ACETYLCYSTEINE MABO 600 mg EFFERVSCENT ORANGE-FLAVORED TABLETS

Introduction

Package Leaflet: Information for the Patient

Acetylcysteine MABO 600 mg Orange-Flavored Effervescent Tablets

Acetylcysteine

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

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly.

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

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

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

Contents of the Package Leaflet

1. What Acetylcysteine MABO is and what it is used for
2. What you need to know before taking Acetylcysteine MABO
3. How to take Acetylcysteine MABO
4. Possible side effects
5. Storage of Acetylcysteine MABO
6. Package Contents and Additional Information

1. What Acetylcysteine MABO is and what it is used for

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

Acetylcysteine MABO belongs to the group of medications called mucolytics.

It acts by decreasing the viscosity of mucus, making it more fluid and facilitating its elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, making it easier to expel in colds and flu in adults.

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

2. What you need to know before taking Acetylcysteine MABO effervescent tablets:

Do not takeAcetylcysteine MABOif:

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

• Do not administer Acetylcysteine to children under 2 years of age.

Warnings and Precautions

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

Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported, associated with the administration of acetylcysteine. If skin changes or mucosal changes occur, medical advice should be sought quickly and acetylcysteine should be discontinued.

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

Children and Adolescents

Persons under 18 years of age cannot take this medication.

Taking Acetylcysteine MABO with other medications

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

Do not take this medication if you are being treated with antitussive medications (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 medication containing minerals such as iron or calcium, or any medication with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of acetylcysteine by at least 2 hours.

Taking Acetylcysteine MABO with food, beverages, and alcohol

The intake of food and beverages 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

Consult your doctor or pharmacist before using a medication.

Although studies conducted in animals have not shown potential fetal harm, the administration of Acetylcysteine MABO is recommended under medical supervision during pregnancy.

Breastfeeding:

Consult your doctor or pharmacist before using a medication.

Since it is unknown whether acetylcysteine passes into breast milk, the administration of Acetylcysteine MABO is recommended under medical supervision during breastfeeding.

Driving and Using Machines:

No effects have been described in this regard.

Acetylcysteine MABO contains sodium.

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

3. How to take Acetylcysteine MABO

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults (from 18 years of age):

Administer 1 tablet (600 mg of acetylcysteine). Do not exceed the dose of 1 tablet (600 mg) per day.

Use in Children and Adolescents:

Persons under 18 years of age cannot take this medication.

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

It is recommended to drink plenty of liquid throughout the day.

Do not administer Acetylcysteine MABO to children under 2 years of age.

If you take more Acetylcysteine MABO than you should:

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

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

If you forget to take Acetylcysteine MABO

Do not take a double dose to make up for forgotten doses. In case of forgetting a dose, wait for the next one.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Immune System Disorders

Uncommon:hypersensitivity reactions, for example, pruritus, urticaria, rash, bronchospasm

Nervous System Disorders

Uncommon:headache

Ear and Labyrinth Disorders

Uncommon:tinnitus (ringing in the ears)

Gastrointestinal Disorders:

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

Skin and Subcutaneous Tissue Disorders

Very rare:hypersensitivity reactions accompanied by urticaria

Respiratory, Thoracic, and Mediastinal Disorders

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetylcysteine MABO

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

Store in the original packaging

Do not store at a temperature above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

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

6. Package Contents and Additional Information

Composition of Acetylcysteine MABO

• The active ingredient is Acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other components (excipients) are Anhydrous Citric Acid, Sodium Bicarbonate, Orange Flavor, L-Leucine, Maltodextrin, and Sodium Saccharin.

Appearance of the Product and Package Contents

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

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

E-Pharma Trento S.p.A.

Via Provina, 2

38040 Trento (Italy)

Date of the Last Revision of this Leaflet:

November 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/