ACETYLCYSTEINE BEXAL 200 mg ORAL SOLUTION POWDER

Introduction

Patient Information Leaflet

Acetilcisteína Bexal 200 mg powder for oral solution EFG

Read this leaflet carefully before starting to take this medicine, as 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 or pharmacist.
• This medicine 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 leaflet. See section 4.

Contents of the Leaflet

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

Acetilcisteína belongs to the group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it more fluid and easier to eliminate.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm in bronchitis, pulmonary complications of cystic fibrosis, and other related conditions, for children between 2 and 12 years old.

2. What you need to know before taking Acetilcisteína Bexal

Do not take Acetilcisteína Bexal

• if you are allergic to the active substance or 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

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 medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance, 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. Caution is recommended in patients with peptic ulcer or 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

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 administer concomitantly with antitussive medicines (for cough) or those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified 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 acetilcisteína from the intake of these medicines by at least 2 hours.

It is not recommended to dissolve acetilcisteína with other medicines.

Taking Acetilcisteína Bexal with food and drinks

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

Pregnancy and lactation

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.

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 saccharose.

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may cause cavities.

3. How to take Acetilcisteína Bexal

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

The corresponding dose of acetilcisteína is taken directly dissolved in a glass of water.

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 200 mg of acetilcisteína, 3 times a day (1 sachet of Acetilcisteina Bexal 200 mg 3 times a day), not exceeding the daily dose of 600 mg.

For children under 7 years, the recommended doses are lower and this presentation is not suitable, although this presentation can be used in cases of pulmonary complications of cystic fibrosis.

In cases of pulmonary complications of cystic fibrosis, the recommended average dose of acetilcisteína is as follows.

• Adults and children over 7 years: 200 to 400 mg of acetilcisteína every 8 hours.
• Children between 2 and 7 years: 200 mg of acetilcisteína every 8 hours.

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 medicine 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 stop taking 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 product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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, 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 available data): facial swelling.

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetilcisteína Bexal

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Acetilcisteína Bexal

• The active substance is acetilcisteína. Each 3g sachet contains 200mg of acetilcisteína.
• The other ingredients are: saccharose, ascorbic acid, saccharin, orange flavor.

Appearance and packaging of the product

Acetilcisteína Bexal is presented in triple-layer paper/aluminum/polyethylene sachets containing 200mg of acetilcisteína. It is presented in packs of 30 sachets.

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

This leaflet was approved in February 2020

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