BROXIVAN 3 MG/ML ORAL SOLUTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Broxivan 3 mg/ml oral solution EFG

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 may 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 Broxivan is and what it is used for
2. What you need to know before taking Broxivan
3. How to take Broxivan
4. Possible side effects
5. How to store Broxivan
6. Contents of the pack and other information

1. What Broxivan is and what it is used for

Ambroxol, the active substance of this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medicine is indicated for the treatment of thick mucus in bronchial and lung diseases with viscous sputum, in adults and children from 2 years of age.

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

2. What you need to know before taking Broxivan

Do not take Broxivan

• If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

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

• if you have severe kidney or liver problems, this medicine should only be used after consulting a doctor;
• if you have a bronchial motor disorder (lung problems) together with a large production of secretions (risk of mucus plugging), you should not take this medicine;
• if you develop a skin rash (including lesions of mucous membranes such as mouth, throat, nose, eyes, genitals), stop using this medicine immediately and consult your doctor. There have been reports of serious skin reactions associated with ambroxol administration;
• if you suffer from histamine intolerance (allergy to foods rich in histamine). In this case, long-term treatment should be avoided, as the active substance of this medicine affects histamine metabolism and may cause symptoms of intolerance (such as headache, runny nose, itching);
• if you are prone to developing peptic ulcers, since mucolytics (such as this medicine) may impair the gastric mucosal barrier. In this case, you should not take this medicine.

Children

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

For children aged 2 to 4 years with persistent or recurrent cough, a doctor should be consulted before treatment.

Other medicines and Broxivan

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

There are no known interactions of ambroxol with other medicines.

While taking ambroxol, you should not use any medicine that suppresses the cough reflex (so-called antitussives). The cough reflex is important for coughing up liquefied mucus and thus clearing it from the lungs.

Taking Broxivan with food and beverages

This medicine may be taken with or without food.

Pregnancy, lactation, and fertility

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.

There is no evidence of adverse effects during pregnancy. However, you should not take ambroxol during the first three months of pregnancy.

Ambroxol hydrochloride is excreted in breast milk; therefore, this medicine is not recommended during breastfeeding.

Animal studies have shown no direct or indirect harmful effects on fertility.

Driving and Use of 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 medicinal product on the ability to drive and operate machinery.

Broxivan contains benzoic acid

This medicinal product contains 0.51 mg of benzoic acid in each ml.

Broxivan contains sodium

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

3. How to take Broxivan

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, please consult your doctor or pharmacist again.

Do not take this medicine for longer than 5 days (within 3 days in children under 6 years of age) without consulting your doctor.

Recommended dose

Use in adults

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

Use in children and adolescents

Adolescents over 12 years of age

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

Children aged 6 to 12 years

5 ml, 2–3 times a day (every 8–12 hours, as needed), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2–3 days, once the patient has improved, the dosing regimen may be reduced to 2 times a day every 12 hours.

Children aged 2 to 5 years

2.5 ml, 3 times a day (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2–3 days, once the patient has improved, the dosing regimen may be reduced to 2 times a day every 12 hours.

Broxivan can be taken with or without food.

To facilitate administration of the oral solution, the package contains a volumetric measuring device.

You should consult a doctor if your condition worsens or does not improve after 5 days (within 3 days in children under 6 years of age).

If you take more Broxivan than you should

No cases of ambroxol poisoning are known.

If you accidentally take more medication than recommended, ambroxol side effects may occur. Symptoms of overdose are consistent with the side effects of ambroxol when taken at recommended doses, and symptomatic treatment may be necessary.

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

If you forget to take Broxivan

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

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

4. Possible adverse effects

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

The following adverse effects may occur:

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

• disturbance in taste sensation,
• nausea,
• decreased sensitivity in the mouth and pharynx (the passages leading to the stomach and lungs)

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

• diarrhoea,
• vomiting, dyspepsia,
• dry mouth,
• abdominal pain

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

• allergic reactions,
• rash,
• urticaria,
• dry throat

Frequency not known (frequency cannot be estimated from available data):

• anaphylactic reactions including anaphylactic shock (potentially life-threatening allergic reactions),
• angioedema (rapid swelling of the skin, tissues beneath the skin, mucosa or submucosa),
• pruritus (itching of the skin),
• severe skin reactions (including erythema multiforme, Stevens-Johnson syndrome / toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http;//www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Broxivan

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

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the month indicated. After first opening the bottle, the medicine remains stable for 6 months.

This medicine does not require any special storage conditions.

Do not freeze.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point located at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Broxivan

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

Appearance of the product and contents of the package

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

Brown type III glass bottles with a filling volume of 100 ml, 125 ml, or 150 ml, closed with child-resistant, tamper-evident plastic caps. The bottles are packed in a cardboard box together with a plastic dosing cup.

The plastic dosing cups have capacities of 2.5 ml, 5 ml, and 10 ml.

Only certain package sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party:

Marketing Authorization Holder:

Medochemie Iberia S.A.

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

São Domingos de Benfica,

1500 662 Lisboa,

Portugal

Manufacturing Responsible Party:

Medochemie Limited

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Local representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last review of this leaflet: August 2021

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