MINISTRY OF PUBLIC HEALTH OF THE REPUBLIC OF BELARUS
Stamp:
Agreed by the Ministry of Public Health of the Republic of Belarus
Order of the Ministry of Public Health of the Republic of Belarus from 21.12.2011 No 1230 committee on drugs No 12 from 01.12.2011
Name of the drug: Angiseptin
General description
INSTRUCTION
(core data sheet for specialists) for medical application of
ANGISEPTIN
Biconvex tablets of yellow to yellow-orange color with some light or dark inclusions on the surface, and with orange-mint aroma.
Ingredients
Each tablet contains:
2 mg of chlorhexidine diacetate, 0,20 mg of tetracaine hydrochloride, 50 mg of ascorbic acid; menthol, sorbitol, sodium saccharinate, talk, calcium stearate, flavour “Orange”, tartrazine.
Dosage form
Throat lozenge
ATC class : R02AA20
Pharmacotherapeutic class:
Other antiseptic agents for larynx and pharynx treatment.
Pharmacological properties
Pharmacodynamics
Chlorhexidine acts as a bacteriostatic agent in small concentration and as a bactericide in high concentration. It’s effective against such microbes as staphylococci, streptococci, Candida albicans, Escherichia coli and other aerobic and anaerobic bacteria. Bacteria with low-grade sensitivity to chlorhexidine: Proteus, Pseudomonas, Klebsiella. Antibacterial action consists of binding with a cell wall of bacteria, which leads to the destruction of their structure.
It’s easily and fully absorbed through mucous membranes (the speed of absorption depends on the place of introduction and dosage). Plasma protein binding is high. It’s completely hydrolyzed mostly in plasma by choline esterase for 1-2 hours with the creation of paminobenzoic acid containing bindings in the liver. The excretion is carried out by kidneys and with bile, and partially goes through the enterohepatic recirculation.
Local anesthetic tetracaine inhibits the excitability of nociceptors, quickly relieves a throat ache and has a long-term effect.
Ascorbic acid increases general resistibility of the organism to infections, prevents from parodontopathy; it’s a necessary component for collagen and intercellular substance formation, it contributes to teeth strengthening, wound healing, decreases an unpleasant chlorhexidine taste.
Pharmacokinetics
Chlorhexidine is badly absorbed through the tunica mucosa of the mouth and then in the gastrointestinal tract (less than1 % of the introduced dose). The maximum concentration in the blood occurs in 30 minutes after an intake. Tetracaine is easily and fully absorbed through mucous membranes. Plasma protein binding is high. Ascorbic acid is absorbed in the small intestine. The maximum concentration of ascorbic acid occurs in 4 hours after an intake. The

degree of its plasma protein binding is approximately 25%, it’s metabolized to dihydroascorbic and oxalic acids.
Chlorhexidine excretion is performed together with excrements (90%), 1% of the dose is excreted together with urine. Tetracaine excretion is performed by kidneys and together with bile, and partially goes through the enterohepatic recirculation. Ascorbic acid is excreted together with urine.
Changes of pharmacokinetic properties of separate components of the drug used simultaneously haven’t been detected.
Indications and usage
Treatment for infectious inflammatory diseases of the oral cavity and the throat (stomatitis, gingivitis, tonsillitis, pharyngitis, parodontosis).
Dosage and administration
Local administration. 1 tablet. Keep in the mouth till completely dissolved.
Adults and children under 15 years old: 1 tablet every 2 hours (maximum – 6 tablets per day).
Children from 10 to 15 years old: 1 tablet every 3 hours (maximum – 4 tablets per day).
Children from 5 to 10 years old: 1 tablet every 4 hours (maximum – 3 tablets per day).
Adverse reactions
In rare cases allergic reactions can occur.
Contraindications
Hypersensitivity to the components of the drug.
Pregnancy (I trimester).
Lactation period.
Overdosage
Overdosage hasn’t been described.
Precautions
Ascorbic acid, which is one of the components of the drug, can change the results of some laboratory tests, which should be informed about while carrying out tests.
The drug should be prescribed with some precaution in case of: pancreatic diabetes, glucose
6-phosphatedehydrogenase deficit, hemochromatosis, sideroblastic anemia, thalassemia, hyperoxaluria, oskalosis, and nephrolithiasis.
Administration during pregnancy and lactation
Should be prescribed with some precaution during pregnancy (II-III trimesters).
Effects on ability to drive and use machines
The drug doesn’t influence the ability to drive and use machines.
Drug interactions
It’s not recommended to use together with drugs for mouth and throat cavities treatment, containing iodine (Lugol's iodine solution, povidone iodine).
Tetracaine decreases an antibacterial effect of sulfanilamide agents. Vasoconstrictive agents prolong the effect of tetracaine and decrease its toxicity. Ascorbic acid increases the concentration of benzylpenicillin and tetracyclines in the blood, increases the risk of crystalluria occurrence while treatment with the help of fast-release salicylates and sulfanilamides, decreases the concentration of oral contraceptives in the blood.
Storage conditions
It should be stored at the temperature not higher than 25°C in a dark dry place.
Keep away from children!
Shelf life is 2 years. Don’t use after the expiration date.
Stamp:
Agreed by the Ministry of Public Health of the Republic of Belarus
Order of the Ministry of Public Health of the Republic of Belarus

Conditions of sales by pharmacies
Available without prescription.
Package Description
6 tablets in a blister, made from polymer wrapping film for medical purposes and aluminum film with thermolacquer coat. Each pack contains two or three blisters with an instruction for use.
Information about the manufacturer:
ООО (LLC) «Rubikon» Belarus, 210002, Vitebsk, M. Gor’kogo str, 62 B, tel/fax: +375(212) 34-06-29
The translation of this document from Russian into English is made by Alina Sasnouskaya, translator.
Настоящий документ переведен с русского языка на английский язык мною, переводчиком САСНОВСКОЙ АЛИНОЙ ВИКТОРОВНОЙ, достоверность перевода подтверждаю.