BucOXON 20 mg pastilles for sucking, peppermint flavour
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bucoxon 20 mg lozenges, mint flavour
ambroxol hydrochloride
Read all of this 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 directed 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 such effects are not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or 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 adverse 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 part of the tablets that provides a local anaesthetic effect, relieving acute sore throat pain.
Bucoxon is indicated for the relief of acute sore throat pain in adults and adolescents from 12 years of age.
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 ingredients 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.
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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.
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If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine. Please note that Bucoxon contains isomalt.
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If you have kidney or liver problems, consult your doctor before taking Bucoxon.
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Bucoxon is not suitable for the treatment of painful mouth lesions (e.g., ulcers or sores).
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If you have mouth ulcers, consult a doctor.
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Intermittent breathing (dyspnea) may occur due to an underlying illness (e.g., throat inflammation). Alternatively, it could 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 feel 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, or 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 crosses the placenta. 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 produce a mild laxative effect as it contains 2.412 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 instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age: take 1 lozenge as needed for 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.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can 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 people):
- Feeling of dizziness (nausea)
- Numbness of mouth, tongue and throat (oral and pharyngeal hypoesthesia)
- Taste disturbance (dysgeusia)
Uncommon (may affect up to 1 in 100 people):
- Diarrhea
- Indigestion (dyspepsia)
- Stomach pain (upper abdominal pain)
- Dry mouth
Rare (may affect up to 1 in 1,000 people):
- 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, mucosa 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, 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. Each pastille contains 20 mg of ambroxol hydrochloride.
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The other components (excipients) are: isomalt (E-953), sodium saccharin (E-954), racemic menthol and peppermint essential oil.
Appearance of the medicine and contents of the pack
This medicine is presented as white, round, flat-edged pastilles.
The pastilles are available in PVC-PVDC/aluminium blister packs.
Pack size: 18 pastilles.
Marketing Authorisation 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 of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.