Leaflet: information for the user

Entero-Silicona 9 mg/ml oral emulsion

Simeticona

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.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after10 days.

1. What isEntero-Siliconaand what it is used for

2. What you need to know before starting to takeEntero-Silicona

3. How to takeEntero-Silicona

4. Possible side effects

5. Storage ofEntero-Silicona

6. Contents of the pack and additional information

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

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

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

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 or 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 infantile colic due to limited available information.

Taking Entero-Silicona with other medications:

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

Using Entero-Silicona with food and beverages:

No known interactions with food or beverages. Preferably use after meals.

Pregnancy and breastfeeding:

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

Driving and operating machinery:

Entero-Silicona has no known effects on the ability to drive or operate machinery.

Entero-Silicona containsparahydroxybenzoate of methyl and ethanol at 96 percent:

May produce allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl.

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

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.

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

10 ml or 1 large spoonful (90 mg of Simeticona) 3 times a day. Do not administer more than 55 ml or 5 and a half large spoonfuls (495 mg of simeticona) per day.

Use in children:

Children from0 to2 years:

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

Children from2 to12 years:

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

Do not administer more than 25 ml or 5 teaspoons (225 mg of simeticona) 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 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 or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Entero-Silicona:

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

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

Like all medications, Entero-Silicona may cause adverse effects, although not all people may experience 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, and respiratory difficulty.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use, webpage: http.//www.notificaram.es.

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

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

No special storage conditions are required.

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

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

Composition of Entero-Silicona:

• The active principle is simeticone. Each ml of oral emulsion contains 9 mg of simeticone.
• The other components are: sodium carmelose (E-466), sodium saccharin (E-954), methyl parahydroxybenzoate (E-218), polyvinyl alcohol, anise essence (ethanol at 96 percent and propylene glycol) and purified water.See section 2 “Entero Silicona contains methyl parahydroxybenzoate and ethanol at 96 percent”.

Appearance of the product and contents of the packaging:

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

The oral emulsion is an opaque white liquid that may present phase separation but which homogenizes upon agitation.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Estedi S.L.

Leopoldo Alas 7-Montseny 41

08012 Barcelona (Spain)

Local representative:

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

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