Prospect: information for the user

Bucoxon 20 mg lozenges, sweetened with licorice flavor

ambroxol hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, 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 not listed in this prospect. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

Bucoxon contains ambroxol hydrochloride as its active ingredient. The active ingredient is the part of the tablets that provides local anesthetic effect, which relieves acute sore throat pain.

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

Do not take Bucoxon

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

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 high fever, consult a doctor.
• If your doctor has told you that you have 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 mouth injuries (e.g. ulcers or sores).
• If you have mouth ulcers, consult a doctor.
• You may experience shortness of breath (dyspnea) due to an underlying disease (e.g. throat inflammation). Or it could be the sensation of throat constriction 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).
• Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals), stop using Bucoxon and consult your doctor immediately.

Children

If you are under 12 years old, do not take Bucoxon.

Taking Bucoxon with other medications

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

Pregnancy and breastfeeding

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

Ambroxol passes into 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 operating machinery

The effect of Bucoxon on the ability to drive and operate machinery is unknown.

Bucoxoncontains isomalt

This medication contains isomalt (E-953). If your doctor has told you that you have intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect because it contains 2.343 g of isomalt per tablet.

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

Bucoxon contains sodium

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years: take 1 lozenge as needed 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 have a high fever, consult a doctor.

Clinical data show a rapid onset of action (at most in 20 minutes). 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, seek advice from your doctor or pharmacist.

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine 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:

The severity of allergic reactions can increase if you take the medicine again or if you take another medicine with the same active ingredient (see section 2. What you need to know before starting to take 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)
• alteration of taste (dysgeusia)

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

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

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

• allergic reactions
• exanthema, urticaria
• dry throat

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

• anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressive swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues) and pruritus.
• severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular exanthema).
• vomiting

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bucoxon

• The active principle is ambroxol hydrochloride.
  Each lozenge contains 20 mg of ambroxol hydrochloride.

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

Appearance of the product and contents of the packaging

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

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

Pack size: 18 lozenges.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - SPAIN

Last review date of this leaflet:June 2020

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