Patient Information Leaflet: Information for the Patient

Acetylcysteine cinfa 600 mg Effervescent Tablets EFG

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

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

1. What is acetylcysteine cinfa and what is it used for

2. What you need to know before starting to take acetylcysteine cinfa

3. How to take acetylcysteine cinfa

4. Possible side effects

5. Storage of acetylcysteine cinfa

6. Contents of the pack and additional information

Acetilcisteína, the active ingredient of thismedication, belongs to a group of medications called mucolitics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

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

Consult a doctor if it worsens or does not improve after 5 days.

Do not takeacetilcisteína cinfa:

• If you are allergic to acetilcisteína or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetilcisteína cinfa:

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

The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is in poor condition.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor or pharmacist. Caution is recommended for patients with peptic ulcers or a history of peptic ulcers.

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

Children and adolescents

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

Other medications and acetilcisteína cinfa

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

The concomitant therapy with nitroglycerin may cause headaches and hypotension, which can be severe.

The concomitant administration with the antiepileptic carbamazepine may reduce the efficacy of carbamazepine.

Do not take concurrently with cough medications or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake of acetilcisteína by at least 2 hours. Do not dissolve acetilcisteína with other medications.

Takingacetilcisteína cinfawith food and beverages

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It is recommended to avoid taking this medication during breastfeeding.

Driving and operating machinery

There is no evidence of effects on the ability to drive and operate machinery.

acetilcisteína cinfa contains sodium

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

The possible presence of a slight sulfurous smell does not indicate alteration of the tablet, but is due to the active ingredient.

Follow exactly the administration instructions for 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 tablet, once a day. Do not exceed 1 tablet per day.

How to take:

Acetilcisteína is taken orally.

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

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

Use in children and adolescents

Children and adolescents cannot take this medication. There are other presentations more suitable for this population.

If you take more Acetilcisteína Cinfa than you should

If you take more Acetilcisteína than you should, you may notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

The following adverse effects may occur:

Rarely(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.

Uncommon(may affect up to 1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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, which may be identified with the simultaneous use of another medication.

Unknown Frequency(cannot be estimated from available data): facial swelling.

In case of any alteration in the skin or mucous membranes, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not usethis medicationafter 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 through drains or inthe trash.Depositthe packaging and medicines that you no longer need at the SIGREcollection point of the pharmacy. In case of doubt, please ask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of acetilcisteína cinfa

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

• The other components are: anhydrous citric acid (E-330), maltodextrin (derived from cornstarch), sodium bicarbonate, L-leucine, sodium saccharin (E-954) and orange flavoring (flavoring preparations, flavoring substances, natural flavoring substances, cornstarch maltodextrin, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)).

Appearance of the product and content of the packaging

acetilcisteína cinfa is presented in the form of effervescent tablets, white in color, cylindrical, flat.

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

L aboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

E-Pharma Trento S.p.A.

Frazione Ravina , Via Provina, 2

38123 Trento (TN) - Italy

Last review date of this leaflet: February 2021

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your 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