AERO-RED FORTE 240 mg SOFT CAPSULES

Introduction

Leaflet: information for the user

AERO-RED FORTE 240 mg soft capsules

Simeticone

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained 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 more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if

they are side effects not listed in this leaflet. See section 4.

• You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the leaflet:

1. What AERO-RED FORTE 240 mg is 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

1. What is Aero-red Forte 240 mg and what is it used for

Simeticone is the active ingredient of this medicine and acts by destroying gas bubbles, facilitating their elimination and relieving the discomfort they cause.

It is indicated for the symptomatic relief of gases in adults

You should consult a doctor if it worsens or does not improve after 10 days.

2. What you need to know before taking Aero-red Forte 240 mg

Do not take AERO-RED FORTE 240 mg

• If you are allergic to simeticone or to any of the other components of this

medicine (listed in section 6).

Warnings and precautions

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

Taking AERO-RED FORTE 240 mg with other medicines

Taking this medicine does not affect the efficacy of other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

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

Taking this medicine 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

3. How to take Aero-red Forte 240 mg

Follow exactly the administration instructions of this medicine 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 medicine is taken orally.

Swallow the capsule with a large glass of water.

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

If the symptoms worsen or do not improve within 10 consecutive days of treatment, you should stop taking it and consult a doctor.

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

No cases of overdose are known.

Even if a much higher amount than indicated is ingested, it is very unlikely that side effects will occur, due to the lack of gastrointestinal absorption of the drug.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service. Phone: 91 562 04 20 (indicating the medicine and the amount ingested)

If you forget to take AERO-RED FORTE 240 mg

Do not take a double dose to make up for forgotten doses.

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

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

4. Possible side effects

Like all medicines, AERO-RED FORTE 240 mg can cause side effects, although not everyone gets them.

During the period of use of simeticone, the following side effects have been observed, whose frequency could not be established:

• mild and transient constipation and nausea
• eructation may occur, which is the normal mechanism of gas elimination with this treatment

• allergic reactions (hypersensitivity) such as skin rash and itching, facial or tongue edema, or difficulty breathing.

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 leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aero-red Forte 240 mg

Keep this medicine out of the sight and reach of children

Do not use this medicine 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 above 30°C.

Medicines should not be disposed of through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of Aero-red Forte 240 mg

Composition of AERO-RED FORTE 240 mg

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

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

Appearance of the product and contents of the pack

AERO-RED 240 mg are transparent gelatin soft capsules.

Each pack contains 20 capsules.

Marketing authorization holder

Uriach Consumer Healthcare, S.L

Av. Generalitat 163-167 08174 Sant Cugat del Vallès (Barcelona - Spain)

Manufacturer

Laboratorios Alcala Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares

(Madrid – Spain)

Date of the last revision of this leaflet: June 2013

Health Education Tips

Digestive problems:

Indigestion:

It can 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):

Some foods are more likely to cause gas because:

They contain air themselves (e.g., carbonated drinks, fresh bread)

They contain high levels of carbohydrates that are not absorbed (e.g., 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.es/