STREPSILS Lozenges Honey & Lemon Flavor

Introduction

Package Leaflet: Information for the User

Strepsils Lozenges Honey and Lemon Flavor

Alcohol 2,4-dichlorobenzyl, amylmetacresol

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

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

Contents of the Package Leaflet

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

1. What Strepsils is and what it is used for

Strepsils belongs to the group of medications called antiseptics.

It is used for the local symptomatic relief of mild mouth and throat infections without fever, in adults and children from 6 years of age.

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

2. What you need to know before taking Strepsils

Do not take Strepsils

• If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, or any of the other components of this medication (listed in section 6).
• If you are under 6 years of age.

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 if you have a high fever, headache, nausea, or vomiting, you should consult a doctor.

Do not exceed the recommended maximum dose.

Using Strepsils with Other Medications

Tell your doctor or pharmacist that you are taking or have recently taken or may need to take any other medication.

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

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 medication.

Driving and Using Machines

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

Strepsils contains sucrose, glucose, wheat starch, sodium, fragrances containing allergens, inverted sugar, and sulfur dioxide

This medication contains sucrose, glucose, and inverted sugar. If your doctor has told you 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 sucrose 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 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), you should not take this medication.

This medication contains less than 23 mg of sodium (1 mmol) per lozenge; it 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 cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfur dioxide.

3. How to Take Strepsils

Follow the administration instructions for Strepsils contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults:1 lozenge every 2 or 3 hours, as needed, up to a maximum of 8 lozenges in 24 hours.

Children

Children from 6 years of age: 1 lozenge every 2 or 3 hours, as needed, up to a maximum of 4 lozenges in 24 hours.

Do not use in children under 6 years of age.

How to take Strepsils:

Bucofaringeal 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 a 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 Toxicology 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.

4. Possible Side Effects

Like all medications, Strepsils can cause side effects, although not everyone will experience them.

Side effects with unknown frequency (cannot be estimated from 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 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting Side Effects

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

5. Storage of Strepsils

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

Do not store above 25°C.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Strepsils

The active ingredients are 0.6 mg of amylmetacresol and 1.2 mg of 2,4-dichlorobenzyl 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 Package Contents

Strepsils lozenges honey and lemon flavor are circular lozenges with a yellow color, honey and lemon flavor, and the Strepsils icon embossed on both sides.

Each package contains 10 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 Package LeafletNovember 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.gob.es