UREX furosemide (frusemide) 40 mg tablet blister pack

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

furosemide, Quantity: 40 mg

Mevcut itibaren:

Arrow Pharma Pty Ltd

Farmasötik formu:

Tablet, uncoated

Kompozisyon:

Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch

Uygulama yolu:

Oral

Paketteki üniteler:

100, 10 tablets (physician's sample)

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

INDICATIONS AS AT 01 JAN 1991 : Oedema : in adults, infants and children 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 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 frusemide may be achieved while thiazides have no effect.

Ürün özeti:

Visual Identification: White, round biconvex tablet. One face plain and other face scored.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Yetkilendirme durumu:

Registered

Yetkilendirme tarihi:

1992-01-17

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