Septolete

Package Leaflet: Information for the Patient

Septolete, 1 mg, Hard Lozenges

Benzalkonii chloridum

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.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

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

1. What is Septolete and what is it used for

Septolete hard lozenges contain benzalkonium chloride, which has bactericidal effects on certain bacteria and fungicidal effects on Candida albicans(white thrush).
Septolete hard lozenges act directly on microorganisms that cause infections, inhibit the development of the infection, and effectively alleviate symptoms in inflammatory conditions of the mouth and throat.
Symptomatic treatment to alleviate pain and disinfect in:

• inflammatory conditions of the mouth, throat, and gums
• unpleasant mouth odor

If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

2. Important information before using Septolete

When not to use Septolete

• if the patient is allergic to benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Septolete, the doctor or pharmacist should be consulted.
A higher dose than recommended should not be used.
In case of prolonged hoarseness, a doctor's advice should be sought.

Septolete and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines the patient plans to take.

Septolete with food and drink

Lozenges should not be taken at the same time as milk, as it reduces the effectiveness of the antimicrobial action of benzalkonium chloride.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnant or breastfeeding women should not use this medicine, as there is insufficient data on the safety of the preparation during pregnancy and breastfeeding.

Driving and using machines

Septolete does not affect or has negligible effects on the ability to drive and use machines.

Septolete contains lactose monohydrate, sucrose, glucose, and sorbitol

Lactose monohydrate
This medicine contains 218.1 mg of lactose monohydrate in each hard lozenge. If the patient has previously been diagnosed with intolerance to some sugars, the doctor should be consulted before taking the medicine.
Sucrose
This medicine contains 623.6 mg of sucrose in each hard lozenge. If the patient has previously been diagnosed with intolerance to some sugars, the doctor should be consulted before taking the medicine. The amount of sucrose in the maximum daily dose is 4989 mg.
Glucose
This medicine contains 174.5 mg of glucose in each hard lozenge. If the patient has previously been diagnosed with intolerance to some sugars, the doctor should be consulted before taking the medicine.
Sorbitol
This medicine contains 152.7 mg of sorbitol in each hard lozenge. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the doctor should be consulted before taking the medicine. Patients with hereditary fructose intolerance should not take this medicine.
Diabetic patients should take into account that each hard lozenge contains 218.1 mg of lactose monohydrate, 623.6 mg of sucrose, 174.5 mg of glucose, and 152.7 mg of sorbitol.

3. How to use Septolete

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
Adults
Maximum 8 lozenges per day. 1 lozenge to be sucked every 2 to 3 hours. Lozenges should not be swallowed, sucked until completely dissolved.
Lozenges should be taken for about a week. If symptoms do not improve or worsen, a doctor's advice should be sought.
If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

Using a higher dose of Septolete than recommended

In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted.
Due to the small amount of active substance in one lozenge, the possibilities of overdose are minimal.
After taking a larger number of lozenges, gastrointestinal disorders may occur - nausea, vomiting, and diarrhea, especially in children. In such a case, the use of the medicine should be stopped, a large amount of water or milk should be drunk, and a doctor or pharmacist should be consulted.

Missing a dose of Septolete

A double dose should not be used to make up for a missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If any of the following serious side effects are noticed, the use of Septolete should be stopped immediately and a doctor consulted:

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, especially when using the medicine in doses higher than recommended.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. 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,
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Septolete

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

6. Package contents and other information

What Septolete contains

• The active substance of the medicine is benzalkonium chloride. Each hard lozenge contains: 1 mg of benzalkonium chloride (Benzalkonii chloridum)
• The other ingredients (excipients) are: levomenthol, thymol, eucalyptus oil, peppermint oil, lactose monohydrate, liquid paraffin, glycerol, first-pressing castor oil, sorbitol, magnesium stearate, quinoline yellow (E 104), liquid glucose, indigo carmine (E 132), titanium dioxide (E 171), Capol 600 (white wax, carnauba wax, shellac), povidone, anti-foaming emulsion (including polydimethylsiloxane), sucrose. See section 2 "Septolete contains lactose monohydrate, sucrose, glucose, and sorbitol".

What Septolete looks like and what the package contains

Round, biconvex hard lozenges with a green color.
Blister packs of PVC/PE/PVDC/Aluminum in a cardboard box.
Package sizes:
10 lozenges (1 blister of 10)
30 lozenges (3 blisters of 10)
30 lozenges (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 about this medicine, the local representative of the marketing authorization holder should be contacted:
KRKA-POLSKA Sp. z o.o.,
ul. Równoległa 5,
02-235 Warsaw,
phone: 22 57 37 500

Date of the last update of the package leaflet: