BUCOXON 20 mg lozenges with liquorice flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bucoxon 20 mg lozenges with liquorice flavour
ambroxol hydrochloride
Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for taking this medicine as described in this leaflet or as indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further 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 a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet
- What Bucoxon is and what it is used for
- What you need to know before taking Bucoxon
- How to take Bucoxon
- Possible side effects
- How to store Bucoxon
- Contents of the pack and other information
1. What Bucoxon is and what it is used for
Bucoxon contains the active substance ambroxol hydrochloride. The active substance is the component of the tablets that provides a local anesthetic effect, relieving acute sore throat pain.
Bucoxon is indicated for the relief of acute throat pain in adults and adolescents aged 12 years and older.
2. What you need to know before starting to take Bucoxon
Do not take Bucoxon
- if you are allergic to ambroxol hydrochloride or to any of the other components of this medicine (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 longer than 3 days. If your symptoms persist after 3 days 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 medicine. 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 occur due to an underlying illness (e.g., throat inflammation). Alternatively, it may be a sensation of throat tightness caused by the local anaesthetic effect of Bucoxon. It could also be an allergic reaction causing swelling of the mouth and throat.
- The throat and mouth may become less sensitive than usual (numbness).
- Serious skin reactions associated with ambroxol hydrochloride administration have been reported. If you develop a skin rash (including mucosal lesions, for example in the mouth, throat, nose, eyes, and genital area), stop using Bucoxon and consult your doctor immediately.
Children
If you are under 12 years of age, do not take Bucoxon.
Taking Bucoxon with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
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.
Ambroxol passes to the fetus. You should 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 unknown whether Bucoxon may affect the ability to drive or operate machinery.
Bucoxon contains isomalt
This medicine contains isomalt (E-953). If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine. It may cause a mild laxative effect as it contains 2.343 g of isomalt per tablet.
Calorific value: 2.3 kcal/g of maltitol/isomalt.
Bucoxon contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet, i.e., essentially "sodium-free".
3. How to take Bucoxon
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age: take 1 lozenge when you need pain relief. 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 develop a high fever, consult a doctor.
Clinical data show a rapid onset of action (within a maximum of 20 minutes). The effect will last at least 3 hours.
If you take more Bucoxon than you should
If you take too many lozenges (more than 6 per day) and notice any symptoms, seek advice from your doctor or pharmacist.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
If you experience any of the following adverse effects, stop taking Bucoxon and contact your doctor immediately:
- allergic reaction with localized swelling of the face, lips, mouth, tongue and/or throat (angioedema). This may cause a sensation of tightness in the throat, difficulty swallowing or breathing.
- sudden-onset allergic reaction affecting the whole body (anaphylactic reactions including anaphylactic shock).
The severity of allergic reactions may increase if the medicine is taken again, or if you take another medicine containing the same substance (see section 2. What you need to know before you start taking Bucoxon).
Other possible adverse effects:
Common (may affect up to 1 in 10 patients):
- dizziness (nausea)
- numbness of mouth, tongue and throat (oral and pharyngeal hypoesthesia)
- altered taste (dysgeusia)
Uncommon (may affect up to 1 in 100 patients):
- diarrhoea
- indigestion (dyspepsia)
- stomach pain (upper abdominal pain)
- dry mouth
Rare (may affect up to 1 in 1,000 patients):
- Hypersensitivity reactions
- Rash, 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.
- Serious skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
- vomiting
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Bucoxon
Keep this medicine out of sight and reach of children.
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.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bucoxon
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The active substance is ambroxol hydrochloride. One lozenge contains 20 mg of ambroxol hydrochloride.
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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 medicinal product and contents of the pack
This medicine is presented as round, flat-edged, brown-colored lozenges.
The lozenges are available in PVC-PVDC/aluminum blister packs.
Pack 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 most recent revision of this leaflet: June 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.