Label: Information for the User

Acetilcisteína Farmasierra 200 mg Powder for Oral Solution EFG

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, 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 label. 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 to 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 egg) 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 in patients with peptic ulcers or a history of peptic ulcers.

During the first days of treatment, you may observe an increase in mucus and phlegm that will decrease over the course of treatment.

It should be administered 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 produce headaches and hypotension should be controlled, which can be severe.

The concomitant administration with the antiepileptic carbamazepine may cause a decrease in 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 medications with 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.

It is not recommended to dissolve acetilcisteina with other medications.

Acetilcisteína Farmasierra with food and beverages

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

It should be avoided during lactation.

Driving and operating machinery

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

Warning about excipients

This medication contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

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, adolescents, and children over 7 years old:

200 mg of acetilcisteína (1 packet of acetilcisteína 200 mg, 3 times a day),every 8 hours. Do not exceed a dose of 3 packets (600 mg of acetilcisteína) per day.

Cystic Fibrosis Pulmonary Complications

The recommended dose is:

Adults, adolescents, and children over 7 years old:

200 to 400 mg of acetilcisteína every 8 hours (1 to 2 packets of acetilcisteína 200 mg, 3 times a day).

Acetilcisteína is taken orally.

The packets are taken dissolved in a glass of water, mixing with a spoon. It is recommended to drink an abundant amount of liquid during the day.

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 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 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 forget 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:

Rarely(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.

Uncommon(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 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.

No special storage conditions are required.

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. 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 package contains 200 mg of acetilcisteína.

The other components (excipients) are: mannitol, anhydrous colloidal silica, sodium saccharin, orange aroma, and β-carotene coloring.

Appearance of the product and contents of the packaging

Farmasierra Acetilcisteína 200 mg is presented in the form of paper and aluminum sachets with an internal polyethylene coating..

Each package contains 30 sachets of white, slightly orange-colored granules with a characteristic 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).