Septolete ultra o smaku eukaliptusovim

Patient Information Leaflet: User Information

Septolete Ultra Eucalyptus Flavor, 3 mg + 1 mg, Hard Lozenges

Benzydamine Hydrochloride + Cetylpyridinium Chloride

Read the 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 patient information leaflet 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 those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

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

1. What is Septolete Ultra Eucalyptus Flavor and what is it used for

Septolete Ultra Eucalyptus Flavor lozenges are an anti-inflammatory, analgesic, and antiseptic medicine for local use in the mouth. The lozenges disinfect the mouth and throat, reducing the symptoms of throat inflammation, such as pain, redness, and swelling. Septolete Ultra Eucalyptus Flavor lozenges are used as an anti-inflammatory, analgesic, and antiseptic in the treatment of:

• throat, mouth, and gum irritation,
• in cases of gum inflammation and throat inflammation.

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

2. Important information before using Septolete Ultra Eucalyptus Flavor

When not to use Septolete Ultra Eucalyptus Flavor

• if the patient is allergic (hypersensitive) to benzydamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age, as this pharmaceutical form is not intended for this age group.

Warnings and precautions

Before starting to use Septolete Ultra Eucalyptus Flavor, the patient should discuss it with their doctor or pharmacist.
Septolete Ultra Eucalyptus Flavor should not be used for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, the patient should contact a doctor.
The use of local medicines, especially for a longer period, may lead to irritation; in such a case, treatment should be discontinued.
Septolete Ultra Eucalyptus Flavor should not be used in combination with anionic compounds, such as those found in toothpastes; therefore, it is not recommended to use the medicine directly before or after brushing teeth.

Children and adolescents

Septolete Ultra Eucalyptus Flavor should not be used in children under 6 years of age, as the lozenges are not indicated for this age group.

Septolete Ultra Eucalyptus Flavor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Septolete Ultra Eucalyptus Flavor should not be used at the same time as other antiseptic medicines.

Septolete Ultra Eucalyptus Flavor with food, drink, and alcohol

The patient should not take Septolete Ultra Eucalyptus Flavor lozenges at the same time as milk, as milk reduces their effectiveness.
The patient should not use Septolete Ultra Eucalyptus Flavor before or during meals. The patient should not drink or eat for at least 1 hour after using Septolete Ultra Eucalyptus Flavor.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
It is not recommended to use Septolete Ultra Eucalyptus Flavor during pregnancy.
Before using Septolete Ultra Eucalyptus Flavor while breastfeeding, the patient should discuss it with their doctor. The doctor will advise whether to stop breastfeeding or stop the treatment.

Driving and using machines

Septolete Ultra Eucalyptus Flavor has no influence or negligible influence on the ability to drive and use machines.

Septolete Ultra Eucalyptus Flavor contains isomalt (E 953)

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Septolete Ultra Eucalyptus Flavor

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Adults
The recommended dosage is 3 to 4 hard lozenges per day. A lozenge should be slowly sucked in the mouth every 3 to 6 hours.
Adolescents over 12 years of age
The recommended dosage is 3 to 4 hard lozenges per day. A lozenge should be slowly sucked in the mouth every 3 to 6 hours.
Children from 6 to 12 years of age
The recommended dosage is 3 hard lozenges per day. A lozenge should be slowly sucked in the mouth every 3 to 6 hours.
Children under 6 years of age
Septolete Ultra Eucalyptus Flavor is contraindicated in children under 6 years of age.

Do not exceed the recommended dose.

The patient should not use Septolete Ultra Eucalyptus Flavor before or during meals.
The patient should not drink or eat for at least 1 hour after using the medicine.
For optimal effect, it is not recommended to use the medicine directly before or after brushing teeth.

Duration of treatment

The medicine should not be used for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, the patient should consult a doctor.

Using more than the recommended dose of Septolete Ultra Eucalyptus Flavor

In case of accidental overdose, the patient should immediately inform their doctor or go to the nearest hospital.

Missing a dose of Septolete Ultra Eucalyptus Flavor

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare (may affect up to 1 in 1000 people):

• hives, increased skin sensitivity to sunlight (phototoxicity),
• sudden, uncontrolled narrowing of the airways in the lungs (bronchospasm).

Very rare (may affect up to 1 in 10,000 people):

• local irritation of the mouth, burning sensation in the mouth.

Frequency not known (cannot be estimated from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), which may include difficulty breathing, chest pain or tightness, and (or) dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, and which may be life-threatening,
• burning sensation in the mouth, loss of sensation (numbness) of the mouth mucosa.

These symptoms are usually temporary. However, if they occur, it is recommended to consult a doctor or pharmacist.
By following the instructions in the patient information leaflet, the risk of side effects can be reduced.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 gathered on the safety of the medicine.

5. How to store Septolete Ultra Eucalyptus Flavor

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store in the original package to protect from light.
There are no special storage temperature requirements.
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 Ultra Eucalyptus Flavor contains

• The active substances of the medicine are benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• Other ingredients of the medicine: eucalyptus oil, levomenthol, citric acid (E 330), sucralose (E 955), isomalt (E 953), brilliant blue FCF (E 133). See section 2. "Septolete Ultra Eucalyptus Flavor contains isomalt (E 953)".

What Septolete Ultra Eucalyptus Flavor looks like and contents of the pack

Round, blue-white to blue lozenges with beveled edges. Small scratches may be present.
Diameter of the lozenge: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
Blisters of PVC/PE/PVDC/Aluminum, in a cardboard box.
Pack sizes: 16 or 24 hard lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

For more detailed information on this medicine, please contact the local representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Date of last revision of the leaflet:30.11.2023