Diamide

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Loperamide hydrochloride 2mg

Tillgänglig från:

Viatris Limited

INN (International namn):

Loperamide hydrochloride 2 mg

Dos:

2 mg

Läkemedelsform:

Capsule

Sammansättning:

Active: Loperamide hydrochloride 2mg Excipient: Erythrosine Gelatin   Indigo carmine   Iron oxide black Lactose monohydrate Magnesium stearate Maize starch Opacode Quinoline yellow Titanium dioxide  

Enheter i paketet:

Blister pack, PVC/Al foil, 10 capsules

Klass:

Pharmacy only

Receptbelagda typ:

Pharmacy only

Tillverkad av:

Sicor (Societa Italiana Corticosteroidi) Srl

Terapeutiska indikationer:

DIAMIDE is indicated for the symptomatic control of acute and chronic diarrhoea. In patients with an ileostomy it can be used to reduce the number and volume of stools and to harden their consistency.

Produktsammanfattning:

Package - Contents - Shelf Life: Blister pack, PVC/Al foil - 10 capsules - 60 months from date of manufacture stored at or below 25°C - Blister pack, PVC/Al foil - 20 capsules - 60 months from date of manufacture stored at or below 25°C

Tillstånd datum:

2004-05-20

Bipacksedel

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DIAMIDE
_LOPERAMIDE HYDROCHLORIDE CAPSULES 2 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking DIAMIDE.
This leaflet answers some common
questions about DIAMIDE.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
DIAMIDE against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT DIAMIDE IS
USED FOR
DIAMIDE is used to treat patients
with sudden (acute) or long-lasting
(chronic) diarrhoea. It is also used
to treat diarrhoea in people with an
ileostomy (part of the intestines
removed by surgery).
DIAMIDE contains the active
ingredient loperamide
hydrochloride.
It works by increasing gut transit
time so that food takes longer to
pass through the gastrointestinal
tract. This allows the bowel time to
absorb water and produce a more
solid stool.
Your doctor or pharmacist may
have recommended this medicine
for another reason.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
RECOMMENDED FOR YOU.
This medicine is available from your
pharmacy in limited quantities.
BEFORE YOU TAKE
DIAMIDE
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE DIAMIDE IF:

you are constipated

you have severe diarrhoea
with blood in the stools and
fever

you have ulcerative colitis
(a type of inflammatory
bowel disease)

you have an infection of the
bowel.
DO NOT TAKE DIAMIDE IF YOU
HAVE AN ALLERGY TO:

any medicine containing
loperamide hydrochloride

any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing
or difficulty breathing; swelling
of the face, lips, tongue or other
parts of the body; rash, itc

Produktens egenskaper

Page 1 of 8
NEW ZEALAND DATA SHEET
DIAMIDE
1. PRODUCT NAME
DIAMIDE, 2 mg, capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg of loperamide hydrochloride.
Excipient with known effect: contains lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard gelatin capsule, size 4 mauve opaque body and a dark green opaque
cap marked
“LOPERA-MIDE 2” in white ink, containing a white powder.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
DIAMIDE is indicated for the symptomatic control of acute and chronic
diarrhoea. In patients with an
ileostomy it can be used to reduce the number and volume of stools and
to harden their consistency.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ADULTS AND CHILDREN OVER 12 YEARS OF AGE_
Acute diarrhoea: the initial dose is 2 capsules; followed by 1 capsule
after every subsequent loose
stool.
Chronic diarrhoea: the initial dose is 2 capsules daily; this initial
dose will be adjusted until 1 to 2
solid stools a day are obtained, which is usually achieved with a
maintenance dose of 1 to 6 capsules
daily.
The maximum dose for acute and chronic diarrhoea is 8 capsules daily.
_4.3_
_CONTRAINDICATIONS_
DIAMIDE is contraindicated in patients with known hypersensitivity to
Ioperamide or to any of the
excipients (see section 6.1).
DIAMIDE must not be used:

in patients with acute dysentery, which is characterised by blood in
stools and high fever;

in patients with acute ulcerative colitis;
Page 2 of 8

in patients with bacterial enterocolitis caused by invasive organisms
including _Salmonella, _
_Shigella_ and _Campylobacter;_

in patients with pseudomembranous colitis associated with the use of
broad-spectrum
antibiotics.
In general, DIAMIDE must not be used when inhibition of peristalsis is
to be avoided due to the
possible risk of significant sequelae including ileus, megacolon and
toxic megacolon. DIAMIDE must
be discontinued promptly when constipation, abdominal distension or
ileus develop.
USE IN CHILDREN
DI