Package leaflet: Information for the patient

Meteosim 40 mg chewable tablets

Simeticone
Please read all of this leaflet carefully before you start 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.

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

Contents of this leaflet:
1. What METEOSIM is and what it is used for
2. What you need to know before taking METEOSIM
3. How to take METEOSIM
4. Possible side effects
5. How to store METEOSIM
6. Contents of the pack and other information

1. What METEOSIM is and what it is used for
METEOSIM contains the active substance simeticone, an anti-foaming agent that helps eliminate gas bubbles formed in the stomach and intestines.
METEOSIM is used in adults to treat symptoms associated with:

gastro-enteric meteorism
aerophagia

Consult your doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before taking METEOSIM

Do not take METEOSIM

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 Meteosim.
Do not exceed the recommended doses.
Other medicines and METEOSIM
No interactions with other drugs are known or have been reported.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
There are insufficient data on the use of Meteosim in pregnant women; therefore, it should not be used during pregnancy unless clearly needed and after assessment of the risk/benefit ratio by the doctor.
Breastfeeding
It is not known whether simethicone is excreted in breast milk. Excretion of simethicone in breast milk has not been studied in animals. The decision whether to continue or discontinue simethicone therapy should take into account the benefit of breastfeeding for the newborn and the benefit of simethicone treatment for the woman.
Driving and using machines
No effects on the ability to drive or use machines have been reported.
METEOSIM contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take METEOSIM

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

The recommended dose is:
Adults: 4 tablets per day (2 at the end of each main meal).
The tablets must be chewed.

Warning: Do not exceed the recommended dose without medical advice.
Take this medicine only for short treatment periods (approximately 7 days). Do not use it for prolonged periods without consulting your doctor.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes in their characteristics.

If you take more METEOSIM than you should
No cases of overdose have been reported with the use of Meteosim.
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital.

If you forget to take METEOSIM
Do not take a double dose to make up for a forgotten dose.
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 can cause side effects, although not everyone experiences them.
However, no side effects due to Meteosim have been reported.
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 via: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METEOSIM

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.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What METEOSIM contains
The active substance is simeticone.
One tablet contains 40 mg of simeticone.
The other ingredients are sodium saccharin, alginic acid, lactose, sodium bicarbonate,
povidone, monohydrated calcium silicate, methylcellulose.
Description of the appearance of METEOSIM and contents of the pack
Box containing 50 tablets of 40 mg in blisters.
Marketing Authorization Holder and Manufacturer
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. Via Fossignano, 2 – Aprilia (LT)