Entero Silicona 9 mg/ml oral emulsion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Entero-Silicona 9 mg/ml oral emulsion

Simeticone

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 10 days.

Contents of the leaflet

1. What Entero-Silicona is and what it is used for
2. What you need to know before taking or using Entero-Silicona
3. How to take Entero-Silicona
4. Possible adverse effects
5. How to store Entero-Silicona
6. Contents of the pack and other information

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

The active substance in Entero-Silicona is simethicone, which belongs to a group of medicines that act in the intestine 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, children, and infants.

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 Entero-Silicona

Do not take Entero-Silicona:

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

In case of known or suspected intestinal perforation or intestinal 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 medicines:

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

Use of Entero-Silicona with food and drink:

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

Pregnancy and breastfeeding:

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

Driving and using machines:

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

Entero-Silicona contains methyl parahydroxybenzoate and 96 percent ethanol:

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

This medicine contains 0.04% (v/v) of 96 percent ethanol (alcohol), a small amount corresponding to 0.3 mg/ml.

3. How to take Entero-Silicona

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults and children over 12 years of age is:

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

Use in children:

Children aged 0 to 2 years:

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

Children aged 2 to 12 years:

The recommended dose is 5 ml or 1 teaspoon (45 mg of simethicone) three 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 well before use.

If you take more Entero-Silicona than you should:

There are no known cases of overdose.

Even if a much larger than recommended amount is ingested, adverse effects are highly unlikely due to the lack of gastrointestinal absorption of the drug.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Entero-Silicona may cause adverse effects, although not everyone experiences them.

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

• Nausea and constipation.
• Hypersensitivity reactions, such as skin rash, itching, facial or tongue swelling, breathing difficulty.

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 via the Spanish Pharmacovigilance System for Human Medicinal Products, website: http://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Entero-Silicona

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

No special storage conditions are required.

Do not use Entero-Silicona after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Entero-Silicona:

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

Appearance of the product and contents of the pack:

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

The oral emulsion is an opaque white liquid which may show phase separation, but becomes homogeneous when shaken.

Marketing Authorisation Holder and Manufacturer:

LABORATORIO ESTEDI S.L.

Leopoldo Alas 7-Montseny 41

08012 Barcelona (Spain)

Local representative:

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.