Patient Information Leaflet

MYLICON Children's Oral Drops Solution

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 of treatment.

Contents of this leaflet:

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

1. What MYLICON is and what it is used for

This medicinal product contains simethicone, an active ingredient that works by eliminating gas that forms in the
stomach or intestine (flatulence).
MYLICON is used in children and infants who, due to flatulence 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 MYLICON

Do not take MYLICON

if you are allergic to simethicone or to any of the other ingredients of this medicine (listed in section 6);

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

Other medicines and MYLICON
Concomitant use of SIMETHICONE and mineral oil-based laxatives (paraffin) is not recommended, as the combination of these two products reduces their effectiveness.
Always 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 intended for use in children and infants only.

Driving and use of machines
This medicine is intended for use in children and infants only.

Important information about some excipients:
MYLICON contains:

0.6 mg of sodium benzoate per dose (20 drops), equivalent to 0.17 mg/kg in a 3.5 kg newborn and 0.03 mg/kg in a 20 kg child. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4 weeks of age.
less than 1 mmol of sodium (23 mg) per dose (20 drops), i.e. essentially 'sodium-free'.

This medicine also contains “raspberry essence” and “concentrated vanilla essence”, which in turn contain:

0.7025 mg of propylene glycol per single dose (20 drops), equivalent to 1.17 mg/ml. If the child is less than 4 weeks old, speak with your doctor or pharmacist before administering this medicine, especially if the child is taking other medicines containing propylene glycol or alcohol.
0.174 mg of alcohol (ethanol) in each single dose (20 drops), equivalent to 0.290 mg/ml. The amount in this medicine is equivalent to less than 0.00435 ml of beer or 0.00174 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.

3. How to take MYLICON

Give this medicine to your child exactly as described in this leaflet or as directed 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 daily, preferably after meals. Do not exceed the recommended doses.
Method of administration
Shake well before use. The drops should be taken with 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 MYLICON than you should
"In case of accidental ingestion/overdose of Mylicon, 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. Reported symptoms have been mild to moderate in nature and can be explained by the pre-existing condition.
If you forget to take MYLICON
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 everyone gets them.
Tell your doctor if you notice the following side effects while using MYLICON:

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, talk to 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 MYLICON

This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the bottle. 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. Package contents and other information

What MYLICON contains
The active substance is: simethicone.
1 ml of solution contains 66.6 mg of simethicone.
The other components are: citric acid monohydrate; sodium citrate; methylhydroxypropylcellulose;
carboxypolymethylene; saccharin; sodium benzoate; sorbic acid; sodium bicarbonate; raspberry flavour;
concentrated vanilla flavour; purified water.

Description of the appearance of MYLICON and contents of the pack
MYLICON is a solution contained in a 30 ml glass dropper bottle.

Marketing Authorization Holder
Johnson & Johnson S.p.A. Via Ardeatina km 23,500 - 00071 Santa Palomba - Pomezia, ROME.

Manufacturer
McNEIL IBERICA S.L.U.
Antigua Ctra. N. II, km 32,800, Alcalá de Henares, 28805 Madrid (Spain)

Health Education Advice
What to do in case of digestive problems?

Indigestion:
You may experience digestive problems if:

you eat too much;
you eat a fatty meal;
you eat too quickly, without chewing properly. Try to avoid these triggering factors.

Gas (flatulence):
Gas accumulation is more likely after certain meals because:

they already contain air (e.g. carbonated drinks, fresh bread);
they contain high levels of carbohydrates that are not absorbed (e.g. dried legumes, cabbage, raw vegetables, onions). Try to avoid these foods. Consult your doctor or pharmacist if you need further information.