XATRAL XL 10MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ALFUZOSIN

Boleh didapati daripada:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ALFUZOSIN

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

SANOFI WINTHROP INDUSTRIE

Risalah maklumat

_ _
1
_ _
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
XATRAL
® XL TABLET
_ _
Alfuzosin (10mg)
_ _
WHAT IS IN THIS LEAFLET
1. What Xatral XL is used for
2. How Xatral XL works
3. Before you use Xatral XL
4. How to use Xatral XL
5. While you are using it
6. Side effects
7. Storage and Disposal of Xatral XL
8. Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT XATRAL XL IS USED FOR
-Xatral XL can be used to treat the
symptoms of
BENIGN PROSTATIC
HYPERPLASIA.
This is when the prostate
gland enlarges (hyperplasia), but the
growth is not cancerous (it is benign).
It can cause problems in passing water
(urine).
-Xatral XL can be used as adjuvant
treatment to catheter in
ACUTE URINARY
RETENTION
related to benign prostatic
hypertrophy.
HOW XATRAL XL WORKS
•
Xatral
belongs
to
a
group
of
medicines called alpha-blockers.
• The prostate gland lies underneath the
bladder. It surrounds the urethra. This
is the tube that takes your water to the
outside of the body.
• If the prostate gets bigger, it presses
on the urethra making it narrower. This
makes it difficult to pass water.
• Your tablets work by relaxing the
prostate gland muscle. This allows the
urethra to get wider and so makes it
easier to pass water.
In a few individual with benign
prostatic hyperplasia, the prostate gland
gets so big that it stops the flow of
urine completely.
This is called Acute Urinary Retention.
• This is very painful and you may need
a short stay in hospital.
• A thin, flexible tube (catheter) is
passed into the bladder. This drains the
water and relieves the pain.
• During this time, Xatral XL may be
used to help the water to flow again.
BEFORE YOU USE XATRAL XL
-
_When you must not use it _
Do not take Xatral XL if:
• You are allergic (hypersensitive) to
alfuzosin and/or any of the other
ingredients of Xatral XL (listed in
section ingredients below)
-Signs of an allergic reaction include: a
rash, swallowing or breathing
problems, swelling of your lips, throat,
or tongue.
• You

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QUALI TA TIVE AND QUANTI TA TIVE COMPOSITION
Eac h prolon ged release tablet contains Alfuzosin hyd rochloride 10mg
PHARMACEUTICAL FORM
Round, biconvex 3 -layer tablets: one white layer between two yellow layers
CLINICAL PARTICULARS
Therapeutic indications
 Treatment of the functional symptoms of benign prost atic hype rtroph y
 Adjuvan t treatmen t to a cathete r in acut e urina ry retention related to benign
prost atic hype rtroph y
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
The tablet must be swallow ed whole with a glass of water (see Special wa rnings and precautions for
use). The recommended dosage is one 10mg tablet per day, to be taken immedi ately after the evening
meal
Adjuvant treatment to a catheter in acute urina ry retention related to benign prost atic
hyper trophy:
The recommended dosa ge is one 10mg tablet per day, to be taken after a meal, from the first day of
catheteriz ation o nwa rds. The treatment is administe red for 3 to 4 days, i.e. 2 to 3 days while the
catheter is in place and one day after it is removed
CONTRAINDICATIONS
This medicinal product must not be administe red in the following situ ations:
 hype rsensit ivity to alfuzosin and/or any of the other ingredients
 postural hypotension
 liver failu re
 severe kidn ey failu re (creatinine clearance < 30 ml/min)
 in combination with potent CYP3A4 inhibitors (See Section Interactions)
 in combination with ombitasvir and paritaprevir (See Section Interaction s)
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
This medicinal product must be used with caution in patients treated with antihypertensives or nitrate derivatives. Use of this
medicinal product is not recommended with antihypertensive alpha -blockers.
Som e patients may experienc e postura l hypotensio n withi n a few hou rs following administr ation, possib ly
with symptoms (dizzy spells , fatigu e, sweating). If this occu rs, patients should remain lying down until the
symptoms have complete ly subsided.