CARDURA-XL TABLET 4MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DOXAZOSIN MESYLATE

Boleh didapati daripada:

VIATRIS SDN. BHD.

INN (Nama Antarabangsa):

DOXAZOSIN MESYLATE

Unit dalam pakej:

30 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

PFIZER PHARMACEUTICALS LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CARDURA
®
XL TABLETS
Doxazosin mesylate (4 mg)
1
WHAT IS IN THIS LEAFLET
1.
What CARDURA XL is used for
2.
How CARDURA XL works
3.
Before you use CARDURA XL
4.
How to use CARDURA XL
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
CARDURA XL
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11
Serial Number
WHAT CARDURA XL IS USED FOR
_Hypertension_
CARDURA XL is indicated for the
treatment of hypertension and can be
used as the initial agent to control
blood pressure in the majority of
patients. In patients not adequately
controlled on a single antihypertensive
agent, doxazosin may be used in
combination with another agent such
as a thiazide diuretic, a beta-blocker, a
calcium antagonist or an angiotensin-
converting enzyme inhibitor.
_Benign Prostatic Hyperplasia_
CARDURA XL is indicated for the
treatment of clinical symptoms in
(enlargement of prostate gland)
benign prostatic hyperplasia (BPH)
and for reduced urinary flow
associated with BPH.
CARDURA XL may be used in BPH
patients who are either hypertensive
(high blood pressure) or normotensive
(normal blood pressure). While the
blood pressure changes in
normotensive (normal blood pressure)
patients with BPH are clinically
insignificant, patients with
hypertension (high blood pressure)
and BPH have had both conditions
effectively treated with CARDURA
XL monotherapy.
HOW CARDURA XL WORKS
CARDURA XL can be used to treat
high blood pressure (hypertension), by
relaxing blood vessels so that blood
passes through them more easily. This
helps to lower blood pressure.
Poor and/or frequent urination is
common in patients with enlarged
prostate gland. CARDURA XL works
by relaxing muscle around the bladder
exit and prostate gland so urine is
passed more easily.
BEFORE YOU USE CARDURA XL
-
_When you must not use it_
Do not take CARDURA XL:
If you have had an allergic reaction
in the past to CARDURA XL, the
active ingredient doxazosin, other
types of quinazolin

Ciri produk

1
CARDURA XL*
Doxazosin mesylate GITS
1.
NAME OF THE MEDICINAL PRODUCT
CARDURA XL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: doxazosin
The GITS tablets contain doxazosin mesylate equivalent to 4 mg and 8
mg doxazosin.
3.
PHARMACEUTICAL FORM
Controlled-release tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypertension_
Doxazosin GITS is indicated for the treatment of hypertension and can
be used as the initial
agent to control blood pressure in the majority of patients. In
patients not adequately
controlled on a single antihypertensive agent, doxazosin may be used
in combination with
another agent such as a thiazide diuretic, a beta-blocker, a calcium
antagonist or an
angiotensin-converting enzyme inhibitor.
_Benign Prostatic Hyperplasia_
Doxazosin GITS is indicated for the treatment of clinical symptoms in
benign prostatic
hyperplasia (BPH) and for reduced urinary flow associated with BPH.
Doxazosin GITS may
be used in BPH patients who are either hypertensive or normotensive.
While the blood
pressure changes in normotensive patients with BPH are clinically
insignificant, patients with
hypertension and BPH have had both the conditions effectively treated
with doxazosin GITS
monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Hypertension and Benign Prostatic Hyperplasia_
Doxazosin GITS can be taken with or without food.
The GITS tablets should be swallowed whole with a sufficient amount of
liquid. Patients
should not chew, divide or crush the tablets (see section 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE: _Information for Patients_).
The initial dose of doxazosin GITS is 4 mg once daily. Over 50% of
patients with mild to
moderate severity hypertension will be controlled on doxazosin GITS 4
mg once daily_. _The
optimal effect of doxazosin may take up to 4 weeks. If necessary, the
dosage may be
increased following this period to 8 mg once daily according to
patient response.
The maximum recommended dose is 8 mg once daily.
2
_Use in Elderly_
Normal adult dosage is recommende