Instructions for Septefril Verde for sore throat, 3 mg lemon-flavored lozenges No. 20
Composition
active ingredient: benzydamine hydrochloride;
1 lollipop contains 3 mg of benzydamine hydrochloride, which is equivalent to 2.68 mg of benzydamine;
excipients: isomalt (E 953), citric acid monohydrate (E 330), aspartame (E 951), quinoline yellow (E 104), lemon flavoring, peppermint oil.
Dosage form
Lollipops.
Main physicochemical properties: round yellow candies with lemon flavor.
Pharmacotherapeutic group
Drugs affecting the respiratory system. Drugs used in throat diseases. Other drugs used in throat diseases. Benzydamine. ATX code R02A X03.
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 of moderate intensity on the oral mucosa.
Pharmacokinetics.
Absorption
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.
Distribution
Approximately 2 hours after administration of a 3 mg lozenge, the maximum plasma concentration of benzydamine is 37.8 ng/mL and the AUC value is 367 ng/mL∗h. However, these concentrations are too low to exert systemic pharmacological effects.
It has been shown that topical application of benzydamine results in accumulation in inflamed tissues, where effective concentrations are achieved due to its ability to penetrate the mucosa.
Breeding
Excretion occurs primarily in the urine, mainly in the form of inactive metabolites or conjugated compounds.
Indication
For the symptomatic treatment of pain, irritation and inflammation of the mouth and throat.
Contraindication
Hypersensitivity to the active substance or to other components of the medicinal product.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
Benzydamine is not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.
Septefril Verde for sore throat should be used with caution in patients with bronchial asthma, particularly in a history, due to the possibility of bronchospasm.
In some patients, oropharyngeal 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 medical advice.
Important information about excipients
The medicine Septefryl Verde for sore throat, lozenges, contains aspartame, which is a source of phenylalanine synthesis. It can be dangerous for patients with phenylketonuria.
The medicine contains isomalt, therefore it should not be used in patients with rare hereditary diseases associated with fructose intolerance.
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 conclusions about the effects of this drug on pregnancy and lactation. There is no information on the potential risk during pregnancy or breastfeeding.
Septefryl Verde should not be used for sore throat during pregnancy and breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When used in recommended doses, the drug has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
The lollipop should be slowly sucked until it is completely dissolved in the mouth. The lollipops should not be swallowed or chewed.
Adults and children over 6 years of age should take 1 lollipop 3 times a day. The duration of treatment should not exceed 7 days.
Children.
This dosage form is used in children aged 6 years and older.
Children aged 6–11 years should use Septefryl Verde for sore throats under adult supervision.
Overdose
However, it is known that benzydamine, when ingested in large doses (which are hundreds of times higher than the possible doses of this dosage form), 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 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).
Respiratory, thoracic and mediastinal disorders: rare - laryngospasm.
From the gastrointestinal tract: rarely - burning sensation in the mouth, dry mouth; frequency unknown - oral hypoesthesia.
On the part of the immune system: rarely - hypersensitivity reactions; frequency unknown - anaphylactic reactions.
Skin and subcutaneous tissue disorders: uncommon - photosensitivity; rare - angioedema.
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
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 lozenges in a blister; 2 blisters in a pack.
Vacation category
Without a prescription.
Producer
LOZI'S PHARMACEUTICALS S.L.
Location of the manufacturer and address of its place of business.
Campus Empresarial, Lecaroz, Navarra, 31795, Spain.
Applicant
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the applicant. Ukraine, 02093, Kyiv, Boryspilska St., 13.
