Package Insert: Information for the User

Bucoxon 20 mg Lozenges, Peppermint Flavor

Ambroxol Hydrochloride

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

Follow exactly the medication administration instructions contained in this package insert or those provided by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 package insert. 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 aged 12 years and above.

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 have a 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. Bucoxon contains isomalta.
• If you have kidney or liver problems, consult your doctor before taking Bucoxon.
• Bucoxon is not suitable for the treatment of painful mouth lesions (e.g. ulcers or sores).
• If you have mouth ulcers, consult a doctor.

-You may experience shortness of breath (dyspnea) due to an underlying illness (e.g. throat inflammation). It could also be the sensation of a constricted 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).
• 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 think you may be 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 operating machinery

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

Bucoxon contains isomalta

This medication contains isomalta (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 2,412 g of isomalta per tablet.

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

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.

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.

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

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:

• allergic reaction with localized inflammation of the face, lips, mouth, tongue, and/or throat (angioedema). This can cause a sensation of choking, difficulty swallowing or breathing.
• allergic reaction that occurs suddenly and affects the entire body (anaphylactic reactions including anaphylactic shock).

The severity of allergic reactions can increase if you take the medicine again, or if you take another medicine with the same substance (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):

• Sensation of dizziness (nausea)
• Mouth, tongue, and throat numbness (oral and pharyngeal hypoesthesia)
• Alteration of taste (dysgeusia)

Less frequent (may affect up to 1 in 100 patients):

• Diarrhea
• Indigestion (dyspepsia)
• Upper abdominal pain (dyspepsia)
• Mouth dryness

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

• Hypersensitivity reactions
• Exanthema, urticaria
• Throat dryness

Unknown frequency (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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, 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 ingredient is ambroxol hydrochloride. A lozenge contains 20 mg of ambroxol hydrochloride.

• The other components (excipients) are: isomalta (E-953), sodium saccharin (E-954), racemic menthol, and peppermint essential oil.

Appearance of the product and content of the packaging

This medication is presented as lozenges, round with a flat edge, off-white in color.

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

Packaging size: 18 lozenges.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:June 2020

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