Package Insert: Information for the User

Septolete 3 mg/1 mg Lozenges, Honey and Lemon Flavor

bencidamina hydrochloride/cetilpiridinio chloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this package insert or those indicated by your pharmacist.

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

This medication contains the active principles bencidamina hydrochloride and cetilpiridinio chloride.

This medication is a local anti-inflammatory, analgesic, and antiseptic by the oral route. This medication disinfects the mouth and throat and reduces the signs of throat inflammation such as pain, redness, swelling, heat, and functional impairment.

This medication is used in adults, adolescents, and children over 6 years old for the short-term local anti-inflammatory, analgesic, and antiseptic treatment of throat, mouth, and gum irritations.

You should consult a doctor if you do not feel better or if you feel worse after 3 days.

Do not take Septolete

• If you are allergic to benzoic acid hydrochloride, cetirizine hydrochloride, or any of the other components of this medication (listed in section 6).
• This medication 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

Consult your doctor or pharmacist before starting to take this medication:

• If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other nonsteroidal anti-inflammatory drugs (NSAIDs), do not use this medication, as benzoic acid hydrochloride also belongs to a class of nonsteroidal anti-inflammatory drugs.
• If you have or have had bronchial asthma. Caution should be exercised in this case.
• If you have open wounds or ulcers in your mouth or throat.

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

The use of topical preparations, especially over a long period of time, may cause sensitization, in which case treatment should be interrupted and a doctor consulted to establish an appropriate therapy.

This medication should not be used in combination with anionic compounds, such as those present in toothpaste, so it is not recommended to use the product immediately before or after brushing your teeth.

Children and adolescents

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

Other medications and Septolete

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

Do not take another type of antiseptic while taking this medication.

Septolete and food, drink, and alcohol

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

This medication is not recommended during pregnancy.

You should discuss breastfeeding with your doctor, and he will decide whether you should stop breastfeeding or interrupt treatment with this medication.

Driving and operating machinery

This medication has not been observed to affect the ability to drive or operate machinery.

This medication contains isomalt (E953), sodium benzoate (E211), and sodium

This medication contains isomalt. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains up to 0.0009 mg of sodium benzoate in each lozenge. Sodium benzoate may cause local irritation.

This medication contains less than 1 mmol (23 mg of sodium) per lozenge; this is essentially "sodium-free".

Always take this medication following the administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults

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

Adolescents over 12 years

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

Children 6 to 12 years

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

Children under 6 years

This medication should not be used in children under 6 years.

Do not exceed the recommended dose.

Do not take this medication immediately before or during meals and drinks.

Do not eat or drink for at least one hour after taking the medication.

Do not recommend using the medication immediately before or after dental cleaning.

Treatment duration

Do not take this medication for more than 7 days. If symptoms do not improve or worsen after 3 days, or if other symptoms appear, such as fever, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Septolete

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• allergic reaction (hypersensitivity).
• severe allergic reaction (anaphylactic shock), whose signs may be difficulty breathing, chest pain or tightness, and/or dizziness/dizziness, intense itching of the skin or hives, swelling of the face, lips, tongue, and/or throat, and may be potentially fatal.

The frequency of these adverse effects is unknown.

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

• hives (urticaria), increased skin reactivity to sunlight (photosensitivity),

• sudden and uncontrolled narrowing of the airways in the lungs (bronchospasm).

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

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

Unknown frequency (frequency cannot be estimated from available data):

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

These side effects are generally transient. However, when they appear, it is recommended to speak with your doctor or pharmacist.

By following the patient information leaflet instructions, you will reduce the risk of side effects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not requireany special storage temperature.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Septolete

See section 2 “Septolete contains isomalta (E953), sodium benzoate (E211) and sodium”.

Appearance of the product and contents of the package

Round lozenges with beveled edges and a rough surface, yellowish in color. They may be present with white spots, uneven coloration, presence of air bubbles in the "hard caramel" mass, and small irregular edges. Diameter of the lozenge: 18 mm - 19 mm, thickness: 7 mm - 8 mm.

Septolete lozenges are available in boxes of 8, 16, 24, 32, and 40 lozenges in blisters.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Responsible manufacturer

TAD Pharma GmbH

Heinz-Lohmann-Strasse 5

27472 Cuxhaven,

Germany

O

KRKA, d.d., Novo mesto,

Šmarješka cesta 6,

8501 Novo mesto,

Slovenia

Further information about this medicinal product can be obtained by contacting the local representative of the holder of the marketing authorization:

KRKA Farmacéutica, S.L.,

C/Anabel Segura 10,

28108 Alcobendas, Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:May 2021

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/.)