WindSetlers 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Simeticone

Available from:

Thornton & Ross Ltd

INN (International Name):

Simeticone

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01010100; GTIN: 5011309861211 5011309861310

Patient Information leaflet

PCP HEADER BOX
APPROVED BY DATE
OPERATOR
ARTWORK NO
CRN
FIX
REASON F
SUF
OR
CHANGE
ISSUED BY
DATE
MHRA/IMB
SUBMISSION
REQUIRED
N/A
A
gill.kennedy
527218
11352
Addition of reporting of side
effects statement
MHRA HEADER BOX
PRODUCT TITLE
C
FONTS USED
OLOURS USED
COMPONENT
PACK SIZE
IG CODE
DIMENSIONS
PROOF NO.
DATE
Leaflet
8's/24's
23643604
210 x 148.5mm
2
13.08.2014
Process Black
Keyline (Does not print)
WindSetlers Wasdell
Helvetica
WINDSETLERS
(simeticone)
READ THE LEAFLET BEFORE YOU USE THIS MEDICINE.
IT INCLUDES OTHER INFORMATION WHICH MIGHT BE
ESPECIALLY IMPORTANT FOR YOU.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need any more
information or advice.
• If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
1. WHAT THE MEDICINE IS FOR
The capsules relieve the symptoms of flatulence
(wind), wind pains, a swollen stomach and
other symptoms associated with intestinal gas.
WindSetlers contain simeticone which breaks
down the bubbles of gas in the stomach to help
eliminate gas and ease wind.
2. BEFORE YOU USE THIS
MEDICINE DO NOT USE THE MEDICINE IF YOU OR
YOUR CHILD HAVE….
• An ALLERGY to any of the ingredients listed in
section 6. PREGNANT OR BREASTFEEDING….
Ask your doctor or pharmacist for advice before
using this medicine if you are pregnant, might
be pregnant or are breastfeeding. WindSetlers
should not be used in pregnancy unless the
doctor has told you to do so. IMPORTANT INFORMATION ABOUT SOME
OF THE INGREDIENTS
• This product contains hydroxybenzoates
which may cause allergic reactions (possibly
delayed).
3. HOW TO USE THIS MEDICINE
Take this medicine by mouth. ADULTS, THE ELDERLY AND CHILDREN
• Take one or two capsules 3 or 4 times a day
or as required. IF YOU TAKE TOO MANY
If you accidentally take too many, see a doctor
straight away. Take the pack with you to show
which medicine you have swallowed.
4. POSSIBLE SIDE EFFECTS
There are no known side effects from using this
medicine when used as directed. If

Summary of Product characteristics

OBJECT 1
WINDSETLERS
Summary of Product Characteristics Updated 02-Oct-2014 | Thornton &
Ross Ltd
1. Name of the medicinal product
WindSetlers.
2. Qualitative and quantitative composition
Each Capsules contains simeticone 100mg
Also contains sodium ethyl parahydroxybenzoate (E215) and sodium
propyl parahydroxybenzoate (E217)
For full list of excipients, see section 6.1
3. Pharmaceutical form
Soft gelatin capsules
4. Clinical particulars
4.1 Therapeutic indications
Anti-flatulent defoaming agent for the symptomatic relief of
flatulence, wind pains, bloating, abdominal
distension and other symptoms associated with intestinal gas
4.2 Posology and method of administration
Oral
_Adults, the elderly and children:_
One or two capsules taken 3 or 4 times daily or as required for relief
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
None stated.
4.5 Interaction with other medicinal products and other forms of
interaction
None reported.
4.6. Fertility, pregnancy and lactation
As dimeticone is not absorbed, it is not anticipated that WindSetlers
will have any adverse effects on
pregnancy and lactation. However, as with all drugs, caution should be
exercised in these conditions.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
As dimeticone is not absorbed from the gastro-intestinal tract,
adverse effects attributable to the active
ingredient would not be expected.
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
No cases of overdose have been reported. Theoretically, constipation
may occur. Treat with fluids and
keep under observation.
5. Pharmacological properties
5.1 Pharmacodynamic properties
WindSetlers