Imodium Dual Action Relief tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride; Simeticone

Available from:

McNeil Products Ltd

INN (International Name):

Loperamide hydrochloride; Simeticone

Dosage:

2mg ; 125mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 3574661044538 3574661609416

Patient Information leaflet

PLEASE READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription. However, you still
need to take IMODIUM
®
Dual Action Relief
Tablets carefully to get the best results.
■
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 symptoms worsen or do not improve
after two days.
■
If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1. What the medicine is for.
2. Before taking this medicine.
3. How to take this medicine.
4. Possible side-effects.
5. Storing this medicine.
6. Further information.
1 WHAT THE MEDICINE IS FOR
The tablets are used to treat a short-lived attack of diarrhoea when
it occurs with stomach cramps, bloating and
wind.
The tablets contain loperamide hydrochloride, which helps reduce
diarrhoea by slowing down an overactive
bowel. It also helps the body to absorb more water and salts from the
bowel. The tablets also contain simeticone,
which breaks up the trapped wind in the bowel that causes cramps and
bloating.
This medicine is for use in adults and children aged 12 years and
over.
2 BEFORE TAKING THIS MEDICINE
This medicine is suitable for most adults and children aged 12 years
and over, but a few people should not use it.
If you are in any doubt, talk to your doctor or pharmacist. DO NOT TAKE THIS MEDICINE…
■
In children less THAN 12 YEARS OLD.
■
If you are allergic (hypersensitive) to loperamide hydrochloride,
simeticone or any of the other ingredients of
the tablets (see section 6).
■
If you have a HIGH TEMPERATURE (e.g. above 38° C) or BLOOD IN YOUR
STOOLS.
■
If you are having a flare up of an INFLAMMATORY BOWEL condition like
ULCERATIVE COLITIS.
■
If you have SEVERE DIARRHOEA after taking antibiotics.
■
If you are CONSTIPATED or your STOMACH APPEARS SWOLLEN.
If any of these apply to you, GET AD

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imodium Dual Action Relief Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains loperamide hydrochloride 2 mg and simeticone
equivalent to
125 mg dimeticone.
_Excipient(s) with known effect _
Each tablet contains less than 0.026 mg of benzyl alcohol and less
than 4.4 mg
of maltodextrin (which contains glucose).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet, uncoated
White, capsule-shaped tablets debossed with “IMO” on one side, the
other side is
debossed with a line between “2”and “125”.
The score line is not intended for breaking the tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imodium Dual Action Relief is indicated for the symptomatic treatment
of acute
diarrhoea in adults and adolescents over 12 years when acute diarrhoea
is associated
with gas-related abdominal discomfort including bloating, cramping or
flatulence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults over 18 years _
Take two tablets initially, followed by one tablet after every loose
stool. Not more
than 4 tablets should be taken in a day, limited to no more than 2
days.
_Adolescents between 12 and 18 years _
Take one tablet initially, followed by one tablet after every loose
stool. Not more than
4 tablets should be taken in a day, limited to no more than 2 days.
_Paediatric population _
Imodium Dual Action Relief is contraindicated in children under12
years (see section
4.3).
_Use in the elderly _
No dosage adjustments are required for the elderly.
_Use in renal impairment _
No dosage adjustment is necessary in patients with renal impairment.
_Use in hepatic impairment _
Although no pharmacokinetic data are available in patients with
hepatic insufficiency,
Imodium Dual Action Relief should be used with caution in such
patients because of
reduced first pass metabolism (see section 4.4).
Method of administration
Swallow the correct number of tablets whole with a drink of water.
4.3
CONTRAINDICAT