MINIPRESS TABLET 1MG

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

PRAZOSIN HYDROCHLORIDE

Sẵn có từ:

PFIZER (MALAYSIA) SDN. BHD.

INN (Tên quốc tế):

PRAZOSIN HYDROCHLORIDE

Các đơn vị trong gói:

100 Tablet Tablets

Sản xuất bởi:

PHARMANIAGA MANUFACTURING BERHAD

Tờ rơi thông tin

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MINIPRESS
®
TABLET
Prazosin Hydrochloride (1 mg, 2 mg & 5 mg)
WHAT IS IN THIS LEAFLET?
1.
What MINIPRESS is used for
2.
How MINIPRESS works
3.
Before you use MINIPRESS
4.
How to use MINIPRESS
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
MINIPRESS
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT MINIPRESS IS USED FOR
MINIPRESS is one of a group of
medicines called alpha-blockers.
It is usually used to treat high blood
pressure (hypertension). It may also be
used to treat heart failure (left ventricle-
related), painful cold fingers (Raynaud’s
Disease) or mild enlargement of the
prostate gland (Benign prostatic
hyperplasia) in men.
HOW MINIPRESS WORKS
In patients with high blood pressure
(hypertension) MINIPRESS works by
relaxing blood vessels (more on
peripheral vessels) so that blood passes
through them more easily. It can be used
alone or in combination with other drugs
used to treat hypertension.
In patients with heart failure,
MINIPRESS works by relaxing the main
blood vessels of the heart, allowing the
heart to pump blood more easily.
MINIPRESS is usually used in heart
failure when other drugs are either no
longer working or have not worked at all.
In patients with Raynaud’s Disease, the
treatment relaxes blood vessels in the
hands, so blood can reach the fingers
more easily. This helps to prevent
coldness and stiffness.
In patients with Benign Prostatic
Hyperplasia, enlargement of the prostate
gland, the medicine is taken to treat the
poor and/or frequent passing of urine.
This is common in patients with
enlargement of the prostate gland. The
treatment works by relaxing muscle
around the bladder and prostate gland so
urine can pass through easily.
You should ask your doctor if you are
unsure why you have been given
MINIPRESS.
BEFORE YOU USE MINIPRESS
- _ When you must not use it _
Do not take MINIPRESS if you:
•
are allergic (hypersensitive) to

Đặc tính sản phẩm

1
PFIZER CONFIDENTIAL
PHARMANIAGA
LPD Title
: MINIPRESS
LPD Date
: 6 January 2015
Country
: Malaysia
References
: CDS version 4 dated 11 November 2014
Reason
: Per RMC of Sep 8, priapism is being added to section 4.4 of the
Prazosin
tablets/capsules CDS. Note that priapism is a listed event in section
4.8 of the
CDS and currently is not included in section 4.4 of the CDS.
Additionally,
format/editorial changes per recent QC review are being made. For
details about
the impact of the CDS-driven changes into the USPI refer to the GLDD
prepared
for the USPI in the widget related documents tab in the GDMS homepage
of the
newly revised USPI.
PFIZER
MINIPRESS*
Prazosin Hydrochloride
1.
NAME OF THE MEDICINAL PRODUCT
MINIPRESS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prazosin hydrochloride tablet contains the equivalent of 1 mg, 2
mg or 5 mg of
prazosin-free base.
3.
PHARMACEUTICAL FORM
Tablets
Minipress 1 mg Tablet:
Orange, round, biconvex tablet with ‘K’ breakline ‘K’ on one
side and Pfizer logo on the
other.
Minipress 2 mg Tablet:
White, round, biconvex tablet with ‘K’ breakline ‘K’ on one
side and Pfizer logo on the
other.
Minipress 5 mg Tablet:
White, diamond shaped tablet with ‘K’ breakline ‘K’ on one
side and ‘MNP’ breakline
‘5’ on the other.
2
PFIZER CONFIDENTIAL
PHARMANIAGA
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
_ _
_Hypertension _
Prazosin hydrochloride is indicated in the treatment of all grades of
essential (primary)
hypertension and all grades of secondary hypertension of varied
etiology. It can be used as
the initial and sole agent or it may be employed in a treatment
program in conjunction with a
diuretic and/or other antihypertensive drugs, as needed, for proper
patient response.
_ _
_Left Ventricular Failure _
Prazosin hydrochloride is indicated in the treatment of left
ventricular failure. Prazosin
hydrochloride may be added to the therapeutic regimen in patients who
have not shown a
satisfactory response or who have become refractory to conventional
t