Dinobroxol 3 mg/ml syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
DINOBROXOL 3 mg/ml Syrup
Ambroxol hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 side effects, talk to your doctor or pharmacist, even if they are side 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 DINOBROXOL is and what it is used for
- What you need to know before taking DINOBROXOL
- How to take DINOBROXOL
- Possible side effects
- How to store DINOBROXOL
- Contents of the pack and other information
1. What Dinobroxol 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, liquefying it and facilitating its removal.
This medicine is indicated to help remove 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 Dinobroxol
Do not take DINOBROXOL
- If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
- The use of this medicine is contraindicated in children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking DINOBROXOL.
If you have kidney or liver function problems, consult your doctor before using this medicine.
Serious skin reactions associated with ambroxol 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 Dinobroxol and contact your doctor immediately.
Children
The use of this medicine is contraindicated in children under 2 years of age.
For children aged 2 to 6 years, consult your doctor.
Other medicines and DINOBROXOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Taking DINOBROXOL with food and drinks
DINOBROXOL can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you might 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 Dinobroxol 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.
Dinobroxol contains sorbitol (E-420).
This medicine contains 500 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 break down fructose, consult your doctor before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
Dinobroxol contains ethanol.
This medicine contains 30 mg of alcohol (ethanol) per ml. The amount in 0.30 ml of this medicine is equivalent to less than 0.05 ml of beer or 0.01 ml of wine.
The small amount of alcohol contained in this medicine does not produce any noticeable effect.
Dinobroxol contains benzoic acid (E-210).
This medicine contains 2 mg of benzoic acid per ml. It may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).
3. How to take Dinobroxol
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 measure of 10 ml of DINOBROXOL three times a day (every 8 hours), corresponding to a maximum daily dose of 90 mg of ambroxol hydrochloride. After 2–3 days, once improvement begins, the dose may be reduced to twice daily, every 12 hours.
Use in children
Children under 2 years of age:
This medicine is contraindicated in children under 2 years of age.
Children from 2 to 5 years of age:
Under medical supervision, take 1 measure of 2.5 ml of DINOBROXOL three times a day (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2–3 days, once improvement begins, the dose may be reduced to twice daily, every 12 hours.
Children from 6 to 12 years of age:
Take 1 measure of 5 ml of DINOBROXOL two or three times a day (every 8 hours), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2–3 days, once improvement begins, the dosing schedule may be reduced to twice daily, every 12 hours.
How to take DINOBROXOL
Dinobroxol is taken orally.
Measure the required amount of medicine using the dosing cup provided in the package and drink directly from it. After each dose, wash the dosing cup.
It is recommended to drink a glass of water after each dose and to maintain abundant fluid intake throughout the day.
Consult a doctor if symptoms worsen or do not improve after 5 days of treatment (3 days in children under 6 years of age).
If you take more Dinobroxol than you should
If you have taken more Dinobroxol 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, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested.
In case of accidental massive ingestion, symptomatic treatment is recommended.
4. Possible adverse effects
Like all medicines, DINOBROXOL may cause adverse effects, although not everyone experiences them.
The following adverse effects may occur:
- Common (may affect more than 1 in 10 people): nausea, altered taste sensation, 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.
- Frequency not known (cannot be estimated from available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous tissues, mucous membranes or submucosal tissues), and pruritus. Serious skin 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, pharmacist, or nurse, 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Dinobroxol
Keep this medicine out of the sight and reach of children.
DINOBROXOL does not require special storage conditions; however, it is advisable to keep it in the original packaging to protect it from light.
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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of DINOBROXOL
- The active substance is ambroxol hydrochloride. Each ml of syrup contains 3 mg of ambroxol hydrochloride.
- The other components (excipients) are: benzoic acid (E-210), tartaric acid, ethanol 96% V/V, glycerol (E-422), hydroxyethylcellulose, sorbitol 70% (E-420), raspberry flavour, and purified water.
Appearance of the product and contents of the pack
DINOBROXOL 3 mg/ml syrup is a slightly viscous, clear and practically colourless liquid with a fruity, aromatic raspberry odour, supplied in amber plastic bottles with screw caps and a dosing cup.
Marketing Authorization Holder and Manufacturer:
WAAS-ANITA, S.A.
General Prim, 13
28035 - Madrid (Spain)
Manufacturer:
ITALFARMACO, S.A.
San Rafael, 3
28108 - Madrid (Spain)
Date of the most recent revision of this leaflet: April 2023
Detailed and up-to-date 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/.