CINFAMUCOL ACETYLCYSTEINE FORTE 600 MG ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

cinfamucol acetilcisteína forte 600 mg powder for oral solution

acetilcisteína

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

Follow exactly 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

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

1. What cinfamucol acetilcisteína forte is and what it is used for

Acetilcisteína, the active principle of this medicine, belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, fluidifying it and facilitating its elimination.

This medicine is indicated to reduce the viscosity of mucus and phlegm, facilitating its expulsion, in catarrhal and flu-like processes, in adults.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking cinfamucol acetilcisteína forte

Do not take cinfamucol acetilcisteína forte

• If you are allergic to acetilcisteína and its derivatives, or to any of the other components of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take cinfamucol acetilcisteína forte.

If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active principle, but it does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine. In that case, you should stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

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

Children and Adolescents

People under 18 years of age cannot take this medicine. There are other more suitable presentations.

Other Medicines and Acetilcisteína Forte

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Concomitant therapy with nitroglycerin may produce headache and hypotension should be monitored, which can be severe.

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not administer concomitantly with antitussive medicines (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate its intake from the intake of cinfamucol acetilcisteína forte by at least 2 hours.

It is not recommended to dissolve cinfamucol acetilcisteína forte with other medicines.

Taking Cinfamucol Acetilcisteína Forte with Food and Drinks

The intake of food and drinks does not affect the efficacy of this medicine.

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.

As a precaution, it is preferable to avoid its use during pregnancy.

Its intake should be avoided during breastfeeding.

Driving and Using Machines

There is no evidence of effects on the ability to drive and use machines.

Cinfamucol Acetilcisteína Forte Contains Aspartame

This medicine contains 20.00 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Cinfamucol Acetilcisteína Forte Contains Yellow Orange S

This medicine may cause allergic reactions because it contains Yellow Orange S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to Take Cinfamucol Acetilcisteína Forte

Follow exactly 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 (from 18 years old)

Administer 1 sachet (600 mg of acetilcisteína). Do not exceed the dose of 1 sachet (600 mg) per day.

Use in Children and Adolescents

People under 18 years of age cannot take this medicine.

How to take

Cinfamucol acetilcisteína forte is taken orally.

Dissolve the contents of the sachet in a glass of water. It is recommended to drink plenty of liquid throughout the day.

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

If You Take More Cinfamucol Acetilcisteína Forte Than You Should

If you take more cinfamucol acetilcisteína forte than you should, you may notice nausea, vomiting, burning, and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible side effects.

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 have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

The following side effects may occur:

Uncommon (may affect up to 1 in 100 patients):hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 patients):somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

Very Rare (may affect up to 1 in 10,000 patients):allergic reactions, anaphylactic shock, hemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant use of another medicine.

Frequency Not Known (cannot be estimated from the available data):facial swelling.

In case of any alteration in the skin or mucous membranes, the administration of acetilcisteína should be interrupted immediately and medical assistance should be sought.

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 Health 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 Acetilcisteína Forte

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

Do not store above 30°C.

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

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

6. Package Contents and Additional Information

Composition of Cinfamucol Acetilcisteína Forte

• The active principle is acetilcisteína. Each sachet contains 600 mg of acetilcisteína.
• The other components are: aspartame (E-951), 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)), Yellow Orange S (E-110), mannitol (E-421), and anhydrous colloidal silica.

Appearance of the Product and Package Contents

Cinfamucol acetilcisteína forte is presented in the form of sachets with a homogeneous orange-colored and flavored powder.

Each package contains 10 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: December2020

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