ENTERO SILICONE 9 mg/ml ORAL EMULSION

Introduction

Package Leaflet: Information for the User

Entero-Silicona 9 mg/ml Oral Emulsion

Simethicone

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the Package Leaflet

1. What Entero-Silicona is and what it is used for
2. What you need to know before taking Entero-Silicona
3. How to take Entero-Silicona
4. Possible side effects
5. Storage of Entero-Silicona
6. Package Contents and Additional Information

1. What Entero-Silicona is and what it is used for

The active ingredient of Entero-Silicona is simethicone, which belongs to a group of medications that act in the intestine by destroying gas bubbles, facilitating their elimination and relieving the discomfort they cause.

It is indicated for the symptomatic relief of gas in adults, children, and infants.

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

2. What you need to know before taking Entero-Silicona

Do not take Entero-Silicona:

If you are allergic to simethicone or any of the other components of this medication (listed in section 6).

Known or suspected intestinal perforation and obstruction.

Warnings and Precautions:

Consult your doctor or pharmacist before starting to take Entero-Silicona.

If symptoms worsen or persist, or in case of prolonged constipation, consult your doctor.

Children:

Simethicone is not recommended for the treatment of infant colic due to limited available information.

Taking Entero-Silicona with other medications:

Inform your doctor or pharmacist if you are using, have recently used, or may need to take any other medication.

Taking Entero-Silicona with food and beverages:

It has no known effects of interaction with food or beverages. Preferably use after meals.

Pregnancy and Breastfeeding:

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

Driving and Using Machines:

Entero-Silicona has no known effects on the ability to drive or use machines.

Entero-Silicona containsmethylparaben and 96% ethanol:

It may cause allergic reactions (possibly delayed) because it contains methylparaben.

This medication contains 0.04% (v/v) of 96% ethanol (alcohol), which corresponds to 0.3 mg/ml.

3. How to take Entero-Silicona

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults and children over 12 years is:

10 ml or 1 large spoon (90 mg of simethicone) 3 times a day. Do not administer more than 55 ml or 5 and a half large spoons (495 mg of simethicone) per day.

Use in Children:

Children from 0 to 2 years:

The recommended dose is 2.5 ml or ½ teaspoon (22.5 mg of simethicone) 3 times a day, administered with the bottle or with another food or liquid. Do not administer more than 25 ml or 5 teaspoons (225 mg of simethicone) per day.

Children from 2 to 12 years:

The recommended dose is 5 ml or 1 teaspoon (45 mg of simethicone) 3 times a day.

Do not administer more than 25 ml or 5 teaspoons (225 mg of simethicone) per day.

Entero-Silicona is administered orally after meals.

Shake the bottle before use.

If you take more Entero-Silicona 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 digestive absorption of the drug.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Entero-Silicona:

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

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

4. Possible Side Effects

Like all medications, Entero-Silicona can cause side effects, although not everyone experiences them.

The following adverse reactions have been reported with an unknown frequency (cannot be estimated from available data):

• Nausea and constipation.
• Hypersensitivity reactions, such as skin rash, itching, facial or tongue edema, 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 that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, website: http://www.notificaram.es.

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

5. Storage of Entero-Silicona

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use Entero-Silicona after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Entero-Silicona:

• The active ingredient is simethicone. Each ml of oral emulsion contains 9 mg of simethicone.
• The other components are: sodium carmellose (E-466), sodium saccharin (E-954), methylparaben (E-218), polyvinyl alcohol, anise essence (96% ethanol and propylene glycol), and purified water. See section 2 "Entero-Silicona contains methylparaben and 96% ethanol".

Appearance of the Product and Package Contents:

Entero-Silicona is presented in a 250 ml bottle of oral emulsion.

The oral emulsion is a white, opaque liquid that may show phase separation but homogenizes when shaken.

Marketing Authorization Holder and Manufacturer:

LABORATORIO ESTEDI S.L.

Leopoldo Alas 7-Montseny 41

08012 Barcelona (Spain)

Local Representative:

This package leaflet was approved in {Month/Year}: October/2013

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