Septolet 3 mg/1 mg pastilles for sucking, cola flavour

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Septolete 3 mg/1 mg lozenges with cola flavour

bencidamine hydrochloride/cetylpyridinium chloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Contents of this leaflet

1. What Septolete is and what it is used for
2. What you need to know before taking Septolete
3. How to take Septolete
4. Possible side effects
5. How to store Septolete
6. Contents of the pack and other information

1. What Septolete is and what it is used for

Septolete contains the active substances benzidamine hydrochloride and cetylpyridinium chloride.

This medicine is a locally-acting anti-inflammatory, analgesic (relieves pain), and antiseptic (prevents the spread of pathogens) intended for oral use. This medicine disinfects the mouth and throat and reduces signs of throat inflammation such as pain, redness, swelling, heat, and impaired function.

This medicine is used in adults, adolescents, and children over 6 years of age for short-term local anti-inflammatory, analgesic, and antiseptic treatment of soreness and irritation in the throat, mouth, and gums.

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Septolete

Do not take Septolete

• if you are allergic to benzidamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6)
• this medicine should not be used in children under 6 years of age, as the pharmaceutical form is not suitable for this age group.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine:

• If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or to other anti-inflammatory painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs), you should not use this medicine, as benzidamine hydrochloride also belongs to the class of non-steroidal anti-inflammatory drugs.
• If you have or have had bronchial asthma. Caution is advised in this case.
• If you have open wounds or ulcers in the mouth or throat (for example, after dental extractions).

Do not take this medicine for longer than 7 days. If symptoms do not improve or worsen after 3 days, or if new symptoms such as fever appear, consult a doctor.

The use of topical preparations, especially over a long period, may lead to sensitization; in such a case, treatment should be discontinued and a doctor should be consulted to establish appropriate therapy.

This medicine should not be used in combination with anionic compounds, such as those present in toothpastes, to avoid neutralization reactions. Therefore, it is not recommended to use the product immediately before or after tooth brushing.

Children and adolescents

Septolete must not be administered to children under 6 years of age, as the pharmaceutical form is not suitable for this age group.

Other medicines and Septolete

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take another type of antiseptic while using this medicine.

Taking Septolete with food, drinks, and alcohol

Do not take this medicine with milk, as milk may reduce its effectiveness.

Do not take this medicine during or immediately before meals or drinks. Do not eat or drink at least one hour before taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

This medicine is not recommended during pregnancy.

You should discuss breastfeeding with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

Septolete contains isomalt (E953), benzyl alcohol (E1519), and butylated hydroxyanisole (E320)

If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 0.012 mg of benzyl alcohol in each lozenge. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant, breastfeeding, or have any liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause side effects (known as "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

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults

The recommended dose is 3 to 4 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours.

Adolescents over 12 years old

The recommended dose is 3 to 4 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours.

Children from 6 to 12 years old

The recommended dose is 3 lozenges per day. One lozenge should be slowly dissolved in the mouth every 3 to 6 hours. An adult should supervise the administration of lozenges in children aged 6 to 12 years.

Children under 6 years old

This medicine must not be used in children under 6 years of age.

Do not exceed the recommended dose

Do not take this medicine immediately before or during meals and 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 tooth brushing.

Duration of treatment

Do not take this medicine for longer than 7 days. If symptoms do not improve or worsen after 3 days, or if other symptoms such as fever appear, consult a doctor.

Consult your doctor if the condition is recurrent or if you notice any recent changes in its characteristics.

If you take more Septolete than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Septolete

Do not take a double dose to make up for forgotten doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you notice any of the following serious adverse effects, stop taking this medicine and contact a doctor immediately:

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), which may include signs such as difficulty breathing, chest pain or tightness, and/or dizziness/fainting, intense itching of the skin or skin lumps, swelling of the face, lips, tongue and/or throat, which may potentially be life-threatening.

The frequency of these adverse effects is unknown.

Rare (may affect more than 1 in 1,000 patients):

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

Very rare (may affect more than 1 in 10,000 patients):

• local irritation in the mouth, burning sensation in the mouth.

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

• burning of the oral mucosa, loss of sensation (anaesthesia) of the oral mucosa.

Generally, these side effects are transient. However, if they occur, it is recommended to consult your doctor or pharmacist.

If you follow the instructions in the patient information leaflet, you will reduce the risk of side effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Septolete

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Septolete

• The active substances are bencidamine hydrochloride and cetylpyridinium chloride. Each pastille contains 3 mg of bencidamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other components (excipients) are: citric acid (E330), sucralose (E955), natural cola flavour (containing benzyl alcohol (E1519), butylhydroxyanisole (E320)), caramel colour (E150a), isomalt (E953). See section 2 “Septolete contains isomalt (E953), benzyl alcohol (E1519) and butylhydroxyanisole (E320)”.

Appearance of the product and contents of the pack

Round pastilles with bevelled edges and a rough brown surface. White spots, uneven colouring, presence of air bubbles in the pastille, and small irregular edges may be present. Diameter of the pastille: approximately 19 mm, thickness: approximately 7.5 mm.

Septolete pastilles are available in packs of 8, 16, 24, 32 and 40 pastilles, in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Manufacturer

TAD Pharma GmbH

Heinz-Lohmann-Strase 5

27472 Cuxhaven,

Germany

Or

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

You can request further information on this medicinal product by contacting the local representative of the Marketing Authorisation Holder:

KRKA Farmacéutica, S.L.,

C/Anabel Segura 10,

28108 Alcobendas, Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 05/2025

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).