ACETYLCYSTEINE BEXAL 200 MG POWDER FOR ORAL SOLUTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylcysteine Bexal 200 mg powder for oral solution EFG

Read this entire 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 or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Acetylcysteine Bexal is and what it is used for
2. What you need to know before taking Acetylcysteine Bexal
3. How to take Acetylcysteine Bexal
4. Possible adverse effects
5. How to store Acetylcysteine Bexal
6. Contents of the pack and other information

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

Acetylcysteine belongs to a group of medicines called mucolytics, which work by reducing the viscosity of mucus, making it thinner and easier to expel.

This medicine is indicated to help eliminate excess mucus and phlegm in bronchitis, pulmonary complications of cystic fibrosis, and other related conditions, in children between 2 and 12 years of age.

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 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 have asthma or suffer from a serious respiratory disease, you must consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort after 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 days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease during the course of treatment.

It should be administered with caution during long-term treatment in patients with histamine intolerance.

Paediatric population

It is contraindicated in children under 2 years of age.

Taking Acetilcisteína Bexal with other medicines

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

Concomitant treatment with nitroglycerin may cause headache, and the occurrence of hypotension—which may be severe—should be monitored.

Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in carbamazepine efficacy.

Do not administer simultaneously with antitussive medicines (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause accumulation of liquefied mucus.

When taking medicines containing minerals such as iron or calcium, or medicines with antibiotics such as (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), administration should be separated by at least 2 hours from the administration of acetylcysteine.

It is not recommended to dissolve acetylcysteine together with other medicines.

Taking Acetilcisteína Bexal with food and drink

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

Pregnancy and breastfeeding

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

Its use should be avoided during breastfeeding.

Driving and use of machines

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

Acetylcysteine Bexal contains sucrose.

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.

3. How to take Acetylcysteine Bexal

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The dose of acetylcysteine should be taken directly dissolved in a glass of water.

Your doctor will determine the duration of treatment with acetylcysteine. Do not stop treatment prematurely, as doing so may prevent achieving the desired effect.

Adults and children over 7 years of age: The recommended daily dose is 200 mg of acetylcysteine, three times a day (1 sachet of Acetylcysteine Bexal 200 mg three times daily), without exceeding the daily dose of 600 mg.

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

In cases of pulmonary complications of cystic fibrosis, the recommended average dose of acetylcysteine is as follows:

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

If you take more Acetylcysteine Bexal than you should

If you have taken more Acetylcysteine Bexal than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Acetylcysteine Bexal

Do not take a double dose to make up for missed doses. Take the missed dose as soon as possible. However, if it is almost time for your next dose, wait until then and continue your regular dosing schedule.

If you stop taking Acetylcysteine Bexal

Do not stop treatment prematurely, as you will not achieve the intended effect.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, 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, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with at least the concomitant use of another medicinal product.

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

If any changes in the skin or mucous membranes occur, acetylcysteine administration must be stopped immediately and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Bexal

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylcysteine Bexal

• The active substance is acetylcysteine. Each 3 g sachet contains 200 mg of acetylcysteine.
• The other components are: sucrose, ascorbic acid, saccharin, orange flavour.

Nature of the product and pack size

Acetylcysteine Bexal is presented as sachets made of triple-layer paper/aluminium/polyethylene film, each containing 200 mg of acetylcysteine. It is available in packs containing 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

or

Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana 1526
Slovenia

This leaflet was approved in February 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es