Septolete ultra with eucalyptus flavor

Septolete ultra o smaku eukaliptusowym, 3 mg + 1 mg, pastylki twarde
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Read the entire package leaflet carefully before taking this 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 doctor or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Table of contents

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

1. What Septolete ultra o smaku eukaliptusowym is and what it is used for

Septolete ultra o smaku eukaliptusowym pastylki is an anti-inflammatory, analgesic and antiseptic medicine intended for local application to the oral mucosa. The tablets disinfect the oral cavity and throat and reduce symptoms of sore throat such as pain, redness and swelling.

Septolete ultra o smaku eukaliptusowym pastylki is used as an anti-inflammatory, analgesic and antiseptic agent in the treatment of:

• irritation of the throat, oral cavity and gums,
• gingivitis and pharyngitis.

If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought.

2. Important information before using Septolete ultra with eucalyptus flavour

When not to use Septolete ultra with eucalyptus flavour

• 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 with eucalyptus flavour, discuss this with your doctor or pharmacist.
Septolete ultra with eucalyptus flavour should not be used for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, contact your doctor.
The use of topical medicines, especially over a prolonged period, may lead to irritation; in such a case, treatment should be discontinued.
Septolete ultra with eucalyptus flavour should not be used in combination with anionic compounds, such as those present in toothpastes; therefore, it is not recommended to use the medicine immediately before or after brushing teeth.

Children and adolescents
Septolete ultra with eucalyptus flavour should not be used in children under 6 years of age, as the tablets are not indicated for this age group.

Septolete ultra with eucalyptus flavour and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Septolete ultra with eucalyptus flavour should not be used simultaneously with other antiseptic medicines.

Septolete ultra with eucalyptus flavour with food, drink and alcohol
Do not take Septolete ultra with eucalyptus flavour tablets with milk, as milk reduces their effectiveness.
Do not use Septolete ultra with eucalyptus flavour immediately before or during a meal. Do not eat or drink for at least 1 hour after using Septolete ultra with eucalyptus flavour.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The use of Septolete ultra with eucalyptus flavour is not recommended during pregnancy.
Before using Septolete ultra with eucalyptus flavour during breastfeeding, discuss this with your doctor. Your doctor will decide whether breastfeeding should be discontinued or whether treatment should be stopped.

Driving and operating machinery
Septolete ultra with eucalyptus flavour has no effect or has a negligible effect on the ability to drive and operate machinery.

Septolete ultra with eucalyptus flavour contains isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Septolete ultra eucalyptus flavoured tablets

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Adults
The recommended dose is 3 to 4 hard tablets per day. The tablet should be slowly sucked in the mouth every 3 to 6 hours.
Adolescents over 12 years of age
The recommended dose is 3 to 4 hard tablets per day. The tablet should be slowly sucked in the mouth every 3 to 6 hours.
Children aged 6 to 12 years
The recommended dose is 3 hard tablets per day. The tablet should be slowly sucked in the mouth every 3 to 6 hours.
Children under 6 years of age
Septolete ultra eucalyptus flavoured tablets are contraindicated in children under 6 years of age.
Do not exceed the recommended dose.
Do not take Septolete ultra eucalyptus flavoured tablets before or during a meal.
Do not eat or drink for at least 1 hour after taking the medicine.
For optimal effectiveness, it is not recommended to use the medicine immediately before or after brushing teeth.
Duration of treatment
Do not use the medicine for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, consult a doctor.
Taking more than the recommended dose of Septolete ultra eucalyptus flavoured tablets
In case of accidental overdose, contact a doctor immediately or go to the nearest hospital.
Missed dose of Septolete ultra eucalyptus flavoured tablets
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 effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Rarely (may occur in fewer than 1 in 1,000 people):

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

Very rarely (may occur in fewer than 1 in 10,000 people):

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

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

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

These symptoms are usually transient. However, if they occur, it is recommended to consult a doctor or pharmacist.
By following the instructions provided in the patient information leaflet, the risk of adverse effects can be reduced.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Septolete ultra eucalyptus flavoured

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following the abbreviation: EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
No special storage temperature requirements.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Septolete ultra eucalyptus flavour contains

• The active substances are: benzidamine hydrochloride and cetylpyridinium chloride. Each tablet contains 3 mg of benzidamine hydrochloride and 1 mg of cetylpyridinium chloride.
• Other components 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 flavour contains isomalt (E 953)".

What Septolete ultra eucalyptus flavour looks like and contents of the pack
Round, blue-white to blue tablets with bevelled edges. Minor surface scratches may be present.
Tablet diameter: 18.0 mm - 19.0 mm, thickness: 7.0 mm - 8.0 mm.
Blister packs made of PVC/PE/PVDC/Aluminium, in a cardboard box.
Pack sizes: 16 or 24 hard tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:

For more detailed information about this medicinal product, please contact
the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa