Sepotlet Plus - instructions for use, dose, side effects, contraindications

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Dosage form: & nbsp

pastilles honey-lime

Composition:

(per lozenge)

Active substances:

Benzocaine 5.00 mg

Cetylpyridinium chloride 1.00 mg

(as a monohydrate)

Excipients:

Levomenthol 3.00 mg

Peppermint leaves 1.00 mg

Flavored lime 25.00 mg

Aromatizer honey 15.00 mg

Maltitol liquid (dry matter) 478.00 mg

Mannitol 167.50 mg

Glycerol 3.50 mg

Regular oil seed cages 1.10 mg (castor oil)

Silica colloidal dioxide 1.00 mg

Magnesium stearate 10.00 mg

* Capol 600 Farma 2.50 mg

Povidone 2.50 mg

Titanium dioxide (E171) 4.00 mg

Dye quinoline yellow (E104) 0.75 mg

Caramel dye (E150a) 0.06 mg

Dye red charming (E129) 0.01 mg

Maltitol up to 1250.00 mg

* Capol 600 Pharma: beeswax white, carnauba wax, shellac.

Description:Round biconvex lozenges with a smooth surface, covered with a shell of dark yellow color.

Pharmacotherapeutic group:Antiseptic + local anesthetic.

ATX: & nbsp

Other drugs

Pharmacodynamics:The preparation contains an antiseptic cetylpyridinium chloride, which has an antimicrobial, antifungal and virucidal effect. Benzocaine is a local anesthetic that reduces pain when swallowing, which often accompanies infectious inflammatory processes in the mouth and throat.The drug Sepotlet® plus contains polyols (maltitol and mannitol), does not contain sugar, which allows you to take the drug for people with diabetes. The sugarless medium increases the activity of the antiseptic.

Pharmacokinetics:

Quaternary ammonium compounds, to which cetylpyridinium chloride, are absorbed, only by 10-20%. Not the absorbed part is excreted through the intestine in unaltered form.

Benzocaine, poorly soluble in water, which determines its minimum absorption. Adsorbed benzocaine hydrolyzed mainly by plasma cholinesterase and a small part is metabolized in the liver. Metabolites are excreted by the kidneys.

Indications:

Infectious and inflammatory diseases of the mouth and throat:

- pharyngitis, laryngitis, the initial stage of angina;

- inflammation of the gums and mucous membrane of the mouth (gingivitis, stomatitis).

Contraindications:

- Hypersensitivity to any of the components of the drug;

- hereditary galactosemia, intolerance to fructose, lactase deficiency, glucose-galactose malabsorption syndrome;

- children's age till 6 years.

Carefully:Diabetes mellitus, the presence of open wounds of the oral cavity, tk. cetylpyridinium chloride slows healing of wounds.

Pregnancy and lactation:

Data on the use of the drug Sepotlet Plus during pregnancy and during breastfeeding are limited, so pregnant and lactating women should not take the drug.

Dosing and Administration:

Adults and children over 12 years.

Dissolve 1 lozenge every 2-3 hours, but not more than 8 lozenges per day.

Children from 6 to 12 years are recommended to dissolve 1 lozenge every 4 hours, but not more than 4 lozenges per day.

The drug Sepotlet® plus should not be taken immediately before meals and simultaneously with milk.

Side effects:

Classification of the incidence of adverse events (WHO):

very often> 1/10

often from> 1/100 to <1/10

infrequently from> 1/1000 to <1/100

rarely from> 1/10000 to <1/1000

very rarely from <1/10000, including individual messages.

From the digestive system:

rarely: nausea, abdominal pain, diarrhea;

From the immune system:

very rarely: allergic reactions.

Overdose:Given the number of active substances contained in a single lozenge, the possibility of an overdose is minimal. Taking doses that are higher than recommended can cause disturbances in the gastrointestinal tract: nausea, vomiting and diarrhea. Benzocaine in high doses can cause methemoglobinemia.If symptoms of an overdose occur, the use of the drug Sepotelet® Plus should be stopped, rinsed and consult a doctor.

Interaction:

Non-narcotic analgesics and cholinesterase inhibitors increase the action of benzocaine.

Benzocaine reduces the antibacterial activity of sulfonamides.

There is no data on the drug interaction of cetylpyridinium chloride with other drugs.

Special instructions:

Do not exceed recommended doses.

The drug Septotelet® Plus contains polyols (maltitol, mannitol), which can cause diarrhea in large doses, especially in children.

Pastilles should not be consumed with milk, as milk reduces the antimicrobial activity of cetylpyridinium chloride.

The drug Septhlet® Plus can not be used with open wounds of the oral cavity, because cetylpyridinium chloride slows healing of wounds.

In disorders of the gastrointestinal tract, the drug should be discontinued. When expressed infectious processes, accompanied by fever, headache and vomiting, you should consult a doctor.

Patients with diabetes mellitus should be aware that in each lozenge of the drug, Septotelet® Plus contains approximately 1 g of maltitol. For its metabolic needs insulin but, because of the slow hydrolysis and poor absorption in the gastrointestinal tract, maltitol, insignificantly affects the concentration of glucose in blood plasma, however, the correction dose hypoglycemic agents is necessary. The energy value of maltitol (10 kJ / g or 2.4 kcal / g) is significantly lower than that of sucrose.

Special information about other components of the drug

The Septolete® Plus lozenges contain mannitol and liquid maltitol. Patients with hereditary galactosemia, fructose intolerance, lactase deficiency, a syndrome of glucose-galactose malabsorption application Septolete® plus the drug is contraindicated.

Effect on the ability to drive transp. cf. and fur:Septolete® plus drug does not affect the ability to drive and work with other technical devices that require high concentration and psychomotor speed reactions.

Form release / dosage:

Pastilles honey-lime.

Packaging:

9 pastilles in the blister of the combined material PVC / PVDH - foil aluminum.

2 blisters are placed in a pack of cardboard along with instructions for use.

Storage conditions:In a place protected from light and moisture, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 of the year.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-000969

Date of registration:18.10.2011 / 19.10.2016

Expiration Date:Unlimited

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA KRKA Slovenia

Information update date: & nbsp28.03.2016

Illustrated instructions

Instructions

Septotlet® plus (Septolete® plus)