Patient Information Leaflet

Simeticone IBI Bambini oral drops, suspension

Simeticone
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor,
pharmacist, or nurse has told you to do.

Keep this leaflet. You may need to read it again.
If you need more advice or information, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.

Contents of this leaflet:

What Simeticone IBI Bambini is and what it is used for
What you need to know before taking Simeticone IBI Bambini
How to take Simeticone IBI Bambini
Possible side effects
How to store Simeticone IBI Bambini
Contents of the pack and other information

1. What Simeticone IBI Bambini is and what it is used for

This medicinal product contains simeticone, an active substance that works by eliminating gas formed in the stomach or intestine (meteorism).
Simeticone IBI Bambini is used to help eliminate gas formed in the gastrointestinal tract (anti-meteorism) and is also used to remove swallowed air (aerophagia) in infants and children.

2. What you need to know before taking Simeticone IBI Bambini

Do not take Simeticone IBI Bambini

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Simeticone IBI Bambini.
Do not exceed the recommended doses.
If you do not notice an improvement in symptoms after a short period of treatment (7 days), consult your doctor. If symptoms persist or worsen, or if you have prolonged constipation, you should consult your doctor. Do not use in case of suspected intestinal perforation or ileus.
Other medicines and Simeticone IBI Bambini
Concomitant use of simethicone and laxatives containing mineral oils (paraffin) is not recommended, as the combination of these two products reduces their effectiveness.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, use simethicone with caution and only after consulting your doctor. Your doctor will decide whether you can take Simeticone IBI Bambini.
Breastfeeding
It is not known whether simethicone passes into breast milk. Your doctor will decide whether you can take Simeticone IBI Bambini, weighing the benefits of breastfeeding for your baby against the benefits of simethicone therapy for you.
Driving and using machines
No effects on the ability to drive or operate machinery have been reported.

3. How to take Simeticone IBI Bambini

Take this medicine exactly as stated in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.

Use in infants and children:
The recommended dose is:
15 drops (=0.6 ml), 2–4 times daily, preferably after meals or otherwise as prescribed by a physician.
Shake well before use.
The drops should be dispersed in a small amount of water.

If you take more Simeticone IBI Bambini than you should
In case of accidental ingestion/overdose of Simeticone IBI Bambini, contact your doctor immediately or go to the nearest hospital.

Paediatric population
Simeticone is a chemically inert substance, pharmacologically inactive, and not absorbed from the gastrointestinal tract. Simeticone is also excreted unchanged in the faeces.
Accidental exposure to the product in children has not revealed symptoms in most cases. Reported symptoms have been mild to moderate in nature and can be explained by the pre-existing condition.

If you forget to take Simeticone IBI Bambini
Do not take a double dose to make up for the forgotten dose.

If you stop using Simeticone IBI Bambini
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Inform your doctor if you notice any of the following side effects while using Simeticone IBI Bambini, which occur very rarely (< 1/10,000):

Vomiting, diarrhoea, abdominal pain, ileus, nausea
Skin rashes
Swelling of the face, eyes, lips, tongue, or throat, with breathing difficulty (angioedema).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simeticone IBI Bambini

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after
"Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Simeticone IBI Bambini contains
The active substance is simeticone.
1 ml of suspension contains 66.6 mg of simeticone.
The other components are: methylcellulose, xanthan gum, sodium saccharin, blackcurrant flavour,
sodium benzoate, sorbic acid, purified water.
Description of the appearance of Simeticone IBI Bambini and contents of the pack
Oral drops, suspension, 30 ml bottle.
Marketing Authorisation Holder and Manufacturer
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. - via Fossignano, 2 – 04011 - Aprilia (LT)
e-mail: [email protected]