SEPTOLETE 1 mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Septolete D, 1 mg, Hard Tablets
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Septolete D and what is it used for
4. Important information before using Septolete D
   1. When not to use Septolete D
   2. Warnings and precautions
   3. Children
   4. Septolete D and other medicines
   5. Using Septolete D with food and drink
   6. Pregnancy and breastfeeding
   7. Driving and using machines
   8. Septolete D contains maltitol and liquid maltitol
5. How to use Septolete D
   1. Adults
   2. Use in children and adolescents
   3. Using a higher dose of Septolete D than recommended
   4. Missing a dose of Septolete D
6. Possible side effects
   1. If the patient notices any of the following serious side effects, they should stop taking Septolete D and contact their doctor immediately:
   2. Other side effects
   3. Reporting side effects
7. How to store Septolete D
8. Contents of the pack and other information
   1. What Septolete D contains
   2. What Septolete D looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Septolete D, 1 mg, Hard Tablets

Benzalkonium Chloride

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Septolete D contains benzalkonium chloride, which has a bactericidal effect on some bacteria and a fungicidal effect on Candida albicans(thrush).
Septolete D acts directly on microorganisms that cause infections, has a local disinfectant effect, and alleviates symptoms in oral and throat infections.
Septolete D does not contain sugar, which does not promote the growth of bacteria that cause dental plaque.
It is also used to help with symptoms of inflammatory conditions caused by bacterial infections of the mouth and throat:

• sore throat
• hoarseness
• bad breath
• gingivitis.

If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using 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, the patient should discuss it with their doctor or pharmacist.
Special caution should be exercised when using Septolete D in the following cases:

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

Do not use higher doses than recommended.

Children

Septolete D should not be used in children under 4 years of age.

Septolete D and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take .

Using Septolete D with food and drink

Septolete D should not be taken immediately before a meal or during a meal.
Do not take the tablets with milk, as it reduces the effectiveness of the antimicrobial action of benzalkonium chloride.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine.
There is not enough data on the safety of using Septolete D during pregnancy and breastfeeding, so it is not recommended to use the medicine during these periods.

Driving and using machines

Septolete D has no or negligible influence on the ability to drive and use machines.

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 some sugars, they should tell their doctor before taking the medicine.

3. How to use Septolete D

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults

Adults are recommended to take 6 to 8 tablets per day. Suck one tablet to dissolve in the mouth every 2 to 3 hours.

Use in children and adolescents

Children over 4 years of age are recommended to take 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 recommended to take 6 to 8 tablets per day.
Suck one tablet to dissolve in the mouth every 2 to 3 hours.
Tablets should not be used in children under 4 years of age.
Tablets should not be chewed or swallowed.
Tablets should not be taken immediately before a meal or during a meal.
If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.
If the patient feels that the effect of Septolete D is too strong or too weak, they should consult their doctor.

Using a higher dose of Septolete D than recommended

In case of taking a higher dose of the medicine than recommended, the patient should contact their doctor or pharmacist.
Due to the small amount of active substance in one tablet, the risk of overdose is very low.
Taking more tablets than recommended may cause gastrointestinal disorders, such as nausea, vomiting, diarrhea. In such a case, the patient should stop taking the medicine, drink more water or milk, and consult their doctor or pharmacist.

Missing a dose of Septolete D

Do not take a double dose to make up for a missed dose.
If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Septolete D can cause side effects, although not everybody gets them.
In recommended doses, Septolete D rarely shows side effects.

If the patient notices any of the following serious side effects, they should stop taking Septolete D and contact their doctor immediately:

Rare (may affect up to 1 in 1000 people)

• hypersensitivity reactions (including bronchospasm, especially in patients with asthma).

Other side effects

Rare (may affect less than 1 in 1000 people):

• gastrointestinal disorders, such as nausea, diarrhea, mainly when using the medicine in doses higher than recommended.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Septolete D

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medicine after the expiry date stated on the carton after the word "EXP" and on the blister pack. The expiry date refers to the last day of the month.
The batch number is stated on the carton after the word "Lot" and on the blister pack.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 oil, peppermint oil, liquid maltitol, mannitol, first-pressing castor oil, glycerol, anhydrous colloidal 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

Round, biconvex, yellow tablets.
PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes:
10 tablets (1 blister of 10)
30 tablets (3 blisters of 10)
30 tablets (2 blisters of 15)

Marketing authorization holder and manufacturer

KRKA, d. d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
phone: 22 573 75 00

Date of last revision of the leaflet: