APO-PRAZOSIN prazosin (as hydrochloride) 2mg tablet blister pack

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

prazosin hydrochloride, Quantity: 2.2 mg (Equivalent: prazosin, Qty 2 mg)

Disponible des:

Arrotex Pharmaceuticals Pty Ltd

formulario farmacéutico:

Tablet, uncoated

Composición:

Excipient Ingredients: croscarmellose sodium; lactose monohydrate; polysorbate 80; magnesium stearate; microcrystalline cellulose

Vía de administración:

Oral

Unidades en paquete:

100 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

In patients with hypertension: Prazosin is indicated in the treatment of hypertension of varied aetiology and all grades of severity. It can be used as the initial and sole agent or it may be employed in a general treatment programme in conjunction with other antihypertensive agents. Renal blood flow and glomerular filtration rate are not impaired by long term oral administration. Prazosin can be used with safety in hypertensive patients with impaired renal function. In patients with congestive heart failure: Prazosin is indicated in the treatment of severe refractory congestive heart failure. Prazosin may be added to the therapeutic regimen in those patients who have become refractory to conventional therapy with cardiac glycosides and diuretics. In patients with Raynaud's Phenomenon and Raynaud's Disease: Prazosin is indicated in the treatment of Raynaud's phenomenon and Raynaud's disease. Benign Prostatic Hyperplasia: Prazosin is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia in patients awaiting prostatic surgery.

Resumen del producto:

Visual Identification: Round, white, biconvex tablets, scored and engraved "APO" over "P2" on one side, the other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Estat d'Autorització:

Licence status A

Data d'autorització:

2000-06-19

Informació per a l'usuari

APO- PRAZOSIN TABLETS
_Contains the active ingredient, prazosin hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Prazosin. It contains the active
ingredient, prazosin (as prazosin
hydrochloride).
It is used to treat:
•
high blood pressure
(hypertension)
•
prostate problems, such as benign
prostatic hyperplasia (BPH) in
men waiting for prostate surgery
•
Raynaud's disease, where the
fingers become white and very
painful when cold
•
certain types of heart failure
Prazosin belongs to a group of
medicines called alpha blockers.
It works by relaxing the muscles in
the walls of blood vessels and
making it easier for blood to flow.
They also relax the muscles in the
prostate gland and increase the flow
of urine.
When used to treat high blood
pressure or heart failure, prazosin is
often used together with other
medicines.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription
There is no known evidence to show
that this medicine is addictive.
There is not enough information to
recommend the use of this medicine
in children under the age of 12 years.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
PRAZOSIN
•
RELATED MEDICINES CALLED
QUINAZOLINES
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some of the

Fitxa tècnica

1
AUSTRALIAN PRODUCT INFORMATION
APO-PRAZOSIN (PRAZOSIN HYDROCHLORIDE) TABLET
1
NAME OF THE MEDICINE
Prazosin hydrochloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains prazosin hydrochloride equivalent to 1 mg, 2 mg
or 5 mg prazosin base.
EXCIPIENTS WITH KNOWN EFFECT
lactose monohydrate
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-PRAZOSIN 1 MG TABLETS
Capsule-shaped, white, flat-faced, bevelled-edged tablets scored and
engraved “APO P1" on
one side, other side plain.
APO-PRAZOSIN 2 MG TABLETS
Round, white, biconvex tablets, scored and engraved “APO” over
“P2" on one side, other side
plain.
APO-PRAZOSIN 5 MG TABLETS
Diamond-shaped, white, biconvex tablets, scored and engraved “APO”
over “P5" on one side,
other side plain.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
IN PATIENTS WITH HYPERTENSION
Prazosin is indicated in the treatment of hypertension of varied
aetiology and all grades of
severity. It can be used as the initial and sole agent or it may be
employed in a general
treatment programme in conjunction with other antihypertensive agents.
Renal
blood
flow
and
glomerular
filtration
rate
are
not
impaired
by
long-term
oral
administration. Prazosin can be used with safety in hypertensive
patients with impaired renal
function.
IN PATIENTS WITH CONGESTIVE HEART FAILURE
Prazosin is indicated in the treatment of severe refractory congestive
heart failure. Prazosin
may be added to the therapeutic regimen in those patients who have
become refractory to
conventional therapy with cardiac glycosides and diuretics.
IN PATIENTS WITH RAYNAUD'S PHENOMENON & RAYNAUD'S DISEASE
Prazosin is indicated in the treatment of Raynaud's phenomenon and
Raynaud's disease.
2
BENIGN PROSTATIC HYPERPLASIA
Prazosin is indicated as an adjunct in the symptomatic treatment of
urinary obstruction caused
by benign prostatic hyperplasia in patients awaiting prostatic
surgery.
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL COMMENT
There is evidence that patien