Package Insert: Information for the User

Cinfamucol Acetylcysteine Forte 600 mg Effervescent Tablets

Acetylcysteine

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

Follow exactly the administration instructions for the medicine contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 5 days.

Acetilcisteína, the active ingredient of this medication, 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 reduce the viscosity of mucus and phlegm, facilitating its expulsion in coughs and flu in adults.

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

Do not take cinfamucol acetilcisteína forte

• If you are allergic to acetilcisteína or 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 cinfamucol acetilcisteína forte.

• 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 spoiled.
• If you experience stomach discomfort while taking the medication, you should 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.

Taking cinfamucol acetilcisteína forte with other medications

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

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

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

Do not take concurrently with cough medications or 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 acetilcisteína intake from the intake of these medications by at least 2 hours. Do not dissolve cinfamucol acetilcisteína forte with other medications.

Taking cinfamucol acetilcisteína forte with 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.

Cinfamucol acetilcisteína forte contains sodium.

This medication contains 194.04 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.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults

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

How to take

Cinfamucol acetilcisteína forte is taken orally.

The effervescent tablets must be dissolved 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 cinfamucol acetilcisteína forte than you should

If you take more cinfamucol acetilcisteína forte 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 medication may produce adverse effects, although not all people may 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, sometimes 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.

Keep the tube perfectly closed to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfamucol acetilcisteína forte

• 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 hydrogen carbonate, sodium saccharin (E-954), orange flavor (flavor preparations, flavoring substances, natural flavoring substances, cornstarch maltodextrin, gum arabic (E-414), ascorbic acid (E-300), and butylated hydroxyanisole (BHA) (E-320)). and leucine.

Appearance of the product and content of the packaging

Cinfamucol acetilcisteína forte is presented in the form of an effervescent tablet, white in color, cylindrical, flat, and in packaging of 10 or 20 tablets.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - España

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - España

or

E-Pharma Trento S.p.A.

Frazione Ravina, Via Provina, 2

38123 Trento (TN)-Italia

Last review date of this prospectus: January 2021

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/