SILDENAFIL-DRx Sildenafil (as citrate) 20 mg film coated tablet blister pack

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Kauptu það núna

Opinber matsskýrsla Opinber matsskýrsla (PAR)
28-11-2017

Virkt innihaldsefni:

sildenafil citrate, Quantity: 28.096 mg (Equivalent: sildenafil, Qty 20 mg)

Fáanlegur frá:

Dr Reddys Laboratories Australia Pty Ltd

INN (Alþjóðlegt nafn):

Sildenafil citrate

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; microcrystalline cellulose; calcium hydrogen phosphate dihydrate; hyprolose; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake

Stjórnsýsluleið:

Oral

Einingar í pakka:

90 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

? To treat patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. ? Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. ? The efficacy of sildenafil has not been evaluated in patients currently on bosentan therapy.

Vörulýsing:

Visual Identification: Blue coloured, round film coated tablets with "R" debossed on one side and '372' debossed on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Licence status A

Leyfisdagur:

2012-09-24

Upplýsingar fylgiseðill

                                _SILDENAFIL-DRx 20mg Tablet _
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_Consumer Medicine Information _
_Dr Reddy’s Laboratories Australia Pty Ltd _
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_v2 Feb, 2012 _
SILDENAFIL-DRX
_ Sildenafil Citrate _
CONSUMER MEDICINE INFORMATION
SILDENAFIL-DRx CMI
Page 1 of 5
SILDENAFIL-DRX
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SILDENAFIL-DRx.
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
your
taking
SILDENAFIL-DRx
against the benefits they expect it will
have for you.
It should be used only under strict
medical supervision.
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 SILDENAFIL-DRX
IS USED FOR
SILDENAFIL-DRx
is
used
to
treat
pulmonary arterial hypertension (high
blood pressure in the blood vessels in
the lungs). SILDENAFIL-DRx brings
down the blood pressure by relaxing
these
vessels.
SILDENAFIL-DRx
tablets
contain
the
active
ingredient
sildenafil
(present
as sildenafil citrate)
which belongs to a group of medicines
called
phosphodiesterase
type
5
inhibitors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SILDENAFIL-
DRX HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SILDENAFIL-DRX
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SILDENAFIL-DRX IF:
1. YOU ARE BEING TREATED FOR ANGINA
(CHEST
PAIN),
OR
OTHER
HEART
CONDITIONS,
WITH
CERTAIN
MEDICINES
CALLED NITRATES.
Nitrate
medicines
include
glyceryl
trinitrate (also called nitroglycerin).
Common tradenames include tablets;
such as Anginine and Tridil; patches
such
as
Nitro-Dur,
Nitradisc,
Transiderm-Nitro,
Nitrocor,
Nitroderm TTS and Minitran; sprays
such
as
Nitrolingual
and
injections
such as Nitronal.
Common tradenames for other nitrate
preparations
include
tablets
such
as
Imdur
Durule,
Sorbidin,
Isordil,
Carvasin,
Cora
                                
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