Loperamide 2mg capsules

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Loperamide hydrochloride

Commercializzato da:

DE Pharmaceuticals

Codice ATC:

A07DA03

INN (Nome Internazionale):

Loperamide hydrochloride

Dosaggio:

2mg

Forma farmaceutica:

Oral capsule

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 01040200

Foglio illustrativo

PACKAGE LEAFLET:
INFORMATION FOR THE USER
LOPERAMIDE 2 MG
HARD CAPSULES
loperamide
hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING 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 is and
what it is used for
2.
What you need to know
before you take Loperamide
3.
How to take Loperamide
4.
Possible side effects
5.
How to store Loperamide
6.
Contents of the pack and
other information
1. WHAT LOPERAMIDE IS AND
WHAT IT IS USED FOR
This medicine contains
Loperamide which helps to stop
diarrhoea by making the stools
more solid and less frequent.
This medicine is used for the
treatment of sudden short-lived
(acute) attacks of diarrhoea in
adults and children over 12 years
of age.
PLEASE NOTE THAT THIS MEDICINE
ONLY RELIEVES THE SYMPTOMS OF
DIARRHOEA AND IT IS IMPORTANT
TO DRINK SUFFICIENT FLUID TO
REPLACE THE WATER LOST IN THE
LOOSE STOOLS.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU TAKE
LOPERAMIDE
DO NOT TAKE LOPERAMIDE:
-
You are allergic to loperamide
or to any of the other
ingredients in this medicine
(listed in section 6).
-
You suffer from colitis
(inflammation of the colon)
or any other inflammatory
bowel disease, such as
ulcerative colitis.
-
You have severe diarrhoea
after taking antibiotics.
-
You have a swollen stomach
or tummy, and/or constipation.
-
You are suffering from acute
dysentery the symptoms of
which may include blood
in your stools and a high
temperature.
-
if it is for a child aged below 12
If any of these apply to you,
get advice from a doctor or
pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or phar

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Loperamide 2mg Capsules
Numark Diarrhoea Relief 2 mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Loperamide Hydrochloride
2mg
3
PHARMACEUTICAL FORM
Capsules, hard
Green and grey hard capsules marked with ‘Max’ on the green cap
and ‘Lop’ on the
grey body.
For a full list of excipients, see section 6.1.
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 (IBS) in adults aged 18 years and over following
initial diagnosis
by a doctor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The capsules should be taken with liquid. For oral administration.
A) ACUTE DIARRHOEA
Adults and children over 12 years of age
Two capsules (4mg) initially followed by 1 capsule (2mg) after every
loose stool
(motion). The usual dose is 3-4 capsules (6mg – 8mg) a day. The
total daily dose
should not exceed 6 capsules (12mg).
B) SYMPTOMATIC TREATMENT OF ACUTE EPISODES OF DIARRHOEA ASSOCIATED
WITH
IRRITABLE BOWEL SYNDROME IN ADULTS AGED 18 YEARS AND OVER.
Two capsules (4mg) to be taken initially, followed by 1 capsule (2mg)
after ever
loose stool (motion), or as previously advised by your doctor. The
maximum daily
dose should not exceed 6 capsules (12mg).
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,
Loperamide Hydrochloride should be used with caution in such patients
because of
reduced first pass metabolism. (see 4.4 Special warnings and special
precautions for
use).
4.3
CONTRAINDICATIONS
This medicine is contraindicated:
•
In patients with known hypersensitivity to Loperamide hydrochloride or
to
any of the excipients.
•
In children less than 12 years of age