BLOOMS THE CHEMIST TAMSULOSIN SR tamsulosin hydrochloride 400 microgram modified release tablet blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

tamsulosin hydrochloride, Quantity: 400 microgram

Disponible desde:

Southern Cross Pharma Pty Ltd

formulario farmacéutico:

Tablet, modified release

Composición:

Excipient Ingredients: microcrystalline cellulose; polyethylene oxide; magnesium stearate

Vía de administración:

Oral

Unidades en paquete:

30 modified release tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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

Resumen del producto:

Visual Identification: White to off-white round tablets with a diameter of approximately 9 mm, debossed with TSLN on one side and 0.4 on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2020-02-25

Información para el usuario

BLOOMS THE CHEMIST TAMSULOSIN SR
1
BLOOMS THE
CHEMIST TAMSULOSIN
SR
_Contains the active ingredient tamsulosin hydrochloride _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BLOOMS THE
CHEMIST TAMSULOSIN 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, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with our medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
BLOOMS THE CHEMIST
TAMSULOSIN SR is a medicine for
use by men only. Tamsulosin SR 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.
Tamsulosin SR belongs to a group of
medicines called alpha-blockers.
Your doctor has prescribed
Tamsulosin SR for you because you
have symptoms caused by an
enlarged prostate gland. BPH occurs
only in men. It is common in men
over the age of 50 years.
The prostate gland is at the outlet of
your urinary bladder. Because your
prostate has become bigger than it
should be, it is affecting how well
you are able to pass your urine.
This causes some, or all of the
following symptoms:
•
urine flow is slow
•
the urine stream may become a
trickle, or it may stop and start
•
you find a delay when you try to
pass urine, and you must strain to
do so
•
you feel that you cannot empty
your bladder completely
•
you may dribble at the end of
passing urine
•
you need to pass urine often
during the day
•
you need to get up often during
the night to pass urine
•
you feel an urgency to pass urine
as soon as you first feel the need
to do so
These symptoms usually start
gradually and increase in sever

Ficha técnica

AUSTRALIAN PRODUCT INFORMATION
BLOOMS THE CHEMIST TAMSULOSIN SR, (TAMSULOSIN HYDROCHLORIDE)
_ _
1. NAME OF THE MEDICINE
Tamsulosin hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BLOOMS THE CHEMIST TAMSULOSIN SR modified release tablets contain the
active ingredient tamsulosin
hydrochloride.
Each BLOOMS THE CHEMIST TAMSULOSIN SR modified release tablet contains
400 micrograms of
tamsulosin hydrochloride
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
BLOOMS THE CHEMIST TAMSULOSIN SR 400 micrograms tablets are white to
off-white round tablets with a
diameter of approximately 9 mm, debossed with “TSLN” on one side
and “0.4” on the other side.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
For the relief of lower urinary tract symptoms (LUTS) associated with
benign prostatic hyperplasia (BPH).
4.2. DOSE AND METHOD OF ADMINISTRATION
One tablet daily.
The tablet must be swallowed whole and not be broken, crunched or
chewed, as this compromises the
modified release properties of the tablet for the active ingredient.
BLOOMS THE CHEMIST TAMSULOSIN SR 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 α
1
-adrenoceptor inhibitor.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
SYNCOPE AND POSTURAL HYPOTENSION
Patients beginning treatment with Tamsulosin tablets should be
cautioned to avoid situations where injury
could result should syncope occur. Postural hypotension can occur
during treatment with Tamsulosin tablets,
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