Imodium Plus caplets

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: 5027097909967 5027097376516

Patient Information leaflet

_PLUS _
CAPLETS_ _
_Loperamide hydrochloride & Simeticone_
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
®
Plus Caplets 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 caplets are used to treat a short-lived attack of diarrhoea when
it occurs with stomach cramps, bloating and
wind.
The caplets 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 caplets 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 caplets (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 SWO

Summary of Product characteristics

OBJECT 1
IMODIUM PLUS CAPLETS (P)
Summary of Product Characteristics Updated 15-Jun-2017 | McNeil
Products Ltd
1. Name of the medicinal product
Imodium Plus Caplets
2. Qualitative and quantitative composition
Each tablet contains loperamide hydrochloride 2 mg and simeticone
equivalent to 125 mg dimeticone.
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_”_.
4. Clinical particulars
4.1 Therapeutic indications
Imodium Plus Caplets are 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 caplets initially, followed by one caplet after every loose
stool. Not more than 4 caplets should
be taken in a day, limited to no more than 2 days.
_Adolescents between 12 and 18 years_
Take one caplet initially, followed by one caplet after every loose
stool. Not more than 4 caplets should
be taken in a day, limited to no more than 2 days.
_Paediatric population_
Imodium Plus 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 Plus
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 caplets whole with a drink of water.
4.3 Contraindications
- Children less than 12 years of age
- Hypersensitivity to the active substances or to any of the
excipients listed in section 6.1
- Patients with acute dysentery, which is charact