Leaflet: information for the user

Acetilcisteína Alter 600 mg effervescent tablets EFG

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

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

2. What you need to know before taking Acetilcisteína Alter

3. How to take Acetilcisteína Alter

4. Possible side effects

5. Storage of Acetilcisteína Alter

6. Contents of the pack and additional information

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 Alter

• If you are allergic to acetilcisteína, or to any of the other components of this medication (listed in section 6).
• Do not administer to children under 2 years.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetilcisteína Alter.

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 in poor condition.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor or pharmacist.

Precautions should be taken in patients with peptic ulcers or a history of peptic ulcers.

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

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.

Taking Acetilcisteína Alter with other medications

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

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

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 an accumulation of fluidified mucus.

When taking medications containing minerals such as iron or calcium, or antibiotics like amfotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake from Acetilcisteína Alter by at least 2 hours.

Do not dissolve Acetilcisteína Alter with other medications.

Taking Acetilcisteína Alter 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, or if you think you may be 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.

Acetilcisteína Alter contains Sodium

This medication contains 194 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 9.7% of the maximum daily sodium intake recommended for an adult.

.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The effervescent tablets must be dissolved in a glass of water, and must be ingested when they have completely dissolved. It is recommended to drink an abundant amount of liquid during the day.

The recommended daily dose for adults and children over 7 years old is 600 mg of acetilcisteína, 1 Acetilcisteina Alter 600 mg tablet once a day (600 mg of acetilcisteína once a day), or 3 doses of 200 mg every 8 hours (for the latter option, there are other formulations that are more suitable) without exceeding the daily dose of 600 mg.

Use in children and adolescents

Children between 2 and 7 years old

The 600 mg dose is not recommended.

There are other formulations that are more suitable for administering to this population.

It is contraindicated in children under 2 years old.

If you take more Acetilcisteína Alter than you should

If you take more Acetilcisteína Alter 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: 91.562.04.20, indicating the medication and the amount taken.

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

Like all medications, Acetilcisteína Alter may produce adverse effects, although not all people will experience them.

The following adverse effects may occur:

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

Very rare (may affect up to 1 in 10,000 patients): 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 acetilcisteína 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 to 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.

This medication does not require special storage conditions.

Keep the tube perfectly closed.

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 the packaging and the medication that you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medication that you no longer need. By doing so, you will help protect the environment.

Composition of Acetilcisteína Alter

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

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

Appearance of the product and content of the packaging

Acetilcisteína Alter is presented in a tube with effervescent tablets, flat and white in color. Each package contains 20 effervescent tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid (Spain)

Responsible for manufacturing

E-Pharma Trento S.p.A.

Frazione Ravina-Via Provina, 2

38123-Trento (Italy)

Date of the last review of this leaflet:December 2020

The detailed and updated information of this medicine is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.