Acetylcysteine Alter 600 mg effervescent tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Alter 600 mg effervescent tablets 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. It could be harmful to them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Acetilcisteína Alter 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 thin excessive and/or thick bronchial secretions.

This medicine is indicated to help eliminate 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 disorders.

2. What you need to know before taking Acetilcisteína Alter

Do not take Acetilcisteína Alter

• If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Acetilcisteína Alter.

If you have asthma or suffer from a serious 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 and does not indicate that the medicine is in poor condition.

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

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

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

Children and adolescents

It is contraindicated in children under 2 years of age.

Taking Acetilcisteína Alter with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Concomitant therapy with nitroglycerin may cause headache, and the occurrence of hypotension—which can be severe—should be monitored.

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

Do not take together with antitussive medicines (for cough) or with medicines that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause 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), separate their administration from that of Acetilcisteína Alter by at least 2 hours.

It is not recommended to dissolve Acetilcisteína Alter together with other medicines.

Taking Acetilcisteína Alter with food and drink

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

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or plan 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 operate machinery.

Acetilcisteína Alter contains Sodium

This medicine contains 194 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 9.7% of the maximum daily intake of sodium recommended for an adult.

3. How to take Acetylcysteine Alter

Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The effervescent tablets must be dissolved in a glass of water and taken once completely dissolved. It is recommended to drink plenty of fluids throughout the day.

The recommended daily dose for adults and children over 7 years of age is 600 mg of acetylcysteine: 1 tablet of Acetylcysteine Alter 600 mg once daily (600 mg of acetylcysteine once daily), or 3 doses of 200 mg every 8 hours (for this latter option, other more suitable formulations are available), without exceeding the daily dose of 600 mg.

Use in children and adolescents

Children between 2 and 7 years of age

The 600 mg dose is not recommended.

Other more suitable formulations are available for this population.

It is contraindicated in children under 2 years of age.

If you take more Acetylcysteine Alter than you should

If you take more Acetylcysteine Alter than you should, you may experience: nausea, vomiting, burning 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 Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount taken.

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

4. Possible adverse effects

Like all medicines, Acetilcisteína Alter may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): 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 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): 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 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 through 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 Alter

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

This medicine does not require any special storage conditions.

Keep the tube tightly closed.

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Acetylcysteine Alter

The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.

The other components (excipients) are: anhydrous citric acid (E330), maltodextrin, sodium hydrogen carbonate, orange flavoring, leucine, and sodium saccharin.

Appearance of the product and contents of the pack

Acetylcysteine Alter is presented as effervescent tablets, flat and white in color, contained in a bottle. Each pack contains 20 effervescent tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Manufacturer

E-Pharma Trento S.p.A.

Frazione Ravina - Via Provina, 2

38123 Trento (Italy)

Date of the most recent review of this leaflet: December 2020

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