Package Insert: Information for the User

Acetilcisteína Farmasierra 600 mg Effervescent Powder EFG

Read this package insert carefully before taking this medication, as it contains important information for you.

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

Acetilcisteína, the active ingredient of this medication, belongs to a group of medications called mucolitics and is used to liquefy excessive and/or thick bronchial secretions.

This medication is indicated to facilitate the elimination of excess mucus and phlegm in respiratory processes that involve excessive or thick mucous secretion, such as: acute and chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), emphysema, pulmonary complications of fibrosis, and other related pathologies.

Do not take Acetilcisteína Farmasierra

• If you are allergic to acetilcisteína or any of the other components of this medication (listed in section 6).
• In children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetilcisteína.

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, 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 that will decrease over time.

Administer with caution in long-term treatment in patients with histamine intolerance.

Children and adolescents

It is contraindicated in children under 2 years old.

Other medications and Acetilcisteína Farmasierra

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 those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics (such as amfotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), separate your acetilcisteína intake from the medication intake by at least 2 hours.

Do not dissolve acetilcisteína with other medications.

Acetilcisteína Farmasierra with food and beverages

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

Pregnancy, breastfeeding, and fertility

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

Avoid taking this medication during breastfeeding.

Driving and operating machinery:

No evidence of effects on the ability to drive and operate machinery.

Warning about excipients

This medicationcontains156mg of sodiumper tablet,equivalentto7.8% of the maximum daily intake of2 g ofsodium recommended by the WHOfor an adult.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended daily dose for adults and children over 7 years old is 600 mg of acetilcisteína, 1 tablet of Acetilcisteína Farmasierra 600 mg once a day (600 mg of acetilcisteína once a day).

The 600 mg dose can be administered in three 200 mg doses, using acetilcisteína 200 mg.

To administer, reconstitute the effervescent powder in water to obtain a pleasant-tasting solution that is drunk directly from the glass.

Use in children and adolescents

Children between 2 and 7 years old

The 600 mg dose is not recommended.

There are other formulations more suitable for administration to this population.

It is contraindicated in children under 2 years old.

If you take more Acetilcisteína Farmasierra than you should

If you take more acetilcisteína than you should, you may experience: 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 or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount taken.

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

If you forgot to take Acetilcisteína Farmasierra

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Acetilcisteína Farmasierra

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 everyone will experience them.

The following adverse effects may occur:

Infrequent(may affect up to 1 in 100 people): 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 people): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

Very Rare(may affect up to 1 in 10,000 people): 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 the event of any skin or mucous membrane alteration, 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 an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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.

Do not store at a temperature above 30° C.

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.

Medicines 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 of the pharmacy. 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 Farmasierra Acetilcisteína

The active ingredient is acetilcisteína. Each sachet contains 600 mg of acetilcisteína.

The other components (excipients) are: mannitol, anhydrous colloidal silica, sodium saccharin, orange aroma, citric acid, sodium bicarbonate, and maltodextrin.

Appearance of the product and contents of the packaging

Farmasierra 600 mg Acetilcisteína is presented in the form of paper and aluminum sachets with an internal polyethylene coating..

Each package contains 20 white effervescent powder sachets with a slight sulfurous odor.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization

Farmasierra Laboratorios S. L.

Carretera de Irún km 26,200

28709 – San Sebastián de los Reyes

Madrid

Spain

Tel.: 916 570 659

Fax: 916 570 820

e-mail: [email protected]

Responsible manufacturer

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200.

28709 – San Sebastián de los Reyes.

Madrid.

Spain

Last review date of this leaflet: April 2022

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