Aero Red 40 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Aero-red 40 mg chewable tablets
Simeticone
Read this 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 indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further 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 10 days.
Contents of the leaflet:
- What Aero-red is and what it is used for
- What you need to know before taking Aero-red
- How to take Aero-red
- Possible adverse effects
- Storage of Aero-red
- Contents of the pack and other information
1. What Aero-red is and what it is used for
Aero-red belongs to a group of medicines that acts in the intestine by breaking down 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 condition worsens or does 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 to any of the components of this medicine
(listed in section 6). -
If you have known or suspected intestinal perforation or obstruction.
Warnings and precautions
Consult your doctor if your condition 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. There are other medicines containing simethicone indicated for infants and children, such as Aero-Red 100 mg/ml oral drops solution.
Taking Aero-red with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
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.
Since absorption of simethicone into the bloodstream is negligible, women who are pregnant or breastfeeding may take this medicine after consulting with their doctor.
Driving and operating machinery
Aero-red has no known effects on the ability to drive or operate machinery.
Aero-red contains glucose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Aero-red
Follow exactly the instructions for administering this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults:
The recommended dose is 2 chewable tablets (80 mg of simethicone), 3 times daily after each of the main meals. Do not administer more than 12 chewable tablets (480 mg of simethicone) per day.
This medicine is administered by oral route.
Chew the tablets thoroughly before swallowing (do not swallow them whole).
If symptoms do not improve within 10 days, discontinue treatment and consult your 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 at telephone number: 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 missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed during the period of simethicone use, the frequency of which could not be established.
Frequency not known (cannot be estimated from available data):
- moderate, transient constipation and nausea.
- allergic reactions (hypersensitivity) such as skin rash, itching, facial or tongue swelling, or difficulty breathing.
Belching may occur, which constitutes the normal mechanism for gas elimination with this treatment.
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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aero-red
Keep this medicine out of the sight and reach of children.
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.
PVC/aluminum blister pack with 30 tablets: Store below 30°C.
Plastic bottle with 100 tablets: This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aero-red
- The active substance is simeticone. Each chewable tablet contains 40 mg of
simeticone.
- The other components are: sucrose, hydrated dextrins (contains glucose), hydrated colloidal silica, magnesium stearate and vanillin. See section 2. “Aero-red
contains glucose and sucrose”.
Appearance of the product and contents of the pack
Aero-red are white, round tablets.
Blister pack, pack size of 30 tablets and bottle of 100 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 November 2014
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/