Leaflet: information for the user

Strepsils lozenges, honey and lemon flavor

2,4-Dichlorobenzoic alcohol, 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 pharmacist, even if they are not listed in this leaflet.See section 4.

• You should consult a 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 are not accompanied by 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 take Strepsils

− If you are allergic (hypersensitive) to dichlorobenzyl alcohol, 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 you have high fever, headache, nausea, or vomiting; you must consult your doctor.

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, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

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

This medication contains saccharose, glucose, and invert sugar. 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 1.441 g of saccharose and 0.976 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.

One lozenge does not contain more than 19.52 micrograms of gluten.

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

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

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

Citral, geraniol, d-limonene, and linalol may cause allergic reactions.

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

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 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 medicine and the amount ingested.

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

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

Adverse effects with 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 with 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 prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they do not appear in this prospectus. 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 point of 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 of amylmetacresol and 1.2 mg of 2,4-dichlorobenzoic alcohol.

The other components (excipients) are: tartaric acid, quinoline yellow (E-104), lemon essence (contains citral, geraniol, d-limonene, and linalol), peppermint essence (contains d-limonene), sucrose, liquid glucose (contains wheat starch and sulfur dioxide (E-220)), honey (inverted sugar).

Appearance of the product and contents of the packaging

Strepsils honey and lemon lozenges are yellow-colored circular lozenges with a honey and lemon flavor and the Strepsils icon engraved on both sides.

Each package contains 10 or 24 lozenges to suck. 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 prospectusNovember 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es