Loperamide 2mg tablets

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Loperamide hydrochloride

Доступно од:

DE Pharmaceuticals

АТЦ код:

A07DA03

INN (Међународно име):

Loperamide hydrochloride

Дозирање:

2mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 01040200

Информативни летак

Package leaflet:
Information for the user
LOPERAMIDE 2 MG
TABLETS
loperamide hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need
to read it again.
-
If you have any further
questions, ask your doctor or
pharmacist.
-
This medicine has been
prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of
illness are the same as yours.
-
If you get any side effects, talk
to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What
LOPERAMIDE TABLET
is and
What it is used for
2. What you need to know before
you use
LOPERAMIDE TABLETS
3. How to use
LOPERAMIDE
TABLETS
4. Possible side effects
5. How to store
LOPERAMIDE
TABLETS
6. Contents of the pack and other
information
1.
WHAT LOPERAMIDE TABLET
IS AND WHAT IT IS USED FOR
Loperamide hydrochloride is the
active ingredient of Loperamide
Tablets. The tablets are available in
one strength. Loperamide is one of
a group of medicines called
"antidiarrhoeals" which are
USED TO
TREAT DIARRHOEA.
Loperamide 2 mg tablets are used to
treat sudden short-lived (acute)
attacks of diarrhoea in adults and
children aged 9 years and over and
long-lasting (chronic) diarrhoea in
adults.
The tablets help reduce diarrhoea by
slowing down an overactive bowel,
which helps the body to absorb
water and salts from this organ,
making the stools more solid and
less frequent.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU USE
LOPERAMIDE TABLETS
DO NOT USE LOPERAMIDE TABLETS
-
if you are
ALLERGIC
to loperamide
hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
-
if you have
SEVERE DIARRHOEA
after taking antibiotics
-
if you are having a flare up of an
inflammatory bowel condition
like
ULCERATIVE COLITIS
-
if you are
CONSTIPATED
or your
STOMACH APPEARS SWOLLEN
(particularly in children with
severe dehydration)
-
if you have
ACUTE DYSENTERY
, the
sy

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loperamide 2mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg loperamide hydrochloride.
Excipients
with
known
effect:
each
tablet
contains
100mg
of
lactose
monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Light green coloured capsule shaped, biconvex uncoated tablets, plain
on one side
and score line on other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
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:
Two tablets (4 mg) initially, followed by one tablet (2 mg) after each
loose stool. The
usual dose is 3-4 tablets (6 mg – 8 mg) a day. The total daily dose
should not exceed
6 tablets (12 mg).
SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA
ASSOCIATED WITH IRRITABLE BOWEL SYNDROME IN ADULTS
AGED 18 YEARS AND OVER
Two tablets (4 mg) to be taken initially, followed by 1 tablet (2 mg)
after every loose
stool, or as previously advised by your doctor. The maximum daily dose
should not
exceed 6 tablets (12 mg).
_Paediatric population_
Lopramide 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,
Lopramide 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 tablets should be