Package Leaflet: Information for the User

Broxivan 3 mg/ml Oral Solution EFG

Ambroxol hydrochloride

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

The ambroxol, 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 for the treatment of mucus dissolution in diseases of the bronchi and lungs with thick mucus, in adults and children aged 2 years and older.

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

Do not take Broxivan

• If you are allergic to ambroxol hydrochloride or any of the other components of this medication (listed in section 6).
• Children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• If you have severe kidney or liver problems, this medication should only be used after consulting with a doctor.
• If you have a motor activity disorder of the bronchi (problems with the lungs) along with a large production of secretions (risk of mucous plug), do not take this medication;
• If a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals) appears, stop using this medication and consult your doctor immediately. There have been reports of severe skin reactions associated with the administration of ambroxol.
• If you have histamine intolerance (allergy to histamine-rich foods). In that case, you should avoid long-term treatment, as the active ingredient of this medication affects histamine metabolism and can cause intolerance symptoms (such as headache, nasal secretion, itching).
• If you have a predisposition to developing peptic ulcers, as mucolytics (such as this medication) can alter the gastric mucosa barrier. In this case, do not take this medication.

Children

Do not give this medication to children under 2 years of age.

In children aged 2 to 4 years with persistent or recurrent cough, consult a doctor before treatment.

Other medications and Broxivan

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

No interactions of ambroxol with other medications are known.

While taking ambroxol, do not use any medication that suppresses the cough reflex (so-called antitussives). The cough reflex is important for coughing up mucus and thus eliminating it from the lungs.

Broxivan with food and drinks

This medication 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 medication.

No evidence of side effects during pregnancy. However, do not take ambroxol during the first three months of pregnancy.

Ambroxol hydrochloride is excreted in breast milk, so this medication is not recommended during breastfeeding.

Animal studies do not indicate direct or indirect harmful effects on fertility.

Driving and operating machinery

No studies have been conducted on the effects of ambroxol on the ability to drive and operate machinery. However, there is no evidence of any effect of this medication on the ability to drive and operate machinery.

Broxivan contains benzoic acid

This medication contains 0.51 mg of benzoic acid per ml.

Broxivan contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per ml, i.e., it is essentially "sodium-free".

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

Do not take this medication for more than 5 days (within 3 days in children under 6 years old) without consulting your doctor.

Recommended dose

Use in adults

10 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 90 mg of ambroxol hydrochloride.

Use in children and adolescents

Adolescents over 12 years old

10 ml, 3 times a day (every 8 hours), which means a maximum daily dose of 90 mg of ambroxol hydrochloride.

Children 6 to 12 years old

5 ml, 2-3 times a day, (every 8-12 hours, as needed), which means a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2-3 days, once the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours.

Children 2 to 5 years old

2.5 ml, 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 the patient improves, the dosage regimen can be reduced to 2 times a day every 12 hours.

Broxivan can be taken with or without food.

To facilitate the administration of the oral solution, the container includes a volume measuring device.

You should consult a doctor if you worsen or do not improve after 5 days (within 3 days in children under 6 years old).

If you take more Broxivan than you should

No cases of intoxication with ambroxol have been reported.

If you accidentally take more medication than recommended, you may experience ambroxol side effects. The symptoms of overdose are consistent with the side effects of ambroxol when taken at the recommended doses and may require symptomatic treatment.

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.

If you forgot to take Broxivan

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

If you have more questions about the use of this medication, consult your doctor or pharmacist.

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

The following adverse effects may occur:

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

• Alteration of taste,
• Nausea,
• Decreased sensitivity in the mouth and pharynx (the passages leading to the stomach and lungs)

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

• Diarrhea,
• Vomiting, dyspepsia,
• Dry mouth,
• Abdominal pain

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

• Allergic reactions,
• Exanthema,
• Urticaria,
• Throat dryness

Unknown Frequency(the frequency cannot be estimated from available data)

• Anaphylactic reactions including anaphylactic shock (potentially fatal allergic reactions),
• Angioedema (rapid swelling of the skin, subcutaneous tissues, mucosa, or submucosa),
• Pruritus (itching in the skin),
• Severe skin reactions (including 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: http;//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 medication after the expiration date that appears on the label after CAD. The expiration date is the last day of the month indicated. After opening the bottle for the first time, the medication remains stable for 6 months.

This medication does not require special storage conditions.

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Broxivan

• The active ingredient is ambroxol hydrochloride.Each ml of oral solution contains 3 mg of hydrochloride of ambroxol.
• The other components are: sucralose, benzoic acid, hydroxyethylcellulose 10900-20300 mPA.s, disodium edetate, cherry powder flavor, dry vanilla powder flavor, concentrated hydrochloric acid, sodium hydroxide, purified water.

Appearance of the product and contents of the package

Colorless to slightly yellowish, transparent liquid, with vanilla and cherry flavor.

Brown type III glass bottles of 100 ml, 125 ml, or 150 ml filling volume, closed with child-resistant plastic stoppers that are also tamper-evident. The bottles are packaged in a cardboard box along with a plastic dosing cup.

The capacity of the plastic dosing cups is 2.5 ml, 5 ml, and 10 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Medochemie Iberia S.A.

Rua Jose Maria Nicolau, n.o 6, 7.oB,

São Domingos de Benfica,

1500 662 Lisboa,

Portugal

Responsible for manufacturing

Medochemie Limited

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Local representative:

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Last review date of this prospectus: August 2021

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/