Acetylcysteine Mabo 600 mg effervescent tablets orange flavor

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Acetylcysteine MABO 600 mg effervescent tablets orange flavour

Acetylcysteine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 adverse effects not listed in this leaflet. See section 4.

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

Contents of the 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 adverse effects
5. How to store Acetylcysteine MABO
6. Contents of the pack and other information

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

Acetilcisteína MABO is available as effervescent tablets, white in color, round, flat, and supplied in packs of 10 or 20 tablets.

Acetilcisteína MABO belongs to a group of medicines known as mucolytics.

It works by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medicine is indicated to reduce the viscosity of mucus and phlegm, facilitating their expulsion in cases of colds and flu in adults.

You should consult your doctor if you worsen or do not improve after 5 days of treatment.

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

Do not take Acetylcysteine MABO:

• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).

• if you have a gastroduodenal ulcer.

• if you have asthma or another severe respiratory insufficiency, as it may increase airway 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's syndrome have been reported in temporal association with acetylcysteine administration. If you experience skin or mucosal changes, seek medical advice immediately and stop taking acetylcysteine.

The possible presence of a slight sulfurous odor does not indicate deterioration of the product, but is characteristic of the active substance.

Children and adolescents

Individuals under 18 years of age should not take this medicine.

Taking Acetylcysteine MABO with other medicines

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

You should not take this medicine if you are undergoing treatment with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics, etc.), 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), you must separate their administration from that of acetylcysteine by at least 2 hours.

Taking Acetylcysteine MABO with food, drinks and alcohol

Taking food and drinks does not affect the effectiveness of this medicine.

This medicine may be taken with or without food.

Pregnancy, breastfeeding and fertility

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.

Pregnancy:

Consult your doctor or pharmacist before using a medication.

Although animal studies have not shown evidence of fetal harm, Acetylcysteine MABO should be administered 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, administration of Acetylcysteine MABO during breastfeeding is recommended under medical supervision.

Driving and use of machines:

No effects have been reported in this regard.

Acetylcysteine MABO contains sodium.

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

3. How to take Acetylcysteine MABO

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults (from 18 years of age):

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

Use in children and adolescents:

This medicine must not be used in individuals under 18 years of age.

Acetylcysteine MABO is taken orally. Effervescent tablets must be dissolved in a glass of water. Do not swallow until the fizzing has completely stopped.

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

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

If you take more Acetylcysteine MABO than you should:

In case of overdose or accidental ingestion, immediately contact your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medication and the amount ingested.

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

If you forget to take Acetylcysteine MABO

Do not take a double dose to make up for a missed dose. If you miss a dose, wait until the next scheduled dose.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience 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 diarrhoea

Skin and subcutaneous tissue disorders

Very rare: hypersensitivity reaction accompanied by urticaria

Respiratory, thoracic and mediastinal disorders

Rare: dyspnoea (difficulty breathing), bronchospasm (especially in patients with hyperreactive bronchial systems such as in bronchial asthma)

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 through the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine MABO

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not store above 30°C.

Medicines must not be disposed of via wastewater drains or in household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

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.

6. Contents of the pack and other information

Composition of Acetylcysteine MABO

• The active substance 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 contents of the pack

Effervescent tablets, white in color, round, flat, in packs 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 most recent review of this leaflet:

November 2016

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/