Instructions Zipelor forte oral spray 3 mg/ml bottle 30 ml
Composition
active ingredient: benzydamine;
1 ml of spray contains benzydamine hydrochloride 3.0 mg;
excipients: ethanol 96%, glycerin, methylparaben (E 218), sodium saccharin, macrogol glyceryl hydroxystearate, mint flavoring, purified water.
Dosage form
Oral spray.
Main physicochemical properties: clear colorless liquid with a characteristic mint odor.
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 to exert any systemic pharmacological effect. Excretion occurs 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
Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry, used after tooth extraction or for preventive purposes.
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
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.
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.
For athletes: the use of medicines containing ethyl alcohol may give a positive result in an anti-doping test.
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 agent to pass into breast milk has not been studied. Animal data are insufficient to draw any conclusions regarding the effects of this agent during pregnancy or breastfeeding. The potential risk to humans is unknown.
Zipelor forte should not be used 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
Before use, the nebulizer must be installed.
When you press 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
Adults: 4 – 8 sprays 2 – 6 times a day.
Do not exceed recommended doses.
Children
The drug is not used in children (under 18 years of age).
Overdose
There have been no reports of overdose with topical benzydamine.
However, it is known that benzydamine, when taken orally in large doses (which exceeded the possible doses of this dosage form by hundreds of times), especially in children, can cause agitation, convulsions, tremors, nausea, increased sweating, ataxia, vomiting. Such an acute overdose requires immediate gastric lavage, treatment of water and electrolyte balance disorders and symptomatic treatment, adequate hydration.
Adverse reactions
Within each frequency grouping, undesirable effects 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.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
15 ml or 30 ml in a bottle.
1 bottle per pack.
Vacation category
Without a prescription.
Producer
PJSC "Farmak".
Location of the manufacturer and its business address
Ukraine, 04080, Kyiv, Frunze St., 74.
