Package leaflet: Information for the patient

Septolete D, 1 mg, hard pastilles
Benzalkonium chloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

What Septolete D is and what it is used for
Important information before using Septolete D
How to use Septolete D
Possible side effects
How to store Septolete D
Contents of the pack and other information

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

Septolete D contains benzalkonium chloride, which has bactericidal activity against certain bacteria and fungicidal activity against Candida albicans (thrush).
Septolete D acts directly on microorganisms causing infections, exerts a local antiseptic effect, and relieves symptoms associated with infections of the mouth and throat.
Septolete D does not contain sugar, which does not promote the growth of bacteria responsible for dental plaque formation.
It is used symptomatically in inflammatory conditions caused by bacterial infections of the mouth and throat:

sore throat
hoarseness
bad breath
gingivitis

If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important information before using the medicine Septolete D

When not to use Septolete D

if the patient is allergic to benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).
in children under 4 years of age.

Warnings and precautions
Before starting to use Septolete D, discuss this with your doctor or pharmacist.
Exercise special caution when using Septolete D in the following cases:

more severe infections, with high fever, headache, and vomiting; if symptoms worsen or do not improve after 3 days, seek medical advice;
diabetes – the patient should be aware that each tablet contains maltitol; due to its slow hydrolysis and gradual absorption from the gastrointestinal tract, maltitol has only a minimal effect on blood glucose levels.

Do not use higher doses than recommended.
Children
Do not use Septolete D in children under 4 years of age.
Septolete D and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking Septolete D with food and drink
Do not take Septolete D immediately before or during a meal.
Do not take the tablets simultaneously with milk, as it reduces the antimicrobial effectiveness of benzalkonium chloride.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There is insufficient data on the safety of using this medicine during pregnancy and breastfeeding; therefore, use of the medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
Septolete D has no effect or has a negligible effect on the ability to drive and operate machinery.
Septolete D contains maltitol and liquid maltitol
The medicine contains 950.67 mg of maltitol and 478.00 mg of liquid maltitol in one tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, inform the doctor before taking the medicine.

3. How to use Septolete D

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Adults are advised to take 6 to 8 tablets per day. One tablet should be sucked and allowed to dissolve in the mouth every 2 to 3 hours.
Use in children and adolescents
Children over 4 years of age are advised up to 4 tablets per day, and children over 10 years of age up to 6 tablets per day. Adolescents over 12 years of age are advised 6 to 8 tablets per day.
One tablet should be sucked and allowed to dissolve in the mouth every 2 to 3 hours.
Do not use the tablets in children under 4 years of age.
Do not chew or swallow the tablets.
Do not use the tablets immediately before or during a meal.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
If you feel that the effect of Septolete D is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Septolete D
If you take more medicine than recommended, contact your doctor or pharmacist.
Due to the small amount of active substance in one tablet, the risk of overdose is very low.
Taking a larger number of tablets may lead to gastrointestinal disturbances such as nausea, vomiting, and diarrhoea. In such a case, stop taking the medicine, drink more water or milk, and consult your doctor or pharmacist.
Missed dose of Septolete D
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
When used at recommended doses, Septolete D rarely causes adverse reactions.
If any of the following severe adverse reactions occur, discontinue use of Septolete D and contact your doctor immediately:
Rare (may occur in up to 1 in 1,000 people):

hypersensitivity reactions (e.g. bronchospasm, particularly in patients with asthma).

Other adverse reactions
Rare (may occur in less than 1 in 1,000 people):

gastrointestinal disturbances such as nausea, diarrhoea, especially when the medicine is used at doses higher than recommended.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Septolete D

Keep the medicine out of sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the cardboard box after the abbreviation "EXP" and on the blister. The expiry date refers to the last day of the specified month.
The batch number is indicated on the cardboard box after the abbreviation "Lot" and on the blister.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Septolete D contains

The active substance is benzalkonium chloride. Each tablet contains 1 mg of benzalkonium chloride (Benzalkonii chloridum).
The other ingredients (excipients) are: levomenthol, thymol, eucalyptus essential oil, peppermint essential oil, liquid maltitol, mannitol, first pressed castor oil, glycerol, colloidal anhydrous silica, magnesium stearate, povidone, Capol 600 (white wax, carnauba wax, shellac), quinoline yellow (E 104), titanium dioxide (E 171), maltitol. See section 2 "Septolete D contains maltitol and liquid maltitol".

What Septolete D looks like and contents of the pack
Yellow, round, hard, biconvex tablets.
PVC/PE/PVDC/Aluminium blisters in a cardboard box.
Pack sizes:
10 tablets (1 blister with 10 tablets)
30 tablets (3 blisters with 10 tablets each)
30 tablets (2 blisters with 15 tablets each)

Marketing Authorisation Holder and Manufacturer
KRKA, d. d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Poland
Tel.: 22 573 75 00