Septolete ultra o smaku citrini i miodu

Package Leaflet: Information for the Patient

Septolete Ultra Lemon and Honey Flavor, 3 mg + 1 mg, Hard Lozenges

Benzydamine Hydrochloride + Cetylpyridinium 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 package leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Package Leaflet

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

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

Septolete Ultra Lemon and Honey Flavor contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride.
Septolete Ultra Lemon and Honey Flavor hard lozenges is an anti-inflammatory, analgesic, and antiseptic medicine for local use in the mouth. Septolete Ultra Lemon and Honey 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 Honey Flavor is used to treat the symptoms of sore throat associated with mild infections in the mouth and throat (including tonsillitis and pharyngitis).
If after 3 days there is no improvement or you feel worse, consult a doctor.

2. Important information before using Septolete Ultra Lemon and Honey Flavor

When not to use Septolete Ultra Lemon and Honey Flavor

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

Warnings and precautions

Before using Septolete Ultra Lemon and Honey Flavor, discuss it with your doctor or pharmacist.
Septolete Ultra Lemon and Honey 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, consult a doctor.
The use of local medicines, especially for a longer period, may lead to irritation. In such a case, treatment should be discontinued and a doctor consulted for appropriate therapy.
Septolete Ultra Lemon and Honey 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.
Particular caution should be exercised:

Children and adolescents

Septolete Ultra Lemon and Honey Flavor should not be used in children under 6 years of age.

Septolete Ultra Lemon and Honey Flavor and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Septolete Ultra Lemon and Honey Flavor should not be used simultaneously with other antiseptic medicines.

Septolete Ultra Lemon and Honey Flavor with food, drink, and alcohol

Do not take Septolete Ultra Lemon and Honey Flavor with milk, as it reduces its effectiveness.
Do not use Septolete Ultra Lemon and Honey Flavor before or during meals or drinks.
Do not eat or drink for at least 1 hour after using Septolete Ultra Lemon and Honey Flavor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
It is not recommended to use Septolete Ultra Lemon and Honey Flavor during pregnancy.
Before using Septolete Ultra Lemon and Honey Flavor during breastfeeding, discuss it with your doctor. The doctor will decide whether to discontinue breastfeeding or stop treatment.

Driving and using machines

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

Septolete Ultra Lemon and Honey Flavor contains isomalt (E 953), sodium benzoate (E 211), and sodium

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
The medicine contains up to 0.0009 mg of sodium benzoate per lozenge. Sodium benzoate may cause local irritation.
The medicine contains less than 1 mmol (23 mg) of sodium per hard lozenge, which means the medicine is considered "sodium-free".

3. How to use Septolete Ultra Lemon and Honey Flavor

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 you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dosage is 3 to 4 hard lozenges per day. Suck one lozenge 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. Suck one lozenge 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. Suck one lozenge slowly in the mouth every 3 to 6 hours.
Children under 6 years of age
Septolete Ultra Lemon and Honey Flavor should not be used in children under 6 years of age.

Do not exceed the recommended dose.

Do not use Septolete Ultra Lemon and Honey Flavor before or during meals or drinks.
Do not eat or drink for at least 1 hour after using Septolete Ultra Lemon and Honey Flavor.
It is not recommended to use the medicine directly before or after brushing teeth.

Duration of treatment

Do not use the medicine for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, consult a doctor.
Tell your doctor if the treated disease recurs or changes in its course.

Using more than the recommended dose of Septolete Ultra Lemon and Honey Flavor

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

Missing a dose of Septolete Ultra Lemon and Honey Flavor

Do not take a double dose to make up for a missed dose of the medicine.
If you have any further doubts about using this medicine, consult your 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 1,000 people):

• hives, increased sensitivity of the skin to sunlight (photosensitivity),
• 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 (frequency cannot be estimated from the available data):

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), which may include difficulty breathing, pain or tightness in the chest and (or) dizziness or fainting, severe itching of the skin or raised bumps on the skin, swelling of the face, lips, tongue, and (or) throat, and which may be life-threatening,

usually, these symptoms are temporary. However, if they occur, it is recommended to consult a doctor or pharmacist.
Following the instructions in the package leaflet, you can reduce the risk of side effects.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your 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:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 allow for more information to be collected on the safety of the medicine.

5. How to store Septolete Ultra Lemon and Honey Flavor

Keep the medicine out of the 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 instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Septolete Ultra Lemon and Honey 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, honey flavor, curcuma (E 100) (containing sodium benzoate (E 211)). See section 2 "Septolete Ultra Lemon and Honey Flavor contains isomalt (E 953), sodium benzoate (E 211), and sodium”.

What Septolete Ultra Lemon and Honey Flavor looks like and contents of the package

Round lozenges with flat edges and rough surface, yellow to light yellow in color.
White spots, uneven coloring, air bubbles in the "hard sugar" mass, and small surface irregularities. 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.
Package sizes: 8, 16, 24, 32, or 40 hard lozenges.
Not all package 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 information about this medicine, please contact the marketing authorization holder:

KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500

Date of last revision of the package leaflet: