ACETYLCYSTEINE ALTER 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Acetylcysteine Alter 600 mg Effervescent Tablets EFG

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

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

Contents of the Package 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. Storage of Acetylcysteine Alter
6. Package Contents and Additional Information

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

Acetylcysteine, the active ingredient in this medication, belongs to a group of medications called mucolytics, and is used to thin out 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 secretions, 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 taking Acetylcysteine Alter

Do not take Acetylcysteine Alter

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

Warnings and Precautions

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

If you have asthma or a severe respiratory disease, you should consult your doctor before taking this medication.

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

If you experience stomach discomfort when taking the medication, 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 few days of treatment, you may notice an increase in mucus and phlegm, which 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.

Taking Acetylcysteine Alter with Other Medications

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

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

Concomitant administration with the antiepileptic carbamazepine may cause a decrease in the efficacy of carbamazepine.

Do not take concomitantly with antitussive medications (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 medication that contains minerals such as iron or calcium, or any medication with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of Acetylcysteine Alter by at least 2 hours.

It is not recommended to dissolve Acetylcysteine Alter with other medications.

Taking Acetylcysteine Alter with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

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

Its use should be avoided during breastfeeding.

Driving and Using Machines

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

Acetylcysteine Alter contains Sodium

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

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3. How to Take Acetylcysteine Alter

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

The effervescent tablets should be dissolved in a glass of water and ingested when they have dissolved completely. It is recommended to drink plenty of liquid 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 a day (600 mg of acetylcysteine once a day), or 3 doses of 200 mg every 8 hours (for this last option, there are other more suitable formulations) without exceeding the daily dose of 600 mg.

Use in Children and Adolescents

Children between 2 and 7 years

The 600 mg dose is not recommended

There are other formulations more suitable for administering to 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 notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other side 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: 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.

4. Possible Side Effects

Like all medications, Acetylcysteine Alter can cause side effects, although not everyone will experience them.

The following side effects may occur:

Uncommon (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.

Rare (may affect up to 1 in 1,000 patients): somnolence, bronchospasm, respiratory distress, gastrointestinal disorders.

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 concomitant use of another medication.

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

If you experience any skin or mucous membrane changes, you should immediately stop taking acetylcysteine and seek medical attention.

Reporting Side Effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetylcysteine Alter

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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Acetylcysteine Alter

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

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

Appearance of the Product and Package Contents

Acetylcysteine Alter is presented in a tube with effervescent tablets, flat and white in color. Each package 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 Last Revision of this Package Leaflet: December 2020

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