Leaflet: information for the user

AERO-RED FORTE 240 mg soft capsules

Simeticone

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.

-For advice on any matter relating to this medicine or if you have any further questions, consult your pharmacist.

-If you experience any side effects, talk to your doctor or pharmacist, even if they do not appear in this leaflet. See section 4.

-You must see a doctor if your symptoms worsen or do not improve after 10 days.

1. What is AERO-RED FORTE 240 mg and what it is used for

2. What you need to know before taking AERO-RED FORTE 240 mg

3. How to take AERO-RED FORTE 240 mg

4. Possible side effects

5. Storage of AERO-RED FORTE 240 mg

6. Contents of the pack and additional information

The active ingredient of this medication is simethicone, which works 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.

Consult a doctor if symptoms worsen or do not improve after 10 days.

Do not take AERO-RED FORTE 240 mg

- If you are allergic to simethicone or to any of the other ingredients in this

medication (listed in section 6).

Warnings and precautions

If symptoms worsen, or if they persist after 10 days of treatment, or if you have constipation that does not improve, you must consult your doctor.

Taking AERO-RED FORTE 240 mg with other medications

The taking of this medication does not affect the efficacy of other medications.

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

Taking AERO-RED FORTE 240 mg with food, drinks, and alcohol

The taking of this medication with food and drinks does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant. Consult your doctor or pharmacist before using this medication.

Although the active ingredient in this medication is not absorbed, pregnant women or breastfeeding women should not take this medication without consulting their doctor.

Driving and operating machines

AERO-RED FORTE 240 mg has no known effects on the ability to drive or operate machines.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 1 capsule after each main meal (lunch and dinner)

This medication is taken orally.

Swallow the capsule with a large glass of water.

Do not take the medication for more than 10 consecutive days.

If symptoms worsen or do not improve within 10 consecutive days of treatment, discontinue and consult your doctor.

If you take more AERO-RED FORTE 240 mg than you should

No cases of overdosing have been reported.

Even in the event of ingesting a much larger amount than indicated, it is very unlikely that adverse effects will occur, due to the lack of digestive absorption of the drug.

In case of overdose or accidental ingestion, consult your doctor, 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 FORTE 240 mg

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

If necessary, take 1 capsule after the next main meal.

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

Like all medications, AERO-RED FORTE 240 mg may cause adverse effects, although not everyone will experience them.

During the period of use of the simethicone, the following adverse effects have been observed, whose frequency has not been established:

- transient moderate constipation and nausea

- may produce belching, which is the normal mechanism of elimination of gases with this treatment

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

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products 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 box and blister after CAD.. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of AERO-RED FORTE 240 mg

The active ingredient is simethicone. Each capsule contains 240 mg of simethicone.

The other components (excipients) are gelatin and glycerol (E-422)

Appearance of the product and contents of the package

AERO-RED 240 mg are soft gelatin transparent capsules.

Each package contains 20 capsules.

Marketing Authorization Holder

Uriach Consumer Healthcare, S.L

Av. Generalitat 163-16708174 Sant Cugat del Vallès (Barcelona - Spain)

Responsible for manufacturing

Laboratorios Alcala Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

(Madrid – Spain)

Last review date of this leaflet: June 2013

Health Education Advice

Digestive problems:

Indigestion:

It may occur if you:

Eat too much

Eat fatty foods

Eat too quickly, without chewing

Drink too much alcohol with meals

Try to avoid these triggers

Gas (flatulence):

With some meals, gas is more likely to occur because:

They contain air themselves (for example, carbonated beverages, fresh bread)

They contain high levels of carbohydrates that are not absorbed (for example, dried vegetables, cabbage, raw vegetables, onions)

Try to avoid these foods

Consult your doctor or pharmacist if you need more information

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