INFACOL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DIMETICONE, ACTIVATED

Available from:

Forest Laboratories UK Ltd

ATC code:

A03AX13

INN (International Name):

DIMETICONE, ACTIVATED

Dosage:

40 Milligram

Pharmaceutical form:

Oral Drops Suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

silicones

Authorization status:

Marketed

Authorization date:

1991-02-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use 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.
-
Ask your pharmacist if you need more information or advice.
-
If your baby gets any side effects talk to your doctor or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.
-
You must talk to a doctor if your baby’s symptoms worsen or do not
improve.
WHAT IS IN THIS LEAFLET:
1. What Infacol is and what it is used for
2. What you need to know before you use Infacol
3. How to use Infacol
4. Possible side effects
5. How to store Infacol
6. Contents of the pack and other information
1. WHAT INFACOL IS AND WHAT IT IS USED FOR
Your baby’s medicine is called Infacol. Infacol contains the active
substance simeticone. It is an antiflatulent
which means that it helps to bring up wind or air trapped in the
tummy. Infacol is given to babies to relieve
griping pain, infant colic or wind due to trapped air. The pain
associated with colic may be caused by the
build-up of small gas bubbles trapped in your baby’s tummy.
Simeticone, the active ingredient in Infacol, helps
all the little trapped gas bubbles join into bigger bubbles which your
baby can easily bring up as wind.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE INFACOL
DO NOT USE INFACOL AND GET ADVICE FROM A DOCTOR IF
-
your baby is being treated for a thyroid disorder.
-
you think your baby might be allergic to any of the ingredients of
Infacol (listed in section 6).
OTHER MEDICINES AND INFACOL
Tell your doctor or pharmacist if your baby is taking, has recently
taken or might take any other medicines,
including medicines obtained without a prescription.
If your baby is being treated with levothyroxine for a thyroid
disorder using Infacol might reduce the amount of
this type of medicine that is absorbed and w

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Infacol 40mg/ml Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose of suspension contains 20 mg of Simeticone.
Excipients with known effect:
Methyl hydroxybenzoate (E218) 0.18%w/v
Propyl hydroxybenzoate (E216) 0.02% w/v
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Suspension
Orange – flavoured, colourless, translucent suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
An antiflatulent for the relief of griping pain, colic or wind due to
swallowed air.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_For adults and elderly:_
Not applicable
_For infants:_
20mg (0.5ml). If necessary this may be increased to 40mg (1ml).
Method of administration
Infacol should be administered orally before each feed.
4.3 CONTRAINDICATIONS
None stated.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Methyl and propyl hydroxybenzoates (E218 and E216) which are also
ingredients in Infacol 40mg/ml Oral Suspension,
may cause allergic reactions (possible delayed).
If symptoms persist, seek medical advice.
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4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Levothyroxine may bind to simeticone. Absorption of levothyroxine may
be impaired if Infacol is given concurre