Instructions for Septefril Verde for sore throat oral solution 1.5 mg/ml bottle 100 ml
Composition
active ingredient: benzydamine hydrochloride;
1 ml of solution contains benzydamine hydrochloride 1.5 mg;
excipients: ethanol (96%), glycerol, methyl parahydroxybenzoate (E 218), saccharin, sodium bicarbonate, polysorbate 20, quinoline yellow (E 104), patent blue V (E 131), purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent green liquid with a characteristic 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 anti-inflammatory and local analgesic effects, and has a local anesthetic effect on the oral mucosa.
Pharmacokinetics.
Absorption through the oral and pharyngeal mucosa has been demonstrated by the presence of measurable amounts of benzydamine in human plasma. However, this is not sufficient to demonstrate any systemic pharmacological effect. Excretion occurs mainly in the urine, mainly in the form of inactive metabolites or conjugates.
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 after tooth extraction or for prophylactic 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 during long-term use, treatment should be discontinued and a doctor should be consulted to prescribe 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 NSAIDs.
The use of the drug may cause bronchospasm in patients with bronchial asthma or a history of it. Such patients should be warned about this.
Important information about excipients.
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg/dose. For athletes: the use of medicinal products containing ethyl alcohol may give a positive result in an anti-doping test, taking into account the limits set by some sports federations.
Septefril Verde for sore throat, oral solution contains methyl parahydroxybenzoate, 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 drug to pass into breast milk has not been studied. Animal data are insufficient to draw conclusions about the effects of this drug 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
When used in recommended doses, the drug has no effect on the ability to drive vehicles and work with other mechanisms.
Method of administration and doses
From the bottle, using a measuring cup, measure 15 ml of Septefryl Verde solution for sore throat and rinse the oral cavity with the undiluted or diluted (15 ml of the measured solution can be diluted with 15 ml of water) preparation. Rinsing should be done 2–3 times a day. The recommended dose should not be exceeded.
Children.
The drug 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 ingestion are gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (dizziness, hallucinations, agitation, anxiety, and irritability).
Very rarely, when benzydamine is taken orally by children in large doses (hundreds of times exceeding the possible doses of this dosage form), the following were observed: agitation, convulsions, tremor, nausea, increased sweating, ataxia, vomiting. Such an acute overdose requires immediate gastric lavage, treatment of water-electrolyte balance disorders and symptomatic treatment, 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).
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.
Septefril Verde for sore throat contains methyl parahydroxybenzoate, which may cause allergic reactions (also delayed reactions).
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
100 ml in a bottle; 1 bottle with a measuring cup 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.
