Patient Information Leaflet: Information for the Patient

Acetilcisteína Bexal 200 mg Oral Solution Powder EFG

Read this leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before starting to take Acetilcisteína Bexal

3. How to take Acetilcisteína Bexal

4. Possible side effects

5. Storage of Acetilcisteína Bexal

6. Contents of the pack and additional information

Acetilcisteína belongs to a group of medications called mucolitics, which act by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

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

Do not take Acetilcisteína Bexal

• ifyouareallergicto the active ingredient or to any of the other components of this medication (listed in section 6),
• do not administer to children under 2 years old.

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 smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is spoiled.

If you experience stomach discomfort while taking the medication, discontinue treatment and consult your doctor. Caution is recommended in patients with peptic ulcers or a history of peptic ulcers.

During the first days of treatment, you may observe an increasein mucus and phlegm, which will decrease over time.

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 old.

Taking Acetilcisteína Bexal with other medications

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

The concomitant treatment with nitroglycerin may cause headaches and hypotension should be controlled, which can be severe.

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

Do not administer concomitantly with cough medications or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidified mucus.

When taking a medication that contains minerals such as iron or calcium, or a medication withantibiotics (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate your intake of acetilcisteína by at least 2 hours.

Do not recommend dissolving 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 lactation

Ifyou are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

It should be avoided during lactation.

Driving and operating machinery

There is no evidence of effects on the ability to drive and operate machinery.

Acetilcisteína Bexal contains saccharose.

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication. It may cause tooth decay.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Your doctor will indicate the duration of treatment with acetilcisteína. Do not suspend the treatment beforehand, 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 tablet of Acetilcisteina Bexal 200 mg 3 times a day), without 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 moreAcetilcisteína Bexalthan you should

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

If you forgot to takeAcetilcisteína Bexal.

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as possible. However, if there is little time left for the next dose, wait until then to continue treatment.

If you interrupt the treatment withAcetilcisteína Bexal

Do not suspend the treatment beforehand, as you will not achieve the desired effect.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur:

Rare (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.

Uncommon (may affect up to1 in 1,000 patients): drowsiness, bronchospasm, respiratory difficulty, digestive discomfort.

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 simultaneous use of another medication.

Unknown frequency (cannot be estimated from available data): facial swelling.

In the event of any skin or mucous membrane alteration, discontinue acetilcysteine administration immediately and seek medical assistance.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Acetilcisteína Bexal

• The active ingredient is acetilcisteína. Each blister pack of 3 g contains 200 mg of acetilcisteína.
• The other components are: sacarosa, ácido ascórbico, sacarina, orange aroma.

Appearance of the product and contents of the packaging

Acetilcisteína Bexal is presented in the form of blister packs of triple-layered paper/aluminum/polyethylene that contain 200 mg of acetilcisteína. It is presented in containers that contain 30 blister packs.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Bexal Farmacéutica, s.a.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Germany

This leaflet was approved in February 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es