Instructions for Anzibel pastilles, honey and lemon flavor, blister pack No. 30
Composition
chlorhexidine hydrochloride, benzocaine, enoxolone;
1 lozenge contains chlorhexidine hydrochloride 5 mg, benzocaine 4 mg, enoxolone 3 mg;
excipients:
lozenges: sorbitol (E 420), acesulfame potassium, magnesium stearate;
menthol-flavored lozenges: sorbitol (E 420), acesulfame potassium, magnesium stearate, menthol flavoring;
honey and lemon flavored lozenges: sorbitol (E 420), acesulfame potassium, magnesium stearate, lemon flavoring, honey flavoring.
Dosage form
Lozenges.
Main physicochemical properties: round biconvex lozenges of white or almost white color, smooth on one side and with the “ŋ” logo on the other;
round, biconvex lozenges of white or almost white color, with a menthol odor, smooth on one side and with the “ŋ” logo on the other;
round, biconvex lozenges of white or almost white color with a lemon and honey smell, smooth on one side and with the “ŋ” logo on the other.
Pharmacotherapeutic group
Means used for diseases of the throat. Antiseptics. ATX code R02A A20.
Pharmacological properties
Pharmacodynamics
Anzibel® is a combined antiseptic preparation for topical use in the oropharyngeal area. The pharmacological effect is provided by the components included in the preparation.
Chlorhexidine has a bacteriostatic effect at low concentrations and a bactericidal effect at high concentrations. The mechanism of action of chlorhexidine is to form bonds with the cell membrane of bacteria, which leads to disruption of their structure. Active against staphylococci, streptococci, Candida albicans, Escherichia coli and some aerobic and anaerobic bacteria. Proteus, Pseudomonas, Klebsiella spp. are weakly sensitive to chlorhexidine.
Benzocaine has a local analgesic effect in the presence of severe pain. It is used to treat wounds on the mucous membrane of the oral cavity or tongue.
Enoxolone has anti-inflammatory and analgesic properties, as well as a pronounced antiviral effect against viruses containing DNA or RNA, as well as various strains of Herpes simplex and Herpes zoster viruses.
Indication
Local treatment of symptoms in infectious inflammatory diseases of the oral cavity and pharynx.
Contraindication
Hypersensitivity to any component of the drug or known hypersensitivity to other agents with anesthetic activity, to ester derivatives with anesthetic activity. Phenylketonuria.
Interaction with other medicinal products and other types of interactions
Do not use with other medicines containing antiseptics.
Concomitant use with drugs containing iodine is not recommended.
Due to the presence of benzocaine, the drug interacts with cholinesterase inhibitors (inhibits the metabolism of local anesthetics, there is an increased risk of systemic toxicity), with sulfonamides (benzocaine metabolites can inhibit the antibacterial activity of sulfonamides).
The simultaneous use of enoxolone and hydrocortisone may potentiate the effects of the latter on the skin.
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 the amount of para-aminobenzoic acid (PABA). It is recommended to stop treatment at least 3 days before the test.
Application features
Do not exceed the recommended dose.
When using local anesthetics, including benzocaine, there is an increased risk of systemic toxicity in elderly patients, in acutely ill patients, or in debilitated patients. When enoxolol is used in elderly patients in high doses or with prolonged use, fluid retention, edema, and hypertension are possible.
Patients with intolerance to ester-type local anesthetics (especially para-aminobenzoic acid (PABA) derivatives, parabens or paraphenylenediamine (hair dye)) may also experience intolerance to benzocaine.
The benefit/risk ratio should be assessed in the following situations: severe mucosal injuries (increased absorption of anesthetics), irreversible staining is possible on filling surfaces or uneven edges due to the action of chlorhexidine.
The drug contains benzocaine, which may cause a positive doping test result in athletes.
Anzibel® contains sorbitol and is not recommended for patients with hereditary fructose intolerance. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Anzibel® contains acesulfame potassium, which should be taken into account in patients with impaired or reduced kidney function or in patients on a potassium-controlled diet.
As the product contains acesulfame potassium, there is a risk of increased potassium levels in the stomach in patients with poor potassium absorption. Increased potassium levels may cause stomach irritation and diarrhea.
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
Anzibel® should not be used during pregnancy.
Enoxolone, when used in high doses and in doses above 60 mg/day and with prolonged use, may contribute to fluid retention, edema, and arterial hypertension, which should be considered in pregnant women.
There are no adequate data on the use of chlorhexidine and benzocaine in pregnant women.
It is not known whether the active ingredients of the drug penetrate into breast milk, so the drug should not be used during breastfeeding.
The ability to influence the reaction speed when driving or working with other mechanisms
No effect.
Method of administration and doses
Apply the drug into the oral cavity. Keep the lozenges until completely dissolved.
Recommended doses for adults and children over 12 years of age: 1 lozenge every 2-3 hours (maximum daily dose – 8 lozenges).
Apply after meals and after brushing your teeth.
It is recommended not to rinse your mouth or drink large amounts of liquid for 2 hours after sucking the lozenges.
The duration of treatment 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
The efficacy and safety of Anzibel® in children under 12 years of age have not been established, therefore the drug should not be prescribed to this age group of patients.
Overdose
Overdose is unlikely.
In case of enoxolone overdose, hypermineralocorticoidism, sodium retention and potassium loss, edema, increased blood pressure, and suppression of the aldosterone-renin-angiotensin system (RAAS) may occur.
In case of an overdose of chlorhexidine, especially in children, symptoms of alcohol poisoning (slurred speech, numbness, or unsteady gait) are observed.
Despite the low absorption of benzocaine, excessive content can cause systemic absorption, symptoms of which may include blurred vision, diplopia, dizziness, convulsions, tinnitus, excitement (CNS stimulation), alternating with drowsiness (CNS depression), increased sweating, decreased blood pressure, slowed pulse and heart rhythm disturbances, and depression of the cardiovascular system.
Treatment of chlorhexidine overdose is symptomatic. Treatment includes the use of oxygen or artificial respiration as needed. Treatment of circulatory depression requires the use of vasoconstrictors and fluids. Patients may develop methemoglobinemia (difficulty breathing, dizziness, weakness, fatigue, lethargy), in which case methylene blue should be used.
Side effects
Immune system disorders: allergic reactions, including nasal congestion.
Skin and subcutaneous tissue disorders: itching, urticaria, skin rashes, contact dermatitis.
Cardiovascular system: with chronic use, edema and arterial hypertension may occur.
On the part of the digestive system: change in taste, plaque, change in color/pigmentation of tooth enamel (brown spots), fillings and dentures, 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 mucous membrane in or around the mouth.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C in the original packaging.
Keep out of reach of children.
Packaging
10 lozenges in a blister.
10 lozenges in a blister; 1, 2 or 3 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
NOBEL ILACH SANAI VE TJARET A.Sh.
Address
Sankaklar Quarter, Eski Akcakoca Ave., No. 299, 81100 Duzce, Turkey.
