Anzibel® [Benzocaine, Chlorhexidine, Enoxolone]

ANZIBEL® lozenges

Instructions for use of the drug

Structure

1 lozenge contains chlorhexidine hydrochloride 5 mg, benzocaine 4 mg, enoxolone 3 mg

Excipients:

lozenges: sorbitol (E 420), potassium acesulfame, magnesium stearate.

pastilles with menthol flavor: sorbitol (E 420), potassium acesulfame, magnesium stearate, menthol flavoring.

lozenges with honey and lemon flavors: sorbitol (E 420), potassium acesulfame, magnesium stearate, lemon flavoring, honey flavoring.

Dosage form

Pastilles.

Basic physical and chemical properties: round, biconvex pastilles of white or almost white color, smooth on the one hand and with the ŋ logo on the other;

round, biconvex pastilles of white or almost white color, with the smell of menthol, smooth on one side and with the логотип logo on the other;

round, biconvex pastilles of white or almost white color with the smell of lemon and honey, smooth on one side and with the logo “ŋ” on the other.

Pharmacotherapeutic group

Drugs used for diseases of the throat. various antiseptics.

PBX code

R02A A20.

Pharmacological properties

Anzibel is a combined antiseptic drug for topical use in the oropharyngeal zone. pharmacological effect due to the components that make up the drug.

Chlorhexidine has a bacteriostatic effect in low concentrations and bactericidal in high concentrations. The mechanism of action of chlorhexidine is the formation of bonds with the cell membrane of bacteria, which leads to a violation of their structure. It is 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 anesthetic effect in the presence of severe pain. It is used to treat wounds of the oral mucosa and pharynx.

Enoxolone is characterized by 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.

Clinical characteristics

Indications

Symptomatic treatment for infectious and inflammatory diseases of the oral cavity and pharynx.

Contraindications

Hypersensitivity to the active ingredients of the drug or known hypersensitivity to other anesthetics, derivatives of esters that exhibit this type of activity. Phenylketonuria.

Interaction with other drugs and other types of interactions

Do not use with other medicines containing antiseptics.

Concomitant use with preparations containing iodine is not recommended.

Benzocaine contained in the drug interacts with cholinesterase inhibitors (inhibits the metabolism of local anesthetics, there is an increased risk of systemic toxicity), sulfonamides (benzocaine metabolites can suppress the antibacterial activity of sulfonamides).

The simultaneous use of enoxolone and hydrocortisone can help potentiate the effect of the latter on the skin.

Interaction with diagnostic tests.

Interactions with diagnostic tests (bentiromide) used to evaluate pancreatic function may occur. 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 recommended dose.

During the use of local anesthetics, including benzocaine, there is an increased risk of systemic toxicity in elderly patients, in acute diseases or in debilitated patients.With the use of enoxolol in elderly patients in high doses or with prolonged use, fluid retention, edema, and arterial hypertension are possible.

Patients with poor tolerance to local ether-type anesthetics (especially para-aminobenzoic acid derivatives (PABA), parabens, or paraphenylenediamine (hair dye)) may also have poor tolerance to benzocaine.

When using the drug, it is necessary to assess the benefit / risk ratio in situations such as severe damage to the oral mucosa (increased absorption of anesthetics).

Irreversible staining is possible on the surfaces of the fillings or their uneven edges due to the action of chlorhexidine.

The drug contains benzocaine, which can lead to a positive doping test in athletes.

Anzibel contains sorbitol, so it is not recommended for patients with hereditary fructose intolerance.

Anzibel contains acesulfame potassium, this should be considered for patients with impaired renal function or for patients on a potassium-controlled diet.

Since the drug contains potassium acesulfame, there is a risk of increased levels of potassium in the stomach in patients with insufficient absorption of potassium. An increase in potassium levels can cause stomach irritation and diarrhea.

In patients with periodontitis, chlorhexidine may contribute to increased supragingival dental deposition.

It is necessary to carry out thorough oral hygiene using toothpastes to remove tartar, in order to prevent an increase in dental deposits and staining of teeth with chlorhexidine.

Use during pregnancy and lactation.

Anzibel should not be used during pregnancy.

Enoxolone when used in high doses and in doses above 60 mg / day, and prolonged use, can contribute to fluid retention, edema and hypertension, this should be considered for pregnant women.

There are no data on the use of chlorhexidine and benzocaine in pregnant women.

It is not known whether the active components of the drug penetrate into breast milk, so the drug should not be used during lactation.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms.

Does not affect.

Dosage and administration

Pastilles are used in the oral cavity until complete resorption.

Recommended doses for adults and children over 12 years: 1 lozenge with an interval of 2-3 hours (maximum daily dose - 8 lozenges).

Apply after eating and after brushing your teeth.

It is recommended not to rinse your mouth and do not drink the liquid for 2 hours after resorption of the lozenges.

The duration of treatment depends on the course of the disease and is usually 3 to 7 days, but if the symptoms of the disease persist or intensify 2 days after the start of the drug, you should consult a doctor.

Children.

The effectiveness and safety of the use of the drug Anzibel for children under 12 years of age have not been established, therefore, the drug should not be prescribed to this age group of patients.

Overdose

An overdose is unlikely.

In case of an overdose of enoxolone, hypermineralcorticoidism, sodium retention and loss of potassium, edema, increased blood pressure and inhibition of the renin-angiotensin-aldosterone system can occur.

With an overdose of chlorhexedine, especially in children, there are symptoms of alcohol poisoning (speech confusion, numbness, or a shaky gait).

Despite the low absorption of benzocaine, its excessive content can cause systemic absorption, the symptoms of which can be blurred vision, diplopia, dizziness, cramps, tinnitus, agitation (CNS stimulation), which is replaced by drowsiness (CNS depression), increased sweating, decreased arterial pressure, slow heart rate and heart rhythm disturbances, inhibition of the cardiovascular system.

Treatment of an overdose of chlorhexedine is symptomatic. Treatment includes the use of oxygen or artificial respiration if necessary. For the treatment of circulatory depression syndrome, the use of vasoconstrictors and the use of fluids are necessary. Patients may experience methemoglobinemia (difficulty breathing, dizziness, weakness, fatigue, lethargy), in which case it is necessary to use methylene blue.

Adverse reactions

From the immune system: allergic reactions, including nasal congestion.

On the part of the skin and subcutaneous tissue: itching, urticaria, skin rash, contact dermatitis.

From the cardiovascular system: with prolonged use, edema, arterial hypertension may occur.

From the digestive system: taste change, plaque, discoloration / 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, and burning, itching, swelling, or redness of the mouth or around.

Shelf life

3 years.

Storage conditions

Store at a temperature not exceeding 25 ° C in the original packaging.

Keep out of the reach of children.

Packaging

10 lozenges per blister.

10 lozenges in a blister, 1 or 3 blisters in a cardboard box.

Holiday Category

Over the counter.

Manufacturer

Nobelfarma ilach sanai ve tijaret A.Sh.

Manufacturers location and address

Sankaklar Koui 81100 Duzce, Turkey