Aero-Red Forte 240 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

AERO-RED FORTE 240 mg soft capsules

Simeticone

Read all of this 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.

• You should consult a doctor if you worsen or do 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 adverse effects
5. How to store AERO-RED FORTE 240 mg
6. Contents of the pack and other information

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

Simethicone is the active substance in this medicine and 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.

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 Forte 240 mg

Do not take AERO-RED FORTE 240 mg

• If you are allergic to simethicone or to any of the other ingredients of this
  medicinal product (listed in section 6).

Warnings and precautions

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

Taking AERO-RED FORTE 240 mg with other medicines

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

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Taking this medicine with food and drinks does not affect its efficacy.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Although the active substance in this medicine is not absorbed, pregnant or breast-feeding women should not take this medicine without consulting their doctor.

Driving and using machines

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

3. How to take Aero-red Forte 240 mg

Follow exactly the instructions for use provided by your doctor or pharmacist. If in 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 longer than 10 consecutive days.

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

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

There are no known cases of overdose.

Even if a much larger amount than recommended is ingested, it is very unlikely that adverse 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 contact the Toxicology Information Service. Telephone: 91 562 04 20 (Indicate 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 missed doses.

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

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

4. Possible adverse effects

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

The following adverse effects have been observed during the period of use of simethicone; their frequency cannot be established:

• moderate, transient constipation and nausea

• belching may occur, which constitutes the normal mechanism for elimination of gas with this treatment

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

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 may 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 Forte 240 mg

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of Aero-red Forte 240 mg

Composition of AERO-RED FORTE 240 mg

The active substance 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 pack

AERO-RED 240 mg are soft, transparent gelatin capsules.

Each package 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 most recent review of this leaflet: June 2013

Health Education Advice

Digestive problems:

Indigestion:

Indigestion may occur if you:

Eat too much
Eat fatty meals
Eat too quickly, without chewing properly
Drink too much alcohol with meals

Try to avoid these triggers.

Gas (flatulence):

Gas is more likely to occur with certain foods because they:

Contain air themselves (e.g., carbonated drinks, fresh bread)
Contain high levels of carbohydrates that are poorly absorbed (e.g., dried legumes, cabbage, raw vegetables, onions)

Try to avoid these foods.

Consult your doctor or pharmacist if you need further information.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es/