AMBROXOL 6 mg /Ml Oral Solution/Suspension

2. What you need to know before taking Ambroxol Cinfa

Do not take Ambroxol 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 problems related to kidney or liver function, consult your doctor before using this medicine.
• There have been reports of serious skin reactions associated with the administration of ambroxol hydrochloride. If you develop a skin rash (including lesions of the mucous membranes, such as 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 6 years, consult a doctor.

Other Medicines and Ambroxol Cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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. 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, and although no adverse effects are expected in the breastfed infant, its use should be avoided during breastfeeding.

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

Driving and Using Machines

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

Ambroxol Cinfa contains Sorbitol.This medicine contains 12.6 mg of sorbitol in each ml.

Ambroxol Cinfa contains Benzoic Acid.This medicine contains 0.2 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).

3. How to take Ambroxol Cinfa

Follow exactly the administration instructions of 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:

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 starts to improve, 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 dose 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 dosage can be reduced to 2 times a day every 12 hours.

Children from 2 to 5 years: 1 dose 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 dosage can be reduced to 2 times a day every 12 hours.

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).

If you take more Ambroxol Cinfa than you should

If you have taken more ambroxol than you should, you may notice nausea, alteration of the sense 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 the sense 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 swelling of the skin, subcutaneous tissues, mucous membranes, or submucosal tissues), and pruritus. Serious skin 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 and Healthcare Products Agency: 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.

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 after 12 months from the date of opening the packaging.

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

6. Contents of the pack and further 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-crystallizing 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 pack

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

The medicine is available in:

• Brown glass bottle with a metal cap containing 125 ml or 200 ml of syrup.

• Brown polyethylene terephthalate bottle with a polypropylene cap containing 125 ml or 200 ml of syrup.

Each pack is provided with a measuring cup with a graduation ranging from 2.5 ml to 15 ml, as well as a measuring syringe with a graduation ranging from 0.25 ml to 5 ml.

Only some 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 last revision of this package leaflet: November 2021

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