Imodium 2mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Loperamide hydrochloride

Available from:

Janssen-Cilag Ltd

ATC code:

A07DA03

INN (International Name):

Loperamide hydrochloride

Dosage:

2mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01040200; GTIN: 5012674040256 5012674040348

Patient Information leaflet

FACE 1
NOW READ THIS WHOLE LEAFL ET CAREFULLY BEFORE YOU
USE THIS MEDICINE. Keep the leafl et: you might need
it again.
1
WHAT THE MEDICINE IS FOR
IMODIUM
®
Classic 2mg Capsules is used to treat
TWO TYPES OF DIARRHOEA. The two types have
diff erent age limits. SHORT-TERM DIARRHOEA
„ For adults and children aged 12 AND OVER.
„ To treat attacks that last up to 48 HOURS.
„ If your attack lasts longer than 48 hours,
TALK TO YOUR DOCTOR.
IBS DIARRHOEA
„ For adults and young people aged 18 AND OVER
who have been diagnosed with IBS (Irritable
Bowel Syndrome).
„ To treat attacks that last up to 48 HOURS.
„ You can use this medicine FOR UP TO
2 WEEKS for repeated attacks, but if any
one attack lasts continuously for LONGER THAN
48 HOURS, TALK TO YOUR DOCTOR.
The capsules contain _loperamide hydrochloride_,
a substance that helps reduce diarrhoea by slowing
down an overactive bowel. This allows water
and salts that are usually lost in diarrhoea to be
absorbed by the body.
„ This medicine is used for two diff erent types
of diarrhoea. They have DIFFERENT AGE LIMITS.
_See Section 1_ c
„ DO NOT TAKE THIS MEDICINE:
„ There are some PEOPLE WHO SHOULD NOT USE
this medicine. _To fi nd out if you are one of them, _
_see Section 2_ c
„ If you have ever had a BAD REACTION to any
of the ingredients. _For the list of ingredients, _
_see Section 6_ c
„ SPEAK TO YOUR DOCTOR:
„ If you suff er from any of the conditions mentioned
in _Section 2_ c
„ If you are taking any OTHER MEDICINES.
_See Section 2_ c
„ IF YOU HAVE IRRITABLE BOWEL SYNDROME (IBS)
_see also Section 2_ Extra warnings for IBS patients c
„ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
_See Section 3_ c
Always take this medicine exactly as described
in this leafl et or as your doctor or pharmacist has
told you.
2
BEFORE TAKING THIS MEDICINE WARNINGS FOR EVERYONE
This medicine is suitable for most people,
but a few people should not use it: DO NOT TAKE THIS MEDICINE…
„ If you have ever had a BAD REACTION to any
of the ingredients.
„ If it is for a child ag

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Imodium Original 2mg Capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg Loperamide hydrochloride.
Excipient with known effect: lactose
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
Opaque green cap and grey body, hard gelatin capsule imprinted with
‘Imodium’ on cap and ‘Janssen’ on body containing white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children aged
12 years and over.
For the symptomatic treatment of acute episodes of diarrhoea
associated with
Irritable Bowel Syndrome in adults aged 18 years and over following
initial
diagnosis by a doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
ACUTE DIARRHOEA
Adults and children over 12:
2 capsules (4 mg) initially followed by 1 capsule (2 mg) after every
loose stool.
The maximum daily dose should not exceed 6 capsules (12 mg).
SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA
ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS
AGED 18 YEARS AND OVER
Two capsules (4 mg) to be taken initially, followed by 1 capsule (2
mg) after every
loose stool, or as previously advised by your doctor. The maximum
daily dose should
not exceed 6 capsules (12 mg).
_Paediatric population_
Imodium is contraindicated in children less than 12 years of age.
_Elderly_
No dose adjustment is required for the elderly.
_Renal impairment_
No dose adjustment is required for patients with renal impairment.
_ _
_Hepatic impairment_
Although no pharmacokinetic data are available in patients with
hepatic impairment,
Imodium should be used with caution in such patients because of
reduced first pass
metabolism. (see 4.4 Special warnings and special precautions for
use).
Method of administration
Oral use. The capsules should be taken with liquid.
4.3
CONTRAINDICATIONS
This medicine is contraindicated:
•
hypersensitivity to the active substance or to any of the excipients
l