Instructions for Farisil lozenges, blister with lemon flavor, No. 20
Composition
active ingredients: chlorhexidine, benzocaine;
1 tablet contains chlorhexidine dihydrochloride 5 mg, benzocaine 5 mg;
excipients: mannitol (E 421), microcrystalline cellulose, povidone, magnesium stearate, sodium cyclamate, sodium saccharin, orange flavor or lemon flavor, menthol flavor.
Dosage form
Lozenges with orange or lemon flavor.
Main physicochemical properties: yellowish-white tablets, round, with a beveled edge and a score on one side.
Pharmacotherapeutic group
Drugs used for throat diseases. Antiseptics.
ATX code R02A A.
Pharmacological properties
Pharmacodynamics
Farisil is a combined antiseptic drug for topical use in infectious and inflammatory diseases of the mouth and throat. The action of the drug is provided by the action of the components that make up the drug.
Chlorhexidine is an antiseptic agent, the action of which is due to surface cationic properties, which leads to a violation of the integrity of the membranes of microorganisms. The drug is active against many bacteria, fungi and viruses, which causes a microbicidal effect.
Benzocaine, which is part of the drug, has a local anesthetic (analgesic) effect. Reduces sore throat, sore throat, and pain when swallowing.
Pharmacokinetics
Approximately 30% of chlorhexidine is absorbed in the oral cavity, excreted with saliva throughout the day, which significantly prolongs its effect. Benzocaine is almost not absorbed in the oral cavity.
Indication
Local treatment of acute infectious and inflammatory diseases of the mouth and throat.
Contraindication
Hypersensitivity to chlorhexidine, benzocaine or other components of the drug or other agents with anesthetic activity. Phenylketonuria.
Interaction with other medicinal products and other types of interactions
The drug should not be used with other local antiseptics. It should be borne in mind that benzocaine metabolites significantly weaken the antibacterial effect of sulfonamide derivatives.
Simultaneous use with iodine-containing drugs is not recommended. Due to the presence of benzocaine, the drug interacts with cholinesterase inhibitors, which inhibit the metabolism of local anesthetics, therefore there is an increased risk of systemic toxicity.
Interaction with diagnostic tests.
There may be an interaction with diagnostic tests for pancreatic function using bentyromide. The results are invalid because benzocaine is metabolized by arylamines and also increases para-aminobenzoic acid (PABA). It is recommended to stop treatment at least 3 days before the test.
Application features
Patients with intolerance to ether-type anesthetics (novocaine), parabens may also be intolerant to benzocaine. The drug should be used with caution in children, elderly patients and seriously ill patients, as they are more sensitive to benzocaine, and exceeding the dose may lead to methemoglobinemia. The tablets should not be chewed or swallowed, as the effect of the drug is local and possible only with direct contact with the affected area. When using local anesthetics, including benzocaine, there is an increased risk of systemic toxicity in acute diseases. In patients with hypersensitivity to ether-type local anesthetics (especially derivatives of para-aminobenzoic acid (PABA), parabens or paraphenyldiamine (hair dye)) hypersensitivity to benzocaine may also be determined.
The benefit/risk ratio should be assessed in the following situations: severe mucosal injuries (increased absorption of anesthetics), irreversible staining from chlorhexidine is possible on filling surfaces or uneven edges.
The drug contains benzocaine, which may cause a positive doping test result in athletes.
In patients with periodontitis, chlorhexidine may cause an increase in tartar.
It is necessary to maintain proper oral hygiene with an anti-tartar toothpaste to prevent tartar buildup and tooth staining due to the effects of chlorhexidine.
Use during pregnancy or breastfeeding
Despite the fact that chlorhexidine and benzocaine do not have embryotoxic and fetotoxic effects, there is insufficient clinical data on the use in pregnant women, therefore the need for prescribing to pregnant women is determined by the doctor, taking into account the expected benefit to the woman and the potential risk to the fetus/child. It is not known whether the active components of the drug are excreted in breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
One tablet should be slowly dissolved in the mouth.
The duration of use of the drug depends on the course of the disease and is usually from 3 to 7 days, but if the symptoms of the disease persist or worsen 2 days after starting the drug, you should consult a doctor.
Children
Farisil is used in children over 12 years of age.
Overdose
Due to the low absorption of the drug, overdose is unlikely. Theoretically, an overdose of chlorhexidine may be accompanied by symptoms of alcohol intoxication (slurred speech, unsteadiness when walking), especially in children. An overdose of benzocaine causes symptoms from the central nervous system (dizziness, double vision, agitation, convulsions, depression).
Treatment is symptomatic, gastric lavage, use of sorbents. In case of methemoglobinemia, methylene blue should be prescribed.
Adverse reactions
Respiratory system: frequency unknown - nasal congestion.
On the part of the digestive tract: frequency unknown - change in taste sensations and irritation of the oral mucosa; with prolonged use of the drug, discoloration of the teeth and tongue is possible, which gradually disappears after discontinuation of the drug.
Allergic reactions: frequency unknown - itching, urticaria, exanthema, angioedema.
Skin and subcutaneous tissue disorders: frequency unknown - skin rashes, contact dermatitis.
Chronic use may cause swelling, hypertension, dental plaque, mumps, irritation of the gastric mucosa, diarrhea, soreness of the tongue and oral mucosa, irritation or inflammation of the oral mucosa and tongue, as well as burning, itching, swelling, or redness of the oral mucosa or skin around the mouth.
Expiration date
2 years.
Do not use the drug after the expiration date indicated on the package.
Storage conditions
Store at a temperature not exceeding 30 ° C. Keep out of the reach of children.
Packaging
10 tablets in a blister. 2 blisters in a cardboard pack.
Vacation category
Without a prescription.
Producer
Laboratorios Alcala Pharma, S.L.
Applicant
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Location of the manufacturer and address of its place of business
Avenida Madrid, 82, Alcala de Henares, 28802 Madrid, Spain.
Location of the applicant and address of its place of business
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
Phone: + 38(0432)52-30-36. E-mail: trade@sperco.com.ua
www.sperco.com.ua
