ACETYLCYSTEINE FARMASIERRA 200 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Acetilcisteína Farmasierra 200 mg Granules for Oral Solution EFG

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

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

Contents of the Package Leaflet

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

1. What Acetilcisteína Farmasierra is and what it is used for

Acetilcisteína, the active substance of this medicine, belongs to a group of medicines called mucolytics and is used to thin out excessive and/or thick bronchial secretions.

This medicine 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 cystic fibrosis, and other related pathologies.

2. What you need to know before taking Acetilcisteína Farmasierra

Do not take Acetilcisteína Farmasierra

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take acetilcisteína.

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

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance, but it does not indicate that the medicine is in poor condition.

If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is recommended in 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 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 of age.

Other Medicines and Acetilcisteína Farmasierra

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

Do not take it concomitantly with antitussive medicines (for cough) or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of thinned mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics (such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate its intake from the intake of acetilcisteína by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medicines.

Taking Acetilcisteína Farmasierra with Food and Drinks

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Its intake should be avoided during breast-feeding.

Driving and Using Machines

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

Warning on Excipients

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

3. How to Take Acetilcisteína Farmasierra

Follow exactly the administration instructions of this medicine 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:

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

Pulmonary Complications of Cystic Fibrosis

The recommended dose is:

Adults, adolescents, and children over 7 years:

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

Acetilcisteína is taken orally.

The sachets are taken dissolved in a glass of water, mixing with a spoon. It is recommended to drink plenty of liquid throughout the day.

It is contraindicated in children under 2 years of age.

If You Take More Acetilcisteína Farmasierra Than You Should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

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

If You Forget to Take Acetilcisteína Farmasierra

Do not take a double dose to make up for the forgotten dose.

If You Stop Taking Acetilcisteína Farmasierra

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

Uncommon (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): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

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 concomitant intake of another drug.

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

If any skin or mucous membrane disorder occurs, the administration of acetilcisteína should be stopped immediately and medical assistance should be sought.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetilcisteína Farmasierra

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Acetilcisteína Farmasierra

The active substance is acetilcisteína. Each sachet contains 200 mg of acetilcisteína.

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

Appearance of the Product and Contents of the Pack

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

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmasierra Laboratorios S. L.

Carretera de Irún km 26,200

28709 – San Sebastián de los Reyes

Madrid

Spain

Phone: 916 570 659

Fax: 916 570 820

e-mail: [email protected]

Manufacturer

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200.

28709 – San Sebastián de los Reyes.

Madrid.

Spain

Date of the Last Revision of this Package Leaflet: April 2022

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