Septolete Iunior

Package Leaflet: Information for the Patient

Septolete Junior, 1.2 mg, lozenges
Cetylpyridinium chloride

Cherry-flavored lozenges

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used in accordance with the description in the package leaflet for the patient or as directed by the doctor.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or further information.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Septolete Junior and what is it used for
• 2. Important information before using Septolete Junior
• 3. How to use Septolete Junior
• 4. Possible side effects
• 5. How to store Septolete Junior
• 6. Contents of the pack and other information

1. What is Septolete Junior and what is it used for

Septolete Junior acts locally as a disinfectant. It contains a disinfectant agent - cetylpyridinium chloride, which has bactericidal effects. It also acts on some viruses and fungi. The lozenges disinfect the mouth and throat, thus relieving inflammation of the mouth and throat. Due to the good solubility of cetylpyridinium chloride, it also penetrates well into the hard-to-reach areas of the mucous membrane of the mouth and throat, inhibiting the growth of bacteria there.
The Septolete Junior lozenges have a cherry flavor. They do not contain sugar.

Indications for use

Septolete Junior is recommended for local treatment of mild infections of the mouth and throat (pharyngitis, laryngitis, initial period of tonsillitis).
If after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Septolete Junior

When not to use Septolete Junior

Warnings and precautions

Particular caution should be exercised when using Septolete Junior in the following cases:

• severe infections associated with high fever, headaches, and vomiting - if symptoms worsen or do not improve after 3 days, you should consult a doctor;
• diabetes - the patient should take into account that each lozenge contains approximately 1 g of maltitol; due to slow hydrolysis and slow absorption from the gastrointestinal tract, maltitol has a minimal effect on blood glucose levels.

Do not use in case of wounds and ulcers in the mouth, as cetylpyridinium chloride slows down the healing process of wounds.
Do not exceed the recommended dose.
Septolete Junior is not recommended for children under 4 years of age.

Other medicines and Septolete Junior

Tell your doctor about all the medicines you have taken recently, even those that are available without a prescription.

Using Septolete Junior with food and drink

Do not take the medicine directly before or during meals, or at the same time as milk.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, you should consult your doctor or pharmacist before using this medicine.
Caution should be exercised when using the medicine in pregnant women.
Caution should be exercised when using the medicine in breastfeeding women.

Driving and using machines

There is no data on the effect of Septolete Junior on the ability to drive and use machines.

Important information about some ingredients of Septolete Junior

The lozenges contain a natural dye, so they may change color to a lighter one when exposed to light over time.
The lozenges contain polyhydric alcohols (maltitol, mannitol), which in large doses may cause diarrhea.
Glycerol in large doses may cause headaches and gastrointestinal disorders.

3. How to use Septolete Junior

This medicine should always be used in accordance with the description in the package leaflet for the patient or as directed by the doctor.
In case of doubt, consult your doctor or pharmacist.
Usually, the recommended dose of Septolete Junior for adults and children over 12 years of age is 8 lozenges per day. Suck 1 lozenge every 2 to 3 hours.
For children over 4 years of age, up to 4 lozenges per day are recommended, and for children from 10 to 12 years of age, up to 6 lozenges per day. Suck 1 lozenge every 3 to 4 hours.
Do not take the medicine directly before or during meals.
If you feel that the effect of Septolete Junior is too strong or too weak, consult your doctor or pharmacist.

In case of using a higher dose of Septolete Junior than recommended

Due to the small amount of active substance in one lozenge, the possibility of overdosing is very low. Taking a larger number of lozenges may cause gastrointestinal disorders, such as nausea, vomiting, diarrhea.
In this case, stop using the medicine, drink more water or milk, and consult your doctor or pharmacist.

In case of missing a dose of Septolete Junior

Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, Septolete Junior can cause side effects, although not everybody gets them.
Rarely, gastrointestinal disorders may occur, such as nausea, diarrhea, especially when using the medicine in doses higher than recommended.
In very rare cases, hypersensitivity reactions may occur, such as irritation and rash.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Septolete Junior

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging. Protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Septolete Junior contains

• The active substance of the medicine is cetylpyridinium chloride. Each lozenge contains 1.2 mg of cetylpyridinium chloride.
• The other ingredients of the medicine are: liquid maltitol (dry matter), maltitol, mannitol, levomenthol, lemon oil, wild cherry flavor, natural red dye (Cochineal, E 120), glycerol, castor oil, colloidal silica anhydrous, magnesium stearate, titanium dioxide (E 171), povidone, Capol 600.

What Septolete Junior looks like and contents of the pack

Purple, round, slightly convex lozenges, with a cherry flavor.
Packaging:18 lozenges in blisters, in a cardboard box.

Marketing authorization holder and manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information, please contact:
KRKA-POLSKA Sp. z o.o.,
ul. Równoległa 5, 02-235
Warsaw
tel: (22) 57 37 500

Date of last revision of the leaflet: