UREX FORTE furosemide (frusemide) 500 mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

furosemide, Quantity: 500 mg

Mevcut itibaren:

Arrotex Pharmaceuticals Pty Ltd

INN (International Adı):

furosemide (frusemide)

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: maize starch; magnesium stearate; lactose monohydrate; silicon dioxide; maltodextrin

Uygulama yolu:

Oral

Paketteki üniteler:

50 tablets (E), 50 tablets

Sınıf:

Medicine Registered

Reçete türü:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Terapötik endikasyonlar:

INDICATIONS AS AT 01 JAN 1991 : Frusemide in a high-dosage formulation such as UREX FORTE ( 500 mg tablets ) is intended exclusively for patients with severely impaired renal function. For use under strict medical supervision only within a hospital setting (see Dosage and Administration). High doses of frusemide may be used as an adjuvant treatment of oliguria and in the promotion of diuresis in the treatment of oedema; in selected patients with acute renal failure, e.g. in the post-operative phase and in association with septic infections; in selected patients with chronic renal failure with fluid retention, both in the pre-dialysis phase and when dialysis has become unavoidable, especially in the presence of acute pulmonary oedema; in selected patients with the nephrotic syndrome with severe impairment of renal function e.g. in chronic glomerulonephritis, lupus erythematous and Kimmelstiel-Wilson syndrome. If diuresis is less than 2.5 L / day dialysis has to be used.

Ürün özeti:

Visual Identification: 17/32" diameter, white, round, flat, bevelled edgewith a single break bar on one face.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2012-06-05

Bilgilendirme broşürü

UREX
®
, UREX
®
-M, UREX
®
FORTE - Consumer Medicine Information
Page 1 of 7
UREX
®
-M
UREX
®
UREX
® FORTE
_Furosemide (frusemide) _
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about this
medicine which is available in
tablets of three different
strengths. Urex-M is a 20-mg
tablet, Urex is a 40 mg tablet,
and Urex Forte is a 500 mg
tablet.
It does not contain all of 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 or
your child taking Urex against
the benefits they expect it will
have.
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 UREX IS USED FOR
The active ingredient in Urex is
called frusemide which belongs
to a group of medicines called
diuretics. Diuretics are used to
help the kidneys remove
excess fluid from the body.
Urex is used to treat a number
of medical conditions,
including:
_ _
•
oedema (swelling of the
body, ankles, feet, legs or
even the brain or lungs due
to excess fluid).
This problem can also occur
in cases of heart, liver or
kidney disease.
•
hypertension (high blood
pressure).
This can occur by itself or in
severe heart, liver or kidney
disease.
Everyone has blood pressure.
This pressure helps move your
blood around your body. Your
blood pressure may vary at
different times of the day,
depending on how busy or
worried you are. You have
hypertension (high blood
pressure) when your blood
pressure stays higher than is
needed, even when you are
calm and relaxed.
If high blood pressure is not
treated it can lead to serious
health problems, including
stroke, heart disease and
kidney failure.
Urex may be taken alone or in
combination with other
medicines to treat your
condition.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY UREX
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed

Ürün özellikleri

1
AUSTRALIAN PI – UREX
® (FUROSEMIDE (FRUSEMIDE) 40 MG TABLETS)
UREX
®
-M (FUROSEMIDE (FRUSEMIDE) 20 MG TABLETS)
UREX
® FORTE (FUROSEMIDE (FRUSEMIDE) 500 MG TABLETS)
1
NAME OF THE MEDICINE
Furosemide (frusemide).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Furosemide (frusemide) is an anthranilic acid derivative. Furosemide
(frusemide) is a sulphonamide-
type loop diuretic and occurs as a white to slightly yellow, odourless
crystalline powder with a pKa of
3.9. It is only slightly soluble in water, sparingly soluble in
alcohol and freely soluble in alkali
hydroxides.
Urex tablets are available in 20mg(Urex-M), 40 mg(Urex) and 500 mg
(Urex Forte).
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
UREX
®
- Each tablet contains furosemide (frusemide) 40mg. white round
biconvex tablet, one face
plain and the other face scored with a diameter of 6.6 mm.
UREX
®
-M - Each tablet contains furosemide (frusemide) 20mg. white to
off-white round plain
uncoated tablet.
UREX
®
FORTE - Each tablet contains furosemide (frusemide) 500mg. white round
uncoated tablet,
one face plain, one face with a break-bar.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
1. UREX (FUROSEMIDE (FRUSEMIDE) 40 MG), UREX-M (FUROSEMIDE (FRUSEMIDE)
20 MG):
OEDEMA: in adults, infants and children furosemide (frusemide) is
indicated for the treatment of
oedema associated with congestive heart failure, cirrhosis of the
liver, renal disease including
nephrotic syndrome and other oedematous states amenable to diuretic
therapy.
HYPERTENSION: May also be used alone in the control of mild to
moderate hypertension and in
combination with other antihypertensive agents in the treatment of
more severe cases. Studies have
shown that furosemide (frusemide) is either less effective than or
equally effective as thiazide diuretics
in uncomplicated hypertension. However, in patients with severe renal
function impairment, a diuretic
and antihypertensive response to furosemide (frusemide) may be
achieved while thiazides h