Patient Information Leaflet: Package Leaflet

Acetilcisteína Bexal 600 mg Effervescent Tablets EFG

Read this leaflet carefully before you start to take 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

Acetilcisteína belongs to the group of medications known as mucolitics and is used to thin out excessive and/or thick bronchial secretions.

It is indicatedto 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.

Do not take Acetilcisteína Bexal

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

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 must consult with 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 in poor condition.

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 few days of treatment, you may observe an increase in 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.

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 combined treatment with nitroglycerin may cause headaches and hypotension, which can be severe.

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

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

When taking medications containing minerals such as iron or calcium, or antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate your intake of acetilcisteína by at least 2 hours.

Do not dissolve acetilcisteína with other medications.

Taking Acetilcisteína Bexal with food and beverages

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

Pregnancy and lactation

If you 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 lactose, sodium, and sorbitol

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

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

This medication contains 40 mg of sorbitol in each tablet.

Follow exactly the administration instructions for this medication as 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 a effervescent tablet in a glass of water and drinking the solution immediately.

Your doctor will indicate the duration of treatment with acetilcisteína. Do not discontinue treatment beforehand, as this will not achieve the desired effect.

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

If you take moreAcetilcisteína Bexalthan you should

If you have taken more Acetilcisteína Bexal than you should, consult your doctor, 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 treatment withAcetilcisteína Bexal

Do not discontinue treatment beforehand, as this will not achieve the desired effect.

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

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

The following adverse effects may occur:

Infrequent (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 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/EXP. The expiration date is the last day of the month indicated.

On a triple-layer paper/aluminum/polyethylene sheet:

Do not store at a temperature above 30°C.

On a polypropylene tube:

Do not store at a temperature above 30°C.

Keep the container perfectly closed to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers 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 effervescent tablet contains 600 mg of acetilcisteína.
• The other components are: ascorbic acid, anhydrous citric acid, anhydrous lactose, mannitol, anhydrous sodium carbonate, dihydrate sodium citrate, dihydrate sodium saccharin, sodium hydrogen carbonate, sodium cyclamate, raspberry flavor (vanillin, maltodextrin, mannitol, glucolactone, sorbitol, and anhydrous colloidal silica).

Appearance of the product and contents of the packaging

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

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

or

Hermes Pharma GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

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 for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es