Leaflet: information for the user

cinfamucol carbocisteine 50 mg/ml oral solution

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

Follow exactly the administration instructions of 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, belonging to the group of medications called mucolitics, acts by reducing the viscosity of mucus, fluidifying 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 12 years and older.

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 carbocisteína 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 ulcer, 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 few 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 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 if you 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 of carbocisteína on 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 and propyl

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 dose (15 ml). 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 dose (15 ml).

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 and adolescents 12 years and older : 15 ml of oral solution 3 times a day, which means a maximum daily dose of 45 ml of oral solution (2.25 g of carbocisteine).

Do not take more than 2.25 g per day, divided into 3 doses. Once you notice improvement, you can reduce to 1.5 g in 24 hours divided into 2 doses of carbocisteine).

How to take

This medication is taken orally.

Measure the amount of medication you need to take with the dosing cup provided in the package. It is recommended that the medication be taken before meals.

Drink a glass of water after each dose and plenty of liquid throughout the day.

If you worsen, or if symptoms persist after 5 days of treatment, or if fever, skin eruptions, persistent headache, or sore throat occur, you should 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 eruptions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, 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 exactness.

Nausea, stomach discomfort, or diarrhea may occasionally appear, 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 for Pharmacovigilance of Medicinal Products 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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfamucol carbocisteine

• Each milliliter of solution contains 50 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

It is presented in the form of an oral solution in glass bottles. Each package contains 200 ml of oral solution and a dosing cup with measurements of 1 to 15 ml.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, 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/