Boots Pharmaceuticals Diarrhoea Relief 2 mg Hard Capsules

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

LOPERAMIDE HYDROCHLORIDE

MAH:

Taw Pharma (Ireland) Ltd

ATC_code:

A07DA; A07DA03

INN:

LOPERAMIDE HYDROCHLORIDE

dosage:

2 milligram(s)

pharmaceutical_form:

Capsule, hard

therapeutic_area:

Antipropulsives; loperamide

authorization_status:

Not marketed

authorization_date:

2002-12-06

PIL

INFORMATION FOR THE USER
(New Logo)
Diarrhoea Relief 2 mg Hard Capsules
(Loperamide Hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat a minor
condition. However, you still
need to take it carefully to get the best results from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice
WHAT THIS MEDICINE IS FOR
This medicine contains Loperamide Hydrochloride which belongs to a
group of medicines
called antidiarrhoeals, which act to relieve the symptoms of sudden,
SHORT TERM DIARRHOEA
(“acute” diarrhoea). It works by making the stools (“poo”)
more solid and less frequent.
It can be used to relieve short term diarrhoea in adults and children
aged 12 years and over.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 12 years and
over. However, diarrhoea
is a common symptom of a number of serious stomach and bowel
conditions and therefore
some people should not take this medicine or should seek the advice of
their pharmacist or
doctor first.
X DO NOT TAKE:

IF YOU ARE ALLERGIC to loperamide or to any of the ingredients in this
medicine (see “What is
in this medicine”)

IF YOU ARE HAVING A FLARE UP OF AN INFLAMMATORY BOWEL CONDITION, such
as ulcerative
colitis

IF YOU HAVE very smelly stools, blood or pus in your stools, stomach
pain, or a fever

IF YOU HAVE DYSENTERY (a disease caused by eating and drinking
contaminated food and
water) – you may have a fever and blood in your stools

IF YOU HAVE SEVERE DIARRHOEA AFTER TAKING ANTIBIOTICS

IF YOU HAVE A SWOLLEN STOMACH

IF YOU ARE CONSTIPATED, or have any condition which may cause
constipation or where
constipation should be avoided

IF YOU HAVE paralysis (non movement) of the bowel muscles, or an
obstruction of the bowel

IF YOU HAVE AN INTOLERANCE TO SOME SUGARS, unless your doctor tells
you to (this medicine
contains lactose)


SPC

Health Products Regulatory Authority
05 July 2022
CRN00CY13
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Diarrhoea Relief 2 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
Loperamide Hydrochloride 2 mg per capsule.
Excipients: Each hard capsule contains 101.25 mg lactose monohydrate
and 4.8 microgram Ponceau 4R (E124).
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Capsules, hard (capsule).
Opaque green cap printed 0611 in black ink and opaque grey body.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of acute diarrhoea in adults and
children over 12 years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The capsules should be taken with liquid. For oral administration.
Adults, including the elderly and children over 12 years
The initial dose is 2 capsules (4 mg) followed by 1 capsule (2 mg)
after every subsequent loose stool up to a maximum of five
capsules in 24 hours.
Children under 12 years
Not recommended.
If symptoms persist for more than 24 hours consult your doctor.
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, loperamide HCl should be used with
caution in such patients because of reduced first pass metabolism (see
section 4.4 special warnings and precautions for use).
4.3 CONTRAINDICATIONS
Loperamide HCl is contraindicated in patients with known
hypersensitivity to loperamide HCl or to any of the excipients.
The loperamide HCl capsule should not be used in children under 12
years of age.
Health Products Regulatory Authority
05 July 2022
CRN00CY13
Page 2 of 7
Loperamide HCl should not be used as the primary therapy:
• in patients with acute dysentery, which is characterised by blood
in stools and high fever,
• in patients with acute ulcerative colitis,
• in patients with ba