Leaflet: information for the user

cinfamucol carbocisteine 750 mg oral solution in sachets

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 of treatment

The active ingredient, carbocisteína, belongs to a group of medications called mucolítics, 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 adolescents aged 12 years and above.

Consult your doctor if symptoms worsen or do not improve after 5 days of treatment.

Do not take cinfamucol carbocisteína

If you are allergic to carbocisteine and its derivatives, or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamucol carbocisteína.

• If you have a stomach ulcer, duodenum, or any thyroid disease
• If you have asthma or any severe respiratory disease, as it may increase airway obstruction.

You may observe an increase in mucus and phlegm during the first days of treatment, which will decrease over time.

Children

Do not administer this medication to children under 12 years old.

Other medications and cinfamucol carbocisteína

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

Do not take this medication with cough suppressants or medications used to reduce bronchial secretions, as it may cause a buildup of fluidified mucus.

Taking cinfamucol carbocisteína with food and drinks

Take this medication preferably before meals. See section 3. How to take cinfamucol carbocisteína.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended for pregnant women or breastfeeding women.

Driving and operating machines

The influence ofcinfamucol carbocisteínaon the ability to drive and operate machines is negligible or insignificant.

cinfamucol carbocisteína contains yellow orange (E-110). This medication may cause allergic reactions because it contains yellow orange (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

cinfamucol carbocisteína contains parahydroxybenzoate of methyl (E-219) and propyl (E-217).This medication may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl (sodium salt) (E-219) and propyl (sodium salt) (E-217).

cinfamucol carbocisteína contains sodium.This medication contains 136.65 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 6.8% of the maximum daily sodium intake recommended for an adult.

cinfamucol carbocisteína contains maltitol.This medication contains maltitol (E-965).If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

cinfamucol carbocisteína contains propylene glycol.This medication contains 90 mg of propylene glycol in each sachet.

Follow exactly the medication administration instructions 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 and adolescents 12 years and older : 1 sachet every 8 hours. Do not take more than 3 sachets per day, divided into 3 doses. Once you notice improvement, you can reduce to 2 sachets in 24 hours, divided into 2 doses. The dose is up to 10 ml of oral solution (500 mg of carbocisteine) 3 times a day, which means a maximum daily dose of 30 ml of oral solution (1.5 g of carbocisteine).

How to take

This medication is taken orally.

Open the sachet and pour the contents directly into the mouth. It is recommended to drink a glass of water after each dose and a large amount of liquid throughout the day.

If it worsens, or if symptoms persist after 5 days of treatment, or if you experience: fever, skin rash, persistent headache or sore throat, you must consult your doctor.

Use in children

Children under 12 years old cannot take this medication.

If you take more cinfamucol carbocisteine than you should

If you have taken more cinfamucol carbocisteine than you should, you may experience stomach pain, nausea, and diarrhea, itching and skin rash.

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.

If you forgot to take cinfamucol carbocisteine

Do not take a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

During the period of use of carbocisteine, the following adverse effects have been observed, whose frequency has not been established with precision.

Nausea, gastric discomfort, or diarrhea may appear in rare cases, which usually disappear when the dose is reduced.

Rarely, other reactions such as stomach or intestinal bleeding, headache, itching, skin eruptions, and angioedema (swelling of certain skin areas) have been observed.

In these cases, it is recommended to interrupt treatment and consult a doctor.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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 store at a temperature above 30°C.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREpoint of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of cinfamucol carbocisteine

• Each sachet contains 750 mg of carbocisteine as the active ingredient.

• The other components (excipients) are: liquid maltitol (E-965), sodium hydroxide (E-524), sodium citrate (E-331), propylene glycol (E-1520), hydroxyethylcellulose, citric acid monohydrate, methyl parahydroxybenzoate (sodium salt) (E-219), sodium saccharin, orange flavor (flavor preparations, flavoring substances, natural flavoring substances, cornstarch, gum arabic (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)), propyl parahydroxybenzoate (sodium salt) (E-217), yellow-orange (E-110), and purified water.

Appearance of the product and contents of the packaging

cinfamucol carbocisteine is a transparent oral solution with an orange odor. Each package contains 12 sachets.

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:October 2021

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