Septalor of the tab. No. 20

Translation of the instruction Mose

СЕПТАЛОР® tablets for application in an oral cavity

Instruction

On medical use of medicine

Septalor®

Ingredients:

Active ingredients: chlorhexidine/ascorbic acid;

1 tablet contains

: a chlorhexidina of dihydrochloride (in terms of 100% dry matter) 5 mg, ascorbic acid of 50 mg;

excipients: sugar confectionery, povidone, magnesium stearate, talc, tartrazine (E 102), ponso 4R (E124), "fruit mix" fragrance (contains propylene glycol).

Dosage form.

Tablet for application in an oral cavity.

Main physical and chemical properties: tablets of pink-orange color, with an impregnation, ploskotsilindrichesky with a facet.

Pharmacotherapeutic group.

Antiseptic and vitamin medicine.

ATX R02A A05 Code.

Pharmacological properties.

Pharmacodynamics.

Septalor ^® – the combined medicine which consists of 2 components. Chlorhexidin has antibacterial effect by nonspecific binding with phospholipids of a cellular membrane of bacteria where chlorhexidin brakes activity of dehydrogenase and ATP-ase and breaks permeability of a membrane for potassium, nucleotides and amino acids.

Chlorhexidin acts with

as bacteriostatic medicine in low concentration (less than 20 mg/l) and as bactericidal medicine in high concentrations. Its action is directed mainly against gram-positive microorganisms and Candida albicans and smaller degree — against gram-negative microorganisms. Chlorhexidin is especially effective against Streptococcus mutans, Streptococcus salvarius, Escherichia coli, Selenomonas, anaerobic bacteria and Candida albicans. Proteus, Pseudomonas, Klebsiella and Veillonella species is slightly less effective against Streptococcus sanquis.

Ascorbic acid reduces inflammation and hypostasis of a mucous membrane of a mouth and nasopharynx, strengthens the immune response and works as a cofactor in synthesis of collagen and angenesis.

Pharmacokinetics.

Chlorhexidin is practically not absorbed by

through a mucous membrane and skin. At resorption chlorhexidin it is gradually released from a tablet in saliva and contacts a mucous membrane of an oral cavity and language then again gets to saliva where its antibacterial action is shown. Chlorhexidin it is possible to swallow with saliva, however, him absorption in digestive tract very low. Chlorhexidin in insignificant degree is metabolized in a liver and brought with bile through intestines. Usually 90% of a chlorhexidin to be removed in steady-state condition with a stake.

Concentration of a chlorhexidin is measured by method of highly effective liquid chromatography with sensitivity to 1 mg/l in environments of an organism.

Ascorbic acid is well absorbed by

from a digestive tract. Extent of its linking with proteins of plasma makes about 25%. Ascorbic acid is metabolized to dehydroascorbic and oxalic acids, removed mainly with urine.

Clinical characteristics.

Indication.

Topical treatment of symptoms of inflammation of a mucous membrane of a throat and throat.

Contraindication.

Hypersensitivity to a chlorhexidin and other components of medicine.

Interaction with other medicines and other types of interactions.

do not have

messages about interaction cases with other medicines.

to

does not recommend combined use with iodine medicines.

Feature of application.

Drug contains sugar confectionery that needs to be considered sick diabetes, intolerance of fructose and also with a sprue of glucose galactose and tendency to caries.

Septalor's ^{Use ®} can temporarily change

flavoring feelings, but for 4 hours after administration of medicament the perception of taste is completely restored. It is recommended to take the medicament after a meal.

Prolonged use of Septalor ^® can cause insignificant temporary coloring of teeth and language, but these phenomena pass after medicament withdrawal, in certain cases for elimination of these phenomena the consultation of the doctor can be required.

Sometimes patients with diseases of a digestive tract and/or liver can complain of nausea, vomiting and an eructation. At emergence of these symptoms, medicine should be cancelled.

Use during pregnancy or feeding by a breast.

Research on studying influence of a chlorhexidin during pregnancy was not conducted by

.

In researches on animals at application of doses, by 300 times (for rats) and 40 times (for rabbits) exceeded doses which the person at application of a chlorhexidin could receive, embriotoksichesky effect it was revealed not. The pregnant woman should consult with the doctor before Septalor's ^{reception ®} .

Penetration of a chlorhexidin into breast milk was not studied by

. Ascorbic acid is excreted in breast milk. The woman during feeding by a breast should consult with the doctor before Septalor's ^{reception ®} .

Ability to influence speed of response at control of motor transport or other mechanisms.

does not influence.

Route of administration and doses.

to Adults and children of 12 years are appointed on 1 tablet by 4 times a day (each 6 hours).

Tablet should be rassasyvat slowly. Septalor ^® accept after a meal and after toothbrushing. It is recommended not to rinse a mouth and not to drink a lot of liquid for 2 hours after resorption of tablets.

Average duration of a course of treatment — 5–7 days; it is not necessary to use medicament more than 14 days.

Children.

not to apply

to children up to 12 years.

Overdose.

Chlorhexidin is practically not absorbed by

from a digestive tract therefore the overdose is very improbable. in case of possible overdose of medicine the clinical inspection and symptomatic treatment is necessary.

Side reactions.

allergic reactions (congestion of a nose, skin rash, peeling of a mucous membrane of a mouth and hypostasis of priushny glands) Occasionally meet; change of taste; increase in a dental plaque; discoloration (brown spots) on teeth, seals and dentures; irritation or inflammation of a mucous membrane of a mouth, irritation of a mucous membrane of a stomach and diarrhea, nausea, vomiting, eructation.

Medicine contains ponso R4 that can cause development of allergic reactions.

Expiration date.

3 years.

Storage conditions.

to Store

in the dry, protected from light place at a temperature not above 25 °C.

to Store

out of children's reach.

Packing.

By No. of 20 (10 × 2) tablets in blisters.

Category of a holiday.

Without recipe.

Producer/applicant.

LLC ternofarm.

Location of the producer and address of the place of implementation of its activity.

LLC ternofarm.

Ukraine, 46010, Ternopil, Fabrichnaya St., 4.