AERO RED 40 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

Aero-red 40 mgchewable tablets

Simethicone

Read the entire package 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 package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 it is a side effect not listed in this package leaflet. See section 4.

You should consult a doctor if your symptoms worsen or do not improve after 10 days.

• You should consult a doctor if your symptoms worsen or do not improve after 10 days.

Contents of the Package 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. Contents of the package and additional information

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

Aero-red belongs to the group of medications that act in the intestine, 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 your symptoms worsen or do not improve after 10 days.

2. What you need to know before starting to take Aero-red

Do not take Aero-red:

• If you are allergic to simethicone or any of the components of this medication (listed in section 6).

If you have a known or suspected intestinal perforation or obstruction.

• If you have a known or suspected intestinal perforation or obstruction.

Warnings and precautions

Consult your doctor if your symptoms worsen or do not improve after 10 days of treatment or if you have prolonged constipation.

Children

This medication is not recommended for use in children. There are other medications that contain simethicone that are indicated for infants and children, such as Aero-Red 100 mg/ml oral drops in solution.

Taking Aero-red with other medications

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

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 medication.

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

Driving and using machines

Aero-red has no known effects on the ability to drive or operate 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 medication.

3. How to take Aero-red

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

Adults:

The recommended dose is 2 chewable tablets (80 mg of simethicone), 3 times a day after each main meal, do not take more than 12 chewable tablets (480 mg of simethicone) per day.

This medication is administered orally.

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

If your symptoms do not improve within 10 days, 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 medication 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 medications, this medication can cause side effects, although not everyone will experience them.

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

Frequency not known (cannot be estimated from the available data):

• transient moderate constipation and nausea.
• allergic reactions (hypersensitivity) such as rash, 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Aero-red

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

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

PVC/aluminum blister pack with 30 tablets: Store below 30°C.

Plastic bottle with 100 tablets: This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the package and additional information

Composition of Aero-red

• The active ingredient is simethicone. Each chewable tablet contains 40 mg of simethicone.

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

• The other components 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 are white, round tablets.

Blister pack, 30-tablet package, and 100-tablet bottle.

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 package leaflet was approved in November 2014.

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.es/