Septolete ultra

Package leaflet: Information for the user

Septolete ultra, (1.5 mg + 5 mg)/ml, oral spray, solution
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• 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 you feel worse, contact your doctor.

Table of contents

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

1. What Septolete ultra is and what it is used for

Septolete ultra oral spray, solution is an anti-inflammatory, analgesic and antiseptic medicine intended for local application in the oral cavity. The oral spray, solution disinfects the mouth and throat and reduces symptoms of sore throat, such as pain, redness and swelling.
Septolete ultra oral spray, solution is used as an anti-inflammatory, analgesic and antiseptic agent in the treatment of:

• irritation of the throat, mouth and gums,
• inflammation of the gums and throat,
• and before and after tooth extraction.

If there is no improvement after 3 days or if you feel worse, consult your doctor.

2. Important information before using Septolete ultra

When not to use Septolete ultra

• 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, consult your doctor or pharmacist.
Do not use Septolete ultra for longer than 7 days. If symptoms worsen or do not improve within 3 days, or if new symptoms appear, such as fever, contact your doctor.
Topical use of medicines, especially over prolonged periods, may lead to irritation. In such a case, treatment should be discontinued.
Do not use Septolete ultra 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.
Avoid direct contact of Septolete ultra with the eyes.
The medicine must not be inhaled.

Children and adolescents
Septolete ultra must not be used in children under 6 years of age, as this pharmaceutical form is not indicated for this age group.

Septolete ultra and other medicines
Inform 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 simultaneously with other antiseptic products.

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

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

Septolete ultra contains ethanol, macrogol glyceryl hydroxystearate, and sodium
This medicine contains 267.60 mg of alcohol (ethanol) per 1 ml of oral aerosol solution. The amount of alcohol in 1 ml of this medicine is equivalent to less than 7 ml of beer or 3 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
Macrogol glyceryl hydroxystearate may cause gastrointestinal disturbances and diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Septolete ultra

This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
To obtain a single dose, press the spray pump one to two times. The dose may be repeated every 2 hours, 3–5 times per day.
Use in children and adolescents
Adolescents over 12 years of age
To obtain a single dose, press the spray pump one to two times. The dose may be repeated every 2 hours, 3–5 times per day.
Children aged 6 to 12 years
To obtain a single dose, press the spray pump once. The dose may be repeated every 2 hours, 3–5 times per day.
Do not use Septolete ultra in children under 6 years of age.
Do not exceed the recommended dose
For optimal effect, it is not recommended to use the medicine immediately before or after tooth brushing.
Instructions for use
Before first use of Septolete ultra, press the spray pump several times until a uniform spray is obtained. If the medicine has not been used for a prolonged period (at least one week), press the spray pump once to obtain a uniform spray.

Before use, remove the
plastic cap.
Open your mouth wide,
direct the applicator
towards the back of the throat,
and press the spray pump
1–2 times.
While spraying, hold your breath.
One actuation releases 0.1 ml of solution containing 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride.
Duration of treatment
Do not use the medicine for longer than 7 days. If symptoms worsen or do not improve within 3 days, or if other symptoms such as fever occur, consult your doctor.
Use of a higher than recommended dose of Septolete ultra
If a dose higher than recommended is used or if a large amount of the medicine is accidentally swallowed, contact your doctor or pharmacist immediately.
Missed dose of Septolete ultra
Do not use a double dose to make up for a missed dose.
If you have any further doubts concerning 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 everybody gets them.

Rare (may occur in less than 1 out of 1,000 people)

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

Very rare (may occur in less than 1 out of 10,000 people)

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

Frequency not known (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/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 of the oral mucosa, 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.
Following the instructions provided in the patient information leaflet can reduce the risk of adverse reactions.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Septolete ultra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following the word:
EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
The shelf-life after first opening the immediate packaging is 1 year, provided the medicine has been stored below 25 °C.
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 package and other information

What Septolete ultra contains

• The active substances in this medicinal product are: benzidamine hydrochloride and cetylpyridinium chloride. Each ml of oral solution contains 1.5 mg of benzidamine hydrochloride and 5 mg of cetylpyridinium chloride. One spray releases 0.1 ml of solution containing 0.15 mg of benzidamine hydrochloride and 0.5 mg of cetylpyridinium chloride.
• Other ingredients are: ethanol (96%), glycerol (E 422), sodium saccharin (E 954), macrogol glycerol hydroxystearate, peppermint oil, and purified water. See section 2 "Septolete ultra contains ethanol, hydroxystearate macrogol glycerol and sodium".

What Septolete ultra looks like and contents of the pack
Septolete ultra is a clear, colourless to slightly yellow solution.
Septolete ultra is available in a cardboard box containing a 30 ml oral aerosol solution in a bottle with a spray pump, applicator and cap.
30 ml of oral aerosol solution is sufficient for 250 sprays.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
This medicinal product 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.
Równoległa 5 Street
02-235 Warsaw