treatment.
In some patients, buccal/pharyngeal ulcers may be due to serious pathological processes. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop a fever or other symptoms, should seek advice from a general practitioner or dentist as appropriate.
Benzydamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
The use of the drug may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients should be warned about this.
This medicine contains tartrazine (E 102), which may cause allergic reactions.
This medicine contains sodium benzoate (E 211), which is moderately irritating to the skin, eyes and mucous membranes when applied externally.
Use during pregnancy or breastfeeding
There are currently no adequate data available on the use of benzydamine in pregnant or breastfeeding women. The ability of this drug to pass into breast milk has not been studied. Animal data are insufficient to draw any conclusions regarding the effects of this drug during pregnancy or breastfeeding. The potential risk to humans is unknown.
You should not use the drug Milistan Pharingo during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in recommended doses, the drug has no effect on the ability to drive vehicles and operate machinery.
Method of administration and doses
Measure 15 ml of Milistan Pharyngo solution from the bottle using a measuring cup and rinse the oral cavity with the undiluted or diluted (15 ml of the solution can be diluted with 15 ml of water) preparation. Rinsing should be done 2–3 times a day. Do not exceed the recommended dose.
Children.
The medicine should not be used in children under 12 years of age due to the possibility of swallowing the solution while rinsing the mouth.
Overdose
Accidental ingestion of large amounts of benzydamine (> 300 mg) may result in poisoning. Characteristic signs of overdose after oral administration are gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, agitation, anxiety, and irritability).
Benzydamine has been reported to cause agitation, convulsions, tremors, nausea, excessive sweating, ataxia, and vomiting when ingested in large doses (hundreds of times the recommended dose of this dosage form), especially in children. Such acute overdose requires immediate gastric lavage, treatment of fluid and electrolyte imbalances, and symptomatic treatment 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 (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency unknown (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Gastrointestinal: rarely - burning sensation in the mouth, dry mouth; frequency unknown - oral hypoesthesia, nausea, vomiting, swelling and discoloration of the tongue, taste changes.
On the part of the immune system: rarely - hypersensitivity reaction; frequency unknown - anaphylactic reaction.
Respiratory, thoracic and mediastinal disorders: very rarely - laryngospasm; frequency unknown - bronchospasm.
Skin and subcutaneous tissue disorders: uncommon - photosensitivity; very rare - angioedema; frequency unknown - rash, itching, urticaria.
Nervous system: frequency unknown - dizziness, headache.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the automated pharmacovigilance information system at the link: https://aisf.dec.gov.ua/.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C, out of the reach of children.
Packaging
100 ml in a bottle with a measuring cup, 1 bottle in a cardboard box.
Vacation category
Without a prescription.
Producer
ICP Health Products Limited /
ICPA Health Products Limited.
Location of the manufacturer and its business address.
286/287/288, GIDC, Ankleshwar, Gujarat, 393002, India /
286/287/288, GIDC, Ankleshwar, Gujarat, 393002, India.
