ACETYLCYSTEINE BEXAL 600 mg EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetilcisteína Bexal 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 or pharmacist.
• 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Acetilcisteína belongs to the group of medications called mucolytics and is used to thin out excessive and/or thick bronchial secretions.

It 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.

2. What you need to know before taking Acetilcisteína Bexal

Do not take Acetilcisteína Bexal

• if you are allergic to the active substance or to 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 Acetilcisteína Bexal.

If you are asthmatic or have 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 substance, 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. 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.

Pediatric population

It is contraindicated in children under 2 years of age.

Taking Acetilcisteína Bexal with other medications

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

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

Concomitant administration with the antiepileptic carbamazepine may decrease 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 acetilcisteína from the intake of these medications by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medications.

Taking Acetilcisteína Bexal with food and drinks

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

Pregnancy and breastfeeding

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.

Acetilcisteína Bexal contains lactose, sodium, and sorbitol

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 138.07 mg of sodium (main component of table salt/cooking salt) per tablet. This is equivalent to 6.9% of the maximum recommended daily sodium intake for an adult.

This medication contains 40 mg of sorbitol per tablet.

3. How to take Acetilcisteína Bexal

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

The corresponding dose of acetilcisteína is taken directly by dissolving one effervescent tablet in a glass of water and drinking the solution immediately.

Your doctor will indicate the duration of treatment with acetilcisteína. Do not stop treatment before, as you will not achieve the desired effect.

Adults and children over 7 years: the recommended daily dose is 600 mg of acetilcisteína per day (1 tablet of Acetilcisteína Bexal per day).

If you take more Acetilcisteína Bexal than you should

If you have taken more Acetilcisteína Bexal than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to take Acetilcisteína Bexal

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible. However, if it is close to the time for the next dose, wait until then to continue treatment.

If you interrupt treatment with Acetilcisteína Bexal

Do not stop treatment before, as you will not achieve the expected effect.

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

4. Possible side effects

Like all medications, this medication 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 any skin or mucous membrane alterations occur, acetilcisteína administration should be discontinued immediately and medical assistance sought.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 Acetilcisteína Bexal

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

Do not use this medication after the expiration date stated on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

Triple-layer paper/aluminum/polyethylene pouch:

Do not store above 30°C.

Polypropylene tube:

Do not store above 30°C.

Keep the container tightly closed to protect it from moisture.

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. Contents of the pack and further information

Composition of Acetilcisteína Bexal

• The active substance is acetilcisteína. Each effervescent tablet contains 600 mg of acetilcisteína.
• The other components are: ascorbic acid, anhydrous citric acid, anhydrous lactose, mannitol, anhydrous sodium carbonate, sodium citrate dihydrate, sodium saccharin dihydrate, sodium hydrogen carbonate, sodium cyclamate, blackcurrant flavor (vanillin, maltodextrin, mannitol, glucolactone, sorbitol, and anhydrous colloidal silica).

Appearance of the product and contents of the pack

Acetilcisteína Bexal is presented in the form of round, white, flat, scored effervescent tablets containing 600 mg of acetilcisteína. It is available in polypropylene tubes containing 20 effervescent tablets. Alternatively, the effervescent tablets are packaged in triple-layer paper/aluminum/polyethylene pouches.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Bexal Farmacéutica, s.a.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

or

Hermes Pharma GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

This package leaflet was approved in February 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