Prospect: information for the user

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

Ambroxol hydrochloride

Read this prospect thoroughly before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isAmbroxol Aldo-Uniónand for what it is used

2. What you need to know before starting to takeAmbroxol Aldo-Unión

3. How to takeAmbroxol Aldo-Unión

4. Possible adverse effects

5. Storage of Ambroxol Aldo-Unión

6. Contents of the package and additional information

Ambroxol Aldo-Unión 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-Unión is indicated for symptomatic treatment in acute and chronic bronchopulmonary processes that are characterized by an excess in mucus production and viscosity, for adults and children aged 2 years and above.

Do not take Ambroxol Aldo-Unión:

• if you are allergic to ambroxolorany of the other ingredients 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 starting to takeAmbroxol Aldo-Unión:

- if you have stomach injuries (peptic ulcer).

- if you have a mild or moderate renal function disorder.

- if you have severe liver problems.

- during the first 3 months of pregnancy or if you are breastfeeding a baby.

NOTE:

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

If a skin rash (including mucosal lesions in the mouth, throat, nose, eyes, or genitals) appears, stop takingAmbroxol Aldo-Uniónand consult a doctor immediately.

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

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

Children

Ambroxol Aldo-Uniónshould not be administeredto children under 2 years of age, as mucolytics may cause respiratory tract obstructions (bronchi).

Use of Ambroxol Aldo-Unión with other medications

Inform your doctor or pharmacist if you are taking,have taken recentlyor may need to takeany other medication.

Before takingAmbroxol Aldo-Unión, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

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

Driving and operating machines

Ambroxol Aldo-Unióndoes not affect the ability to drive and operate machines.

Ambroxol Aldo-Unión containssodium

This medication contains lessthan 23 mg (1 mmol) per ampoule, making itessentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

For inhalation by nebulizer:

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

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

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

For oral use:

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

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

Children 2 to 5 years: 1 ml (half ampule), 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 using half dose, close the single-dose ampule by pressing on the cap and store it in the refrigerator (2-8 °C) for a maximum of 12 hours.

If you take more Ambroxol Aldo-Unión than you should

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

If you forget to takeAmbroxol Aldo-Unión

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Ambroxol Aldo-Unión

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

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

Stop taking Ambroxol Aldo-Unión immediately and consult a doctor if any of the following conditions appear: itching, skin rashes (urticaria, skin eruption), facial, eye, lip, and/or throat swelling with difficulty breathing due to allergy (hypersensitivity).

Other adverse effects:

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

• Alteration or decrease in sense of taste (dysgeusia).
• Decreased sensitivity (hypoesthesia) in the mouth or pharynx (oral cavity).
• Nausea.

Infrequent(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(cannot be estimated from available data):

• Anaphylactic reactions, such as anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissue, 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).
• Obstruction of respiratory passages (bronchi).
• Throat dryness.

Reporting Adverse Effects

If you experienceany type of adverse effect, consultyour doctor or pharmacist, even if it is a possible adverse effectthat does notappear in this prospectus.You can also report them directly to theSpanish 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.

Do not use this medicationafter the expiration date that appears on the box, aluminum foil, or ampuleafter “CAD”.The expiration date is the last day of the month indicated.

Once the aluminum foil is opened, single-dose ampules must be used within a maximum period of three months while being kept inside the foil.

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

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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAmbroxol Aldo-Unión

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

Appearance of the product and content of the container

Ambroxol Aldo-Uniónis presented in single-dose polyethylene vials of low density of 2 ml grouped in strips of 5 vials packaged in an aluminum sachet.

It is presented in containers of 15 or 30 vials of 2 ml.

Only some of the container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Responsible for manufacturing

GENETIC S.p.A.

Contrada Canfora

Fisciano (SA)

(Italy)

Last review date of this leaflet:July 2020

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