Septolete ultra with lemon and honey flavour

Package leaflet: Information for the patient

Septolete ultra lemon and honey flavour, 3 mg + 1 mg, hard pastilles
Benzydamini hydrochloridum + Cetylpyridinii chloridum
Please read carefully all the information in this leaflet before using the 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
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 of the leaflet

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

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

Septolete ultra lemon and honey flavour contains the active substances: benzydamine hydrochloride and cetylpyridinium chloride.
Septolete ultra lemon and honey flavour hard pastilles are an anti-inflammatory, analgesic and antiseptic medicine for local use in the oral cavity. Septolete ultra lemon and honey flavour disinfects the mouth and throat and reduces symptoms of sore throat such as pain, redness, swelling, burning sensation and impaired function.
Septolete ultra lemon and honey flavour is used in the treatment of sore throat symptoms associated with mild infections of 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. Information before using Septolete ultra lemon and honey flavour

When not to use Septolete ultra lemon and honey flavour

• if the patient is allergic to benzylamine 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 use Septolete ultra lemon and honey flavour, discuss it with your doctor or pharmacist.
Do not use Septolete ultra lemon and honey flavour 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 and you should contact your doctor to initiate appropriate therapy.
Do not use Septolete ultra lemon and honey 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.
Exercise particular caution:

• if the patient has a history of allergy to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs). The use of this medicine is not recommended.
• if the patient has or has ever had bronchial asthma. In this case, caution is required.

Children and adolescents
Septolete ultra lemon and honey flavour must not be used in children under 6 years of age.
Septolete ultra lemon and honey flavour 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 lemon and honey flavour simultaneously with other antiseptic medicines.
Septolete ultra lemon and honey flavour with food, drink and alcohol
Do not take Septolete ultra lemon and honey flavour with milk, as milk reduces its effectiveness.
Do not take Septolete ultra lemon and honey flavour immediately before or during meals or drinking.
Do not eat or drink for at least 1 hour after using Septolete ultra lemon and honey flavour.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The use of Septolete ultra lemon and honey flavour during pregnancy is not recommended.
Before using Septolete ultra lemon and honey flavour during breastfeeding, discuss it with your doctor. The doctor will decide whether breastfeeding should be discontinued or whether treatment should be stopped.
Driving and operating machinery
Septolete ultra lemon and honey flavour has no effect or has a negligible effect on the ability to drive and operate machinery.
Septolete ultra lemon and honey flavour contains isomalt (E 953), sodium benzoate (E 211) and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains up to 0.0009 mg of sodium benzoate per tablet. Sodium benzoate may cause local irritation.
The medicine contains less than 1 mmol (23 mg) of sodium per lozenge, meaning the medicine is considered "sodium-free".

3. How to use Septolete ultra lemon and honey flavoured lozenges

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 hard lozenges per day. The lozenge 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 lozenges per day. The lozenge should be slowly sucked in the mouth every 3 to 6 hours.
Children aged 6 to 12 years
The recommended dose is 3 hard lozenges per day. The lozenge should be slowly sucked in the mouth every 3 to 6 hours.
Children under 6 years of age
Septolete ultra lemon and honey flavoured lozenges must not be used in children under 6 years of age.
Do not exceed the recommended dose.
Do not take Septolete ultra lemon and honey flavoured lozenges before or during meals or drinks.
Do not eat or drink for at least 1 hour after taking the medicine.
It is not recommended to use the medicine immediately before or after brushing your 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 your doctor.
Inform your doctor if the condition being treated recurs or changes in any way.
Accidental overdose of Septolete ultra lemon and honey flavoured lozenges
In case of accidental ingestion of an excessive dose of the medicine, contact your doctor immediately or go to the nearest hospital.
Missed dose of Septolete ultra lemon and honey flavoured lozenges
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 may cause adverse reactions, although not everyone will experience them.
Rare (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 rare (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/fainting, severe skin itching 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 this leaflet, inform
your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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.
By reporting adverse reactions, additional information on the safety of this medicine can be
collected.

5. How to store the medicine Septolete ultra o smaku cytryny i miodu

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 after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
No special temperature storage conditions apply 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 Septolete ultra lemon and honey flavour contains

• The active substances are: benzydamine hydrochloride and cetylpyridinium chloride. Each hard tablet contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• Other components are: peppermint oil, levomenthol, sucralose (E 955), citric acid (E 330), isomalt (type M) (E 953), lemon flavour, honey flavour, curcumin (E 100) (containing sodium benzoate (E 211)). See section 2 "Septolete ultra lemon and honey flavour contains isomalt (E 953), sodium benzoate (E 211) and sodium".

What Septolete ultra lemon and honey flavour looks like and contents of the pack
Round, bevelled-edge tablets with a rough surface, pale yellow to yellow 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 cardboard cartons.
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:
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 more detailed information about this medicinal product, please contact the
responsible entity's representative:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500