APOXOL 3 mg/ml SYRUP

Introduction

Leaflet: information for the user

Apoxol 3 mg/ml syrup EFG

ambroxol hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days (3 days for children under 6 years).

Contents of the leaflet:

1. What Apoxol is and what it is used for
2. What you need to know before taking Apoxol
3. How to take Apoxol
4. Possible side effects
5. Storage of Apoxol
6. Package contents and additional information

1. What Apoxol is and what it is used for

Ambroxol, the active ingredient of this medication, belongs to a group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, in adults and children from 2 years old.

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

2. What you need to know before taking Apoxol

Do not take Apoxol

• If you are allergic to ambroxol hydrochloride or any of the other components of this medication (listed in section 6.1).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Apoxol.

If you have kidney or liver function problems, consult your doctor before using this medication.

There have been reports of severe skin reactions associated with the administration of ambroxol hydrochloride. If you experience a skin rash (including lesions of the mucous membranes, such as the mouth, throat, nose, eyes, and genitals), stop using Apoxol and consult your doctor immediately.

Children

Apoxol is contraindicated in children under 2 years of age.

In children from 2 to 6 years old, consult a doctor.

Other medications and Apoxol

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking Apoxol with food and drinks

Apoxol 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 harmful effects have been observed during pregnancy. However, the usual precautions regarding the use of medications during pregnancy should be followed. The use of Apoxol is not recommended, especially during the first trimester of pregnancy.

The active ingredient of this medication, ambroxol, may pass into breast milk, and although no harmful effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Studies in animals do not indicate direct or indirect harmful effects on fertility.

Apoxol contains benzoic acid (E-210)

This medication contains 2 mg of benzoic acid per ml.

Benzoic acid may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

Apoxol contains propylene glycol (E-1520)

This medication contains 30 mg of propylene glycol per ml.

If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Apoxol contains sorbitol (E-420)

This medication contains 450.1 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

Apoxol contains sodium

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

3. How to take Apoxol

Follow the administration instructions of Apoxol contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years:

Take 1 dose of 10 ml of Apoxol, 3 times a day (every 8 hours), which means a maximum daily dose of 90 mg of ambroxol hydrochloride.

After 2-3 days, once you start improving, you can reduce the dosage to 2 times a day, every 12 hours.

Use in children

Children from 6 to 12 years:

Take 1 dose of 5 ml of Apoxol, 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 you start improving, you can reduce the dosage to 2 times a day, every 12 hours.

Children from 2 to 5 years:

Take, under medical supervision, 1 dose of 2.5 ml of Apoxol, 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 you start improving, you can reduce the dosage to 2 times a day, every 12 hours.

Children under 2 years:

This medication is contraindicated in children under 2 years.

How to take Apoxol

This medication is for oral use only.

Measure the amount of medication to take with the administration device provided in the box (dosing cup).

It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.

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

If you take more Apoxol than you should

If you have taken more Apoxol than you should, you may notice nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth, or any other side effect described in section 4 "Possible side effects".

In case of overdose or accidental administration, consult the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount taken.

In case of massive accidental administration, symptomatic treatment is recommended.

4. Possible side effects

Like all medications, Apoxol can cause side effects, although not everyone experiences them.

The following side effects may occur:

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

Nausea, alteration of taste, sensation of numbness of the pharynx, sensation of numbness of the mouth.

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

Vomiting, diarrhea, indigestion, abdominal pain, dry mouth

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

Hypersensitivity reactions, exanthema, urticaria, dry throat

• Frequency not known (cannot be estimated from available data)

Anaphylactic reactions, such as anaphylactic shock, angioedema (rapidly progressing swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus.

Severe skin reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Apoxol

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30 °C.

Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Apoxol 3 mg/ml syrup

The active ingredient is ambroxol hydrochloride. Each ml of syrup contains 3 mg of ambroxol hydrochloride.

The other ingredients are: raspberry flavor, citric acid monohydrate, glycerol, hydroxyethylcellulose, benzoic acid, propylene glycol, sorbitol 70%, sodium saccharin, and purified water.

Appearance of the product and package contents

Apoxol syrup is a clear, colorless or slightly yellowish solution.

It is presented in a 200 ml package, packaged in a topaz-colored glass bottle with a white polyethylene screw cap and a safety closure, and a dosing cup.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Laboratórios Basi – Indústria Farmacêutica, S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16

3450-232 Mortágua

Portugal

Date of the last revision of this leaflet:April 2023

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