Leaflet: information for the user

Strepsils with vitamin C lozenges

2,4-dichlorobenzoic alcohol, amylmetacresol, ascorbic acid and sodium ascorbate

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

Follow exactly the administration instructions contained in this leaflet or those indicated 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 you get worse or do not improve after 2 days.

1. What is Strepsils with vitamin C and what it is used for.

2. What you need to know before starting totakeStrepsils with vitamin C.

3.How to takeStrepsils with vitamin C.

4. Possible side effects.

5. Storage of Strepsils with vitamin C.

6. Contents of the pack and additional information.

Strepsils with vitamin C belongs to a group of medicines called antiseptics.

It contains an association of two antiseptics alcohol 2,4-dichlorobenzoic and amylmetacresol. Additionally, it contains vitamin C (as ascorbic acid and sodium ascorbate).

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 it worsens or does not improve after 2 days.

Do not takeStrepsils with vitamin C

• If you are allergic (hypersensitive) toalcohol 2,4-dichlorobenzoic acid, amylmetacresol, ascorbic acid, sodium ascorbate, 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 with vitamin C.

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

Do not exceed the maximum recommended dose.

Use of Strepsils with vitamin C 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 antiseptic lozenges (medications for mild throat infections such as Strepsils with vitamin C) while taking this medication, although interactions are not expected.

Vitamin C may interact with medications such as: ethinylestradiol, deferoxamine, antacids containing aluminum, disulfiram, antidepressants, trimethoprim/sulfamethoxazole.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, etc… tests) inform your doctor that you are taking/using this medication, as it may alter the results.

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 ofthismedicationon the ability to drive and operate machinery is negligible or insignificant.

Strepsils with vitamin C contains saccharose, glucose, red Ponceau 4R, yellow orange S, wheat starch, propylene glycol, sodium, fragrances containing allergens, sulfur dioxide, and ethanol.

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 contains1,438 gof saccharose and0,968 gof glucose per lozenge.

This medication may cause allergic reactions because it contains red Ponceau 4R and yellow orange S. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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 19.36 micrograms of gluten.

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

This medication contains 3 mg of propylene glycol in each lozenge.

This medication contains 69.92 mg of sodium (main component of table salt/for cooking) in each 8 lozenges. This is equivalent to 34.96% of the recommended daily maximum sodium intake for an adult.

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

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

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

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

This medication contains 0.156 µg of alcohol (ethanol) per dose, which is equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medication will not produce noticeable effects.

Follow exactly the administration instructions for Strepsils with Vitamin C 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 aged 6 years and above: 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.

How to take Strepsils

Oral buccal use, to dissolve in the mouth.

Leave a dissolvable tablet to suck 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, consult your doctor as soon as possible.

If you take more Strepsils with Vitamin C 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 with vitamin C may produce adverse effects, although not all people will 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 it is an adverse effect that does 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 medicines you no longer need at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of packaging and medicines you no longer need. This way, you will help protect the environment.

Composition of Strepsils with vitamin C

The active principles are 0.6 mg ofamylmetacresol, 1.2 mg of alcohol 2,4-dichlorobenzoic, 33.5 mg of ascorbic acid and 74.9 mg of sodium ascorbate.

The other components (excipients) are: tartaric acid, orange essence (contains citral, citronellol, d-limonene, geraniol, linalol and ethanol), levomenthol, yellow orange S (E-110), red Ponceau 4R (E-124) (contains sodium in trace amounts), propylene glycol (E-1520), sucrose, liquid glucose (contains wheat starch and sulfur dioxide (E-220)).

Appearance of the product and contents of the packaging

Strepsils with vitamin C are orange-colored, orange-flavored and mint-flavored circular lozenges with the Strepsils with vitamin C icon engraved on both sides.

Each package contains 8 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 on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/