Ambroxol Cinfa 6 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ambroxol Cinfa 6 mg/ml syrup

Ambroxol hydrochloride

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

Follow exactly the instructions for use provided in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Leaflet contents

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 adverse effects
5. How to store Ambroxol Cinfa
6. Contents of the pack and other information

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

Ambroxol, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medicine is indicated to help eliminate excess mucus and phlegm in colds and flu, for adults and children from 2 years of age.

You should consult a doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before starting to take Ambroxol Cinfa

Do not take Ambroxol Cinfa

• If you are allergic to ambroxol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking ambroxol.

• If you have problems related to kidney or liver function, consult your doctor before using this medicine.
• Serious skin reactions have been reported in association with ambroxol hydrochloride administration. If you develop a skin rash (including mucosal lesions, for example, in the mouth, throat, nose, eyes, and genital area), stop using ambroxol and consult your doctor immediately.

Children

• Ambroxol is contraindicated in children under 2 years of age.
• In children aged 2 to 6 years, consult your doctor.

Other medicines and Ambroxol Cinfa

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

Taking Ambroxol Cinfa with food and drinks

Ambroxol may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might 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, usual precautions regarding 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 substance of this medicine, ambroxol, may pass into breast milk. Although harmful effects in the breastfed infant are not expected, its use should be avoided during breastfeeding.

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

Driving and using machines

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

Ambroxol Cinfa contains sorbitol. This medicine contains 12.6 mg of sorbitol per ml.

Ambroxol Cinfa contains benzoic acid. This medicine contains 0.2 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).

3. How to take Ambroxol Cinfa

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 10 ml, twice daily (every 12 hours), corresponding to a maximum daily dose of 120 mg of ambroxol hydrochloride. Once the patient's condition improves, the dose may be reduced by half.

Adolescents over 12 years: 5 ml to 7.5 ml, as needed (30 mg to 45 mg of ambroxol hydrochloride), twice daily (every 12 hours), corresponding to a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.

Use in children

Children aged 6 to 12 years: 1 measure of 2.5 ml, 2–3 times daily (every 8–12 hours, as needed), corresponding to a maximum daily dose of 45 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosage regimen may be reduced to twice daily (every 12 hours).

Children aged 2 to 5 years: 1 measure of 1.25 ml, 3 times daily (every 8 hours), corresponding to a maximum daily dose of 22.5 mg of ambroxol hydrochloride. After 2–3 days, once the patient improves, the dosage regimen may be reduced to twice daily (every 12 hours).

How to take it

This medicine is taken orally. Measure the prescribed amount using the measuring device provided in the package. It is recommended to drink a glass of water after each dose and to maintain adequate fluid intake throughout the day.

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

If you take more Ambroxol Cinfa than you should

If you have taken more ambroxol than recommended, you may experience nausea, altered taste sensation, numbness of the pharynx, numbness of the mouth, or any other adverse effect listed in section 4, "Possible side effects."

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause 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 taste sensation, pharyngeal numbness, and oral numbness.

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

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

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

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ambroxol Cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

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.

Do not use this medicine more than twelve months after opening the container.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the Sigre Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ambroxol Cinfa

• The active substance is ambroxol hydrochloride. Each ml of syrup contains 6 mg of ambroxol hydrochloride.

• The other components (excipients) are: benzoic acid (E-210), hydroxyethylcellulose, sucralose (E-955), non-crystallizable liquid sorbitol (E-420), vanilla flavour, strawberry flavour (propylene glycol (E-1520)), anhydrous citric acid (E-330) and purified water.

Appearance of the product and contents of the pack

Ambroxol Cinfa is a syrup presented as a clear solution.

The medicine is available in:

• Amber glass bottle fitted with a metal cap, containing 125 ml or 200 ml of syrup.

• Amber polyethylene terephthalate (PET) bottle fitted with a polypropylene cap, containing 125 ml or 200 ml of syrup.

Each pack includes a dosing cup graduated from 2.5 ml to 15 ml and a dosing syringe graduated from 0.25 ml to 5 ml.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: November 2021

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