CINFAMUCOL CARBOCISTEINE 750 MG ORAL SOLUTION IN SACHETS

Introduction

Package Leaflet: Information for the User

cinfamucol carbocisteína 750 mg oral solution in sachets

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

Follow the administration instructions of the medicine 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 carbocisteína is and what it is used for.
2. What you need to know before taking cinfamucol carbocisteína.
3. How to take cinfamucol carbocisteína.
4. Possible side effects.
5. Storage of cinfamucol carbocisteína.
6. Contents of the pack and further information.

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

Carbocisteína, the active ingredient of this medicine, belongs to the group of medicines called mucolytics, which act by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu for adults and adolescents from 12 years of age.

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 carbocisteína

Do not take cinfamucol carbocisteína

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

Warnings and precautions

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

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

During the first days of treatment, you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.

Children

Do not administer this medicine to children under 12 years of age.

Other medicines and cinfamucol carbocisteína

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

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

Taking cinfamucol carbocisteína with food and drinks

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

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 medicine.

This medicine is not recommended for pregnant or breastfeeding women.

Driving and using machines

The influence of cinfamucol carbocisteínaon the ability to drive and use machines is nil or insignificant.

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

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

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

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

cinfamucol carbocisteína contains propylene glycol. This medicine contains 90 mg of propylene glycol per sachet.

3. How to take cinfamucol carbocisteína

Follow 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 and adolescents from 12 years of age: 1 sachet every 8 hours. Do not take more than 3 sachets per day, divided into 3 doses. Once you observe 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 carbocisteína) 3 times a day, which means a maximum daily dose of 30 ml of oral solution (1.5 g of carbocisteína).

How to take

This medicine 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 your condition worsens, or if symptoms persist after 5 daysof treatment, or if you experience: fever, skin rash, persistent headache, or sore throat, you should consult your doctor.

Use in children

Children under 12 years of age cannot take this medicine.

If you take more cinfamucol carbocisteína than you should

If you have taken more cinfamucol carbocisteína than 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 immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take cinfamucol carbocisteína

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Rarely, nausea, stomach 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 of 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 Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of cinfamucol carbocisteína

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of cinfamucol carbocisteína

• Each sachet contains 750 mg of carbocisteína 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 contents of the pack

cinfamucol carbocisteína is a clear oral solution with an orange flavor. Each pack contains 12 sachets.

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:October 2021

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