TAMSULOSIN SANDOZ SR tamsulosin hydrochloride 400 microgram prolonged release tablet

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

tamsulosin hydrochloride, Quantity: 400 microgram

Saatavilla:

Sandoz Pty Ltd

INN (Kansainvälinen yleisnimi):

Tamsulosin hydrochloride

Lääkemuoto:

Tablet, modified release

Koostumus:

Excipient Ingredients: quinoline yellow; purified talc; polyethylene oxide; cochineal; microcrystalline cellulose; magnesium stearate; hyprolose; butylated hydroxytoluene; macrogol 400; titanium dioxide; iron oxide black; hypromellose; colloidal anhydrous silica

Antoreitti:

Oral

Kpl paketissa:

30, 10

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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

Tuoteyhteenveto:

Visual Identification: Brown, round, biconvex film-coated tablets with debossing '0.4' on one side and 'SZ' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2013-03-06

Pakkausseloste

TAMSULOSIN SANDOZ
®
SR
1
TAMSULOSIN SANDOZ
®
SR
_tamsulosin hydrochloride modified release tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Tamsulosin Sandoz
SR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TAMSULOSIN
SANDOZ SR IS USED
FOR
TAMSULOSIN SANDOZ SR IS FOR USE
BY MEN ONLY.
This medicine is used for the relief of
lower urinary tract symptoms
(LUTS) associated with a condition
called benign prostatic hyperplasia
(BPH). BPH is NOT prostate cancer.
BPH is a condition where your
prostate gland (which is near your
bladder) has become bigger making
it more difficult for you to pass urine.
This can lead to symptoms such as:
•
weak or interrupted stream of
urine
•
delay before you start to pass
urine, and you have to strain to do
so.
•
feeling that you cannot empty
your bladder completely
•
may dribble at the end of passing
urine.
•
needing to pass urine often,
especially at night
•
feeling that you must pass urine
right away.
BPH occurs only in men and is
common over the age of 50 years. In
some men, BPH can lead to serious
problems, including urinary tract
infections and the sudden inability to
pass urine at all.
This medicine contains the active
ingredient tamsulosin hydrochloride.
Tamsulosin hydrochloride belongs to
a group of medicines called alpha-
blockers.
Tamsulosin Sandoz SR works by
helping relax the smooth muscles in
the prostate, in that way it improves
the flow of urine, thus relieving the
pain when passing urine.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescri

Valmisteyhteenveto

190815-Tamsulosin Sandoz SR-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
TAMSULOSIN SANDOZ
®
SR
(TAMSULOSIN HYDROCHLORIDE)
MODIFIED RELEASED TABLETS
1
NAME OF THE MEDICINE
Tamsulosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tamsulosin Sandoz SR 400 µg modified release tablet contains 400
µg tamsulosin
hydrochloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tamsulosin Sandoz SR 400 µg are brown, round, biconvex film-coated
tablets with debossing
‘0.4’ on one side and ‘SZ’ on the other 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
DOSAGE
One tablet daily.
METHOD OF ADMINISTRATION
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.
Tamsulosin Sandoz SR can be taken on an empty stomach, or before, with
or after food.
4.3
C
ONTRAINDICATIONS
•
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 10 mL/min.
•
Concurrent use of another
α
1
-adrenoceptor inhibitor.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
SYNCOPE AND POSTURAL HYPOTENSION
Patients beginning treatment with Tamsulosin Sandoz SR tablets should
be cautioned to avoid
situations where injury could result should syncope occur. Postural
hypotension can occur
during treatment with Tamsulosin Sandoz SR, but rarely results in
syncope. However, the
190815-Tamsulosin Sandoz SR-pi
Page 2 of 13
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 o