Septolete

Patient Information Leaflet

Septolete, 1 mg, hard pastilles
Benzalkonii chloridum
Please read carefully the entire leaflet before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or additional information is needed, please consult your pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.
• If there is no improvement after 3 days of treatment, or if symptoms worsen, consult a doctor.

Table of Contents

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

1. What Septolete is and what it is used for

Septolete hard pastilles contain benzalkonium chloride, which has bactericidal activity against certain bacteria and fungicidal activity against Candida albicans (thrush).
Septolete hard pastilles act directly on microorganisms causing infection, inhibit the spread of infection, and effectively relieve discomfort associated with inflammatory conditions of the mouth and throat.
Symptomatic treatment to relieve pain and disinfect in cases of:

• inflammatory conditions of the mouth, throat, and gums
• unpleasant breath (halitosis)

If there is no improvement after 3 days of treatment, or if the patient feels worse, consult a doctor.

2. 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, discuss this with your doctor or pharmacist.
Do not use higher doses than recommended.
If hoarseness persists for a prolonged period, consult a doctor.
Septolete with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Food and drink with Septolete
Do not take the tablets at the same time as milk, as milk reduces the antimicrobial effectiveness of benzalkonium chloride.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnant and breastfeeding women should not use this medicine, as there is insufficient data on the safety of the product during pregnancy and breastfeeding.
Driving and operating machinery
Septolete has no effect or has a negligible effect on the ability to drive and operate machinery.
Septolete contains monohydrate lactose, sucrose, glucose, and sorbitol
Monohydrate lactose
This medicine contains 218.1 mg of monohydrate lactose in each hard tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Sucrose
This medicine contains 623.6 mg of sucrose in each hard tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine. The amount of sucrose in the maximum daily dose according to the dosing schedule is 4989 mg.
Glucose
This medicine contains 174.5 mg of glucose in each hard tablet. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Sorbitol
This medicine contains 152.7 mg of sorbitol in each hard tablet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or has previously been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, the patient should contact a doctor before taking this medicine. Patients with hereditary fructose intolerance must not take this medicine.
Diabetic patients should be aware that each hard tablet contains 218.1 mg of monohydrate lactose, 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 patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Maximum of 8 pastilles per day. Suck 1 pastille every 2 to 3 hours. Do not swallow the pastilles; suck until completely dissolved.
The pastilles should be used for approximately one week. If symptoms do not improve or worsen, consult a doctor.
If there is no improvement after 3 days, or if the patient feels worse, contact a doctor.
Taking more Septolete than recommended
If more medicine has been taken than recommended, contact a doctor or pharmacist.
Due to the small amount of active substance in one pastille, the risk of overdose is minimal.
After taking an excessive amount of pastilles, gastrointestinal disturbances such as nausea, vomiting, and diarrhoea may occur, especially in children. In such cases, stop taking the medicine, drink plenty of water or milk, and contact a doctor or pharmacist.
If you forget to take Septolete
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 any medicine, this medicinal product may cause adverse reactions, although not everybody will experience them.
When used at recommended doses, Septolete rarely causes adverse reactions.
If any of the following severe adverse reactions occur, discontinue use of Septolete immediately
and contact your doctor without delay:
Rare (may affect up to 1 in 1,000 people):

• hypersensitivity reactions (including bronchoconstriction, particularly in patients with asthma).

Other adverse reactions
Rare (may affect fewer than 1 in 1,000 people):

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

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 Authorisation Holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Septolete

Keep the medicine in a place invisible and inaccessible to children.
Store below 25°C, protect from moisture and light.
Do not use this medicine after the expiry date stated on the cardboard packaging 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 packaging 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. Such practices help protect the environment.

6. Contents of the packaging and other information

What the medicine Septolete contains

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

What the medicine Septolete looks like and contents of the pack
Round, double convex hard pastilles with a green colour.
Blister packs made of PVC/PE/PVDC/Aluminium in cardboard boxes.
Pack sizes:
10 pastilles (1 blister containing 10 units)
30 pastilles (3 blisters containing 10 units each)
30 pastilles (2 blisters containing 15 units each)

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

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.,
Równoległa 5 St.,
02-235 Warsaw,
Phone: 22 57 37 500