Strepsils with Lidocaine lozenges for sucking

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Strepsils with lidocaine lozenges

2,4-dichlorobenzyl alcohol, amylmetacresol, lidocaine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this 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 any 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 lidocaine is and what it is used for.
2. What you need to know before taking Strepsils with lidocaína.
3. How to take Strepsils with lidocaine.
4. Possible side effects.
5. How to store Strepsils with lidocaine.
6. Contents of the pack and other information.

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

Strepsils with lidocaine belongs to the group of medicines known as antiseptics.

Strepsils with lidocaine is a combination 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 associated with pain and without fever in adults and adolescents aged 12 years and older.

You should consult a doctor if symptoms worsen or do 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 had an allergic reaction to local anaesthetics.
• If you have had or are suspected of having methaemoglobinaemia.
• If you have experienced asthma attacks or bronchospasm.

Warnings and precautions

Talk to your doctor or pharmacist before taking Strepsils with lidocaine:

• If you suffer from asthma.
• The anaesthesia caused by this medicine in the throat area may increase the risk of aspiration (coughing while eating, feeling like choking) when swallowing food or drink. This medicine should not be used before meals or drinking.
• Prolonged use of this medicine for more than 5 days is not recommended, as it may disrupt the natural microbial balance of the throat.
• Do not exceed the maximum recommended dose. If taken in large amounts or repeatedly, this medicine may enter the bloodstream and affect the heart and nervous system, potentially causing seizures.
• Elderly, ill, or weakened individuals should consult their doctor before taking this medicine, as they may be more sensitive to possible adverse reactions.

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 your doctor.

Do not exceed the maximum recommended dose.

Children and adolescents

Children under 12 years of age must not take this medicine, as it is contraindicated.

This medicine is intended for adults and adolescents aged 12 years and older.

Taking Strepsils with lidocaine with other medicines

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

In particular, inform them if you are taking any of the following medicines, as dosage adjustments may be necessary:

• Beta-blockers (used to treat heart conditions or arterial diseases) and medicines such as cimetidine (used to treat stomach ulcers).
• Other local anaesthetics (amide-type).
• Medicines used for heart rhythm disorders, such as mexiletine or procainamide.
• Medicines such as fluvoxamine (used to treat depression).
• Antibiotics such as erythromycin and itraconazole.

Do not take other oropharyngeal antiseptics (medicines for mild throat infections like Strepsils with lidocaine) while 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, 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 is no available data regarding fertility.

Driving and using machines

Be aware of how this medicine affects you. At the recommended doses, drowsiness or reduced reaction ability is not expected; however, if such effects occur, do not drive or operate dangerous machinery.

Strepsils with lidocaine contains sucrose, glucose, wheat starch, sodium, sulphur dioxide, and fragrances containing allergens

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

Patients with diabetes mellitus should be aware that each lozenge contains 1.495 g of sucrose and 1.017 g of glucose.

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

One lozenge contains no more than 20.30 micrograms of gluten.

If you have a wheat allergy (distinct from coeliac disease), you must not take this medicine.

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

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

This medicine contains fragrances containing anisyl alcohol, d-limonene, and linalool.

Anisyl alcohol, d-limonene, and linalool may cause allergic reactions.

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

3. How to take Strepsils with lidocaine

Follow exactly the dosage instructions for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Adults and adolescents aged 12 years and over: 1 tablet every 2 or 3 hours as needed, up to a maximum of 8 tablets in 24 hours.

Use in children

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

How to take Strepsils with lidocaine:

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

If you take more Strepsils with lidocaine than you should

An increase or alteration in the normal heart rhythm, increased blood pressure, sedation, breathing disturbances during sleep, unconsciousness, cardiovascular collapse, insomnia, hallucinations, tremors and epileptic seizures (symptoms of central nervous system depression or stimulation) may occur. Drowsiness may be a sign of overdose. In children, agitation may occur.

In case of overdose or accidental ingestion of large quantities, you may experience gastrointestinal discomfort, blurred vision, tinnitus (ringing in the ears), and drowsiness. Contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.

Prolonged use of this medicine for more than 5 days is not recommended, as it may alter the natural microbial balance of the throat.

Use of high doses over long periods in children may cause seizures.

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 lidocaine may cause adverse effects, although not everyone will experience them.

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

Adverse effects with unknown frequency (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 mouth (glossodynia).

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 Medicines (www.notificaram.es). By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Strepsils with lidocaine

The active substances are 0.6 mg of amylocresol, 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 anisyl alcohol, d-limonene and linalool), quinoline yellow (E-104), indigo carmine (E-132), sodium saccharin (E-954), sucrose, liquid glucose (contains wheat starch and sulfur dioxide (E-220)).

Appearance of the medicine and contents of the pack:

Strepsils with lidocaine are light bluish-green, circular lozenges with the Strepsils logo imprinted on both sides.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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, Netherlands

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

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