SIMECRIN 40 mg Chewable Tablet

Зміст інструкції

1. SIMECRIN 80 mg/ml Oral Emulsion
   1. What is SIMECRIN and what is it used for
   2. What you need to know before you take SIMECRIN
   3. How to take SIMECRIN
   4. Possible side effects
   5. How to store SIMECRIN
   6. Contents of the pack and other information
2. SIMECRIN 40 mg chewable tablets, 80 mg chewable tablets, 120 mg chewable tablets
   1. What is SIMECRIN and what is it used for
   2. What you need to know before you take SIMECRIN
   3. How to take SIMECRIN
   4. Possible side effects
   5. How to store SIMECRIN
   6. Contents of the pack and other information
3. SIMECRIN Bambini 66,6 mg/ml oral drops, emulsion
   1. What is SIMECRIN and what is it used for
   2. What you need to know before taking SIMECRIN
   3. How to take SIMECRIN
   4. Possible side effects
   5. How to store SIMECRIN
   6. Contents of the pack and other information

SIMECRIN 80 mg/ml Oral Emulsion

Simeticone

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you would like more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Talk to your doctor if you do not feel better or if your symptoms worsen after 7 days.

Contents of this leaflet:

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

1. What is SIMECRIN and what is it used for

SIMECRIN contains the active ingredient simethicone, an antimetreotic which works by promoting the elimination of
gases that form in the stomach and intestines.
SIMECRIN is used in adults to treat symptoms in cases of:
gastro-enteric flatulence
aerophagia.
See a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you take SIMECRIN

Do not take SIMECRIN
if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed
in section 6).
during pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking SIMECRIN.
Do not exceed the recommended doses.

Children
This medicine is not suitable for children as it is available in another form suitable for
administration to children: ask your doctor or pharmacist.

Other medicines and SIMECRIN
No interactions with other medicines are known.
However, tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy and breastfeeding
There are no adequate data on the safety and efficacy of SIMECRIN during pregnancy and breastfeeding, therefore
do not take this medicine if you are in these conditions.
Your doctor may advise you to take SIMECRIN only if considered strictly necessary and after
careful evaluation of the risks and benefits related to its use.

Driving and operating machinery
No known effects.

SIMECRIN contains para-hydroxybenzoates and sodium
Para-hydroxybenzoates may cause allergic reactions (even delayed).
This medicine contains less than 1 mmol (23 mg) of sodium per ml of emulsion, i.e. essentially
‘sodium-free’.

3. How to take SIMECRIN

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-1.5 ml of emulsion (at the end of each main meal).
Withdraw the prescribed amount of emulsion with the measuring syringe attached to the package and disperse it in
a glass of water.

If you take more SIMECRIN than you should
Cases of overdose are not known.
If you accidentally take an excessive dose, contact your doctor immediately or go to the nearest
hospital.

If you forget to take SIMECRIN
Skip the missed dose and do not take a double dose to make up for the missed dose.

4. Possible side effects

No side effects have been reported following the use of SIMECRIN.

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 through 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 SIMECRIN

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

6. Contents of the pack and other information

What SIMECRIN contains
The active ingredient is simethicone. 1 ml of emulsion contains 80 mg of simethicone.
The other ingredients are citric acid monohydrate, sodium citrate, carbomers, sodium saccharin,
hypromellose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, tutti-frutti flavour, purified
water.

Description of the appearance of SIMECRIN and contents of the pack
Fluid emulsion, white in colour, with a mixed fruit odour and flavour.
SIMECRIN is available in 100 ml glass bottle with a dosing syringe.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milano

Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 – Lainate (MI)

SIMECRIN 40 mg chewable tablets, 80 mg chewable tablets, 120 mg chewable tablets

Simeticone

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any of the undesirable effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Talk to your doctor if you do not feel better or if you feel worse after 7 days.

Contents of this leaflet:

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

1. What is SIMECRIN and what is it used for

SIMECRIN contains the active ingredient simeticone, an antimetreotic which works by promoting the elimination of
gases that form in the stomach and intestines.
SIMECRIN is used in adults to treat symptoms in cases of:
gastro-enteric flatulence
aerophagia.
See a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you take SIMECRIN

Do not take SIMECRIN
if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed
in section 6).
during pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking SIMECRIN.
Do not exceed the recommended doses.

Children
The tablets are not indicated for use in children.
This medicine is available in another form suitable for administration to children: ask your
doctor or pharmacist.

Other medicines and SIMECRIN
No interactions with other medicines are known.
However, inform your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy and breastfeeding
There are no adequate data on the safety and efficacy of SIMECRIN during pregnancy and breastfeeding, therefore
do not take this medicine if you are in these conditions.
Your doctor may advise you to take SIMECRIN only if considered strictly necessary and after
careful evaluation of the risks and benefits associated with its use.

Driving and operating machinery
No known effects.

SIMECRIN contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to take SIMECRIN

Take this medicine following exactly as indicated in this leaflet or by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is
SIMECRIN 40 mg: 4 tablets a day (2 at the end of each main meal).
SIMECRIN 80 mg: 2 tablets a day (1 at the end of each main meal).
SIMECRIN 120 mg: 2 tablets a day (1 at the end of each main meal).
The tablets must be chewed.

