Package Insert: Information for the Patient

Aero-red 40 mgChewable Tablets

Simeticona

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

- Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.

- You should consult a doctor if you worsen or do not improve after 10 days.

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

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

3. How to take Aero-red

4. Possible adverse effects

5. Storage of Aero-red

6. Contents of the package and additional information

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

It is indicated for symptomatic relief of gas in adults

Consult a doctor if it worsens or does not improve after 10 days.

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 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 medication is not recommended for use in children. There are other medications containing 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 taken recently, or may need to take any other medication.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machines

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

Aero-red contains glucose and saccharose

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 of the main meals, do not administer 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 symptoms do not improve in 10 days, discontinue 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Aero-red

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not everyone may experience them.

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

Unknown frequency (cannot be estimated from available data):

- transient moderate constipation and nausea.

- allergic reactions (hypersensitivity) such as rash and itching on the skin, edema on the face or tongue, or difficulty breathing.

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in the prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

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

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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), hydrated colloidal silica, magnesium stearate, and vanillin. See section 2. “Aero-red

contains glucose and sucrose”.

Appearance of the product and contents of the packaging

Aero-red are white, round tablets.

Blister, packaging of 30 tablets and bottle of 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Uriach Consumer Healthcare, S.L

Av. Generalitat 163-167

08174 Sant Cugat del Vallès (Barcelona - Spain)

Responsible for manufacturing

Noucor Health S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona - Spain)

This leaflet was approved in November 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/