HYDROCHLORZIDE-50 TABLET

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
31-01-2020
Ciri produk Ciri produk (SPC)
04-10-2019

Bahan aktif:

HYDROCHLOROTHIAZIDE

Boleh didapati daripada:

GoodScience Sdn. Bhd.

INN (Nama Antarabangsa):

HYDROCHLOROTHIAZIDE

Unit dalam pakej:

30 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HYDROCHLORZIDE TABLET
Hydrochlorothiazide (25mg, 50mg)
1
WHAT IS IN THIS LEAFLET
What Hydrochlorzide is used for

How Hydrochlorzide works

Before you take Hydrochlorzide

How to take Hydrochlorzide

While you are using Hydrochlorzide

Side effects

Storage and Disposal of Hydrochlorzide

Product description

Manufactured and Product Registration Holder

Date of Revision
_ _
WHAT IS HYDROCHLORZIDE USED FOR
It is used to treat fluid retention (oedema)
and high blood pressure (hypertension).
HOW HYDROCHLORZIDE WORKS
Hydrochlorothiazide belongs to a group of
medicines called thiazide diuretic that acts
directly on the kidney to increase water
excretion and thus decrease blood volume
and pressure of the blood vessels.
BEFORE YOU TAKE HYDROCHLORZIDE
_When you must not take it _
Do not take Hydrochlorzide if you:

are allergic (hypersensitivity) to
Hydrochlorothiazide, other
sulfonamide-derived drugs or any
ingredients in the medicines.

experience absence of urine (anuria).
_ _
_BEFORE START TO TAKE IT _
Tell your doctor or pharmacist if you:

have liver or kidney impairment.

know
you
have
low
electrolyte
(potassium,
sodium,
chloride,
magnesium) level and is dehydrated.

have gout and/or diabetes.

have
autoimmune
disorder
(SLE,
_Systemic lupus erythematosus_
).

are pregnant or plan to pregnant.

are breast feeding or plan to start breast
feeding.
_TAKING OTHER MEDICINES _
Tell your doctor or pharmacist if you are
taking
or
have
recently
taken
alcohol,
barbiturates, narcotics, antidiabetic drugs,
other
hypertensive
drugs,
corticosteroids
and
ACTH,
lithium
including
medicines
obtained without prescription.
HOW TO TAKE HYDROCHLORZIDE
_HOW MUCH TO TAKE _
_Adults _

Oedema: 25 mg to 100 mg once or twice
daily. Maximum dose is 200mg daily.

Hypertension: 25 mg to 50 mg daily.
Maximum dose is 100 mg daily.
_ _
_Children _
2.5mg/kg/day, given in two divided dose.
_ _
_WHEN TO TAKE IT _
Use
as
directed
by
your
doctor

                                
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Ciri produk

                                HY0102/HY0202/HY0203-004
09.19
Important information. Please read carefully.
Tablets
COMPOSITION
Hydrochlorzide-25
Tablet:
Each
tablet
contains
Hydrochlorothiazide
25mg.
Hydrochlorzide-50
Tablet:
Each
tablet
contains
Hydrochlorothiazide
50mg.
PHARMACODYNAMICS
Hydrochlorothiazide is a diuretic which acts by reducing resorption of
electrolytes from renal tubules, thereby increasing excretion of
sodium
and chloride ions and consequently of water. It also reduces carbonic-
anhydrase activity, to increase the excretion of bicarbonate, without
significant change in urinary pH.
Non-melanoma
skin
cancer:
Based
on
available
data
from
epidemiological
studies,
cumulative
dose-dependent
association
between hydrochlorothiazide 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 hydrochlorothiazide use (>50,000 mg cumulative) was
associated with an adjusted OR of 1.29 (95% CI: 1.23-1.35) for BCC and
3.98 (95% CI: 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
hydrochlorothiazide:
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% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for
high
use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose
(~100,000 mg).
PHARMACOKINETICS
Hydrochlorothiazide is fairly rapidly absorbed from the
gastrointestinal
tract. It is reported to have a bioavailability of 65 to 70%. It has
been
estimated to have a plasma half-life of between about 5 and 15 hours
and appears to be preferentially bound to red blood cells. It is
excreted
mainly
unchanged
in
the
urine.
Hydrochlorothiazide
crosses
the
placental barrier and is distributed into breast milk.
INDICATIONS
HYDROCHLORZIDE
is
in
                                
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