Diamide Relief

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Loperamide hydrochloride 2mg

Available from:

Viatris Limited

INN (International Name):

Loperamide hydrochloride 2 mg

Dosage:

2 mg

Pharmaceutical form:

Capsule

Composition:

Active: Loperamide hydrochloride 2mg Excipient: HEG Gelatin capsule size 4, grey cap and green body Lactose

Units in package:

Blister pack, Clear PVC/Al foil blister; cardboard outer carton; 400 capsules, 400 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Vasudha Pharma Chem Limited

Therapeutic indications:

? The control and symptomatic treatment of acute nonspecific diarrhoea, and of chronic diarrhoea. ? Reducing the volume of discharge in patients with ileostomies, colostomies, and other intestinal resections.

Product summary:

Package - Contents - Shelf Life: Blister pack, Clear PVC/Al foil blister; cardboard outer carton; 400 capsules - 400 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2010-02-10

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
DIAMIDE RELIEF
_LOPERAMIDE HYDROCHLORIDE CAPSULES 2 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking DIAMIDE
RELIEF.
This leaflet answers some common
questions about DIAMIDE RELIEF.
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 has weighed
the risks of you taking DIAMIDE
RELIEF 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
RELIEF IS TAKEN FOR
DIAMIDE RELIEF is taken to treat
patients with sudden (acute) or
long-lasting (chronic) diarrhoea. It is
also used to treat diarrhoea in
people with an ileostomy or
colostomy (part of the intestines
removed by surgery).
DIAMIDE RELIEF 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 may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
DIAMIDE RELIEF
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE DIAMIDE
RELIEF 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
RELIEF 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 o

Summary of Product characteristics

Page 1 of 8
NEW ZEALAND DATA SHEET
DIAMIDE RELIEF
1. PRODUCT NAME
DIAMIDE RELIEF, 2 mg, capsules.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 2 mg of loperamide hydrochloride.
Excipient with known effect: Contains sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard gelatin capsules of size 4 filled with almost white powder. Cap
colour: grey. Body colour: green.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
DIAMIDE RELIEF is indicated for:

The control and symptomatic treatment of acute nonspecific diarrhoea,
and of chronic
diarrhoea.

Reducing the volume of discharge in patients with ileostomies,
colostomies, and other
intestinal resections.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
_ACUTE DIARRHOEA _
The recommended initial dose of DIAMIDE RELIEF in adults is two
capsules (4 mg) followed by one
capsule (2 mg) after each unformed stool. Daily dose should not exceed
eight capsules (16 mg).
Clinical improvement is usually observed within 48 hours.
_CHRONIC DIARRHOEA AND REDUCTION IN VOLUME OF DISCHARGE OF INTESTINAL
RESECTIONS _
The recommended initial dose of DIAMIDE RELIEF is two capsules (4 mg)
followed by one capsule
(2 mg) after each unformed stool until diarrhoea is controlled, after
which dosage of DIAMIDE
RELIEF should be reduced to meet individual requirements. When the
optimal maintenance daily
dosage has thus been established, this amount can then be administered
as a single dose or in two
or three divided doses.
The average daily maintenance dosage in clinical trials was two to
four capsules (4 to 8 mg). A
dosage of five capsules (10 mg) was rarely exceeded. A temporary
exacerbation of diarrhoea was
controlled by increasing the Ioperamide dosage to achieve further
control followed by titration back
to the established maintenance dose.
Page 2 of 8
_SPECIAL POPULATIONS_
USE IN CHILDREN
DIAMIDE RELIEF capsules are contraindicated in children under the age
of 12 years.
METHOD OF ADMINISTRATION
DIAMIDE RELIEF capsules sh