Leaflet: information for the user

Strepsils with lidocaine lozenges

Alcohol 2,4-dichlorobenzoic, amylmetacresol, lidocaine hydrochloride

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 you get worse or do not improve after 2 days.

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

2. What you need to know before starting totakeStrepsils with lidocaine.

3.How to takeStrepsils with lidocaine.

4. Possible side effects.

5. Storage of Strepsils with lidocaine.

6. Contents of the pack and additional information.

Strepsils with lidocaine belongs to the group of medicines called antiseptics.

Strepsils with lidocaine is an association of two antiseptics, 2,4-dichlorobenzylic alcohol and amylmetacresol, and a local anesthetic for the throat, lidocaine hydrochloride.

It is used for the local symptomatic relief of mild infections of the mouth and throat that are accompanied by pain and without fever in adults and adolescents from 12 years old.

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

Do not take Strepsils with lidocaína

• If you are allergic (hypersensitive) toalcohol 2,4-dichlorobenzoic acid, amylmetacresol, lidocaína hydrochloride, or anyof the other components of this medication (listed in section 6).
• If you are under 12 years old.
• If you have had an allergy to local anesthetics.
• If you have had or suspect you have metaglobinemia.

- If you have had an asthma attack or bronchospasm.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Strepsils with lidocaína:

• If you have asthma.

• The anesthesia caused by this medication at the throat level may favor false passages (coughing during a meal, having the impression of choking), while eating food. Do not use this medication before meals or before drinking.

• The prolonged use of this medication for more than 5 days is not recommended because it may modify the natural microbial balance of the throat.

• Do not exceed the maximum recommended dose. If you take it in large quantities or repeatedly, this medication, when passing into the bloodstream, may act on the heart and the nervous system with the possibility of seizures occurring.

• People with serious or weakened illnesses should consult their doctor before taking this medication, as they are more sensitive to its possible adverse reactions.

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

Do not exceed the maximum recommended dose.

Children and adolescents

Children under 12 years old should not take this medication, it is contraindicated.

This medication is indicated for adults and adolescents 12 years old and above.

Use of Strepsils with lidocaína with other medications

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

And in particular, if you are taking any of the following medications, as it may be necessary to modify the dose of one of them:

- Beta-blockers (to treat the heart or to treat arterial diseases) and medications like cimetidine (to treat stomach ulcers).

- Other local anesthetics (type amide).

- Medications indicated for cardiac rhythm disorders such as mexiletine or

procainamide.

- Medications like fluvoxamine (to treat depression).

- Antibiotics like erythromycin and itraconazole.

Do not take other buccal and pharyngeal antiseptics (medications for mild throat infections like Strepsils with lidocaína) if you are taking this medication, although interactions are not expected.

Taking Strepsils with lidocaína with food, drinks, and alcohol

Do not use this medication before meals or before drinking.

During treatment with this medication, avoid consuming alcoholic beverages.

Pregnancy, lactation, 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.

Pregnancy:consult your doctor or pharmacist before using any medication.

This medication is not recommended for use during pregnancy.

Lactation:consult your doctor or pharmacist before using any medication.

Fertility:no data available on fertility.

Driving and operating machinery

Observe your response to the medication. At the recommended doses, drowsiness or a decrease in reaction capacity is not expected, but if so, do not drive or use hazardous machinery.

Strepsils with lidocaína contains saccharose, glucose, wheat starch, sodium, 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 him before taking this medication.

Patients with diabetes mellitus should note that this medication contains1,495 gof saccharose and1,017 gof 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 20.30 micrograms of gluten.

If you are allergic to wheat (other than celiac disease), do not take this medication.

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

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

This medication contains fragrances with anisic alcohol, d-limonene, and linalol.

Anisic alcohol, d-limonene, and linalol may cause allergic reactions.

This medication contains terpenes provided by levomenthol, which, at excessive doses, may cause seizures in young 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 this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents 12 years and older: 1 tablet every 2 or 3 hours as needed, up to a maximum of 8 tablets in 24 hours.

Use in children

This medication is contraindicated in children under 12 years.

How to take Strepsils with lidocaine:

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, worsens after 2 days of treatment, or has high fever, headache, nausea, or vomiting; consult your doctor.

If you take more Strepsils with lidocaine than you should

You may experience an increase or alteration of the normal heart rhythm, increased blood pressure, sedation, altered breathing during sleep, unconsciousness, cardiovascular collapse, insomnia, hallucinations, tremors, and seizures (symptoms of central nervous system depression or stimulation). Drowsiness may be a symptom of overdose. In children, agitation may appear.

In case of overdose or accidental ingestion of large quantities, you may notice gastrointestinal discomfort, blurred vision, ringing in the ears, and drowsiness. Consult your doctor or pharmacist or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

The prolonged use of this medication, more than 5 days, is not recommended because it may modify the natural microbial balance of the throat.

The use of large doses and prolonged periods of time in children may cause seizures.

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

Like all medications, Strepsils with lidocaine 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 (erythema), 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 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 about the safety of this medication.

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

Do not store at a temperature above 30°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 medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Strepsils with lidocaine

The active principles are 0.6 mg ofamylmetacresol, 1.2 mg of 2,4-dichlorobenzoic alcohol and 2 mg of lidocaine hydrochloride.

The other components (excipients) are: tartaric acid, levomenthol, peppermint oil (contains d-limonene), star anise oil (contains anisaldehyde, d-limonene, and linalol), quinoline yellow (E-104), indigotin (E-132), sodium saccharin (E-954), saccharose, liquid glucose (contains wheat starch and sulfur dioxide (E-220)).

Appearance of the product and contents of the packaging:

Strepsils with lidocaine are blue-green clear circular lozenges with the Strepsils logo engraved on both sides.

Each package contains 16 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 leafletNovember 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/