BTC TAMSULOSIN 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

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:

Registered

Valtuutus päivämäärä:

2022-09-19

Pakkausseloste

BTC Tamsulosin SR®
1
BTC TAMSULOSIN®
SR
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 BTC TAMSULOSIN SR?
BTC Tamsulosin SR contains the active ingredient tamsulosin and
belongs to a group of medicines called alpha-blockers. BTC
Tamsulosin SR is used in men who have a medical condition called
benign prostatic hyperplasia (also known at BPH). In BPH
the prostate gland is bigger than normal. BPH is NOT prostate cancer.
For more information, see Section
1. Why am I using BTC
Tamsulosin SR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BTC TAMSULOSIN SR?
BTC Tamsulosin SR is for use by MEN only. If you are a woman or a
child, do not take BTC Tamsulosin SR. If you are not sure
whether you should start taking BTC Tamsulosin SR, 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 your before taking BTC
Tamsulosin SR.
Do not use BTC Tamsulosin SR if you have ever had an allergic reaction
to tamsulosin or any of the ingredients listed at the end
of the CMI. For more information, see Section 2. What should I know
before I use BTC Tamsulosin SR?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BTC Tamsulosin SR 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 BTC TAMSULOSIN SR?
•
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 BTC
Tamsulosin SR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BTC TAMSULOSIN SR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BTC Tamsulosin SR or if you are
about to

Valmisteyhteenveto

220919-BTC Tamsulosin SR-pi
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION
BTC TAMSULOSIN
®
SR
(TAMSULOSIN HYDROCHLORIDE) MODIFIED
RELEASED TABLETS
1
NAME OF THE MEDICINE
Tamsulosin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BTC Tamsulosin 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
BTC Tamsulosin 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.
BTC Tamsulosin 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 BTC Tamsulosin SR tablets should be
cautioned to avoid
situations where injury could result should syncope occur. Postural
hypotension can occur
during treatment with BTC Tamsulosin SR, but rarely results in
syncope. However, the patient
220919-BTC Tamsulosin SR-pi
Page 2 of 13
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