ACETYLCYSTEINE CINFA 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetylcysteine Cinfa 600 mg Effervescent Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Acetylcysteine Cinfa is and what it is used for
2. What you need to know before taking Acetylcysteine Cinfa
3. How to take Acetylcysteine Cinfa
4. Possible side effects
5. Storage of Acetylcysteine Cinfa
6. Contents of the pack and further information

1. What Acetylcysteine Cinfa is and what it is used for

Acetylcysteine, the active ingredient of this medication, belongs to a group of medications called mucolytics, which work by reducing the viscosity of mucus, making it more fluid and easier to eliminate.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in colds and flu, for adults.

You should consult a doctor if your symptoms worsen or do not improve after 5 days.

2. What you need to know before taking Acetylcysteine Cinfa

Do not takeAcetylcysteine Cinfa:

• If you are allergic to acetylcysteine or any of the other components of this medication (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 Acetylcysteine Cinfa:

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

The possible sulfur-like odor (like rotten eggs) of the medication is characteristic of the active ingredient, but it does not indicate that the medication is spoiled.

If you experience stomach discomfort when taking the medication, stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or a history of peptic ulcer.

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

Children and Adolescents

Children and adolescents should not take this medication. There are other formulations more suitable for this population.

Other Medications and Acetylcysteine Cinfa

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

Concomitant therapy with nitroglycerin may cause headaches and hypotension should be monitored, as it can be severe.

Concomitant administration with the antiepileptic carbamazepine may decrease the efficacy of carbamazepine.

Do not take concomitantly with antitussive medications (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 medication containing minerals such as iron or calcium, or any medication with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate the intake of Acetylcysteine Cinfa by at least 2 hours. It is not recommended to dissolve Acetylcysteine Cinfa with other medications.

TakingAcetylcysteine Cinfawith Food and Drinks

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

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.

Its use should be avoided during breastfeeding.

Driving and Using Machines

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

Acetylcysteine Cinfa contains Sodium

This medication contains 193.9 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 9.7% of the maximum recommended daily intake of sodium for an adult.

The possible slight sulfur-like odor of the medication is characteristic of the active ingredient, but it does not indicate that the medication is spoiled.

3. How to take Acetylcysteine Cinfa

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: 1 effervescent tablet, 1 time a day. Do not exceed the dose of 1 effervescent tablet per day.

How to take:

Acetylcysteine is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has stopped completely. It is recommended to drink plenty of liquid during the day.

You should consult a doctor if your symptoms worsen or do not improve after 5 days of treatment.

Use in Children and Adolescents

Children and adolescents should not take this medication. There are other formulations more suitable for this population.

If you take moreAcetylcysteine Cinfathan you should

If you take more Acetylcysteine than you should, you may notice: nausea, vomiting, heartburn, 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 medication and the amount ingested.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication 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, 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 medication.

Frequency not known(cannot be estimated from the available data): facial swelling.

If you experience any skin or mucous membrane disorders, you should stop taking Acetylcysteine immediately and seek medical attention.

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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Acetylcysteine Cinfa

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

Store in the original packaging. Do not store above 30°C.

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

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition ofAcetylcysteine Cinfa

• The active ingredient is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

• The other ingredients are: anhydrous citric acid (E-330), maltodextrin (from corn starch), sodium bicarbonate, L-leucine, sodium saccharin (E-954), and 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)).

Appearance of the product and pack contents

Acetylcysteine Cinfa is presented as effervescent tablets, white, cylindrical, and flat.

It is presented in polypropylene tubes closed with a polyethylene plug filled with silica gel as a desiccant. Each pack contains a tube with 20 effervescent tablets.

Alternatively, the tablets are packaged in 20 sealed triple-layer laminated paper/aluminum/polyethylene sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

E-Pharma Trento S.p.A.

Frazione Ravina, Via Provina, 2

38123 Trento (TN) - Italy

Date of the last revision of this package leaflet:February 2021

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

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67763/P_67763.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67763/P_67763.html