Tamsulosin Hydrochloride

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Tamsulosin hydrochloride 0.4mg

Available from:

Douglas Pharmaceuticals Limited

INN (International Name):

Tamsulosin hydrochloride 0.4 mg

Dosage:

0.4 mg

Pharmaceutical form:

Capsule

Composition:

Active: Tamsulosin hydrochloride 0.4mg Excipient: Brilliant blue FCF   Carmoisine Gelatin   Talc (Extragranular ingredients) Ink Iron oxide yellow Magnesium stearate Methacrylic acid - ethyl acrylate copolymer   Microcrystalline cellulose Ponceau 4R Purified talc Quinoline yellow Sodium hydroxide Sunset yellow FCF Titanium dioxide     Triacetin

Units in package:

Blister pack, PVC/PVDC, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sun Pharmaceutical Industries Ltd

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 30 capsules - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PVDC - 90 capsules - 24 months from date of manufacture stored at or below 25°C

Authorization date:

2006-03-09

Patient Information leaflet

New Zealand Consumer Medicine Information
TAMSULOSIN HYDROCHLORIDE CAPSULES
_TAMSULOSIN HYDROCHLORIDE _
_0.4 MG CAPSULES_
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Tamsulosin
Hydrochloride
Capsule.
This leaflet answers some common questions about Tamsulosin
Hydrochloride
Capsule. 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 using
Tamsulosin Hydrochloride Capsule against the benefits they expect it
will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TAMSULOSIN HYDROCHLORIDE CAPSULE IS USED FOR
Tamsulosin is a medicine used by MEN only. It is used in men who have
noncancerous enlargement of the prostate gland. This is a medical
condition called
benign prostatic hyperplasia, also known as BPH.
Tamsulosin is from a group of medicines called alpha-blockers.
Tamsulosin is used for symptoms caused by an enlarged prostate gland.
This occurs
only in men. BPH is common in men over the age of 50 years.
_HOW DOES TAMSULOSIN WORK _
_ _
The prostate gland lies deep in your pelvis, below your bladder. As
your prostate has
become bigger than it should be, it would affect how well you are able
to pass your
urine. This causes some, or all of the following symptoms; they
usually start gradually
and can increase in severity:
1

You feel an urgency to pass urine as soon as you first feel the need
to do so

Urine flow is slow and the stream is poor.

You feel that you cannot empty your bladder completely.

You may dribble at the end of passing urine.

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 have to strain to
do so.

You need to pass urine often during the day.

You need to pass urine often during the night as well.
Whe

Summary of Product characteristics

DATA SHEET
TAMSULOSIN HYDROCHLORIDE 0.4 MG CAPSULES
_TAMSULOSIN HYDROCHLORIDE _
PRESENTATION
Capsule 0.4 mg: a capsule (size #2) with an orange body, brown cap and
imprinted with ‘R’
on cap and ‘TSN400’ on body in black edible ink.
Each capsule contains 0.4 mg tamsulosin hydrochloride equivalent to
0.367 mg tamsulosin,
which can be identified as white to off-white granular beads.
USES
_ACTIONS _
Tamsulosin hydrochloride binds selectively and competitively to
postsynaptic α
1
-
adrenoceptors, particularly to subtypes alpha
1A
and alpha
1D
. It brings about relaxation of
prostatic and urethral smooth muscle.
Tamsulosin Hydrochloride 0.4 mg increases the maximum urinary flow
rate. It relieves
obstruction by relaxing smooth muscle in prostate and urethra.
It also improves the irritative symptoms in which bladder instability
plays an important role.
These effects on storage and voiding symptoms are maintained during
long-term therapy.
The need for surgical treatment is significantly delayed.
Alpha
1
-blockers can reduce blood pressure by lowering peripheral resistance.
No reduction in
blood pressure of any clinical significance was observed during
studies with Tamsulosin
Hydrochloride MR 0.4 mg.
_PHARMACOKINETICS _
ABSORPTION
Tamsulosin is rapidly absorbed from the intestine and is almost
completely bioavailable.
Absorption of tamsulosin is reduced by a recent meal.
The patient always taking TAMSULOSIN HYDROCHLORIDE 0.4 mg capsules
after the same
meal can promote uniformity of absorption.
Tamsulosin shows linear kinetics.
After a single dose of TAMSULOSIN HYDROCHLORIDE 0.4 mg capsules in the
fed state,
plasma levels of tamsulosin peak at around 6 hours and in the steady
state, which is reached
by day 5 of multiple dosing, C
max
in patients is about two-thirds higher than that reached after
a single dose. Although this was seen in elderly patients, the same
finding would also be
expected in young ones.
There is a considerable inter-patient variation in plasma levels both
after single and multiple
dosing.
DISTR