Imodium IBS Relief 2mg capsules

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Loperamide hydrochloride

Disponible desde:

McNeil Products Ltd

Código ATC:

A07DA03

Designación común internacional (DCI):

Loperamide hydrochloride

Dosis:

2mg

formulario farmacéutico:

Oral capsule

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 01040200; GTIN: 3574661187709

Información para el usuario

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„ If your doctor has confi rmed that you have
IRRITABLE BOWEL SYNDROME (IBS), this product
can help you treat attacks of IBS diarrhoea
associated with this condition. _See also _
_Section 2 _Extra Warnings for IBS patients.
„ This medicine can also be used to treat short-
term diarrhoea. The AGE LIMIT and TREATMENT
PERIOD for this is different. _See Section 1 _
„ DO NOT TAKE THIS MEDICINE:
„
There are some PEOPLE WHO SHOULD NOT USE
this medicine. _To find out if you are one of _
_them, see Section 2 _
„
If you have ever had a BAD REACTION to any
of the ingredients. _For the list of ingredients, _
_see Section 6 _
„ SPEAK TO YOUR DOCTOR:
„
If you suffer from any of the conditions
mentioned in _Section 2 _
„
If you are taking any OTHER MEDICINES.
_See Section 2 _
„ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
See Section 3
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE
YOU USE THIS MEDICINE. Keep the leafl et:
you might need it again.
1 WHAT THE MEDICINE IS FOR
IMODIUM
®
IBS Relief 2 mg Soft Capsules
is used to treat TWO TYPES OF DIARRHOEA.
The two types have different age limits.
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.
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.
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.
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 ingred

Ficha técnica

OBJECT 1
IMODIUM IBS RELIEF 2MG SOFT CAPSULES
Summary of Product Characteristics Updated 09-Apr-2018 | McNeil
Products Ltd
1. Name of the medicinal product
Imodium IBS Relief 2 mg Capsules, soft
2. Qualitative and quantitative composition
Each capsule contains 2 mg Loperamide hydrochloride.
Excipient with known effect: Each capsule contains 115.31 mg Propylene
Glycol which is equivalent to
0.65 mg/mg, also contains 0.06 micrograms of soya lecithin.
For a full list of excipients, see Section 6.1.
3. Pharmaceutical form
Capsule, soft (soft capsule).
A clear blue oval soft gelatin capsule.
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
THE CAPSULES SHOULD BE SWALLOWED WHOLE WITH WATER.
ACUTE DIARRHOEA
Adults and children aged 12 years and over:
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).
USE IN 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.
4.3 Contraindications
This medicine is contraindicated:
• in patie