SEPTOLETE 3 MG/1 MG LOZENGES HONEY & LEMON FLAVORED

Introduction

Package Leaflet: Information for the User

Septolete 3 mg/1 mg lozenges with honey and lemon flavor

benzydamine hydrochloride/cetylpyridinium chloride

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your pharmacist.

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

Package Leaflet Contents

1. What is Septolete and what is it used for
2. What you need to know before taking Septolete
3. How to take Septolete
4. Possible side effects
5. Storage of Septolete
6. Package Contents and Additional Information

1. What is Septolete and what is it used for

This medicine contains the active ingredients benzydamine hydrochloride and cetylpyridinium chloride.

This medicine is an anti-inflammatory, analgesic, and antiseptic for local use by mouth. This medicine disinfects the mouth and throat and reduces signs of throat inflammation such as pain, redness, swelling, heat, and impairment of function.

This medicine is used in adults, adolescents, and children over 6 years for 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.

2. What you need to know before taking Septolete

Do not take Septolete

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

Warnings and Precautions

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

• If you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other non-steroidal anti-inflammatory analgesics (NSAIDs), you should not use this medicine, as benzydamine hydrochloride also belongs to a 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.

Do not take this medicine 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 for a long period, can cause sensitization, in which case treatment should be discontinued and a doctor consulted to establish adequate therapy.

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

Children and Adolescents

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

Other Medicines and Septolete

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

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

Taking Septolete with Food, Drink, and Alcohol

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

Do not take this medicine 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 cleaning.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, and he will decide whether you should interrupt breastfeeding or interrupt treatment with this medicine.

Driving and Using Machines

No effect of this medicine on the ability to drive or use machines has been observed.

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

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

This medicine contains up to 0.0009 mg of sodium benzoate per lozenge. Sodium benzoate may cause local irritation.

This medicine contains less than 1 mmol (23 mg of sodium) per lozenge; i.e., it is essentially "sodium-free".

3. How to Take Septolete

Always take this medicine following the administration instructions contained in this package leaflet or as indicated 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 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 from 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 intake of lozenges in children from 6 to 12 years.

Children under 6 years

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

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 cleaning.

Duration of Treatment

Do not take this medicine 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.

Consult your doctor if the condition is recurrent or if you notice any recent change 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, phone: 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

The frequency of these side effects is unknown.

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

• hives (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 oral cavity, burning sensation in the oral cavity.

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

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

These side effects are usually transient. However, when they appear, it is recommended to talk to your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website (http://www.aemps.gob.es/). By reporting side 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 expiration date stated on the package after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require any special temperaturefor storage.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Septolete

• The active ingredients are benzydamine hydrochloride and cetylpyridinium chloride. Each lozenge contains 3 mg of benzydamine hydrochloride and 1 mg of cetylpyridinium chloride.
• The other ingredients are peppermint oil, levomenthol, sucralose (E955), citric acid (E330), isomalt (E953), lemon flavor, honey flavor, curcumin (E100) (contains sodium benzoate (E211)).

See section 2 "Septolete contains isomalt (E953), sodium benzoate (E211), and sodium".

Appearance of the Product and Package Contents

Lozenges are round with beveled edges and a rough surface, light yellow to yellow in color. White spots, uneven coloring, presence of air bubbles in the "hard candy" mass, and small irregular edges may be present. Lozenge diameter: 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L.,

C/Anabel Segura 10,

28108 Alcobendas, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this package leaflet:May 2021

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