Septolete ultra with cola flavour

Package leaflet: Information for the user

Septolete ultra o smaku coli, 3 mg + 1 mg, hard pastilles
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please 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, consult a doctor.

Table of contents

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

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

Septolete ultra o smaku coli contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride.
Septolete ultra o smaku coli, hard pastilles, is an anti-inflammatory, mild analgesic (pain-relieving), and antiseptic (prevents the spread of pathogens) medicine intended for local application on the oral mucosa. Septolete ultra o smaku coli disinfects the mouth and throat and reduces symptoms of sore throat, such as pain, redness, swelling, burning sensation, and impaired function.
Septolete ultra o smaku coli is used for local, short-term anti-inflammatory, analgesic, and antiseptic treatment of irritation of the throat, oral cavity, and gums (including gingivitis and sore throat) in adults, adolescents, and children aged 6 years and above.
If there is no improvement after 3 days, or if your condition worsens, consult a doctor.

2. Important information before taking Septolete ultra o smaku coli

When not to take Septolete ultra o smaku coli

• if the patient is allergic to benzidamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6);
• this medicine must not be used in children under 6 years of age.

Warnings and precautions
Before starting to take Septolete ultra o smaku coli, discuss it with your doctor or
pharmacist.

• If the patient has a known allergy to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), use of this medicine is not recommended.
• If the patient currently has or has ever had bronchial asthma, caution is advised.
• If the patient has open wounds or ulcers in the mouth or throat (e.g. after tooth extraction).

Do not use Septolete ultra o smaku coli 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.
The use of topical medicines, especially over a prolonged period, may cause irritation. In such a case, treatment should be discontinued and the patient should contact a doctor to receive appropriate treatment.
Do not use Septolete ultra o smaku coli 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 o smaku coli must not be used in children under 6 years of age.
Septolete ultra o smaku coli 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.
Do not use Septolete ultra o smaku coli simultaneously with other antiseptic medicines.
Septolete ultra o smaku coli with food, drink and alcohol
Do not take Septolete ultra o smaku coli with milk, as milk reduces its effectiveness.
Do not use Septolete ultra o smaku coli before or during meals or drinking. Do not eat
or drink for at least one hour after using Septolete ultra o smaku coli.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Use of Septolete ultra o smaku coli during pregnancy is not recommended.
Before using Septolete ultra o smaku coli during breastfeeding, discuss it
with a doctor. The doctor will decide whether breastfeeding should be discontinued or whether use of the medicine should be stopped.
Driving and operating machinery
Septolete ultra o smaku coli has no effect or has a negligible effect on the ability to drive
and operate machinery.
Septolete ultra o smaku coli contains isomalt (E 953), benzyl alcohol (E 1519) and
butylated hydroxyanisole (E 320)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking this medicine.
This medicine contains 0.012 mg of benzyl alcohol in each tablet. Benzyl alcohol may
cause allergic reactions. Pregnant or breastfeeding women, patients with liver or kidney
diseases should consult a doctor or pharmacist before using this medicine, as a large
amount of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis)
or irritation of the eyes and mucous membranes.

3. How to take Septolete ultra o smaku coli

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
The recommended dose is 3 to 4 hard pastilles per day. The pastille 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 pastilles per day. The pastille should be slowly sucked in the
mouth every 3 to 6 hours.
Children aged 6 to 12 years
The recommended dose is 3 hard pastilles per day. The pastille should be slowly sucked in the mouth
every 3 to 6 hours. Use of pastilles in children aged 6 to 12 years should be supervised by an adult.
Children under 6 years of age
Septolete ultra o smaku coli must not be used in children under 6 years of age.
Do not exceed the recommended dose.
Do not take Septolete ultra o smaku coli before or during meals or drinks.
Do not eat or drink for at least one hour after taking the medicine.
It is not recommended to use the medicine immediately before or after brushing teeth.
Duration of treatment
Do not use this medicine for longer than 7 days. If symptoms worsen or do not improve after
3 days, or if new symptoms occur, such as fever, consult your doctor.
Inform your doctor if the condition being treated recurs or changes in any way.
Accidental overdose of Septolete ultra o smaku coli
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Missed dose of Septolete ultra o smaku coli
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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Rarely (may occur in less than 1 in 1,000 people):

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

Very rarely (may occur in less 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), which may include symptoms such as: difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, intense itching of the skin or raised skin rashes, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening,
• burning sensation of the oral mucosa, loss of sensation (numbness) of the oral mucosa.

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

5. How to store the medicine Septolete ultra o smaku coli

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 stated month.
Do not store above 30°C.
Keep in the original packaging to protect from light and moisture.
Medicines must 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 pack and other information

What Septolete ultra o smaku coli contains

• The active substances are benzidamine hydrochloride and cetylpyridinium chloride. Each hard pastille contains 3 mg of benzidamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: citric acid (E 330), sucralose (E 955), natural cola flavour (containing benzyl alcohol (E 1519), butylated hydroxyanisole (E 320)), caramel (E 150a), isomalt (E 953). See section 2 "Septolete ultra o smaku coli contains isomalt (E 953), benzyl alcohol (E 1519) and butylated hydroxyanisole (E 320)".

What Septolete ultra o smaku coli looks like and contents of the pack
Brown, round pastilles with bevelled edges and a rough surface. White specks, uneven colouring, presence of air bubbles within the pastille and minor surface irregularities at the edges may occur.
Pastille diameter: approximately 19 mm, thickness: approximately 7.5 mm.
Septolete ultra o smaku coli is available in blister packs contained in a cardboard box.
Pack sizes: 8, 16, 24, 32 or 40 hard pastilles.
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 medicinal product is authorised in the European Economic Area countries under the following names:

For further information on this medicinal product, please contact
the representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warszawa
Poland
Tel. +48 22 57 37 500