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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Ambroxol hydrochloride

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

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

Leaflet contents

1. What Ambroxol Aldo-Unión is and what it is used for
2. What you need to know before taking Ambroxol Aldo-Unión
3. How to take Ambroxol Aldo-Unión
4. Possible adverse effects
5. How to store Ambroxol Aldo-Unión
6. Contents of the pack and other information

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

Ambroxol Aldo-Unión contains the active substance ambroxol, which belongs to a group of medicines called mucolytics, used to help clear mucus from the respiratory tract.

Ambroxol Aldo-Unión is indicated for the symptomatic treatment of acute and chronic bronchopulmonary conditions associated with excessive mucus production and increased mucus viscosity, in adults and children from 2 years of age.

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

Do not take Ambroxol Aldo-Unión:

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

Warnings and precautions

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

• if you have stomach lesions (peptic ulcer).
• if you have mild or moderate impairment of kidney function.
• if you suffer from serious liver problems.
• during the first 3 months of pregnancy or if you are breastfeeding.

PLEASE NOTE:

Serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in association with ambroxol administration. Specifically, the initial phase of these conditions may present with flu-like symptoms such as fever, pain, cold (rhinitis), cough, and sore throat.

If a skin rash appears (including lesions in the mucous membranes of the mouth, throat, nose, eyes, or genitals), stop taking Ambroxol Aldo-Unión and consult a doctor immediately.

If an irritating cough occurs during administration of the nebulized solution, try to inhale and exhale normally during inhalation. If you are particularly sensitive, you may pre-warm the solution to body temperature before inhalation.

If you suffer from bronchial asthma, it is advisable to administer a medication (bronchial spasmolytic) prior to inhalation.

Children

Ambroxol Aldo-Unión must not be administered to children under 2 years of age, as mucolytics may cause obstruction of the airways (bronchi).

Use of Ambroxol Aldo-Unión with other medicines

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

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

No interactions with other medicines have been observed.

Pregnancy and breastfeeding

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.

Pregnancy

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

Breastfeeding

Ambroxol Aldo-Unión is excreted in breast milk; therefore, use of this medicine is not recommended during breastfeeding.

Driving and using machines

Ambroxol Aldo-Unión does not affect the ability to drive or operate machinery.

Ambroxol Aldo-Unión contains sodium

This medicine contains less than 23 mg (1 mmol) per ampoule and is therefore considered essentially "sodium-free".

3. How to take Ambroxol Aldo-Unión

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in 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).

Solution for nebulization:

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

Children aged 2 to 5 years: 1 ml – 2 ml (half an ampoule – 1 ampoule), 1 or 2 times daily.

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

Oral solution:

Adults: 2 ml – 4 ml (1 – 2 ampoules), three times daily.

Children over 5 years: 1–2 ml (half an ampoule – 1 ampoule), 2 to 3 times daily.

Children aged 2 to 5 years: 1 ml (half an ampoule), 2 to 3 times daily.

Dilute the solution in a small amount of water, tea, milk, or fruit juice. The medicine should be taken with meals.

If using a half dose, reseal the single-dose ampoule by pressing the cap back on, and store it in the refrigerator (2–8 °C) for up to 12 hours.

If you take more Ambroxol Aldo-Unión than you should

The risk of experiencing adverse reactions increases. In case of accidental ingestion/overdose of Ambroxol Aldo-Unión, inform your doctor immediately or go to the nearest hospital.

If you forget to take Ambroxol Aldo-Unión

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

If you stop using Ambroxol Aldo-Unión

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Immediately stop administration of Ambroxol Aldo-Unión and consult a doctor if any of the following disorders occur: itching, skin rash (urticaria, rash) or swelling (angioedema) of the face, eyes, lips and/or throat with difficulty breathing due to allergy (hypersensitivity).

Other adverse effects:

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

• altered or reduced sense of 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.

Not known: (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.
• serious skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).
• airway obstruction (bronchi).
• dry throat.

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambroxol Aldo-Unión

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton, aluminium pouch, or ampoule, following "EXP". The expiry date refers to the last day of the month indicated.

After opening the aluminium pouch, the single-dose ampoules must be used within a maximum of three months, remaining stored inside the pouch.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Ambroxol Aldo-Unión

• The active substance is ambroxol.
• The other components are sodium chloride and water for injections.

Appearance of the medicine and contents of the pack

Ambroxol Aldo-Unión is supplied in single-dose polyethylene ampoules of 2 ml, grouped in strips of 5 ampoules, packed in an aluminium pouch.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Aldo-Unión, 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 most recent revision of this summary: July 2020

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