Instructions for Septefril Verde for sore throat, oral spray 3 mg/ml, 30 ml bottle
Composition
active ingredient: benzydamine hydrochloride;
1 ml of spray contains benzydamine hydrochloride 3 mg;
Excipients: ethanol (96%), glycerin, methyl parahydroxybenzoate (E 218), sodium saccharin, macrogol glyceryl hydroxystearate, purified water.
Dosage form
Oral spray.
Main physicochemical properties: clear colorless liquid with a characteristic odor.
Pharmacotherapeutic group
Other agents for the local treatment of oral diseases; benzydamine. ATX code A01A D02.
Pharmacological properties
Pharmacodynamics.
Benzydamine is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antiexudative properties. It has anti-inflammatory and antiseptic effects, and has a local analgesic effect on the oral mucosa.
In clinical trials, it was shown that the first relief of acute pain was observed within 1 minute of application of the spray (78% of patients) and increased after 2 minutes (91% of patients). After 15 minutes, 75% of patients maintained significant pain relief. The relief after application lasted up to 4 hours. In addition, there was an improvement in the feeling of throat swelling and ease of swallowing.
The study confirmed the effectiveness of benzydamine in providing rapid pain relief and a good safety profile.
Pharmacokinetics.
Absorption
When applied topically, benzydamine penetrates well through the skin and mucous membranes and accumulates in inflamed tissues.
Distribution
The fraction of the dose absorbed systemically is low with a late peak plasma concentration. The amount of benzydamine in serum after absorption through the human oropharyngeal mucosa is insufficient to achieve systemic pharmacological effects.
Breeding
The drug is excreted in the urine, mainly as an inactive metabolite and conjugation products.
Indication
Anti-inflammatory and analgesic drug for inflammatory diseases of the throat, oral cavity and gums.
In dentistry after tooth extraction.
For inflammatory processes and complications in the larynx after radiation therapy.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the medicinal product.
Interaction with other medicinal products and other types of interactions
No interactions with other medicinal products have been established.
Application features
If sensitivity occurs during long-term use, treatment should be discontinued and a doctor should be consulted to prescribe appropriate treatment.
The patient should consult a doctor if there is no positive result after a seven-day treatment period with benzydamine.
The medicine is specially designed for patients who have difficulty gargling.
Important information about excipients.
This medicine contains a small amount of ethanol (alcohol), less than 100 mg/dose.
The medicine contains methyl parahydroxybenzoate (E 218), which may cause allergic reactions (possibly delayed).
Use during pregnancy or breastfeeding
There are currently no adequate data available on the use of benzydamine in pregnant or lactating 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 lactation. The potential risk to humans is unknown.
Septefril Verde should not be used for sore throat during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the ability to drive a car or operate other mechanisms.
Method of administration and doses
Adults: 2–4 sprays 2–6 times a day (1 spray dose contains 0.17 ml, corresponding to 0.51 mg of benzydamine hydrochloride).
Do not exceed recommended doses.
Children.
The drug should not be used in children (under 18 years of age).
Overdose
Accidental ingestion of large amounts of benzydamine (> 300 mg) may result in poisoning. Intoxication is only possible if large amounts of benzydamine (> 300 mg) are accidentally ingested.
Symptoms. Characteristic signs of overdose after internal use are gastroenterological symptoms (most often nausea, vomiting, abdominal pain, esophageal irritation) and symptoms from the central nervous system (dizziness, hallucinations, agitation, restlessness, anxiety and irritability are possible).
Treatment: In case of acute overdose, only symptomatic treatment is possible. Patients should be closely monitored and receive supportive therapy and adequate hydration.
Side effects
All adverse reactions are listed by system organ class and frequency: very common (≥ 1/10), common (≥ 1/100 - < 1/10), uncommon (≥ 1/1,000 - < 1/100), rare (≥ 1/10,000 - < 1/1,000), rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
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.
Local adverse reactions are associated with the anesthetic effect of benzydamine.
They are usually transient, resolve spontaneously, and rarely require further treatment.
Topically applied benzydamine is absorbed into the bloodstream in small amounts, so systemic side effects are uncommon. Reducing the dose of the drug usually eliminates these symptoms.
Reporting of suspected adverse reactions.
Reporting suspected 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/or lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
1.5 years.
The shelf life after first opening the bottle is 30 days.
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C. Do not freeze. Keep out of the reach of children.
Packaging
30 ml in a bottle, 1 bottle with a dosing spray nozzle in a pack.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and address of its place of business.
Ukraine, 02093, Kyiv, Boryspilska St., 13.
