CINFAMUCOL CARBOCYSTEINE 50 MG/ML ORAL SOLUTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfamucol carbocysteine 50 mg/ml oral solution

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

Follow exactly the instructions for administration 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Leaflet contents

1. What cinfamucol carbocysteine is and what it is used for.
2. What you need to know before taking cinfamucol carbocysteine.
3. How to take cinfamucol carbocysteine.
4. Possible adverse effects.
5. How to store cinfamucol carbocysteine.
6. Contents of the pack and other information.

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

Carbocisteine, the active substance of this medicine, belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it less thick and facilitating its elimination.

This medicine is indicated to help remove excess mucus and phlegm in colds and flu in adults and adolescents aged 12 years and older.

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 starting to take cinfamucol carbocisteine

Do not take cinfamucol carbocisteine

• If you are allergic to carbocisteine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take cinfamucol carbocisteine.

• If you have a stomach or duodenal ulcer, or if you have any thyroid disease.
• If you suffer from asthma or any other serious respiratory disease, as airway obstruction may increase.

During the first few days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.

Children

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

Other medicines and cinfamucol carbocisteine

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

Do not take this medicine with medications used to suppress non-productive cough (antitussives) or with medications that reduce bronchial secretions, as this may cause accumulation of liquefied mucus.

Taking cinfamucol carbocisteine with food and drinks

Take this medicine 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 are planning 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 effect of carbocisteine on the ability to drive and use machines is none or negligible.

cinfamucol carbocisteine contains sunset yellow (E-110)

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

cinfamucol carbocisteine contains methyl and propyl parahydroxybenzoate

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

cinfamucol carbocisteine contains sodium

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

cinfamucol carbocisteine contains maltitol

This medicine contains maltitol (E-965). If your doctor has diagnosed you with intolerance to certain sugars, consult him before taking this medicine.

cinfamucol carbocisteine contains propylene glycol

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

3. How to take cinfamucol carbocisteine

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 12 years and older: 15 ml of oral solution three times daily, corresponding to a maximum daily dose of 45 ml of oral solution (2.25 g of carbocisteine).

Do not exceed 2.25 g per day, divided into 3 doses. Once improvement is observed, the dose may be reduced to 1.5 g over 24 hours, divided into 2 doses of carbocisteine.

How to take

This medicine is taken orally.

Measure the amount of medicine to be taken using the dosing cup provided in the package. It is preferable to take the medicine before meals.

It is recommended to drink a glass of water after each dose and to maintain adequate fluid intake throughout the day.

If your condition worsens, or if symptoms persist beyond 5 days of treatment, or if you develop fever, skin rash, persistent headache, or sore throat, you should consult your doctor.

Use in children

This medicine must not be used in children under 12 years of age.

If you take more cinfamucol carbocisteine than you should

If you have taken more cinfamucol carbocisteine than recommended, you may experience stomach pain, nausea, diarrhea, itching, or skin rashes.

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

If you forget to take cinfamucol carbocisteine

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the period of use of carbocysteine, the frequency of which cannot be precisely determined.

Nausea, gastric discomfort or diarrhoea may occasionally occur, which usually disappear when the dose is reduced.

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

In such cases, it is advisable to discontinue treatment and consult your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of cinfamucol carbocisteine

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry 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. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamucol carbocisteine

• Each ml of solution contains 50 mg of carbocisteine as the active substance.

• The other components (excipients) are: liquid maltitol (E-965), sodium hydroxide (E-524), sodium citrate (E-331), propylene glycol (E-1520), hydroxyethylcellulose, monohydrate citric acid, methylparaben (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)), propylparaben (sodium salt) (E-217), orange yellow (E-110) and purified water.

Appearance of the product and contents of the pack

It is presented as an oral solution in glass bottles. Each pack contains 200 ml of oral solution and a dosing cup with markings 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 most recent revision of this leaflet: November 2021

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