Apoxol 3 mg/ml syrup EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Apoxol 3 mg/ml syrup EFG
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 administration provided in this leaflet or those given 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 they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 5 days (3 days for children under 6 years of age).
Contents of the leaflet:
- What Apoxol is and what it is used for
- What you need to know before taking Apoxol
- How to take Apoxol
- Possible adverse effects
- How to store Apoxol
- Contents of the pack and other information
1. What Apoxol is and what it is used for
Ambroxol, the active substance in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and easier to expel.
This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, in adults and children aged 2 years and older.
You should consult a doctor if symptoms worsen or do not improve after 5 days (3 days in children under 6 years of age).
2. What you need to know before taking Apoxol
Do not take Apoxol
- If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6.1).
- In children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Apoxol.
If you have kidney or liver function problems, consult your doctor before using this medicine.
Serious skin reactions have been reported in association with ambroxol hydrochloride administration. If you develop a skin rash (including mucosal lesions, for example in the mouth, throat, nose, eyes, and genital areas), stop using Apoxol and contact your doctor immediately.
Children
Apoxol is contraindicated in children under 2 years of age.
For children aged 2 to 6 years, consult your doctor.
Other medicines and Apoxol
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking Apoxol with food and drinks
Apoxol can be taken with or without food.
Pregnancy, breastfeeding, and fertility
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.
No harmful effects have been observed during pregnancy. However, usual precautions regarding the use of medicines during pregnancy should be followed. The use of Apoxol is not recommended, especially during the first trimester of pregnancy.
The active substance in this medicine, ambroxol, may pass into breast milk. Although harmful effects in the breastfed infant are not expected, use during breastfeeding should be avoided.
Driving and using machines
No effects on the ability to drive or operate machinery have been observed.
Animal studies do not indicate any direct or indirect harmful effects on fertility.
Apoxol contains benzoic acid (E-210)
This medicine contains 2 mg of benzoic acid per ml.
Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
Apoxol contains propylene glycol (E-1520)
This medicine contains 30 mg of propylene glycol per ml.
If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.
Apoxol contains sorbitol (E-420)
This medicine contains 450.1 mg of sorbitol per ml.
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Apoxol contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml; this is essentially "sodium-free".
3. How to take Apoxol
Follow exactly the instructions for use of Apoxol 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 measure of 10 ml of Apoxol, 3 times a day (every 8 hours), corresponding to a maximum daily dose of 90 mg of ambroxol hydrochloride.
After 2–3 days, once symptoms begin to improve, the dosing regimen may be reduced to 2 times a day, every 12 hours.
Use in children
Children aged 6 to 12 years:
Take 1 measure of 5 ml of Apoxol, 2–3 times a day (every 8–12 hours, as needed), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride.
After 2–3 days, once symptoms begin to improve, the dosing regimen may be reduced to 2 times a day, every 12 hours.
Children aged 2 to 5 years:
Take, under medical supervision, 1 measure of 2.5 ml of Apoxol, 3 times a day (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride.
After 2–3 days, once symptoms begin to improve, the dosing regimen may be reduced to 2 times a day, every 12 hours.
Children under 2 years of age:
This medicine is contraindicated in children under 2 years of age.
How to take Apoxol
This medicine is for oral use only.
Measure the required dose using the dosing device provided in the package (dosage cup).
It is recommended to drink a glass of water after each dose and to maintain adequate fluid intake throughout the day.
Consult a doctor if symptoms worsen or do not improve after 5 days of treatment (after 3 days in children under 6 years of age).
If you take more Apoxol than you should
If you have taken more Apoxol than recommended, you may experience nausea, altered taste sensation, numbness of the pharynx, numbness of the mouth, or any other adverse reaction described in section 4, “Possible side effects.”
In case of overdose or accidental ingestion, contact the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.
In the event of accidental massive ingestion, symptomatic treatment is recommended.
4. Possible adverse effects
Like all medicines, Apoxol may produce adverse effects, although not everyone experiences them.
The following adverse effects may occur:
- Common (may affect up to 1 in 10 people)
Nausea, altered sense of taste, sensation of numbness in the pharynx, sensation of numbness in the mouth.
- Uncommon (may affect up to 1 in 100 people)
Vomiting, diarrhoea, indigestion, abdominal pain, dry mouth
- Rare (may affect up to 1 in 1,000 people)
Hypersensitivity 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, 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).
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 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 Apoxol
Keep this medicine out of the sight and reach of children.
Do not store above 30 ºC.
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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Apoxol 3 mg/ml syrup
The active substance is ambroxol hydrochloride. Each ml of syrup contains 3 mg of ambroxol hydrochloride.
The other components are: raspberry flavour, citric acid monohydrate, glycerol, hydroxyethylcellulose, benzoic acid, propylene glycol, 70% sorbitol, sodium saccharin and purified water.
Appearance of the medicinal product and contents of the container
Apoxol syrup is a transparent, colourless or slightly yellow solution.
It is supplied in a 200 ml pack, contained in a topaz glass bottle with a white polyethylene screw cap with safety closure, and a dosing cup.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Manufacturer
Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal
Date of the most recent revision of this leaflet: April 2023
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.