MODURIDE TABLET

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

HYDROCHLOROTHIAZIDE; AMILORIDE HYDROCHLORIDE

Mevcut itibaren:

DUOPHARMA (M) SDN. BHD.

INN (International Adı):

HYDROCHLOROTHIAZIDE; AMILORIDE HYDROCHLORIDE

Paketteki üniteler:

100 Tablets

Tarafından üretildi:

DUOPHARMA (M) SDN. BHD.

Bilgilendirme broşürü

_Consumer Medication Information Leaflet (RIMUP)_
1
MODURIDE TABLET®
Amiloride Hydrochloride/Hydrochlorothiazide (5/50mg)
WHAT IS IN THE LEAFLET?
1.
What MODURIDE is used
for
2.
How MODURIDE works
3.
Before you use MODURIDE
4.
How to use MODURIDE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
MODURIDE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT MODURIDE IS USED FOR
MODURIDE
is
used
to
help
reduce the amount of excess fluid
in the body for people who have:
•
oedema,
swelling
of
the
ankles, feet and legs
•
ascites
due
to
liver
disease,
resulting
in
fluid
accumulation in the stomach
area.
MODURIDE is also used to help
people with hypertension or high
blood pressure.
HOW MODURIDE WORKS
The
combination
of
active
ingredients in MODURIDE work
by
making
your
kidneys
pass
more
water
and
salt
whilst
minimizing potassium loss. This
helps reduce high blood pressure
and
some
forms
of
swelling,
while at the same time helping to
maintain
normal
levels
of
potassium in your blood.
BEFORE YOU USE MODURIDE
-
_When you must not use it_
Do not take MODURIDE if you
have ever had an allergic reaction
to:
•
amiloride hydrochloride
•
hydrochlorothiazide,
sulphonamide
or
sulfur
medicines
Hydrochlorothiazide
is
a
sulfur
containing
medicine
(a
sulfonamide).
Therefore,
if
you
are allergic to sulfur medicines,
such as some antibiotics, you are
likely
to
be
allergic
to
MODURIDE.
Check
with
your
doctor
or
pharmacist
if
you
are
not
sure
whether you are allergic to sulfur
medicines.
•
any of the ingredients listed at
the end of this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing
or
difficulty
in
breathing;
swelling
of the
face,
lips, tongue or any other parts of
the body; rash, itching or hives
on the skin.
Do not take MODURIDE if you
are pregnant or intend to become
pregnant
unless
you
and
your
doctor
have
discussed the
risks
and benefits involved.
It
may
affect
your
developing
baby
if
you
take
it
during
pregnancy.
Do not ta

Ürün özellikleri

[DUOPHARMA (M) SDN BHD]
[Page 1/2]
[Ref.Moduride (12.05.2022)]
MODURIDE TABLET
DESCRIPTION: A 7 mm round, scored tablet, light purple in colour with
markings ‘d’ and ‘DUO 861’.
COMPOSITION: Each tablet contains Amiloride HCl 5 mg,
Hydrochlorothiazide 50 mg.
PHARMACODYNAMICS: CLINICAL PHARMACOLOGY: Moduride provides diuretic
and antihypertensive activity (principally due to the
hydrochlorothiazide component), while acting through the amiloride
component to prevent the excessive potassium loss that may occur in
patients receiving a thiazide diuretic. Due to its amiloride
component, the urinary excretion of magnesium is less with Moduride
than with
a thiazide or loop diuretic used alone. The onset of the diuretic
action of Moduride is within 1 to 2 hours and this action appears to
be sustained for approximately 24 hours.
Non-melanoma skin cancer: Based on available data from epidemiological
studies, cumulative dose-dependent association between HCTZ and NMSC
has been observed. One study included a population
comprised of 71,533 cases of BCC and of 8,629 cases of SCC matched to
1,430,833 and 172,462 population controls, respectively. High HCTZ use
(≥50,000mg cumulative) was associated with an adjusted
OR of 1.29 (95% CI: 1.23-1.35) for BCC and 3.98 (95% Cl: 3.68-4.31)
for SCC. A clear cumulative dose response relationship was observed
for both BCC and SCC. Another study showed a possible
association between lip cancer (SCC) and exposure to HCTZ: 633 cases
of lip-cancer were matched with 63,067 population controls, using a
risk-set sampling strategy. A cumulative dose-response
relationship was demonstrated with an adjusted OR 2.1 (95% Cl:
1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000mg) and
OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000mg).
PHARMACOKINETICS: AMILORIDE HCL: Amiloride HCl usually begins to act
within two hours after an oral dose. Its effect on electrolyte
excretion reaches a peak between 6 and 10 hours and lasts about 24
hours. Peak plasma levels are obtained in 3