STREPSILS WITH VITAMIN C LOZENGES

Introduction

Leaflet: Information for the user

Strepsils with Vitamin C lozenges

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

Read the entire 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 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 leaflet:

1. What Strepsils with Vitamin C is and what it is used for.
2. What you need to know before taking Strepsils with Vitamin C.
3. How to take Strepsils with Vitamin C.
4. Possible side effects.
5. Storage of Strepsils with Vitamin C.
6. Package contents and additional information.

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

Strepsils with Vitamin C belongs to the group of medications called antiseptics.

It contains an association of two antiseptics, 2,4-dichlorobenzyl alcohol and amylmetacresol. It also contains Vitamin C (as ascorbic acid and sodium ascorbate).

It is used for the local symptomatic relief of mild mouth and throat infections that occur 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 with Vitamin C

Do not takeStrepsils with Vitamin C

• If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, 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, worsens after 2 days of treatment, or is accompanied by high fever, headache, nausea, or vomiting, you should consult a doctor.

Do not exceed the recommended maximum dose.

Using Strepsils with Vitamin C 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 buccal antiseptics (medications for mild throat infections like Strepsils with Vitamin C) if you are 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 laboratory tests:

If you are going to have any laboratory tests (including blood, urine, etc.), tell 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 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 negligible or insignificant.

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

This medication contains sucrose and glucose. 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 1.438 g of sucrose and 0.968 g of glucose per lozenge.

This medication may cause allergic reactions because it contains Ponceau 4R red and orange yellow S. It may provoke 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 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 (distinct from celiac disease), you should 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/cooking salt) in each 8 lozenges. This is equivalent to 34.96% of the maximum recommended daily 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 suffocation) because it contains sulfur dioxide.

This medication contains terpenes provided by levomenthol, which, in excessive doses, may cause convulsions in small children (under 6 years), although at the doses and route of administration 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.

3. How to take Strepsils with Vitamin C

Follow the administration instructions for Strepsils with Vitamin C contained in this 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 old: 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 old.

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 the discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea, or vomiting, you should consult a 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 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 with Vitamin C may cause side effects, although not everyone experiences 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 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 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 with Vitamin C

Keep this medication out of sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiration date shown 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 medications you no longer need 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 with Vitamin C

The active ingredients are 0.6 mg of amylmetacresol, 1.2 mg of 2,4-dichlorobenzyl alcohol, 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, orange yellow S (E-110), Ponceau 4R red (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 package contents

Strepsils with Vitamin C are circular lozenges with an orange color and orange and mint flavor, and the Strepsils with Vitamin C icon engraved on both sides.

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