CARDURA TABLET 2MG

Ülke: Malezya

Dil: İngilizce

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

Aktif bileşen:

DOXAZOSIN MESYLATE

Mevcut itibaren:

VIATRIS SDN. BHD.

INN (International Adı):

DOXAZOSIN MESYLATE

Paketteki üniteler:

100 Tablets

Tarafından üretildi:

Pfizer Manufacturing Deutschland GmbH.

Bilgilendirme broşürü

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
CARDURA
®
TABLET
Doxazosin mesylate (2 mg)
2
WHAT IS IN THIS LEAFLET
1.
What CARDURA is used for
2.
How CARDURA works
3.
Before you use CARDURA
4.
How to use CARDURA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CARDURA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11
Serial Number
WHAT CARDURA IS USED FOR
_Hypertension_
Doxazosin 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 is also indicated for the
treatment of the blockage in urinary
flow and symptoms associated with
(enlargement of prostate gland in men)
benign prostatic hyperplasia (BPH).
CARDURA may be used in BPH
patients who are either hypertensive
(high blood pressure) or normotensive
(normal blood pressure). While the
blood pressure changes in normal
blood pressure patients with BPH are
clinically insignificant, patients with
high blood pressure and BPH have had
both conditions effectively treated
with doxazosin monotherapy.
HOW CARDURA WORKS
CARDURA is one of a group of
medicines called alpha-blockers.
CARDURA 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. In
patients with an enlarged prostate
gland, CARDURA works by relaxing
muscle around the bladder exit and
prostate gland so urine is passed more
easily.
BEFORE YOU USE CARDURA
-
_When you must not use it_
Do not take CARDURA:

If you have had an allergic
reaction in the past to
CARDURA, the active ingredient
doxazosin, other types of
quinazolines or any of the other
ingredients listed under
�

Ürün özellikleri

2
CARDURA
®
Doxazosin Mesylate
1.
NAME OF THE MEDICINAL PRODUCT
CARDURA
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: doxazosin
The tablets contain doxazosin mesylate salt equivalent to 1 mg, 2 mg
and 4 mg
doxazosin.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Hypertension_
Doxazosin 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 is also indicated for the treatment of the urinary outflow
obstruction and
symptoms associated with benign prostatic hyperplasia (BPH). Doxazosin
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 conditions
effectively treated with
doxazosin monotherapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Doxazosin may be administered either in the morning or in the evening.
_Hypertension_
3
The full dosage range of doxazosin is 1 mg to 16 mg daily. It is
recommended that
therapy be initiated at 1 mg once daily for 1 or 2 weeks to minimize
the potential for
postural hypotension and/or syncope (see section 4.4 SPECIAL WARNINGS
AND
PRECAUTIONS FOR USE). The dosage may then be increased to 2 mg once
daily for an
additional 1 or 2 weeks. If necessary, the daily dosage should then be
increased
gradually at similar intervals to 4 mg, 8 mg, and 16 mg, as determined
by patient
response, to achieve the desired reduction in blood pressure. The
usual dose is 2 mg to
4 mg once daily.
_Benign Prostatic Hyperplasia_
The recommended initial dosage of doxazosin is 1 mg once daily to
minimize the
potential for postural hy