Acetylcysteine Farmasierra 200 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Farmasierra 200 mg effervescent granules for oral solution EFG

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

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

Leaflet contents

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

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

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

This medicine is indicated to facilitate the removal of excess mucus and phlegm in respiratory conditions associated with excessive or thick mucus secretion, such as acute and chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), emphysema, pulmonary complications of fibrosis, and other related conditions.

2. What you need to know before starting Acetylcysteine Farmasierra

Do not take Acetylcysteine Farmasierra

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take acetylcysteine.

If you have asthma or suffer from a serious respiratory disease, you must consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is spoiled.

If you experience stomach discomfort when taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is advised in patients with peptic ulcer or history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease as treatment continues.

Use with caution during long-term treatment in patients with histamine intolerance.

Children and adolescents

It is contraindicated in children under 2 years of age.

Other medicines and Acetylcysteine Farmasierra

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

Concomitant therapy with nitroglycerin may cause headache, and hypotension should be monitored, as it may be severe.

Concomitant administration with the antiepileptic carbamazepine may result in reduced efficacy of carbamazepine.

Do not take together with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may lead to accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics (such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), administration should be separated from that of acetylcysteine by at least 2 hours.

Dissolving acetylcysteine with other medicines is not recommended.

Taking Acetylcysteine Farmasierra with food and drinks

Taking food and drinks does not affect the effectiveness of this medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Its use should be avoided during breastfeeding.

Driving and using machines

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

Warning about excipients

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

3. How to take Acetylcysteine Farmasierra

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, adolescents and children over 7 years of age:

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

Pulmonary complications of cystic fibrosis

The recommended dose is:

Adults, adolescents and children over 7 years of age:

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

Acetylcysteine is taken orally.

The sachets should be dissolved in a glass of water and mixed with a spoon. It is recommended to drink plenty of fluids throughout the day.

It is contraindicated in children under 2 years of age.

If you take more Acetylcysteine Farmasierra than you should

If you take more acetylcysteine than you should, you may experience: nausea, vomiting, burning and stomach pain, diarrhoea, 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, telephone 915 620 420, indicating the medicine and the amount taken.

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

If you forget to take Acetylcysteine Farmasierra

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

If you stop taking Acetylcysteine Farmasierra

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, 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, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 people): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with the concomitant intake of another medicinal product.

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

If any changes occur in the skin or mucous membranes, administration of acetylcysteine must be stopped immediately and medical advice should be sought.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the package and other information

Composition of Acetylcysteine Farmasierra

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

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

Appearance of the medicinal product and contents of the pack

Acetylcysteine Farmasierra 200 mg is presented as paper and aluminium sachets with an inner polyethylene coating.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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]

Manufacturer

Farmasierra Manufacturing S. L.

Carretera de Irún km 26,200

28709 – San Sebastián de los Reyes

Madrid

Spain

Date of the most recent revision of this 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).