BROXIVAN 6 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Broxivan 6 mg/ml Oral Solution EFG

Ambroxol Hydrochloride

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Broxivan and what is it used for

Ambroxol, the active substance of this medicine, belongs to a group of medicines called mucolytics, which act by reducing the viscosity of mucus, making it more fluid and easier to eliminate.

This medicine is indicated for the treatment of dissolution of mucus in diseases of the bronchi and lungs with thick mucus, in adults.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before you take Broxivan

Do not take Broxivan

• If you are allergic to ambroxol hydrochloride or 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 taking this medicine.

• If you have severe kidney or liver problems, this medicine should only be used after consulting a doctor.
• If you have a disorder of bronchial motor activity (lung problems) along with a large production of secretions (risk of a mucous plug), you should not take this medicine;
• If you experience a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals), stop using this medicine and consult your doctor immediately. There have been reports of serious skin reactions associated with the administration of ambroxol.
• If you have histamine intolerance (allergy to foods rich in histamine). In this case, you should avoid long-term treatment, as the active substance of this medicine influences histamine metabolism and may cause intolerance symptoms (such as headache, nasal discharge, itching).
• If you are prone to developing peptic ulcers, as mucolytics (such as this medicine) may alter the gastric mucosa barrier. In this case, you should not take this medicine.

Children

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

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

Other Medicines and Broxivan

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

No interactions of ambroxol with other medicines are known.

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

Taking Broxivan with Food and Drinks

This medicine can be taken with or without food.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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, so this medicine is not recommended during breast-feeding.

Animal studies do not indicate direct or indirect harmful effects with respect to fertility.

Driving and Using Machines

No studies on the effects of ambroxol on the ability to drive and use machines have been performed. However, there is no evidence of any effect of this medicine on the ability to drive and use machines.

Broxivan contains Benzoic Acid

This medicine contains 0.51 mg of benzoic acid in each ml.

Broxivan contains Sodium

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

3. How to Take Broxivan

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Do not take this medicine for more than 5 days without consulting your doctor.

Recommended Dose

Use in Adults

10 ml, 2 times a day (every 12 hours), which means a maximum daily dose of 120 mg of ambroxol hydrochloride.

Once the patient starts improving, the dose can be reduced to half.

Use in Children and Adolescents.

Broxivan 3 mg/ml Oral Solution EFG is available for children and adolescents.

Broxivan can be taken with or without food.

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

You should consult a doctor if it worsens or does not improve after 5 days.

If you Take More Broxivan than you Should

No cases of overdose with ambroxol are known.

If you accidentally take more medicine than recommended, ambroxol side effects may occur. The symptoms of overdose are consistent with the side effects of ambroxol when taken in 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 medicine and the amount taken.

If you Forget to Take Broxivan

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

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

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

• alteration of taste,
• nausea,
• decreased sensitivity in the mouth and pharynx (the passages that lead to the stomach and lungs)

Uncommon(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,
• dry throat

Frequency Not Known(frequency cannot be estimated from the available data)

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at http://www.notificaram.es. By reporting side effects, 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 which is stated on the label after EXP. The expiry date refers to the last day of the month shown. After opening the bottle for the first time, the medicine remains stable for 6 months.

This medicine does not require any special storage conditions.

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Broxivan

• The active substance is ambroxol hydrochloride. Each ml of oral solution contains 6 mg of ambroxol hydrochloride.
• The other ingredients are: sucralose, benzoic acid, hydroxyethylcellulose 10900-20300 mPA.s, disodium edetate, cherry flavor powder, vanilla flavor powder, hydrochloric acid, sodium hydroxide, purified water.

Appearance and Pack Size

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

Brown glass type III bottles of 200 ml fill volume, closed with tamper-evident caps. The bottles are packed in a cardboard box with a plastic measuring cup.

The capacity of the plastic measuring cups is 10 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medochemie Iberia S.A.

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

São Domingos de Benfica,

1500 662 Lisboa,

Portugal

Manufacturer

Medochemie Limited

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

You can obtain further information on this medicine from the representative of the Marketing Authorization Holder:

Local Representative:

Medochemie Iberia S.A., Branch in Spain

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

28044 Madrid

Spain

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

Date of Last Revision of this Package Leaflet: August 2021

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