STREPSILS lemon flavored lozenges

Introduction

Package Leaflet: Information for the User

Strepsils Lemon Flavor Lozenges

2,4-Dichlorobenzyl alcohol, 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 doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

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

2. What you need to know before taking Strepsils

Do not takeStrepsils

• 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 the discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea, or vomiting, you should consult your doctor as soon as possible.

Do not exceed the recommended maximum dose.

Using 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 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 isomalt, liquid maltitol, sodium, and fragrances that contain allergens.

This medication contains isomalt (E-953) and liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may produce a slight laxative effect because it contains 1.830 g of isomalt per lozenge and 0.458 g of liquid maltitol.

Caloric value: 2.3 kcal/g of isomalt/maltitol.

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

This medication contains fragrances with benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool.

Benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool may cause allergic reactions.

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:

Buccal use, to dissolve in the mouth.

Let one lozenge dissolve slowly in the mouth.

Do not swallow, chew, or bite.

If you do not improve, if you worsen after 2 days of treatment, or have a high fever, headache, nausea, or vomiting; you should consult your 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 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 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 packaging 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 packaging and unused medications at the pharmacy's SIGRE Point. Ask your pharmacist how to dispose of the packaging 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: lemon flavor (contains benzyl alcohol, citral, citronellol, d-limonene, geraniol, and linalool), sodium saccharin (E-954), tartaric acid, isomalt (E-953), and liquid maltitol (E-965).

Appearance of the Product and Package Contents

Strepsils are circular lozenges with a color between white and pale yellow, lemon flavor, and the Strepsils icon engraved on both sides.

Each package contains 24 lozenges.

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/