Package Insert: Information for the Patient

Acetilcisteína MABO 600 mg Effervescent Tablets, Orange Flavor

Acetilcisteína

Read this entire package insert carefully before starting to take this medication, as it contains important information for you

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

• You should consult a doctor if your condition worsens or does not improve after 5 days.

Acetilcisteína MABO is presented in the form of effervescent tablets, white in color, round, flat, and in containers of 10 or 20 tablets.

Acetilcisteína MABO belongs to the group of medications known as mucolytics.

It acts by reducing the viscosity of mucus, fluidifying it, and facilitating its elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating its expulsion in colds and flu in adults.

You should consult a doctor if it worsens or does not improve after 5 days of treatment..

Do not takeAcetilcisteína MABO:

• if you are allergic to acetylcysteine or any of the other components of this medication (listed in section 6).
• if you have a stomach or duodenal ulcer.
• if you have asthma or other severe respiratory insufficiency, as it may increase airway obstruction.

-Do not administer Acetilcisteína to children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Acetilcisteína MABO.

Severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, associated in time with the administration of acetylcysteine, have been rarely reported. If you experience skin or mucous membrane changes, seek medical advice quickly and discontinue acetylcisteína.

The presence of a slight sulfurous odor does not indicate alteration of the preparation, but is a characteristic of the active principle.

Children and adolescents

People under 18 years old cannot take this medication.

Acetilcisteína MABO with other medications

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

Do not take this medication if you are being treated with cough suppressants or medications that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluid 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, separate your Acetilcisteína intake from the medication intake by at least 2 hours.

Acetilcisteína MABO with food, drinks, and alcohol

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

This medication can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Consult your doctor or pharmacist before using a medication.

Although animal studies have not shown fetal damage, it is recommended to administer Acetilcisteína MABO under medical supervision during pregnancy.

Breastfeeding:

Consult your doctor or pharmacist before using a medication.

Since the passage of acetylcysteine to breast milk is unknown, it is recommended to administer Acetilcisteína MABO under medical supervision during breastfeeding.

Driving and operating machinery:

No effects have been described.

Acetilcisteína MABO contains sodium.

This medication contains 200 mg of sodium (main component of table salt/for cooking) in each tablet. This corresponds to 51.15% of the maximum daily sodium intake recommended for an adult.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults (18 years and older):

Take 1 tablet (600 mg of acetilcisteína). Do not exceed a dose of 1 tablet (600 mg) per day.

Use in children and adolescents:

People under 18 years old cannot take this medication.

Acetilcisteína MABOis taken orally. The effervescent tablets must be dissolved in a glass of water. Do not ingest until the bubbling has completely stopped.

It is recommended to drink an abundant amount of liquid during the day.

Do not administer Acetilcisteína MABO to children under two years old.

If you take more than the recommended amount of Acetilcisteína MABO:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Acetilcisteína MABO

Do not take a double dose to compensate for the missed doses. If you forget a dose, wait for the next one.

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

Immune System Disorders

Rare:allergic reactions, for example, itching, hives, urticaria, bronchospasm

Nervous System Disorders

Rare: headache

Vestibular Disorders

Rare: tinnitus (ringing in the ears)

Gastrointestinal Disorders:

Rare: abdominal pain, nausea, vomiting, and diarrhea.

Skin and Subcutaneous Tissue Disorders

Very Rare: allergic reactions accompanied by hives

Respiratory, Thoracic, and Mediastinal Disorders

Rare: dyspnea (difficulty breathing), bronchospasm, (especially in patients with hyperreactive bronchial tubes in asthma)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store in the original packaging

Do not store at a temperature above30°C.

Do not dispose of medications through drains or trash. Deposit 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 containers and medications you no longer need. This will help protect the environment.

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.

Composition of Acetilcisteína MABO

• The active ingredient is Acetilcisteina. Each tablet contains 600 mg of acetilcisteina
• The other components (excipients) are Anhydrous citric acid, sodium bicarbonate, orange flavor, L-leucine, maltodextrin and sodium saccharin.

Appearance of the product and contents of the packaging

Effervescent tablets, white in color, round, flat and in packs of 10 or 20 tablets.

Holder of the marketing authorization

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Responsible for manufacturing

E-Pharma Trento S.p.A.

Via Provina, 2

38040 Trento (Italy)

Date of the last review of this leaflet:

November 2016

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