Septolete ultra o smaku citrini i harnego bzu

Leaflet attached to the packaging: patient information

Septolete ultra lemon and black elderflower flavor, 3 mg + 1 mg, hard lozenges

Benzydamine hydrochloride + Cetylpyridinium chloride

You should carefully read the contents of the 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 ultra lemon and black elderflower flavor and what is it used for
• 2. Important information before using Septolete ultra lemon and black elderflower flavor
• 3. How to use Septolete ultra lemon and black elderflower flavor
• 4. Possible side effects
• 5. How to store Septolete ultra lemon and black elderflower flavor
• 6. Contents of the packaging and other information

1. What is Septolete ultra lemon and black elderflower flavor and what is it used for

Septolete ultra lemon and black elderflower flavor contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride.
Septolete ultra lemon and black elderflower flavor hard lozenges is an anti-inflammatory, analgesic, and antiseptic medicine for local use in the mouth. Septolete ultra lemon and black elderflower flavor disinfects the mouth and throat and reduces the symptoms of throat inflammation, such as pain, redness, swelling, burning, and functional disorders.
Septolete ultra lemon and black elderflower flavor is used to treat the symptoms of sore throat associated with mild infections in the mouth and throat (including gingivitis and pharyngitis).
If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Septolete ultra lemon and black elderflower flavor

black elderflower flavor

When not to use Septolete ultra lemon and black elderflower flavor

• this medicine should not be used in children under 6 years of age.

Warnings and precautions

Before starting to use Septolete ultra lemon and black elderflower flavor, the patient should discuss it with their doctor or pharmacist.
Septolete ultra lemon and black elderflower flavor should not be used for more than 7 days. If the symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, the patient should consult their doctor.
The use of local medicines, especially for a longer period, may lead to irritation. In such a case, the treatment should be discontinued and the patient should consult their doctor for appropriate therapy.
Septolete ultra lemon and black elderflower flavor should not be used in combination with anionic compounds, such as those found in toothpastes, and it is not recommended to use the medicine directly before or after brushing teeth.
Special caution is required:

Children and adolescents

Septolete ultra lemon and black elderflower flavor should not be used in children under 6 years of age.

Septolete ultra lemon and black elderflower flavor 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.
Septolete ultra lemon and black elderflower flavor should not be used at the same time as other antiseptic medicines.

Septolete ultra lemon and black elderflower flavor with food, drink, and alcohol

The patient should not take Septolete ultra lemon and black elderflower flavor at the same time as milk, as it reduces the effectiveness of the medicine.
The patient should not use Septolete ultra lemon and black elderflower flavor before or during meals or drinks. The patient should not eat or drink for at least 1 hour after using Septolete ultra lemon and black elderflower 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.
The use of Septolete ultra lemon and black elderflower flavor is not recommended during pregnancy.
Before using Septolete ultra lemon and black elderflower flavor during breastfeeding, the patient should discuss it with their doctor. The doctor will decide whether to stop breastfeeding or stop the treatment.

Driving and using machines

Septolete ultra lemon and black elderflower flavor has no or negligible influence on the ability to drive and use machines.

Septolete ultra lemon and black elderflower flavor contains isomalt (E 953), butylhydroxyanisole (E 320), sodium benzoate (E 211), and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Butylhydroxyanisole may cause local skin reactions (e.g., contact dermatitis) or eye and mucous membrane irritation.
The medicine contains up to 0.00075 mg of sodium benzoate in each lozenge. Sodium benzoate may cause local irritation.
This medicine contains less than 1 mmol (23 mg) of sodium per lozenge, which means the medicine is considered "sodium-free".

3. How to use Septolete ultra lemon and black elderflower flavor

This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
Adults
The recommended dosage is 3 to 4 hard lozenges per day. The lozenge should be sucked slowly 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. The lozenge should be sucked slowly 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. The lozenge should be sucked slowly in the mouth every 3 to 6 hours.
Children under 6 years of age
Septolete ultra lemon and black elderflower flavor should not be used in children under 6 years of age.

Do not exceed the recommended dose.

Septolete ultra lemon and black elderflower flavor should not be used before or during meals or drinks.
The patient should not eat or drink for at least 1 hour after using the medicine.
The patient should not use the medicine directly before or after brushing teeth.

Duration of treatment

The medicine should not be used for more than 7 days. If the symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, the patient should consult their doctor.
The patient should inform their doctor in case of recurrence of the treated disease or changes in its course.

Using a higher dose of Septolete ultra lemon and black elderflower flavor than recommended

In case of accidental ingestion of an excessive dose of the medicine, the patient should immediately inform their doctor or go to the nearest hospital.

Missing a dose of Septolete ultra lemon and black elderflower flavor

The patient should not take a double dose to make up for a missed dose of the medicine.
If the patient has any further doubts about the use of this medicine, they 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):

• urticaria, increased skin sensitivity to sunlight (photosensitivity),
• sudden, uncontrolled constriction 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 (frequency cannot be estimated from the available data):

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

These symptoms are usually temporary. However, if they occur, the patient should consult their 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 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 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 lemon and black elderflower flavor

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiration date stated on the carton and blister after the abbreviation EXP. The expiration date refers to the last day of the month.
The medicine should be stored in the original packaging to protect it from light.
There are no special precautions for storage temperature.
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 packaging and other information

What Septolete ultra lemon and black elderflower flavor contains

• The active substances of the medicine are: benzydamine hydrochloride and cetylpyridinium chloride. Each hard lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients of the medicine are: peppermint oil, levomenthol, sucralose (E 955), citric acid (E 330), isomalt (type M) (E 953), lemon flavor (containing butylhydroxyanisole (E 320)), elderflower flavor, curcumin dye (E 100) (containing sodium benzoate (E 211)), copper complexes of chlorophyllin (E 141) (containing sodium). See section 2 "Septolete ultra lemon and black elderflower flavor contains isomalt (E 953), butylhydroxyanisole (E 320), sodium benzoate (E 211), and sodium”.

What Septolete ultra lemon and black elderflower flavor looks like and what the packaging contains

Round lozenges with cut edges and a rough surface, greenish-yellow in color. White spots, uneven coloring, air bubbles in the "hard sugar" mass, and small surface irregularities. Lozenge diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Pack sizes: 8, 16, 24, 32, or 40 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/Importer:

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:

In order to obtain more detailed information on this medicine, you should contact the representative of the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Phone: 22 57 37 500

Date of the last update of the leaflet: 20.02.2025