If you take more SIMECRIN than you should
No cases of overdose are known.
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest
hospital.

If you forget to take SIMECRIN
Skip the missed dose and do not take a double dose to make up for the forgotten tablet.

4. Possible side effects

No side effects have been reported following the use of SIMECRIN.

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 through 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 SIMECRIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in 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 SIMECRIN contains
The active ingredient is simethicone. One tablet contains 40 mg, 80 mg or 120 mg of simethicone.
The other ingredients are mannitol (E421), hydrated colloidal silica, pregelatinized starch, lactose
monohydrate, polyvinylpyrrolidone K 30, crospovidone, talc, magnesium stearate, mint flavour.

Description of the appearance of SIMECRIN and contents of the pack
SIMECRIN 40 mg: chewable round, convex tablets, white in colour with a mint flavour,
available in packs of 50 tablets.
SIMECRIN 80 mg: chewable oblong tablets white in colour with a mint flavour, available in
packs of 30 tablets.
SIMECRIN 120 mg: chewable round, flat tablets, white in colour with a mint flavour, available
in packs of 24 tablets.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan

Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 – Lainate (MI)

SIMECRIN Bambini 66,6 mg/ml oral drops, emulsion

Simeticone

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you would like more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
See a doctor if you do not feel better or if your symptoms worsen after 7 days of
treatment.

Contents of this leaflet:

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

1. What is SIMECRIN and what is it used for

This medicine contains simeticone, an active ingredient that works by eliminating gases that form in the
stomach and intestines (flatulence).
SIMECRIN is used in children and infants who, due to flatulence caused, for example, by a tendency
to swallow air (aerophagia), have bloating, abdominal pain, cramps, belching, and gas.
Consult your doctor if your child does not feel better or if they feel worse after 7 days of treatment.

2. What you need to know before taking SIMECRIN

Do not take SIMECRIN
if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed
in section 6).
during pregnancy.

Warnings and precautions
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment. In case of
persistence or worsening of symptoms or in case of prolonged constipation, the patient should consult the
doctor.
Do not use in case of suspected intestinal perforation or ileus.
Simecrin is used in children and infants.

Other medicines and SIMECRIN
The concomitant use of SIMETICONE and laxatives based on mineral oils (paraffin) is not
recommended, as the combination of these two products reduces their effectiveness.
However, inform your doctor or pharmacist if your child is taking, has recently taken or
may take any other medicine.

Pregnancy and breastfeeding
This medicine is used only in children and infants.
There are no adequate data on the safety and efficacy of SIMECRIN in pregnancy and breastfeeding, therefore
do not take this medicine if you are in these conditions.

Driving and operating machinery
This medicine is used only in children and infants.
No known effects.

SIMECRIN contains sodium and sodium benzoate (E211)
This medicine contains less than 1 mmol (23 mg) of sodium per ml of emulsion, i.e. essentially
‘sodium-free’.
This medicine contains 1 mg of sodium benzoate per ml of emulsion. Sodium benzoate may increase
jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.

3. How to take SIMECRIN

Give this medicine to your child following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 drops (= 0.6 ml) 2-4 times a day, preferably after meals. Do not
exceed the recommended doses.
Method of administration
Shake well before use and disperse the drops in a little water..
Consult your doctor if you do not feel better or if you feel worse after 7 days of treatment.

If you take more SIMECRIN than you should

“In case of ingestion/accidental intake of an excessive dose of Simecrin, immediately notify your

doctor or go to the nearest hospital”.
Paediatric population
Simethicone is a chemically inert substance, pharmacologically inactive and not absorbed by the gastrointestinal tract. Simethicone is also excreted unchanged in the faeces.
Accidental exposure to the product in children has not revealed symptoms in most cases. The
reported symptoms have been mild to moderate in nature and can be explained by the pre-existing condition.

If you forget to take SIMECRIN
Do not administer a double dose to compensate for the forgotten dose. Administer the next dose normally.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if, during the use of Simecrin, you notice the following side effects:

• vomiting, diarrhea, abdominal pain, ileus, nausea
• rashes on the skin;
• swelling of the face, eyes, lips, tongue, or throat with difficulty breathing (angioedema). These effects occur very rarely.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help to provide more information on the safety of this
medicine.

5. How to store SIMECRIN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 SIMECRIN contains
The active ingredient is simeticone. One ml of emulsion contains 66.6 mg of simeticone.
The other ingredients are citric acid monohydrate, sodium citrate, hypromellose, carboxypolymethylene, saccharin, sodium benzoate (E211), sorbic acid, sodium bicarbonate, raspberry essence, concentrated vanilla essence, purified water.

Description of the appearance of SIMECRIN and contents of the pack
Fluid emulsion, white in colour, with a mixed raspberry and vanilla odour and flavour.
SIMECRIN is available in 30 ml glass bottles with a built-in dropper.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milano

Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 – 20045 Lainate (MI)