ACETYLCYSTEINE ABEX 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetylcysteine Abex 600 mg Effervescent Tablets

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

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

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

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

Acetylcysteine belongs to a group of medicines called mucolytics, which act by decreasing the viscosity of mucus, facilitating its elimination from the respiratory tract.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults.

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Acetylcysteine Abex

Do not take Acetylcysteine Abex:

• If you are allergic to acetylcysteine or to any of the other components of this medicine (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 this medicine.

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 ingredient, but it 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 history of peptic ulcer.

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

Children and Adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

Taking Acetylcysteine Abex with other medicines

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

Concomitant therapy with nitroglycerin may produce headache and hypotension should be controlled, 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 medicines (for cough) or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidized 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 the intake of this medicine from the intake of that medicine by at least 2 hours.

It is not recommended to dissolve this medicine with other medicines.

Taking Acetylcysteine Abex with food and drinks

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

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 medicine.

It should not be taken during breastfeeding.

Driving and Using Machines

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

Acetylcysteine Abex contains sodium and sorbitol (E-420)

This medicine contains 356.8 mg of sodium (main component of table salt/cooking salt) per effervescent tablet. This is equivalent to 17.8% of the maximum recommended daily sodium intake for an adult.

This medicine contains 695 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to take Acetylcysteine Abex

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet, 1 time a day. Do not exceed the dose of 1 tablet per day.

How to take:

This medicine is taken orally.

Dissolve in a glass of water, do not drink until the effervescence has completely stopped. It is recommended to drink plenty of liquid throughout the day.

You should consult a doctor if it worsens or does not improve after 5 days of treatment.

Use in Children and Adolescents

Children and adolescents should not take this medicine. There are other presentations more suitable for this population.

If you take more Acetylcysteine Abex than you should

If you take more acetylcysteine 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 medicine and the amount taken.

If you have any other questions about 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 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 drug.

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

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

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Abex

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

Carton:

This medicine does not require special storage conditions. Keep in the original packaging to protect it from light.

Tube:

Do not store above 30°C. Keep in the original packaging to protect it from light.

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

6. Contents of the pack and further information

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

The other ingredients (excipients) are: Ascorbic acid, citric acid, sodium carbonate, sodium hydrogen carbonate, sorbitol (E-420), macrogol, sodium citrate, sodium saccharin, and lemon flavor.

Appearance of the product and packaging contents

The effervescent tablets are round, white, and approximately 25 mm in diameter.

Acetylcysteine Abex is packaged in:

• Polypropylene tubes with a polyethylene cap containing 20 effervescent tablets.
• Paper laminated sachets (paper/polyethylene/aluminum/ionomer) in a hermetically sealed strip in boxes of 20 effervescent tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer:

PharmaEstica Manufacturing OÜ

Vanapere tee 3, Pringi küla, Viimsi Vald,

74011 Harju Maakond,

Estonia

Date of the last revision of this package leaflet: 07/2024

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