FLOMAXTRA tamsulosin hydrochloride 400 microgram prolonged release tablet blister pack

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

tamsulosin hydrochloride, Quantity: 400 microgram

可用日期:

Astellas Pharma Australia Pty Ltd

INN（国际名称）:

Tamsulosin hydrochloride

药物剂型:

Tablet, modified release

组成:

Excipient Ingredients: colloidal anhydrous silica; macrogol 8000; macrogol 7000000; hypromellose; butylated hydroxytoluene; iron oxide yellow; magnesium stearate

给药途径:

Oral

每包单位数:

30 Tablets, 10 tablets

处方类型:

(S4) Prescription Only Medicine

疗效迹象:

For the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

產品總結:

Visual Identification: 9mm, round, biconvex, yellow, film-coated tablet debossed with '04' on one side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

授权状态:

Registered

授权日期:

2006-01-18

资料单张

FLOMAXTRA
®
F
L
O
M
A
X
T
R
A
®
Prolonged release tablets
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING FLOMAXTRA®?
FLOMAXTRA
®
is used in men who have a medical condition called benign prostatic
hyperplasia (also known as BPH). In BPH the
prostate gland is bigger than normal. BPH is NOT prostate cancer.
FLOMAXTRA
®
belongs to a group of medicines called alpha-blockers.
For more information, see Section 1. Why am I using FLOMAXTRA®? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE FLOMAXTRA
®
?
FLOMAXTRA® is for use by MEN only. If you are a woman or a child, do
not take FLOMAXTRA®. If you are not sure whether you
should start taking FLOMAXTRA® you should contact your doctor.
There are a number of circumstances in which a person should not use
this medicine or may need to use caution. It is important to
understand if these apply to you before taking FLOMAXTRA
®
(see Section 2. What should I know before I use FLOMAXTRA®? in
the full CMI for more details).
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FLOMAXTRA
®
and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE FLOMAXTRA
®
?
The usual dose is one tablet a day.
The tablet should be swallowed whole, preferably with a glass of
water. Do not crunch, bite or chew the tablet.
More instructions can be found in Section 4. How do I use FLOMAXTRA®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING FLOMAXTRA
®
?
THINGS YOU
SHOULD DO
•
If you are about to be started on any new medicine, tell your doctor
and pharmacist that you are taking
FLOMAXTRA
®
.
•
If you are going to have eye surgery for cataracts or glaucoma, please
tell your surgeon that you are
taking or have taken FLOMAXTRA
®
.
THINGS YOU
SHOULD NOT DO
•
Do not give FLOMAXTRA
®
to anyone else, even if they have the same condition

产品特点

1
AUSTRALIAN PRODUCT INFORMATION
FLOMAXTRA
® (TAMSULOSIN HYDROCHLORIDE) PROLONGED
RELEASE TABLETS
1
NAME OF THE MEDICINE
Tamsulosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLOMAXTRA® is a film-coated, prolonged release tablet containing 400
µg tamsulosin hydrochloride, an
α1-adrenoceptor blocking agent, equivalent to 367 µg of tamsulosin
per tablet
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
FLOMAXTRA® is a film-coated, prolonged release tablet.
FLOMAXTRA® tablets are yellow, approximately 9 mm, round, bi-convex,
film-coated and debossed with
the code ‘04’ on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the relief of lower urinary tract symptoms (LUTS) associated with
benign prostatic hyperplasia (BPH).
4.2
D
OSE AND METHOD OF ADMINISTRATION
One tablet daily.
The tablet must be swallowed whole and not be broken, crunched or
chewed, as this compromises the
prolonged release properties of the tablet for the active ingredient.
FLOMAXTRA® can be taken on an empty stomach, or before, with or after
food.
4.3
CONTRAINDICATIONS
•
Hypersensitivity,
including drug-induced angioedema,
to tamsulosin hydrochloride or any other
component of the product.
•
A history of orthostatic hypotension.
•
SEVERE hepatic impairment (Child-Pugh scores >9).
•
SEVERE renal impairment with creatinine clearance of less than
10mL/min.
•
Concurrent use of another

1
-adrenoceptor inhibitor.
2
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
SYNCOPE AND POSTURAL HYPOTENSION
Patients beginning treatment with FLOMAXTRA® tablets should be
cautioned to avoid situations where
injury could result should syncope occur. Postural hypotension can
occur during treatment with
FLOMAXTRA®, but rarely results in syncope. However, the patient
should be warned of this possibility and
advised to sit or lie down if symptoms of hypotension should occur.
EXCLUSION OF PROSTATIC CARCINOMA AND OTHER UROLOGICAL CONDITIONS
Carcinoma of the prostate and other condit