AMBROXOL ALDO-UNION 15 mg/2 ml ORAL SOLUTION OR CONCENTRATE FOR NEBULIZER INHALATION

Introduction

Leaflet: information for the user

Ambroxol Aldo-Union 15 mg/2 ml oral solution or concentrate for inhalation by nebulizer

Ambroxol hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Ambroxol Aldo-Union and what is it used for

Ambroxol Aldo-Union contains the active ingredient ambroxol, which belongs to a group of medications called mucolytics used to facilitate the elimination of mucus from the respiratory tract.

Ambroxol Aldo-Union is indicated for the symptomatic treatment of acute and chronic bronchopulmonary processes with an excess of mucus production and viscosity, for adults and children from 2 years of age.

2. What you need to know before taking Ambroxol Aldo-Union

Do not take Ambroxol Aldo-Union:

• if you are allergic to ambroxol or any of the other components of this medication (listed in section 6).
• if you have a severe liver and/or kidney disease.
• in children under 2 years of age.
• if you are in the first trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before taking Ambroxol Aldo-Union:

• if you have stomach ulcers (peptic ulcer).
• if you have mild or moderate kidney function impairment.
• if you have severe liver problems.
• during the first three months of pregnancy or if you are breastfeeding.

Consider:

There have been reports of severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) associated with the administration of ambroxol. Specifically, the initial phase of these diseases could manifest with symptoms similar to those of the flu, such as fever, pain, cold (rhinitis), cough, and sore throat.

If a skin rash appears (including lesions in the mouth, throat, nose, eyes, or genital mucosa), stop taking Ambroxol Aldo-Union and consult a doctor immediately.

If an irritating cough appears during the administration of the nebulized solution, try to inhale and exhale normally during inhalation. If you are particularly sensitive, you can pre-heat the solution to inhale to body temperature.

If you have bronchial asthma, it is advisable to administer a medication (bronchial spasmolytic) before inhalation.

Children

Ambroxol Aldo-Union should not be administered to children under 2 years of age, as mucolytics can cause respiratory tract obstruction (bronchi).

Use of Ambroxol Aldo-Union with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Before taking Ambroxol Aldo-Union, inform your doctor that you are taking medications such as amoxicillin, cefuroxime, or erythromycin (antibiotics used to treat bacterial infections).

No interactions with other medications have been observed.

Pregnancy and breastfeeding

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.

Pregnancy

Ambroxol Aldo-Union is not recommended during the first trimester. During the second and third trimesters, Ambroxol Aldo-Union should only be used after consulting a doctor and evaluating the risk/benefit ratio of each individual case.

Breastfeeding

Ambroxol Aldo-Union is excreted in breast milk, and therefore, its use is not recommended during breastfeeding.

Driving and using machines

Ambroxol Aldo-Union does not affect the ability to drive and use machines.

Ambroxol Aldo-Union containssodium

This medication contains less than 23 mg (1 mmol) per ampoule, so it is considered essentially "sodium-free"

3. How to take Ambroxol Aldo-Union

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Each single-dose ampoule contains 2 ml and includes a mark indicating a volume of 1 ml (half dose).

Nebulizer inhalation solution:

Adults and children over 5 years: 2 ml (1 ampoule) twice a day.

Children from 2 to 5 years: 1 ml - 2 ml (half ampoule - 1 ampoule), 1 or 2 times a day.

The solution can be administered using the aerosol therapy devices normally used. It can also be diluted in distilled water in a 1:1 ratio.

Oral solution:

Adults: 2 ml - 4 ml (1 - 2 ampoules), 3 times a day.

Children over 5 years: 1-2 ml (1/2 ampoule - 1 ampoule), 2 to 3 times a day.

Children from 2 to 5 years: 1 ml (half ampoule), 2 to 3 times a day.

Dilute the solution in a little water, tea, milk, or fruit juice. The medication should be taken with meals.

If you use half a dose, close the single-dose ampoule again by pressing the cap and store it in the refrigerator (2-8 °C) for a maximum of 12 hours.

If you take more Ambroxol Aldo-Union than you should

The risk of adverse reactions increases. In case of accidental ingestion/taking of an excessive dose of Ambroxol Aldo-Union, inform your doctor or go to the nearest hospital immediately.

If you forget to take Ambroxol Aldo-Union

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Ambroxol Aldo-Union

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Stop taking Ambroxol Aldo-Union immediately and consult a doctor if you experience any of the following disorders: itching, skin spots (urticaria, skin rash), swelling (angioedema) of the face, eyes, lips, and/or throat with difficulty breathing, due to allergy (hypersensitivity).

Other side effects:

Frequent(may affect up to 1 in 10 people):

• alteration or decrease in taste (dysgeusia).
• decreased sensitivity (hypoesthesia) in the mouth or pharynx (oral cavity).
• nausea.

Uncommon(may affect up to 1 in 100 people):

• vomiting.
• diarrhea.
• digestive difficulties (dyspepsia).
• abdominal pain.
• dry mouth.

Rare(may affect up to 1 in 1,000 people):

• headache;
• hypersensitivity reactions;
• rash, urticaria.

Unknown:(frequency cannot be estimated from available data):

• anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissue, mucous membranes, or submucosal tissues) and pruritus.
• severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
• respiratory tract obstruction (bronchi).
• throat dryness.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Ambroxol Aldo-Union

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the box, aluminum pouch, or ampoule after "EXP". The expiration date is the last day of the month indicated.

Once the aluminum pouch is opened, the single-dose ampoules must be used within a maximum of three months, stored inside the pouch.

When using half a dose, the ampoule must be stored between 2-8 °C (in the refrigerator) and used within a maximum of 12 hours.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ambroxol Aldo-Union

• The active ingredient is ambroxol.
• The other components are sodium chloride and water for injectable preparations.

Appearance of the product and package contents

Ambroxol Aldo-Union is presented in 2 ml low-density polyethylene single-dose ampoules, grouped in strips of 5 ampoules, packaged in an aluminum pouch.

It is available in packages of 15 or 30 ampoules of 2 ml.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio Aldo-Union, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Manufacturer

GENETIC S.p.A.

Contrada Canfora

Fisciano (SA)

(Italy)

Date of the last revision of this leaflet:July 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/