AERO-RED 120 mg CHEWABLE TABLETS

Introduction

Patient Information Leaflet

Aero-red 120 mg Chewable Tablets

Simethicone

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

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet:

1. What is Aero-red and what is it used for
2. What you need to know before taking Aero-red
3. How to take Aero-red
4. Possible side effects

5 Conservation of Aero-red

1. Package contents and additional information

1. What is Aero-red and what is it used for

Aero-red belongs to the group of medicines that act in the intestine by destroying gas bubbles, facilitating their elimination and relieving the discomfort they cause.

It is indicated for the symptomatic relief of gas in adults.

You should consult a doctor if it worsens or does not improve after 10 days.

2. What you need to know before taking Aero-red

Do not take Aero-redif you are allergic to simethicone or any of the other components of this medicine (listed in section 6).

Known or suspected intestinal perforation and obstruction.

Warnings and precautions

Consult your doctor if it worsens or does not improve after 10 days of treatment or if you have prolonged constipation.

Children

This medicine is not recommended for use in children due to the lack of experience in this population.

Taking Aero-red with other medicines

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Since the passage of simethicone into the bloodstream is insignificant, pregnant and breastfeeding women may take this medicine after consulting their doctor.

Driving and using machines

Aero-red has no known effects on the ability to drive or use machines.

Aero-red contains glucose and sucrose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Aero-red

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

The recommended dose is 1 chewable tablet (120 mg of simethicone) after each of the main meals.

This dose may be repeated as needed, up to a maximum of 4 chewable tablets (480 mg of simethicone) per day.

This medicine is taken orally.

Chew the tablets well before swallowing (do not swallow them whole).

If symptoms worsen or persist after 10 days of treatment, you should stop treatment and consult a doctor.

If you take more Aero-red than you should

In case of overdose or accidental ingestion, go to a medical center, consult your doctor or pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Aero-red

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

During the use of simethicone, the following side effects have been observed, whose frequency could not be established.

Unknown frequency (cannot be estimated from the available data):

• transient moderate constipation and nausea.
• allergic reactions (hypersensitivity) such as rash and itching of the skin, swelling of the face or tongue, or difficulty breathing.

Eructation may occur, which is the normal mechanism of gas elimination with this treatment.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Aero-red

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

Do not store above 30°C.

Do not use this medicine after the expiration date stated on the packaging after CAD.

The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Aero-red

• The active ingredient is simethicone. Each chewable tablet contains 120 mg of simethicone.

The other ingredients are: sucrose, hydrated dextrates (contains glucose), colloidal silica, magnesium stearate, and vanillin. See section 2 "Aero-red contains glucose and sucrose".

Appearance of the product and package contents

Aero-red is a white, round tablet. Each package contains 40 chewable tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Uriach Consumer Healthcare S.L.

Av. Generalitat 163-167

08174 Sant Cugat del Vallès (Barcelona - Spain)

Manufacturer

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona - Spain)

This leaflet was approved in July 2009

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