Aero-Red 120 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Aero-red 120 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 provided in this leaflet or those given 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.
Contents of this 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 side 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 medications that act in the intestine by breaking down gas bubbles, facilitating their elimination and relieving discomfort caused by gas.
It is indicated for the symptomatic relief of gas in adults.
You should consult a doctor if 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 to any of the other ingredients of this medicine (listed in section 6).
Known or suspected gastrointestinal 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 due to 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 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, pregnant and breastfeeding women may take this medicine after consulting with their doctor.
Driving and using machines
Aero-red has no known effects on the ability to drive or operate machinery.
Aero-red contains glucose and sucrose
If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Aero-red
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 1 chewable tablet (120 mg of simeticone) after each of the main meals.
This dose may be repeated, whenever necessary, up to a maximum of 4 chewable tablets (480 mg of simeticone) per day.
This medicine is taken by mouth.
Chew the tablets well before swallowing them (they must not be swallowed whole).
If symptoms worsen or persist for more than 10 days of treatment, treatment must be discontinued and you should 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 forgotten doses.
If you have any further questions about the use of this product, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following adverse effects have been observed during the period of use of simethicone, for which frequency could not be established.
Frequency unknown (cannot be estimated from available data):
- moderate, transient constipation and nausea.
- allergic reactions (hypersensitivity) such as rash, itching of the skin, 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 Medicinal Products: 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 store above 30°C.
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.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and empty containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Aero-red
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The active substance is simethicone. Each chewable tablet contains 120 mg of simethicone.
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The other components are: sucrose, hydrated dextrins (contains glucose), colloidal anhydrous silica, magnesium stearate and vanillin. See section 2 "Aero-red contains glucose and sucrose".
Appearance of the medicinal product and contents of the pack
Aero-red are white, round tablets. Each pack 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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/