Leaflet: information for the user

Lemon-flavored Strepsils lozenges

Alcohol 2,4-dichlorobenzoic, amylmetacresol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-For advice on any side effects talk to your pharmacist.

• If you experience any side effects, talk to your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.

-You must see your doctor if your symptoms worsen or do not improve after 2 days.

1. What is Strepsils and what it is used for.

2. What you need to know before you start taking Strepsils.

3. How to take Strepsils.

4. Possible side effects.

5. Storage of Strepsils.

6. Contents of the pack and additional information.

Strepsils belongs to the group of medicines known as antiseptics.

It is used for the local symptomatic relief of mild infections of the mouth and throat that do not occur with fever in adults and children aged 6 years and above.

Consult a doctor if it worsens or does not improve after 2 days.

Do not takeStrepsils

• If you are allergic (hypersensitive) toalcohol 2,4-dichlorobenzoic acid, amylmetacresol, or any of the other components of this medication (listed in section 6).
• If you are under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Strepsils.

If the discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea, or vomiting, you should consult your doctor as soon as possible.

Do not exceed the maximum recommended dose.

Use of Strepsils with other medications

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

Do not take other buccal and pharyngeal antiseptics (medications for mild throat infections such as Strepsils) while taking this medication, although interactions are not expected.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

The influence ofthismedicationon the ability to drive and operate machines is negligible or insignificant.

Strepsils contains isomalt, liquid maltitol, sodium, and fragrances that contain allergens.

This medication contains isomalt (E-953) and liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause a mild laxative effect because it contains 1,830 g of isomalt per lozenge and 0.458 g of liquid maltitol.

Nutritional value: 2.3 kcal/g of isomalt/liquid maltitol.

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

This medication contains fragrances with benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalol.

Benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalol may cause allergic reactions.

Follow exactly the administration instructions for Strepsils contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:1 tablet every 2 or 3 hours, as needed, up to a maximum of 8 tablets in 24 hours.

Children

Children from 6 years old: 1 tablet every 2 or 3 hours, as needed, up to a maximum of 4 tablets in 24 hours.

Do not use in children under 6 years old.

How to take Strepsils:

Oral buccal use, to dissolve in the mouth.

Leave a tablet to dissolve slowly in the mouth.

Do not swallow or chew, or bite.

If it does not improve, if it worsens after 2 days of treatment or has high fever, headache, nausea, or vomiting; you must consult the doctor.

If you take more Strepsils than you should

In case of overdose or accidental ingestion of large quantities, you may experience gastrointestinal discomfort. In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

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

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

Adverse effects of unknown frequency (cannot be estimated from available data): allergic reactions (hypersensitivity) such as redness (urticaria), itching or swelling of the skin (eruption), tingling or swelling of the mouth or throat (angioedema), difficulty breathing (bronchospasm), hypotension with syncope.

Adverse effects of unknown frequency (cannot be estimated from available data): abdominal pain, nausea or oral discomfort that may present as throat irritation, swelling of the mouth or throat, tingling sensation in the mouth (paresthesia) or burning sensation in the mouth (glossodynia).

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this leaflet.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaram.es). By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above25ºC.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointof the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Strepsils

The active principles are 0.6 mg ofamylmetacresol and 1.2 mg of 2,4 dichlorobenzyl alcohol.

The other components (excipients) are:lemon aroma (contains benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalol), sodium saccharin (E-954), tartaric acid, isomalta (E-953), and liquid maltitol (E-965).

Appearance of the product and contents of the packaging

Strepsils are circular white to pale yellow tablets with a lemon flavor and the Strepsils logo engraved on both sides.

Each package contains 24 lozenges to suck.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

RECKITT BENCKISER HEALTHCARE S.A.

C/ Mataró, 28

08403 Granollers (Spain)

Responsible for manufacturing

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the last review of this leafletNovember 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/