Strepsils with Vitamin C lozenges for sucking

Package leaflet: Information for the user

Introduction

Package 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 you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of the medicine contained in this leaflet or those provided 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult your doctor if you worsen or do not improve after 2 days.

Leaflet contents:

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. How to store Strepsils with vitamin C.
6. Contents of the pack and other information.

1. What Strepsils vitamin C is and what it is used for

Strepsils with vitamin C belongs to a group of medicines called antiseptics.

It contains a combination of two antiseptic agents: 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 infections of the mouth and throat without fever in adults and children aged 6 years and over.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

2. What you need to know before starting to take Strepsils with vitamin C

Do not take Strepsils with vitamin C

• If you are allergic (hypersensitive) to 2,4-dichlorobenzyl alcohol, amylmetacresol, ascorbic acid, sodium ascorbate, or any of the other ingredients of this medicine (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 with vitamin C.

If your symptoms do not improve, worsen after 2 days of treatment, or if you develop high fever, headache, nausea, or vomiting, you should consult a doctor.

Do not exceed the recommended maximum dose.

Use of Strepsils with vitamin C with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You should not take other oropharyngeal antiseptics (medicines for mild throat infections such as Strepsils with vitamin C) while taking this medicine, although interactions are not expected.

Vitamin C may interact with medicines such as: ethinylestradiol, deferoxamine, aluminium-containing antacids, disulfiram, antidepressants, trimethoprim/sulfamethoxazole.

Interference with diagnostic tests:

If you are due to have any laboratory tests (including blood or urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

The effect of this medicine on the ability to drive and operate machinery is none or negligible.

Strepsils with vitamin C contains sucrose, glucose, Ponceau 4R, sunset yellow FCF, wheat starch, propylene glycol, sodium, fragrances containing allergens, sulfur dioxide, and ethanol.

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

Patients with diabetes mellitus should be aware that this medicine contains 1.438 g of sucrose and 0.968 g of glucose per lozenge.

This medicine may cause allergic reactions as it contains Ponceau 4R and sunset yellow FCF. It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

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 coeliac disease.

One lozenge contains no more than 19.36 micrograms of gluten.

If you have a wheat allergy (other than coeliac disease), you should not take this medicine.

This medicine contains 3 mg of propylene glycol in each lozenge.

This medicine contains 69.92 mg of sodium (a main component of table/cooking salt) in every 8 lozenges. This corresponds to 34.96% of the maximum daily sodium intake recommended for an adult.

This medicine contains fragrances containing citral, citronellol, d-limonene, geraniol, and linalool.

Citral, citronellol, d-limonene, geraniol, and linalool may cause allergic reactions.

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

This medicine contains terpenes from levomenthol which, in excessive doses, may cause seizures in young children (under 6 years of age), although at the doses and route of administration used in this medicine, absorption and activity of terpenes are very low.

This medicine contains 0.156 µg of alcohol (ethanol) per dose, equivalent to less than 1 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine will not produce noticeable effects.

3. How to take Strepsils with vitamin C

Follow exactly the administration instructions for Strepsils with vitamin C provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:

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

Children

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

Not recommended for children under 6 years of age.

How to take Strepsils

For oropharyngeal use, to be dissolved in the mouth.

Allow one lozenge to dissolve slowly in the mouth.

Do not swallow, chew or bite.

If discomfort persists for more than 2 days, worsens, or is accompanied by high fever, headache, nausea or vomiting, consult your 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 the event of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medication and amount ingested.

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

4. Possible adverse effects

Like all medicines, Strepsils with vitamin C may produce adverse effects, although not everyone will experience them.

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

Adverse effects with frequency not known (cannot be estimated from the available data): abdominal pain, nausea or oral discomfort which may present as throat irritation, swelling of the mouth or throat, tingling sensation in the mouth (paresthesia), or burning sensation in the mouth (glosodynia).

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Strepsils with vitamin C

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

Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Strepsils with vitamin C

The active substances 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 flavour (containing citral, citronellol, d-limonene, geraniol, linalool, 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 (containing wheat starch and sulfur dioxide (E-220)).

Appearance of the product and contents of the pack

Strepsils with vitamin C are orange-coloured, circular lozenges with an orange and mint flavour, and the Strepsils with vitamin C logo imprinted on both sides.

Each pack contains 8 or 24 lozenges for oral sucking. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Reckitt Benckiser Healthcare, S.A.
Paseo de Gracia, 9, 08007, Barcelona, Spain

Manufacturer

RB NL Brands B.V.
Schiphol Blvd 207, 1118 BH Schiphol, The Netherlands

Date of the most recent revision of this leaflet: November 2020.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/