Leaflet: information for the user

Ambroxol Cinfa 6 mg/ml syrup

Ambroxol hydrochloride

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

Follow exactly the administration instructions for 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 you get worse or do not improve after 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 indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults and children aged 2 years and above.

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

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

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 6 years, consult a doctor.

Other medicines and Ambroxol Cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need 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 plan 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 on the ability to drive and use 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).

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:

Adults: 10 ml, 2 times a day (every 12 hours), which means a maximum daily dose of 120 mg of ambroxol hydrochloride. Once the patient improves, the dose can be reduced to half.

Adolescents over 12 years:5 ml to 7.5 ml, as needed (30 mg to 45 mg of ambroxol hydrochloride), 2 times a day (every 12 hours), which means a maximum daily dose of 60 to 90 mg of ambroxol hydrochloride.

Use in children

Children from 6 to 12 years: 1 measure of 2.5 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 from 2 to 5 years: 1 measure of 1.25 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.

How to take

This medication is taken orally. Measure the amount of medication to take with the device included in the box. It is recommended to drink a glass of water after each dose and plenty of liquid during 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 Ambroxol Cinfa than you should

If you have taken more ambroxol than you should, you may experience 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 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 everyone will 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.

Infrequent(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.

This medication does not require special storage conditions.

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.

Do not use this medication after twelve months of the packaging opening date.

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

Composition ofAmbroxol Cinfa

• The active ingredient 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 flavor, strawberry flavor (propylene glycol (E-1520)), anhydrous citric acid (E-330), and purified water.

Appearance of the product and contents of the packaging

Ambroxol Cinfa is a syrup that is presented as a transparent solution.

The medicine is presented in:

-Topaz glass bottle with a metal cap containing 125 ml or 200 ml of syrup.

-Topaz polyethylene terephthalate bottle with a polypropylene cap containing 125 ml or 200 ml of syrup.

Each package is provided with a dosing cup with a graduation ranging from 2.5 ml to 15 ml as well as a dosing syringe with a graduation ranging from 0.25 ml to 5 ml.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: November 2021

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/