AMBROXOL CINFA 3 mg/ml SYRUP

Introduction

Package Leaflet: Information for the User

Ambroxol Cinfa 3 mg/ml Syrup EFG

Ambroxol Hydrochloride

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

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

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

1. What Ambroxol Cinfa is and what it is used for

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

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for children from 2 to 12 years old.

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

2. What you need to know before taking Ambroxol Cinfa

Do not takeAmbroxol Cinfa

• If you are allergic to ambroxol hydrochloride or to any of the other components 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.
• Reports of serious skin reactions associated with the administration of ambroxol hydrochloride have been received. If a skin rash appears (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 from 2 to 5 years old, consult a doctor.

OthermedicinesandAmbroxol Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

No harmful effects have been observed during pregnancy. However, the usual precautions related to the use of medicines during pregnancy should be followed. The use of ambroxol is not recommended, especially during the first trimester of pregnancy.

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

Studies in animals have not shown any direct or indirect harmful effects on fertility.

Driving and using machines

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

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 old).

Ambroxol Cinfa contains propylene glycol (E-1520).

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

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines that contain propylene glycol or alcohol.

Ambroxol Cinfa contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; i.e., 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 cavities.

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 the body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not administer this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it. This medicine should not be used for more than one week in children under 3 years old unless indicated by your doctor or pharmacist.

3. How to take Ambroxol Cinfa

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Use in children

Children from 6 to 12 years old: 1 dose 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 dosage can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years old: 1 dose 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 dosage can be reduced to 2 times a day every 12 hours. In this population, consult a doctor.

Children under 2 years old: This medicine is contraindicated in children under 2 years old.

How to take:

This medicine is taken orally. Measure the amount of medicine to be taken with the measuring device included in the box. 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 old).

If you take more Ambroxol Cinfa than you should

If you have taken more ambroxol 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 adverse effect described in section 4 Possible side effects.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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, and sensation of numbness of the mouth.

Uncommon(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, exanthema, urticaria, and dry throat.

Frequency not known(cannot be estimated from the available data): anaphylactic reactions such as anaphylactic shock, angioedema (rapidly progressing skin, subcutaneous tissue, mucous membrane, or submucosal tissue swelling), and pruritus. Serious cutaneous adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis, and acute generalized exanthematous pustulosis).

Reporting of side effects

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambroxol Cinfa

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Ambroxol Cinfa

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

• The other ingredients are: raspberry flavor (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-crystallizing liquid sorbitol (E-420), sodium saccharin, and purified water.

Appearance of the product and package contents

Ambroxol Cinfa is a syrup that appears as a clear, colorless, or slightly yellowish solution.

The medicine is presented in:

• A type III amber glass bottle with an aluminum cylindrical cap for closure.

• An amber polyethylene terephthalate bottle with a polypropylene cap, accompanied by a measuring cup adapted to the aforementioned bottle.

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

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet:April 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package leaflet and packaging with your mobile phone (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 at: https://cima.aemps.es/cima/dochtml/p/63626/P_63626.html