Patient Information Leaflet

Simeticone Dompé

40 mg chewable tablets
80 mg chewable tablets
120 mg chewable tablets
80 mg/ml oral emulsion
Read 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 instructed you.
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, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice improvement or if you experience worsening of symptoms after 5–7 days.

Contents of this leaflet:

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

1. What Simeticone Dompé is and what it is used for

Simeticone Dompé contains the active substance simeticone, which belongs to the class of drugs for gastrointestinal functional disorders.
Simeticone Dompé is used for the treatment of gastro-enteric meteorism, i.e. increased presence of air, and aerophagia, i.e. tendency to swallow air, in adults, relieving symptoms such as pain, cramps, feeling of tension, burping, flatulence, i.e. emission of foul-smelling gas, promoting the elimination of gases formed in the gastrointestinal tract.
Consult your doctor if you do not feel better or if you feel worse after 5–7 days.

2. What you should know before taking Simeticone Dompé

Do not take Simeticone Dompé

if you are allergic to simeticone, or to any of the other ingredients of this medicine (listed in section 6).
if you are pregnant or breastfeeding, unless after careful evaluation by your doctor (see section 2 "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Simeticone Dompé.
Do not exceed the recommended doses.
If after a short period of treatment (approximately 7 days) there are no noticeable results, consult your doctor.

Other medicines and Simeticone Dompé
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No incompatibilities with other drugs are known or have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy and breastfeeding, Simeticone Dompé should be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.

Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been reported.

Simeticone Dompé chewable tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Simeticone Dompé oral emulsion contains methyl parahydroxybenzoate, propyl parahydroxybenzoate. These may cause allergic reactions (including delayed reactions).

3. How to take Simeticone Dompé

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Simeticone Dompé should be taken at the end of a main meal.
It should not be taken for longer than 5–7 days. Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.
The tablets of Simeticone Dompé should be chewed.
The prescribed amount of oral emulsion should be drawn up using the dosing syringe and dispersed in a glass of water.

Simeticone Dompé 40 mg chewable tablets:
The recommended dose is 4 tablets per day (two at the end of each main meal).

Simeticone Dompé 80 mg chewable tablets:
The recommended dose is 2 tablets per day (one at the end of each main meal).

Simeticone Dompé 120 mg chewable tablets:
The recommended dose is 2 tablets per day (one at the end of each main meal).

Simeticone Dompé 80 mg/ml oral emulsion:
The recommended dose is 1–1.5 ml (at the end of each main meal).

Do not exceed the recommended doses without medical advice.

If you take more Simeticone Dompé than you should
Overdose symptoms have not been reported with the use of simeticone. In case of accidental ingestion or overdose of Simeticone Dompé, contact your doctor immediately or go to the nearest hospital.

If you forget to take Simeticone Dompé
Do not take a double dose to make up for the missed dose.

If you stop taking Simeticone Dompé
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
No side effects due to simeticone have been identified.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simeticone Dompé

Tablets: Keep in the original packaging to protect the medicine from light and
moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label 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 no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Simeticone Dompé Contains
SIMETICONE DOMPÉ 40 mg Chewable Tablets:

The active substance is simeticone. One tablet contains 40 mg of simeticone.
Other components are: Mannitol, Colloidal Anhydrous Silica, Pregelatinized Starch, Lactose monohydrate, Polyvinylpyrrolidone K30, Crospovidone, Talc, Magnesium stearate, Peppermint flavour.

SIMETICONE DOMPÉ 80 mg Chewable Tablets

The active substance is simeticone. One tablet contains 80 mg of simeticone.
Other components are: Mannitol, Colloidal Anhydrous Silica, Pregelatinized Starch, Lactose monohydrate, Polyvinylpyrrolidone K30, Crospovidone, Talc, Magnesium stearate, Peppermint flavour.

SIMETICONE DOMPÉ 120 mg Chewable Tablets

The active substance is simeticone. One tablet contains 120 mg of simeticone.
Other components are: Mannitol, Colloidal Anhydrous Silica, Pregelatinized Starch, Lactose monohydrate, Polyvinylpyrrolidone K30, Crospovidone, Talc, Magnesium stearate, Peppermint flavour.

SIMETICONE DOMPÉ 80 mg/ml Oral Emulsion

The active substance is simeticone. One ml contains 80 mg of simeticone.
Other components are: Citric acid monohydrate, Sodium citrate, Carbomer, Sodium saccharin, Methylhydroxypropylcellulose, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Mixed fruit flavour, Purified water q.s.

Description of the Appearance of Simeticone Dompé and Package Contents
Simeticone Dompé is available in the form of chewable tablets and oral emulsion.
Packaging contents:
Simeticone Dompé 40 mg chewable tablets: 50 tablets
Simeticone Dompé 80 mg chewable tablets: 30 tablets
Simeticone Dompé 120 mg chewable tablets: 24 tablets
Simeticone Dompé 80 mg/ml oral emulsion: 100 ml bottle. The package includes an oral dosing syringe.

Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Manufacturer
Cosmo S.p.A. Via C. Colombo, 1 Lainate (MI)