Label: Information for the User

DINOBROXOL 3 mg/ml Syrup

Ambroxol hydrochloride

Read this label carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. 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)

Ambroxol, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, in adults and children aged 2 years and above.

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

Do not take DINOBROXOL

• If you are allergic to ambroxol hydrochloride or any of the other components of this medication (listed in section 6).
• The use of this medication is contraindicated in children under 2 years old.

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 medication.

Severe skin reactions have been reported associated with the administration of ambroxol. If a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genitals) appears, stop using Dinobroxol and consult your doctor immediately.

Children

The use of this medication is contraindicated in children under 2 years old.

In children aged 2 to 6 years, consult a doctor.

Other medications and DINOBROXOL

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

Taking DINOBROXOL with food and drinks

DINOBROXOL can be taken with or without meals.

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 medication.

No adverse effects have been observed during pregnancy. However, usual precautions should be taken regarding the use of medications during pregnancy. The use of Dinobroxol is not recommended, especially in the first trimester of pregnancy.

The active ingredient of this medication, ambroxol, may pass into breast milk, so, although adverse effects are not expected in the infant, its use should be avoided during breastfeeding.

Driving and operating machinery

No effects have been observed on the ability to drive and operate machinery.

Dinobroxol contains sorbitol (E-420).

This medication contains 500 mg of sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) suffer from 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 (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

Dinobroxol contains ethanol.

This medication contains 30 mg of alcohol (ethanol) in each ml. The amount in 0.30 ml of this medication is equivalent to less than 0.05 ml of beer or 0.01 ml of wine.

The small amount of alcohol contained in this medication does not produce any perceptible effect.

Dinobroxol contains benzoic acid (E-210).

This medication contains 2 mg of benzoic acid per ml. It may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks old).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years:

Take 1 dose 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 you are improving, you can reduce the dose to 2 times a day, every 12 hours.

Use in children

Children under 2 years:

This medication is contraindicated in children under 2 years.

Children from 2 to 5 years:

Take, under medical supervision, 1 dose 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 you are improving, you can reduce the dose to 2 times a day, every 12 hours.

Children from 6 to 12 years:

Take 1 dose 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 you are improving, you can reduce the dosage regimen to 2 times a day, every 12 hours.

How to take DINOBROXOL

Dinobroxol is taken orally.

Measure the amount of medication to take 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 abundant liquid throughout the day.

You should consult a doctor if you worsen or do 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 in the pharynx, sensation of numbness in the mouth, or any other adverse effect described in section 4 Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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

Like all medications, DINOBROXOL may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur:

• Frequent (may affect more than 1 in 10 people): nausea, alteration of taste, sensation of numbness in the throat, sensation of numbness in the mouth.
• Infrequent (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.
• Unknown frequency (cannot be estimated from available data): anaphylactic reactions, such as anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling) and pruritus. Severe cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and generalized acute pustular exanthema).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use;www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

DINOBROXOL does not require special conditions for conservation, although it is advisable to store it in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 content of the container

DINOBROXOL 3mg/ml syrup, is a slightly viscous, clear and practically colorless liquid, with a fruity, aromatic raspberry smell, packaged in topaz-colored plastic bottles with screw cap and dosing vial.

Holder of the marketing authorization and responsible for manufacturing:

WAAS-ANITA, S.A.

General Prim, 13

28035 - Madrid (Spain)

Responsible for manufacturing:

ITALFARMACO, S.A.

San Rafael, 3

28108 - Madrid (Spain)

Last review date of this leaflet: April 2023

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.