Leaflet: information for the user

Ambroxol cinfa 3 mg/ml syrup EFG

Ambroxol Hydrochloride

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

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

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improveafter 5 days.

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 indicatedto facilitate the elimination of excess mucus and phlegm, in colds and flu, for children aged 2 to 12 years.

Consult a doctor if it worsens or does not improve after 5 days.

Do not takeambroxol cinfa

• 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 starting to take ambroxol.

• If you have kidney or liver function problems, consult your doctor before using this medicine.
• 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 ambroxol and consult your doctor immediately.

Children

-Ambroxol is contraindicated in children under 2 years of age.

• In children aged 2 to 5 years, consult a doctor.

Othermedicinesandambroxol cinfa

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

Taking ambroxol cinfa with food and drinks

Ambroxol can be taken with or without food.

Pregnancy, breastfeeding 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.

No adverse effects have been observed during pregnancy. However, the usual precautions regarding the use of medicines during pregnancy should be followed. Ambroxol is not recommended, especially in the first trimester of pregnancy.

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

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

Driving and operating machinery

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

Ambroxol cinfa contains sorbitol (E-420).

This medicine contains 450.1 mg of sorbitol in each ml.

Ambroxol cinfa contains benzoic acid (E-210).

This medicine contains 2 mg of benzoic acid in each ml.

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

Ambroxol cinfa contains propylene glycol (E-1520).

This medicine contains 30.030 mg of propylene glycol in each ml.

If the baby is under 4 weeks of age, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

Ambroxol cinfa contains sodium.

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

Ambroxol cinfa contains glucose.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause tooth decay.

Ambroxol cinfa contains benzyl alcohol (E-1519).

This medicine contains 0.023 mg of benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding.

This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor recommends it. This medicine should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist advises it.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Use in children

Children aged 6 to 12 years:1 measure of 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 dosing regimen can be reduced to 2 times a day every 12 hours.

Children aged 2 to 5 years:1 measure of 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 dosing regimen can be reduced to 2 times a day every 12 hours. In this population, consult a doctor.

Children under 2 years:This medication is contraindicated in children under 2 years.

How to take:

This medication is taken orally. Measure the amount of medication to be taken with the measuring device included in the box. It is recommended to drink a glass of water after each dose and abundant liquid throughout the day.

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 ambroxol cinfa than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

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): nausea, alteration of taste, sensation of numbness in the throat, and sensation of numbness in the mouth.

Less frequent(may affect up to 1 in 100 people): vomiting, diarrhea, indigestion, abdominal pain, and dry mouth.

Rare(may affect up to 1 in 1,000 people): hypersensitivity reactions, rash, urticaria, and dry throat.

Unknown frequency(cannot be estimated from available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapid progression of skin, subcutaneous tissues, mucous membranes, or submucosal tissues swelling), 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: 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 store at a temperature above 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of ambroxol cinfa

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

• The other components are: raspberry aroma (contains glucose syrup, propylene glycol (E-1520) and benzyl alcohol (E-1519)), citric acid monohydrate, glycerol (E-422), hydroxyethylcellulose, benzoic acid (E-210), propylene glycol (E-1520), non-crystallizable liquid sorbitol (E-420), sodium saccharin and purified water.

Appearance of the product and contents of the packaging

Ambroxol cinfa is a syrup that appears as a transparent, colorless or slightly yellowish solution.

The medicine is presented in:

• Topaz type III glass bottle with a cylindrical aluminum cap.

• Topaz polyethylene terephthalate bottle with a polypropylene stopper, accompanied by a dosing cup adapted to the aforementioned bottle.

Each package contains a 200 ml bottle of syrup and is provided with a dosing cup with a graduation that ranges from 2.5 ml to 15 ml.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet: April 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63626/P_63626.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63626/P_63626.html