Simegut

Italy
Brand name Simegut
Form drops, oral emulsion
Active substance / Dosage
ACTIVATED DIMETHICONE
Prescription type Non-prescription – not available over the counter
ATC code
A03AX13
Registration number 037962
Manufacturer BIOPROJET ITALIA S.R.L.
Simegut drops, oral emulsion

Table of Contents

Package leaflet: Information for the user

SIMEGUT

66.6 mg/ml Paediatric oral drops, emulsion
Simethicone
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

  • 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, talk to your doctor or pharmacist. See section 4.
  • Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 7 days of treatment.

Contents of this leaflet

  1. What SIMEGUT is and what it is used for
  2. What you need to know before using SIMEGUT
  3. How to use SIMEGUT
  4. Possible side effects
  5. How to store SIMEGUT
  6. Contents of the pack and other information

1. What SIMEGUT is and what it is used for

SIMEGUT contains the active substance simeticone (an anti-foaming agent) which belongs to the group of
medicines used for gastrointestinal disorders.
SIMEGUT is used in infants and children to treat symptoms of gastrointestinal flatulence and aerophagia, promoting the elimination of gas formed in the gastrointestinal tract and removal of swallowed air.
Consult your doctor if the child does not feel better or feels worse after 7 days of treatment.

2. What you should know before using SIMEGUT

Do not use SIMEGUT

  • if the child is 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 using SIMEGUT.
SIMEGUT is used in children and infants.
Do not exceed the recommended doses.
If there is no noticeable improvement after a short period of treatment (7 days), consult your doctor.

Other medicines and SIMEGUT
Tell your doctor or pharmacist if the child is taking, has recently taken, or might take any other medicines.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
This medicine is used in children and infants.
Simethicone should not be used during pregnancy unless clearly necessary and only after medical evaluation.

Breastfeeding
This medicine is used in children and infants.
It is not known whether simethicone is excreted in breast milk. Ask your doctor for advice before using this medicine.

Driving and using machines
This medicine is used in children and infants.
No effects on the ability to drive vehicles or operate machinery are known.

SIMEGUT contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate
Methyl p-hydroxybenzoate and propyl p-hydroxybenzoate may cause allergic reactions (including delayed reactions).

3. How to use SIMEGUT

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Infants and children:
The recommended dose is 20 drops (= 0.6 ml) 2–4 times daily, preferably after meals. Do not exceed the recommended doses.
If you have any doubts about the recommended doses, ask your doctor or pharmacist.
Method of administration
Shake well before use.
The drops should be taken with a small amount of water.
If you use more SIMEGUT than you should
Overdose symptoms have not been reported.
If you forget to use SIMEGUT
Do not take a double dose to make up for the forgotten dose.
If you stop using SIMEGUT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
No side effects have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://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 SIMEGUT

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.
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 SIMEGUT contains

  • The active substance is simethicone. 1 ml of emulsion contains 66.6 mg of simethicone.
  • The other components are: hydroxypropylcellulose, carbopol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, citric acid, banana flavour, purified water.

Description of the appearance of SIMEGUT and contents of the pack
30 ml bottle.
Marketing Authorization Holder
Bioprojet Italia Srl,
Via Giovanni Battista Pirelli, 11
20124 Milan
Manufacturer
Cosmo S.p.A
Via C. Colombo, 1
20045 - Lainate (MI)