Septolete ultra with lemon and blackcurrant flavor

Package leaflet: Information for the user

Septolete ultra lemon and blackcurrant flavour, 3 mg + 1 mg, hard pastilles
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Please read carefully the entire leaflet before using the medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your 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 you feel worse, consult your doctor.

Table of contents

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

1. What Septolete ultra lemon and blackcurrant flavour is and what it is used for

Septolete ultra lemon and blackcurrant flavour contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride.
Septolete ultra lemon and blackcurrant flavour hard pastilles are an anti-inflammatory, analgesic and antiseptic medicine for local use in the oral cavity. Septolete ultra lemon and blackcurrant flavour disinfects the mouth and throat and reduces symptoms of throat inflammation such as pain, redness, swelling, burning sensation, and impaired function.
Septolete ultra lemon and blackcurrant flavour is used in the treatment of sore throat symptoms associated with mild infections in the mouth and throat (including gingivitis and pharyngitis).
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before taking Septolete ultra lemon and blackcurrant flavour

When not to use Septolete ultra lemon and blackcurrant flavour

• if you are allergic to benzydamine 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 treatment with Septolete ultra lemon and blackcurrant flavour, discuss it with your doctor or pharmacist.
Do not use Septolete ultra lemon and blackcurrant flavour for longer than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, consult your doctor.
The use of locally acting medicines, especially over prolonged periods, may lead to irritation. In such a case, discontinue treatment and consult your doctor for appropriate therapy.
Do not use Septolete ultra lemon and blackcurrant flavour 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.

Take special care:

• if you have previously been diagnosed with hypersensitivity 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 you have or have ever had bronchial asthma. In this case, caution is advised.

Children and adolescents
Septolete ultra lemon and blackcurrant flavour must not be used in children under 6 years of age.

Septolete ultra lemon and blackcurrant flavour with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Do not use Septolete ultra lemon and blackcurrant flavour simultaneously with other antiseptic medicines.

Septolete ultra lemon and blackcurrant flavour with food, drink and alcohol
Do not take Septolete ultra lemon and blackcurrant flavour with milk, as milk reduces its effectiveness.
Do not use Septolete ultra lemon and blackcurrant flavour immediately before or during meals or drinking. Do not eat or drink for at least 1 hour after using Septolete ultra lemon and blackcurrant flavour.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Use of Septolete ultra lemon and blackcurrant flavour during pregnancy is not recommended.
Before using Septolete ultra lemon and blackcurrant flavour during breastfeeding, discuss it with your doctor. Your doctor will decide whether to discontinue breastfeeding or to stop treatment.

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

Septolete ultra lemon and blackcurrant flavour contains isomalt (E 953), butylated hydroxyanisole (E 320), sodium benzoate (E 211) and sodium
If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Butylated hydroxyanisole may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
The medicine contains up to 0.00075 mg of sodium benzoate per pastille. Sodium benzoate may cause local irritation.
This medicine contains less than 1 mmol (23 mg) of sodium per hard pastille, meaning the medicine is considered "sodium-free".

3. How to use Septolete ultra with lemon and blackcurrant flavour

This medicine should always be used exactly as described in this patient information 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 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 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 pastilles per day. The pastille should be slowly sucked in the mouth every 3 to 6 hours.
Children under 6 years
Septolete ultra with lemon and blackcurrant flavour must not be used in children under 6 years of age.
Do not exceed the recommended dose.
Do not use Septolete ultra with lemon and blackcurrant flavour immediately before or during meals or drinking.
Do not eat or drink for at least 1 hour after using the medicine.
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 within 3 days, or if other symptoms such as fever occur, consult your doctor.
Inform your doctor if the condition recurs or changes in any way.
Overdose of Septolete ultra with lemon and blackcurrant flavour
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
Missed dose of Septolete ultra with lemon and blackcurrant flavour
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 everybody will experience them.
Rarely (may occur in fewer 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 fewer than 1 in 10,000 people):

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

Frequency unknown (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/fainting, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and (or) throat, and 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 this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Septolete ultra o smaku cytryny i czarnego bzu

Keep this 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.
Store in the original packaging in order to protect from light.
There are no special storage temperature requirements for this medicine.
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 package and other information

What the medicine Septolete ultra lemon and black elderflower flavour contains

• The active substances are: benzidamine hydrochloride and cetylpyridinium chloride. Each hard tablet contains 3 mg of benzidamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are: peppermint oil, levomenthol, sucralose (E 955), citric acid (E 330), isomalt (type M) (E 953), lemon flavour (containing butylated hydroxyanisole (E 320)), black elderflower flavour, curcumin colour (E 100) (containing sodium benzoate (E 211)), copper complexes of chlorophyllins (E 141) (containing sodium). See section 2: "Septolete ultra lemon and black elderflower flavour contains isomalt (E 953), butylated hydroxyanisole (E 320), sodium benzoate (E 211) and sodium".

What Septolete ultra lemon and black elderflower flavour looks like and contents of the pack
Round hard tablets with bevelled edges and a rough surface, light green to green in colour. White specks, uneven colouring, air bubbles in the "hard sugar" mass and minor surface irregularities may be observed. Diameter of the hard tablet: 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: 8, 16, 24, 32 or 40 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/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 authorised in the European Economic Area under the following names:

For further information on this medicinal product, please contact the
responsible entity's representative:
KRKA-POLSKA Sp. z o.o.
Równoległa Street 5
02-235 Warsaw
Tel. 22 57 37 500