Sepotelet Neo - instructions for use, dose, side effects, contraindications

Active substanceCetylpyridinium chlorideCetylpyridinium chloride

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Septotlet® Neo

lozenges inwards

KRKA, dd, Novo mesto, AO

Dosage form: & nbsppastilles [apple, lemon, cherry]

Composition:

1 apple lozenge contains:

Active substance:

Cetylpyridinium chloride monohydrate 1.26 mg (corresponding to cetyl pyridinium chloride 1.2 mg)

Excipients: maltitol, liquid (dry matter) 476.64 mg, mannitol 163.88 mg, levomentol 2.00 mg, lemon oil 3.00 mg, apple flavoring 10.00 mg, dye yellow (E100) (dye curcumin E-100, water, gum acacia, maltodextrin, citric acid E330, emulsifier E472c, potassium sorbate and sodium benzoate) 0.65 mg, dye green (E141) (dye chlorophyll copper E-141, water, propylene glycol and polysorbate 80) 1.95 mg, glycerol 3.50 mg, castor oil 1.10 mg, silicon dioxide colloid 1.00 mg, magnesium stearate 3.00 mg, titanium dioxide (E171) 3.00 mg, povidone 2.50 mg, capol 600 Pharma (beeswax , wax carnauba, shellac) 2.50 mg, maltitol up to 1200.00 mg.

1 pastilles lemon contains:

Active substance:

Cetylpyridinium chloride monohydrate 1.26 mg (corresponding to cetyl pyridinium chloride 1.2 mg)

Excipients: maltitol, liquid (dry matter) 476.64 mg, mannitol 163.88 mg, levomentol 2.00 mg, lemon oil 3.00 mg, lemon flavor 3.00 mg, citrus flavor 3.00 mg, orange oil 4.00 mg,yellow color (E100) (dye curcumin E-100, water, acacia gum, maltodextrin, citric acid E330, emulsifier E472c, potassium sorbate and sodium benzoate) 2.60 mg, glycerol 3.50 mg, castor oil 1.10 mg, silicon dioxide colloid 1.00 mg, magnesium stearate 3.00 mg, titanium dioxide (E171) 3.00 mg, povidone 2.50 mg, capol 600 Pharma (beeswax, carnauba wax, shellac) 2.50 mg, maltitol before 1200.00 mg.

1 lozenge cherry contains:

Active substance:

Cetylpyridinium chloride monohydrate 1.26 mg (corresponding to cetyl pyridinium chloride 1.2 mg)

Excipients: maltitol, liquid (dry matter) 476.64 mg, mannitol 163.88 mg, levomenthol 2.00 mg, lemon oil 3.00 mg, cherry flavoring 10.00 mg, colorant violet (E120) (carminic acid (E120), sodium hydroxide solution, citric acid) 2.60 mg, glycerol 3.50 mg, Castor oil 1.10 mg, Silica colloidal dioxide 1.00 mg, magnesium stearate 3.00 mg, titanium dioxide (E171) 3.00 mg, povidone 2.50 mg, Capol 600 Farma (beeswax, carnauba wax, shellac) 2.50 mg, maltitol up to 1200,00 mg.

Description:

Apple pastels: Round biconvex pastilles of green color, slight inclusions of a lighter color are allowed.

Pastilles lemon: Round biconvex pastilles of yellow color, slight inclusions of a lighter color are allowed.

Cherry lozenges: Round biconvex pastilles from pink to pink with a lilac shade of color, slight inclusions of a lighter color are allowed.

Pharmacotherapeutic group:Antiseptic

ATX: & nbsp

R.02.A.A.06 Cetylpyridinium chloride

Pharmacodynamics:Cetylpyridinium chloride - antiseptic from the troupe of quaternary ammonium compounds, has antimicrobial, antifungal and virucidal action.

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:Individual intolerance. Children under 4 years.

Pregnancy and lactation:Septoletone® NEO should be used with caution in pregnant women and nursing mothers.

Dosing and Administration:

The recommended dose for adults and children over the age of 12 is up to 8 lozenges a day. The lozenge must melt in the mouth. The lozenges are taken every 2-3 hours.The recommended dose for children over 4 years up to 4 lozenges per day, and for children aged 10 to 12 years - up to 6 lozenges a day. The lozenge must melt in the mouth. The lozenges are taken every 3-4 hours.

Lozenges should not be taken immediately before or during meals.

Side effects:

Side effects are rare when taking Septolete® NEO lozenges in the recommended doses.

Allergic reactions, gastrointestinal disorders (nausea, diarrhea), the manifestation of which the drug should be discontinued.

The preparation contains polyols (maltitol, mannitol), which can cause diarrhea in large doses, especially in children.

Overdose:Given the amount of active substance contained in a single lozenge, the possibility of an overdose is minimal. Taking doses that are higher than recommended can cause disorders of the gastrointestinal tract, nausea, vomiting and diarrhea. In this case, stop taking the medication and consult a doctor.

Interaction:Lozenges should not be taken with milk, as it reduces the antimicrobial activity of cetylpyridinium chloride.

Special instructions:

Pastilles should not be taken with open wounds in the mouth, as cetipyridinium chloride slows the healing of wounds.

In case of severe infections accompanied by fever, headache and vomiting, consult a doctor, especially if the condition does not improve after 3 days.

Patients with diabetes should remember that each lozenge contains about 1 g of maltitol. For the metabolism of maltitol, insulin is needed, but because of slow hydrolysis and absorption in the gastrointestinal tract, the glycemic index is low. The energy value of maltitol (10 kJ / g or 2.4 kcal / g) is also significantly lower than that of sucrose. Do not take higher doses than recommended.

Effect on the ability to drive transp. cf. and fur:Pastilles have no effect on the ability to drive / work with machinery.

Form release / dosage:

Pastilles [apple, lemon, cherry], 1.2 mg.

Packaging:

For 9 pastilles in a blister of thermoforming PVC / PVDH 250/60 transparent-foil aluminum (foil thermo forming PVC / PVDC 250/60 transparent-foil aluminum). 2 blisters per cardboard pack together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C, in the original packaging.Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LSR-000075

Date of registration:25.05.2007 / 27.06.2016

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, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp10.10.2015

Illustrated instructions

Instructions

Septotlet® Neo (Septolete® Neo)