BUCOXON 20 mg LOZENGES WITH LICORICE FLAVOR

Introduction

Package Leaflet: Information for the User

Bucoxon 20 mg lozenges with licorice flavor

ambroxol hydrochloride

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

Follow exactly the administration instructions of 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the Package Leaflet

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

1. What is Bucoxon and what is it used for

Bucoxon contains ambroxol hydrochloride as the active ingredient. The active ingredient is the part of the lozenges that provides a local anesthetic effect that relieves acute throat pain.

Bucoxon is indicated for the relief of acute throat pain in adults and adolescents from 12 years of age.

2. What you need to know before taking Bucoxon

Do not take Bucoxon

• if you are allergic to ambroxol hydrochloride or to any of the other components of this medication (listed in section 6).
• if you have hereditary fructose intolerance.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bucoxon.

• Do not use Bucoxon for more than 3 days. If after 3 days you still have symptoms or if you have a high fever, consult a doctor.
• If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medication. See Bucoxon contains isomalt.
• If you have kidney or liver problems, consult your doctor before taking Bucoxon.
• Bucoxon is not suitable for the treatment of painful lesions in the mouth (e.g., ulcers or sores).
• If you have mouth ulcers, consult a doctor.
• Shortness of breath (dyspnea) may be observed due to a disease you are suffering from (e.g., throat inflammation). Or it could be a feeling of oppression in the throat due to the local anesthetic effect of Bucoxon. It could also be an allergic reaction that causes inflammation of the mouth and throat.
• The throat and mouth may be less sensitive than usual (numb).
• Reports of serious skin reactions associated with the administration of ambroxol hydrochloride have been received. If a skin rash appears (including lesions of the mucous membranes, e.g., mouth, throat, nose, eyes, and genitals), stop using Bucoxon and consult your doctor immediately.

Children

If you are under 12 years of age, you should not take Bucoxon.

Taking Bucoxon with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Pregnancy and breastfeeding

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.

Ambroxol passes to the fetus. Do not take Bucoxon if you are pregnant, especially during the first trimester.

Ambroxol passes into breast milk. Do not take Bucoxon if you are breastfeeding.

Driving and using machines

It is not known if Bucoxon can affect the ability to drive and use machines.

Bucoxoncontains isomalt

This medication contains isomalt (E-953). 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 mild laxative effect because it contains 2.343 g of isomalt per lozenge.

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

Bucoxon contains sodium

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

3. How to take Bucoxon

Follow exactly the administration instructions of the medication 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 and adolescents over 12 years of age: take 1 lozenge when you need to relieve pain. Do not take more than 6 lozenges per day.

Do not take Bucoxon for more than 3 consecutive days. If after 3 days you still have symptoms or if you have a high fever, consult a doctor.

Clinical data show a rapid onset of action (within 20 minutes at most). The effect will last for at least 3 hours.

If you take more Bucoxon than you should

If you take too many lozenges (more than 6 per day) and observe any symptoms, ask your doctor or pharmacist for advice.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

4. Possible side effects

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

If you experience any of the following side effects, stop taking Bucoxon and contact your doctor immediately:

• allergic reaction with localized inflammation of the face, lips, mouth, tongue, and/or throat (angioedema). This can cause a feeling of oppression in the throat, difficulty swallowing, or breathing.
• sudden onset allergic reaction that affects the whole body (anaphylactic reactions including anaphylactic shock).

The severity of allergic reactions may increase if you take the medication again or if you take another medication with the same substance (see section 2. What you need to know before taking Bucoxon).

Other side effects that may occur:

Frequent (may affect up to 1 in 10 patients):

• feeling of dizziness (nausea)
• numbness of mouth, tongue, and throat (oral and pharyngeal hypoesthesia)
• taste alteration (dysgeusia)

Uncommon (may affect up to 1 in 100 patients):

• diarrhea
• indigestion (dyspepsia)
• abdominal pain (upper abdominal pain)
• dry mouth

Rare (may affect up to 1 in 1,000 patients):

• Hypersensitivity reactions
• Exanthema, urticaria
• Throat dryness

Frequency not known (cannot be estimated from available data):

• Anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus.
• Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
• vomiting

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bucoxon

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

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.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, 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 Bucoxon

• The active ingredient is ambroxol hydrochloride. One lozenge contains 20 mg of ambroxol hydrochloride.

• The other components (excipients) are: isomalt (E-953), licorice extract, sodium saccharin (E-954), ammonium chloride, racemic menthol, licorice flavor (anethole, menthol, methylcyclopentenolone, propylene glycol (E-1520), and vanillin), eucalyptus flavor (eucalyptus oil, peppermint oil, and menthol), and purified water.

Appearance of the product and package contents

This medication is presented as lozenges, round with a flat edge, brown in color.

The lozenges are available in PVC-PVDC/aluminum blister packs.

Package size: 18 lozenges.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - SPAIN

Date of the last revision of this package leaflet:June 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.