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SEPTALOR® tablets for oral use
Instruction
For medical use of the medicinal product
Septalor®
Composition:
Active ingredients: chlorhexidine / ascorbic acid;
1 tablet contains: chlorhexidine dihydrochloride (calculated on 100% dry matter) 5 mg, ascorbic acid 50 mg;
excipients: confectioner's sugar, povidone, magnesium stearate, talc, tartrazine (E 102), ponceau 4R (E124), "fruit assortment" flavoring (contains propylene glycol).
Dosage form.
Tablets for oral use.
Main physicochemical properties: pink-orange tablets, with inclusions, flat-cylindrical with a bevel.
Pharmacotherapeutic group.
Antiseptic and vitamin preparation.
PBX code R02A A05.
Pharmacological properties.
Pharmacodynamics.
SEPTALOR ® is a combined preparation consisting of 2 components. Chlorhexidine has an antibacterial effect by non-specific binding to phospholipids of the bacterial cell membrane, where chlorhexidine inhibits the activity of dehydrogenase and ATPase and disrupts the permeability of the membrane for potassium, nucleotides and amino acids.
Chlorhexidine acts as a bacteriostatic agent at low concentrations (less than 20 mg/l) and as a bactericidal agent at high concentrations. Its action is directed mainly against gram-positive microorganisms and Candida albicans and to a lesser extent against gram-negative microorganisms. Chlorhexidine is particularly effective against Streptococcus mutans, Streptococcus salvarius, Escherichia coli, Selenomonas, anaerobic bacteria and Candida albicans. It is slightly less effective against Streptococcus sanquis, Proteus, Pseudomonas, Klebsiella and Veillonella species.
Ascorbic acid reduces inflammation and swelling of the oral and nasopharyngeal mucosa, enhances the immune response, and acts as a cofactor in collagen synthesis and tissue regeneration.
Pharmacokinetics.
Chlorhexidine is practically not absorbed through the mucous membrane and skin. When resorbed, chlorhexidine is gradually released from the tablet into saliva and binds to the mucous membrane of the oral cavity and tongue, after which it again enters the saliva, where its antibacterial effect is manifested. Chlorhexidine can be swallowed with saliva, however, its absorption in the gastrointestinal tract is very low. Chlorhexidine is metabolized to a small extent in the liver and excreted in the bile through the intestines. Usually 90% of chlorhexidine is excreted unchanged in the feces.
The concentration of chlorhexidine in body media is measured by high-performance liquid chromatography with a sensitivity of up to 1 mg/L.
Ascorbic acid is well absorbed from the digestive tract. The degree of its binding to plasma proteins is about 25%. Ascorbic acid is metabolized to dihydroascorbic and oxalic acids, and is excreted mainly in the urine.
Clinical characteristics.
Indication.
Local treatment of symptoms of inflammation of the mucous membrane of the throat and larynx.
Contraindication.
Hypersensitivity to chlorhexidine and other components of the drug.
Interaction with other drugs and other types of interactions.
There are no reports of interactions with other drugs.
Concomitant use with iodine preparations is not recommended.
Application features.
The drug contains confectioner's sugar, which should be taken into account by patients with diabetes mellitus, fructose intolerance, as well as glucose-galactose malabsorption syndrome and a tendency to caries.
The use of SEPTALOR ® may temporarily change the sense of taste, but within 4 hours after taking the drug, taste perception is fully restored. It is recommended to take the drug after a meal.
Long-term use of SEPTALOR® may cause slight temporary staining of the teeth and tongue, but these phenomena disappear after discontinuation of the drug; in some cases, a doctor's consultation may be required to eliminate these phenomena.
Sometimes patients with diseases of the gastrointestinal tract and / or liver may complain of nausea, vomiting and belching. If these symptoms appear, the drug should be discontinued.
Use during pregnancy or breastfeeding.
No studies have been conducted to examine the effects of chlorhexidine during pregnancy.
In animal studies, when using doses that were 300 times (for rats) and 40 times (for rabbits) higher than the doses that humans could receive when using chlorhexidine, no embryotoxic effect was detected. Pregnant women should consult a doctor before taking SEPTALOR ®.
The penetration of chlorhexidine into breast milk has not been studied. Ascorbic acid is excreted in breast milk. A woman during breastfeeding should consult a doctor before taking SEPTALOR ®.
The ability to influence the reaction speed when driving vehicles or other mechanisms.
No effect.
Method of administration and doses.
Adults and children over 12 years of age are prescribed 1 tablet 4 times a day (every 6 hours).
The tablet should be slowly dissolved. SEPTALOR ® is taken after meals and after brushing your teeth. It is recommended not to rinse your mouth or drink a lot of fluids for 2 hours after dissolving the tablets.
The average duration of treatment is 5-7 days; the drug should not be used for more than 14 days.
Children.
Do not use in children under 12 years of age.
Chlorhexidine is practically not absorbed from the digestive tract, so overdose is very unlikely. In case of possible overdose of the drug, clinical examination and symptomatic treatment are necessary.
Adverse reactions.
Allergic reactions (nasal congestion, skin rashes, peeling of the oral mucosa and swelling of the parotid glands) are rare; taste changes; increased plaque; discoloration (brown spots) of teeth, fillings and dentures; irritation or inflammation of the oral mucosa, irritation of the gastric mucosa and diarrhea, nausea, vomiting, belching.
The medicine contains Ponceau R4, which may cause allergic reactions.
Expiration date.
3 years.
Storage conditions.
Store in a dry place, protected from light, at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging.
For No. 20 (10 × 2) tablets in blisters.
Vacation category.
Without a prescription.
Manufacturer/applicant.
"Ternofarm" LLC.
Location of the manufacturer and address of its place of business.
"Ternofarm" LLC.
Ukraine, 46010, Ternopil, Fabrychna St., 4.
