CINFAMUCOL CARBOCISTEINE 50 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

cinfamucol carbocisteine 50 mg/ml oral solution

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Contents of the Package Leaflet

1. What cinfamucol carbocisteine is and what it is used for.
2. What you need to know before taking cinfamucol carbocisteine.
3. How to take cinfamucol carbocisteine.
4. Possible side effects.
5. Storage of cinfamucol carbocisteine.
6. Package contents and additional information.

1. What cinfamucol carbocisteine is and what it is used for

Carbocisteine, the active ingredient of this medication, belongs to the group of medications called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid 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 from 12 years old.

You should consult your doctor if your condition worsens or does not improve after 5 days of treatment.

2. What you need to know before taking cinfamucol carbocisteine

Do not take cinfamucol carbocisteine

• If you are allergic to carbocisteine or 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 carbocisteine.

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

During the first few days of treatment, you may notice an increase in mucus and phlegm that will decrease throughout the treatment.

Children

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

Other medications and cinfamucol carbocisteine

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

Do not take this medication with medications used to reduce non-productive cough (antitussives) or with medications used to decrease bronchial secretions, as it may cause an accumulation of fluidified mucus.

Taking cinfamucol carbocisteine with food and beverages

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

Pregnancy and Breastfeeding

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

It is not recommended to take this medication during pregnancy or breastfeeding.

Driving and Using Machines

The influence of carbocisteine on the ability to drive and use machines is nil or insignificant.

cinfamucol carbocisteine contains orange yellow (E-110)

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

cinfamucol carbocisteine contains methyl and propyl parahydroxybenzoate

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (sodium salt) (E-219) and propyl parahydroxybenzoate (sodium salt) (E-217).

cinfamucol carbocisteine contains sodium

This medication contains 136.65 mg of sodium (main component of table salt/cooking salt) per dose (15 ml). This is equivalent to 6.8% of the maximum recommended daily sodium intake for an adult.

cinfamucol carbocisteine contains maltitol

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

cinfamucol carbocisteine contains propylene glycol

This medication contains 90 mg of propylene glycol per dose (15 ml).

3. How to take cinfamucol carbocisteine

Follow the administration instructions for the medication 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 and adolescents from 12 years old: 15 ml of oral solution 3 times a day, which means a maximum daily dose of 45 ml of the 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 contained in the package. It is preferable to take the medication before meals.

It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.

If your condition worsens, or if symptoms persist after 5 days of treatment, or if you develop a fever, skin rash, persistent headache, or sore throat, 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 carbocisteinethan you should, you may notice stomach pain, nausea, and diarrhea, itching, and skin rash.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take cinfamucol carbocisteine

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

During the use of carbocisteine, the following side effects have been observed, whose frequency cannot be established with precision.

Rarely, nausea, gastric discomfort, or diarrhea may appear, which usually disappear when the dose is reduced.

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

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

Reporting Side Effects

If you experience any type of 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of cinfamucol carbocisteine

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

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of cinfamucol carbocisteine

• Each ml 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 (flavoring preparations, flavoring substances, natural flavoring substances, corn maltodextrin, gum arabic (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)), propyl parahydroxybenzoate (sodium salt) (E-217), orange yellow (E-110), and purified water.

Appearance of the Product and Package Contents

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 measures from 1 to 15 ml.

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