Infacol 40mg/ml oral suspension

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simeticone

Available from:

Teva UK Ltd

INN (International Name):

Simeticone

Dosage:

40mg/1ml

Pharmaceutical form:

Oral suspension

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010100; GTIN: 5014398000042 5017007600848 5017007600855

Patient Information leaflet

Page 1 of 2
SIMETICONE 40 MG PER 1 ML ORAL SUSPENSION
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOUR BABY.
–
Keep this leaflet. You may need to read it again.
–
Ask your pharmacist if you need more information or advice.
–
You must contact a doctor if your baby’s symptoms worsen or do not
improve.
–
If any side effects occur, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Infacol is and what it is used for
2. Before you give Infacol
3. How to give Infacol
4. Possible side effects
5. How to store Infacol
6. Further information
1. WHAT INFACOL IS AND WHAT IT IS USED FOR
Your baby’s medicine is called Infacol. 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. It can be given from birth onwards. 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. BEFORE YOU GIVE INFACOL
Do not give Infacol and get advice from a doctor if your baby is being
treated for a thyroid
disorder.
Do not give Infacol if you think your baby might be allergic
(hypersensitive) to any of the
ingredients of Infacol (see section 6 of this leaflet).
USING OTHER MEDICINES
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 weaken
the effect of their
treatment.
3. HOW TO GIVE INFACOL
Follow the instructions about when and how to use the product. You
should check with
your doctor or pharmacist if you are not sure.
DOSE
Infacol is very simple to give, even when your baby is crying. The
normal dose is one
dropper full (0.5ml) which should be given before each feed. If after
3 or 4 days your b

Summary of Product characteristics

OBJECT 1
INFACOL
Summary of Product Characteristics Updated 05-Feb-2018 | Teva UK
Limited
1. Name of the medicinal product
INFACOL
2. Qualitative and quantitative composition
Active ingredient:
Simeticone 40mg/ml
Excipients:
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
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
For adults and elderly:
Not applicable.
For infants:
20mg (0.5ml) administered before each feed. If necessary this may be
increased to 40mg (1ml).
Treatment with Infacol may provide a progressive improvement in
symptoms over several days.
4.3 Contraindications
None stated
4.4 Special warnings and precautions for use
The parahydrobenzoates used in Infacol may cause delayed
hypersensitivity reactions.
If symptoms persist, seek medical advice.
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
concurrently to infants treated for thyroid disorders.
4.6 Pregnancy and lactation
Not applicable
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
None stated.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard.
4.9 Overdose
In the event of deliberate or accidental overdose, treat symptoms on
appearance.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Physiologically the active ingredient is a chemically inert,
non-systemic gastric defoaming agent that
works by altering the elasticity of