CINFAMUCOL ACETYLCYSTEINE FORTE 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Cinfamucol Acetylcysteine Forte 600 mg Effervescent Tablets

Acetylcysteine

Read this package 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, 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 Acetylcysteine Forte is and what it is used for
2. What you need to know before taking Cinfamucol Acetylcysteine Forte
3. How to take Cinfamucol Acetylcysteine Forte
4. Possible side effects
5. Storage of Cinfamucol Acetylcysteine Forte
6. Package Contents and Additional Information

1. What Cinfamucol Acetylcysteine Forte is and what it is used for

Acetylcysteine, the active ingredient of this medicine, belongs to a 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 reduce the viscosity of mucus and phlegm, making it easier to expel in colds and flu 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 Acetylcysteine Forte

Do not take Cinfamucol Acetylcysteine Forte

• If you are allergic to acetylcysteine or 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 Acetylcysteine 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 ingredient, but it does not indicate that the medicine is in poor condition.
• If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.
• During the first days of treatment, you may notice an increase in mucus and phlegm that will decrease throughout the treatment.

Children and Adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

Taking Cinfamucol Acetylcysteine Forte with Other Medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take 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 take concomitantly with antitussive medicines (for cough) or 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 the intake of acetylcysteine from the intake of these medicines by at least 2 hours. It is not recommended to dissolve Cinfamucol Acetylcysteine Forte with other medicines.

Taking Cinfamucol Acetylcysteine 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.

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 Acetylcysteine Forte contains Sodium

This medicine contains 194.04 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 9.7% of the maximum daily intake of sodium recommended for an adult.

3. How to Take Cinfamucol Acetylcysteine 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

1 effervescent tablet, 1 time a day. Do not exceed the dose of 1 effervescent tablet (600 mg) per day.

How to Take

Cinfamucol Acetylcysteine Forte is taken orally.

The effervescent tablets should be dissolved in a glass of water, do not drink until the effervescence has completely stopped. 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.

Use in Children and Adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

If you Take More Cinfamucol Acetylcysteine Forte than you Should

If you take more Cinfamucol Acetylcysteine Forte than you should, you may notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other side 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 everybody 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, 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 intake of another drug.

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 acetylcysteine should be stopped immediately and medical assistance should be sought.

Reporting of Side Effects

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

5. Storage of Cinfamucol Acetylcysteine Forte

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

Keep the tube perfectly closed to protect it from moisture.

Do not use this medicine after the expiration date that appears on the packaging 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 packaging and medicines that you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Cinfamucol Acetylcysteine Forte

• The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other components are: anhydrous citric acid (E-330), maltodextrin (derived from corn starch), sodium hydrogencarbonate, sodium saccharin (E-954), 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)) and leucine.

Appearance of the Product and Package Contents

Cinfamucol Acetylcysteine Forte is presented in the form of an effervescent tablet, white in color, cylindrical, flat, and in packages of 10 or 20 tablets.

They are presented in polypropylene tubes closed with a polyethylene plug filled with silica gel as a desiccant. Each package contains a tube with 10 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

or

E-Pharma Trento S.p.A.

Frazione Ravina, Via Provina, 2

38123 Trento (TN)-Italy

Date of the Last Revision of this Package Leaflet:January 2021

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/