STREPSILS WITH LIDOCAINE LOZENGES

Introduction

Package Leaflet: Information for the User

Strepsils with Lidocaine Lozenges

2,4-Dichlorobenzyl alcohol, amylmetacresol, lidocaine hydrochloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 it worsens or does not improve after 2 days.

Contents of the Package Leaflet:

1. What Strepsils with Lidocaine is and what it is used for.
2. What you need to know before taking Strepsils with Lidocaine.
3. How to take Strepsils with Lidocaine.
4. Possible side effects.
5. Storage of Strepsils with Lidocaine.
6. Package Contents and Additional Information.

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

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

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

It is used for the local symptomatic relief of mild mouth and throat infections with pain and without fever in adults and adolescents from 12 years of age.

You should consult your doctor if it worsens or does not improve after 2 days.

2. What you need to know before taking Strepsils with Lidocaine

Do not take Strepsils with Lidocaine

• If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, lidocaine hydrochloride, or any of the other components of this medicine (listed in section 6).
• If you are under 12 years of age.
• If you have suffered an allergy to local anesthetics.
• If you have had or are suspected of having methemoglobinemia.

• If you have suffered asthma attacks or bronchospasm.

Warnings and Precautions

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

• If you have asthma.
• The anesthesia caused by this medicine at the level of the throat can favor false routes (coughing during a meal, having the impression of choking), while food is being ingested. This medicine should not be used before meals or before drinking.
• Prolonged use of this medicine for more than 5 days is not recommended because it can 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 medicine can pass into the bloodstream and act on the heart and nervous system, with the possibility of convulsions.
• Elderly, sick, or debilitated people should consult their doctor before taking this medicine, as they are more sensitive to its possible adverse reactions.

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

Do not exceed the maximum recommended dose.

Children and Adolescents

Children under 12 years of age should not take this medicine; it is contraindicated.

This medicine is indicated for adults and adolescents from 12 years of age.

Using Strepsils with Lidocaine with Other Medicines

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

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

• Beta-blocker medicines (for heart treatment or for treating arterial diseases) and medicines such as cimetidine (for treating stomach ulcers).
• Other local anesthetics (amide type).
• Medicines for cardiac rhythm disorders, such as mexiletine or procainamide.

• Medicines such as fluvoxamine (for treating depression).
• Antibiotics such as erythromycin and itraconazole.

Do not take other buccopharyngeal antiseptics (medicines for mild throat infections, such as Strepsils with Lidocaine) if you are taking this medicine, although interactions are not expected.

Taking Strepsils with Lidocaine with Food, Drinks, and Alcohol

This medicine should not be used before meals or before drinking.

During treatment with this medicine, consumption of alcoholic beverages should be avoided.

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 medicine.

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

The use of this medicine during pregnancy is not recommended.

Breastfeeding:consult your doctor or pharmacist before using any medicine.

Fertility:there are no available data on fertility.

Driving and Using Machines

Observe your response to the medication. At the recommended doses, it is not expected to cause drowsiness or decreased reaction capacity, but if it does, do not drive or use hazardous machinery.

Strepsils with Lidocaine contains sucrose, glucose, wheat starch, sodium, sulfur dioxide, and fragrances that contain allergens

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

Patients with diabetes mellitus should note that this medicine contains 1.495 g of sucrose and 1.017 g of glucose per lozenge.

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

One lozenge does not contain more than 20.30 micrograms of gluten.

If you have a wheat allergy (different from celiac disease), you should not take this medicine.

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

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

This medicine contains fragrances with anise alcohol, d-limonene, and linalol.

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

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

3. How to Take Strepsils with Lidocaine

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents from 12 years of age: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Use in Children

This medicine is contraindicated in children under 12 years of age.

How to take Strepsils with Lidocaine:

Buccopharyngeal use, to dissolve in the mouth.

Let one lozenge 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 if you have a high fever, headache, nausea, or vomiting, you should consult your doctor.

If you take more Strepsils with Lidocaine than you should

It may cause an increase or alteration of the normal heart rhythm, increased blood pressure, sedation, alteration of breathing during sleep, unconsciousness, cardiovascular collapse, insomnia, hallucinations, tremors, and epileptic seizures (symptoms of depression or stimulation of the central nervous system). 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 Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

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

The use in large doses and for long periods of time in children can cause convulsions.

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

4. Possible Side Effects

Like all medicines, Strepsils with Lidocaine can cause side effects, although not everyone gets them.

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

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

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Strepsils with Lidocaine

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

Do not store above 30°C.

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Strepsils with Lidocaine

The active ingredients are 0.6 mg of amylmetacresol, 1.2 mg of 2,4-dichlorobenzyl alcohol, and 2 mg of lidocaine hydrochloride.

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

Appearance of the Product and Package Contents

Strepsils with Lidocaine are light greenish-blue circular lozenges with the Strepsils logo embossed on both sides.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

RECKITT BENCKISER HEALTHCARE, S.A.

C/ Mataró, 28

08403 Granollers (Spain)

Manufacturer

RB NL Brands B.V.

Schiphol Blvd 207, 1118 BH Schiphol, Netherlands

Date of the Last Revision of this LeafletNovember 2020.

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