Leaflet: information for the user

Menthol 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.

-If you need advice or more information, consult your pharmacist.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult 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 starting to take 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 called antiseptics.

It is used for the local symptomatic relief of mild infections of the mouth and throat that occur without fever in adults and children aged 6 years and above.

Consult a doctor if symptoms worsen or do not improve after 2 days.

Do not takeStrepsils

• If you are allergic (hypersensitive) toalcohol 2,4-dichlorobenzoic, 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 it does not improve, if it worsens after 2 days of treatment or has high fever, headache, nausea, or vomiting; you must consult your doctor.

Do not exceed the recommended maximum 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.

You should 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

Strepsils contains saccharose, glucose, wheat starch, sulfur dioxide, and fragrances containing allergens

This medication contains saccharose and glucose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 1.38 g of saccharose and 1.10 g of glucose per lozenge.

This medication contains very low levels of gluten (from wheat starch). It is considered “gluten-free” and it is very unlikely to cause problems if you have celiac disease.

A lozenge does not contain more than 22.04 micrograms of gluten.

If you have a wheat allergy (other than celiac disease), you should not take this medication.

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

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

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sulfur dioxide (E-220).

This medication contains terpenes provided by levomenthol, which, at excessive doses, may cause convulsions in small children (under 6 years old), although at the doses and administration route used in this medication, the absorption and activity of terpenes are very low.

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, chew, or bite.

If symptoms persist for more than 2 days, worsen, or are accompanied by high fever, headache, nausea, or vomiting, you must consult your doctor as soon as possible.

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 may 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), burning 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 on the safety of this medication.

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

Do not store at a temperature above 25°C.

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 point at 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-dichlorobenzoic alcohol.

The other components (excipients) are:xylitol, a minty aroma with a fresh sensation (contains d-limonene and linalol), levomenthol, a lavender aroma (contains benzyl alcohol, cinnamyl alcohol, citral, citronellol, d-limonene, eugenol, and linalol), eucalyptus oil (contains d-limonene), sucrose, liquid glucose (contains wheat starch and sulfur dioxide (E-220)).

Appearance of the product and contents of the packaging

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

Each package contains 16 or 24 lozenges to suck on. Not all package sizes may be marketed.

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

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