Apoxol 3 mg/ml jarabe efg

Package Insert: Information for the User

Apoxol 3 mg/ml Syrup EFG

Ambroxol hydrochloride

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• For advice on any matter relating to this medicine or if you have any further questions on the use of this product, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they do not appear in this package insert.See section 4.
• You must consult a doctor if your symptoms worsen or do not improve after 5 days (3 days for children under 6 years).

Ambroxol, the 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 to facilitate the elimination of excess mucus and phlegm, in colds and flu, in adults and children aged 2 years and above.

Consult a doctor if symptoms worsen or do not improve after 5 days (3 days in children under 6 years).

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 problems related to kidney or liver function, consult your doctor before using this medication.

Severe skin reactions have been reported associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including mucosal lesions, for example, in 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 aged 2 to 6 years, consult a doctor.

Other medications and Apoxol

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

Apoxol with food and drinks

Apoxol can be taken with or without meals.

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 adverse 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 in the first trimester of pregnancy.

The active ingredient of this medication, ambroxol, may pass into breast milk, and although adverse effects are not expected in the infant, its use should be avoided during breastfeeding.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been observed.

Animal studies 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 of age).

Apoxol contains propylene glycol (E-1520)

This medication contains 30 mg of propylene glycol per ml.

If the baby is under 4 weeks of age, consult your doctor or pharmacist, particularly 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 a fructose intolerance or hereditary fructose intolerance (HF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort 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".

Follow exactly the administration instructions for Apoxol contained in this leaflet or those indicated by your doctor or pharmacist. 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 dosing regimen 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 dosing regimen 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 dosing regimen 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 only to be taken orally.

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 abundant liquid throughout the day.

You should consult a doctor if you worsen or do 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 in the throat, sensation of numbness in the mouth, or any other adverse effect described in section 4 “Possible adverse effects”.

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

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

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

The following adverse effects may occur:

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

Nausea, altered sense of taste, sensation of tongue numbness, sensation of mouth numbness.

• Infrequent (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)

Allergic reactions, rash, urticaria, dry throat

• Unknown frequency (cannot be estimated from available data)

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

Severe cutaneous adverse reactions (such as 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 or pharmacist, 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: https://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 store at a temperature above 86°F (30°C).

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

Unused medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

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 components are: raspberry aroma, citric acid monohydrate, glycerol, hydroxyethylcellulose, benzoic acid, propylene glycol, 70% sorbitol, sodium saccharin, and purified water.

Appearance of the product and content of the packaging

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

It is presented in a 200 ml packaging conditioned in a glass bottle, topaz color, with a white polyethylene screw cap with a safety closure, and a dosing vial.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Laboratórios Basi – Indústria Farmacêutica, S.A.

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

3450-232 Mortágua

Portugal

Date of the last review of this leaflet:April 2023

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