MODIM CAPSULE

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LOPERAMIDE HYDROCHLORIDE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

LOPERAMIDE HYDROCHLORIDE

Unit dalam pakej:

500 Capsules

Dikeluarkan oleh:

Sriprasit Pharma Co. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MODIM CAPSULE
Loperamide Hydrochloride (2 mg)
_ _
1
WHAT IS IN THE LEAFLET
1.
What MODIM is used for
2.
How MODIM works
3.
Before you use MODIM
4.
How to use MODIM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of MODIM
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT MODIM IS USED FOR
MODIM is used for control and symptomatic
relief
of
acute
(sudden,
short
term)
and
chronic (long-term) diarrhoea. In people with
an ileostomy, it can be used to reduce the
number and volume of stools.
HOW MODIM WORKS
MODIM
contains
the
active
ingredient
Loperamide hydrochloride, which belongs to
a group of medicine called Antidiarrheal. It
helps to relieve symptoms of diarrhoea by
making
the
stools
more
solid
and
less
frequent.
BEFORE YOU USE MODIM _ _
-
_When you must not use it_
Do not take MODIM if you:
• are allergic to loperamide hydrochloride or
any other ingredients in the formulation.
• have colon constipation.
• have acute dysentery which is characterized
by blood in stools and high fever.
• have acute inflammation of the colon which
can
be
associated
with
broad
spectrum
antibiotics.
Do not give MODIM to children under 6
years of age.
-
_Before you start to use it _
Tell your doctor if you have allergies to any
other
medicines,
foods,
preservatives
or
dyes.
Please inform your doctor or pharmacist if:
• you suffer from liver problems.
• you are depleting water and salts.
• you have diarrhoea that lasts for more than
48 hours.
• you have AIDS and your stomach becomes
swollen, stop taking MODIM immediately
and contact your doctor.
If you are not sure whether you should start
taking this medicine, talk to your doctor.
-
_Taking other medicines _
Inform your doctor or pharmacist if you are
taking or if you have recently taken any other
medicines,
including
medicines
obtained
without a prescription.
Some medicines and MODIM may interfere
with each other. It is important to tell your
doctor or pharm

Ciri produk

CONTENT
Each capsule contains Loperamide hydrochloride 2 mg.
DESCRIPTION
White granules in green-light green no.4 capsule, imprinted with
“SPS” in white colour on cap and body.
INDICATION
MODIM capsule is used in the symptomatic treatment of acute and
chronic diarrhoea. In patients with ileostomies, MODIM capsule may
be used to control the frequency and fluidity of the stools.
RECOMMENDED DOSAGE
Adults and Children 6 to 17 years
_Acute Diarrhoea_: Initial dose of 2 capsules (4 mg) for adults and 1
capsule (2 mg) for children, followed by 1 capsule (2 mg) after each
loose stool.
_Chronic Diarrhoea_: Initial dose of 2 capsules (4 mg) daily for
adults
and 1 capsule (2 mg) daily for children. Initial dose should be
adjusted until 1 – 2 solid stools a day are obtained. This is
usually
achieved with a maintenance dose of 1 – 6 capsules (2 mg – 12 mg)
daily.
Maximum dose for acute and chronic diarrhoea is 8 capsules (16
mg) daily for adults; in children, it must be related to the body
weight
(3 capsules / 20 kg) but should not exceed a maximum of 8 capsules
per day.
Elderly
No dose adjustment is required for the elderly.
Renal impairment
No dose adjustment is required for patients with renal impairment.
ROUTE OF ADMINISTRATION
For oral administration. Capsules should be taken with liquid.
CONTRAINDICATIONS
MODIM capsules should not be taken in:
•
Patients with known hypersensitivity to loperamide hydrochloride
or to any of the excipients.
•
Children under 6 years of age.
•
When inhibition of peristalsis is to be avoided due to the possible
risk of significant sequelae including ileus, megacolon and toxic
megacolon.
MODIM capsules should not be used as the primary therapy in:
•
Patients with acute dysentery, which is characterized by blood in
stools and high fever.
•
Patients with acute ulcerative colitis.
•
Patients with bacterial enterocolitis caused by invasive organisms
including _Salmonella_, _Shigella_, and _Campylobacter_.
•
Patients with pseudomembranous colitis associated with the use of