Simecrin

Package leaflet: Information for the user

SIMECRIN 80 mg/ml Oral emulsion

Simeticone
Please 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 or
pharmacist 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,
contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement 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 taking 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 SIMECRIN is and what it is used for

SIMECRIN contains the active substance simethicone, an anti-foaming agent that works by promoting the elimination of gas formed in the stomach and intestines.
SIMECRIN is used in adults to treat symptoms in cases of:
gastrointestinal flatulence
aerophagia.
Consult your doctor if you do not feel better or feel worse after 7 days.

2. What you need to know before taking SIMECRIN

Do not take SIMECRIN
if you are allergic to the active substance 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 another formulation appropriate for administration in children is available: please consult your doctor or pharmacist.

Other medicines and SIMECRIN
No interactions with other medicines are known.
Nevertheless, 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 strictly necessary and after careful evaluation of the risks and benefits related to its use.

Driving and using machines
No known effects.

SIMECRIN contains parahydroxybenzoates and sodium
Parahydroxybenzoates may cause allergic reactions (including delayed reactions).
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 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 1–1.5 ml of emulsion (after each main meal).
Draw up the prescribed amount of emulsion using the dosing syringe supplied with 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 too much, 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 dose.

4. Possible side effects

No adverse reactions 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, consult your
doctor or pharmacist. You may 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 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 SIMECRIN contains
The active substance is simethicone. 1 ml of emulsion contains 80 mg of simethicone.
The other components 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
White, fluid emulsion with a mixed fruity odour and taste.
SIMECRIN is available in 100 ml amber glass bottles with a dosing syringe.
Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan
Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 – Lainate (MI)

Package leaflet: Information for the user

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

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 or pharmacist has told you to do.
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, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement 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 taking 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 SIMECRIN is and what it is used for

SIMECRIN contains the active substance simethicone, an anti-foaming agent that works by promoting the elimination of gas formed in the stomach and intestines.
SIMECRIN is used in adults to treat symptoms in cases of:
gastro-enteric flatulence
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 SIMECRIN

Do not take SIMECRIN
if you are allergic to the active substance 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 formulation suitable for administration in children: please consult your
doctor or pharmacist.

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

Pregnancy and breastfeeding
There are inadequate 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 strictly necessary and after careful evaluation of the risks and benefits associated with its use.

Driving and using machines
No known effects.

SIMECRIN 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 SIMECRIN

Take 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.
The recommended dose is:
SIMECRIN 40 mg: 4 tablets per day (2 at the end of each main meal).
SIMECRIN 80 mg: 2 tablets per day (1 at the end of each main meal).
SIMECRIN 120 mg: 2 tablets per day (1 at the end of each main meal).
The tablets must be chewed.
If you take more SIMECRIN than you should
Cases of overdose are not 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 contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 carton 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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SIMECRIN contains
The active substance is simethicone. One tablet contains 40 mg, 80 mg or 120 mg of simethicone.
The other components are mannitol (E421), hydrated colloidal silica, pregelatinized starch, lactose monohydrate, polyvinylpyrrolidone K 30, crospovidone, talc, magnesium stearate, peppermint flavor.

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

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

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

Patient Information Leaflet

SIMECRIN Children 66.6 mg/ml oral drops, emulsion

Simeticone
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you would like more information or advice, consult your pharmacist.
If any of the side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if you experience worsening of symptoms 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 taking 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 SIMECRIN is and what it is used for

This medicinal product contains simeticone, an active substance that works by eliminating gas formed in the
stomach and intestines (meteorism).
SIMECRIN is used in children and infants who, due to meteorism caused for example by the tendency to swallow air (aerophagia), experience bloating, abdominal pain, cramps, belching, and flatulence.
Consult your doctor if your child does not feel better or feels 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 substance 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 a doctor.
Do not use in case of suspected intestinal perforation or ileus.
SIMECRIN is used in children and infants.

Other medicines and SIMECRIN
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 might take any other medicines.

Pregnancy and breastfeeding
This medicine is used exclusively in children and infants.
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 such conditions.

Driving and using machines
This medicine is used exclusively 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 exactly as stated in this leaflet or as directed by the doctor or pharmacist. If you have any doubts, consult the doctor or pharmacist.
The recommended dose is 20 drops (= 0.6 ml) 2–4 times daily, preferably after meals. Do not exceed the recommended doses.
Method of administration
Shake well before use and disperse the drops in a small amount of water.
Contact 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 accidental ingestion/overdose of SIMECRIN, 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. The reported symptoms were mild to moderate in nature and could be explained by the pre-existing condition.
If you forget to take SIMECRIN
Do not administer a double dose to make up for the missed dose. Take the next dose as normally scheduled.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Inform your doctor if you notice the following side effects while using Simecrin:

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You may 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 stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SIMECRIN contains
The active substance is simethicone. One ml of emulsion contains 66.6 mg of simethicone.
The other components are citric acid monohydrate, sodium citrate, hypromellose, carbopolymethylene,
saccharin, sodium benzoate (E211), sorbic acid, sodium bicarbonate, raspberry flavour, concentrated
vanilla flavour, purified water.
Description of the appearance of SIMECRIN and contents of the pack
White, fluid emulsion with a mixed raspberry and vanilla odour and flavour.
SIMECRIN is available in a 30 ml glass bottle with an integrated dropper.
Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 - 20136 Milan
Manufacturer
Cosmo S.p.A., Via C. Colombo, 1 – 20045 Lainate (MI)