DINOBROXOL 3 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

DINOBROXOL 3 mg/ml Syrup

Ambroxol hydrochloride

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days. (3 days for children under 6 years)

Contents of the Package Leaflet

1. What is DINOBROXOL and what is it used for
2. What you need to know before taking DINOBROXOL
3. How to take DINOBROXOL
4. Possible side effects
5. Storage of DINOBROXOL
6. Package contents and additional information

1. What is Dinobroxol and what is it used for

Ambroxol, the active ingredient of this medicine, belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, in adults and children from 2 years of age.

You should consult a doctor if it worsens or does not improve after 5 days (3 days in children under 6 years).

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 components of this medicine (listed in section 6).
• The use of this medicine is contraindicated in children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take DINOBROXOL.

If you have problems related to kidney or liver function, consult your doctor before using this medicine.

There have been reports of severe skin reactions associated with the administration of ambroxol. If you experience a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Dinobroxol and consult your doctor immediately.

Children

The use of this medicine is contraindicated in children under 2 years of age.

In children from 2 to 6 years of age, consult a doctor.

Other medicines and DINOBROXOL

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No harmful effects have been observed during pregnancy. However, the usual precautions should be taken when using medicines during pregnancy. The use of Dinobroxol is not recommended, especially during the first trimester of pregnancy.

The active ingredient of this medicine, ambroxol, may pass into breast milk, so although no harmful effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

Driving and using machines

No effects have been observed on the ability to drive and use machines.

Dinobroxol contains sorbitol (E-420).

This medicine contains 500 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Dinobroxol contains ethanol.

This medicine contains 30 mg of alcohol (ethanol) per ml. The amount in 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 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 administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years:

Take 1 measure of 10 ml of DINOBROXOL 3 times a day (every 8 hours), which means a maximum daily dose of 90 mg of ambroxol hydrochloride. After 2-3 days, once improvement is observed, the dose can be reduced to 2 times a day, every 12 hours.

Use in children

Children under 2 years:

This medicine is contraindicated in children under 2 years of age.

Children from 2 to 5 years:

Take, under medical supervision, 1 measure of 2.5 ml of DINOBROXOL, 3 times a day (every 8 hours), which means a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2-3 days, once improvement is observed, the dose can be reduced to 2 times a day, every 12 hours.

Children from 6 to 12 years:

Take 1 measure of 5 ml of DINOBROXOL 2 or 3 times a day (every 8 hours), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once improvement is observed, the dose can be reduced to 2 times a day, every 12 hours.

How to take DINOBROXOL

Dinobroxol is taken orally.

Measure the amount of medicine to be taken with the dosing cup included in the box 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 plenty of liquid throughout the day.

You should consult a doctor if it worsens or does not improve after 5 days of treatment (3 days in children under 6 years).

If you take more DINOBROXOL than you should

If you have taken more DINOBROXOL than you should, you may experience nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other side effect 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, phone 915 620 420, indicating the medicine and the amount ingested.

In case of massive accidental administration, symptomatic treatment is recommended.

4. Possible side effects

Like all medicines, DINOBROXOL can cause side effects, although not everyone experiences them.

The following side effects may occur:

• Frequent (may affect more than 1 in 10 people): nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.
• Uncommon (may affect up to 1 in 100 people): vomiting, diarrhea, 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 progressing 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 acute generalized exanthematous pustulosis).

Reporting of side effects

If you experience any side effect, consult your doctor, pharmacist, or nurse, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side 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, although it is advisable to keep it in the original packaging to protect it from light.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of DINOBROXOL

• The active ingredient 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 flavor, and purified water.

Appearance of the product and package contents

DINOBROXOL 3mg/ml syrup is a slightly viscous, clear, and almost colorless liquid, with a fruity, aromatic raspberry odor, packaged in topaz-colored plastic bottles with a screw cap 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 last revision of this package leaflet: April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/.