Loperamide 2mg tablets

Страна: Велика Британія

мова: англійська

Джерело: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активний інгредієнт:

Loperamide hydrochloride

Доступна з:

Waymade Healthcare Plc

Код атс:

A07DA03

ІПН (Міжнародна Ім'я):

Loperamide hydrochloride

Дозування:

2mg

Фармацевтична форма:

Oral tablet

Адміністрація маршрут:

Oral

Клас:

No Controlled Drug Status

Тип рецепту:

Valid as a prescribable product

Огляд продуктів:

BNF: 01040200

інформаційний буклет

1.3.1 - 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LOPERAMIDE 2MG TABLETS
•
This medicine is used for two different types of diarrhoea. They have
DIFFERENT
AGE LIMITS
.
_See Section 1._
•
DO NOT TAKE THIS MEDICINE:
o
There are some
PEOPLE WHO SHOULD NOT USE
this medicine.
_To find out if _
_you are one of then, see section 2. _
o
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:
o
If you suffer from any of the conditions mentioned in Section 2.
o
If you are taking any
OTHER MEDICINES
. See Section 2.
•
IF YOU HAVE IRRITABLE BOWEL SYNDROME (IBS)
_See also Section 2 _
Extra warnings for IBS patients.
•
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY.
See Section 3.
Always take this medicine exactly as described in this leaflet or as
your doctor or
pharmacist has told you.
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE.
Keep the leaflet:
you might need it again.
1.
WHAT LOPERAMIDE TABLETS ARE FOR
Loperamide 2mg Tablets are used to treat
TWO TYPES OF DIARRHOEA
. The two types have
different 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
.
1.3.1 - 2
The tablets 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 YOU TAKE LOPERAMIDE TABLETS
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

Характеристики продукта

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: 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
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 taken with liquid.
4.3
CONTRAINDICATIONS
Loperamide 2mg Tablets are co