Sildenafil 50mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Sildenafil citrate

Fáanlegur frá:

Milpharm Ltd

ATC númer:

G04BE03

INN (Alþjóðlegt nafn):

Sildenafil citrate

Skammtar:

50mg

Lyfjaform:

Tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 07040500

Upplýsingar fylgiseðill

READ ALL OF THIS LEAFLET
CAREFULLY BEFORE
YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You
may need to read it
again.
-
If you have any
further questions,
ask your doctor or
pharmacist.
-
This medicine has
been prescribed for
you only. Do not pass
it on to others. It may
harm them, even if
their signs of illness
are the same as
yours.
-
If you get any side
effects, talk to your
doctor or pharmacist.
This includes any
possible side effects
not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sildenafil is and
what it is used for
2.
What you need to
know before you take
Sildenafil
3.
How to take Sildenafil
4.
Possible side effects
5.
How to store
Sildenafil
6.
Contents of the pack
and other information 1.
WHAT SILDENAFIL IS
AND WHAT IT IS USED
FOR
Sildenafil contains the
active substance sildenafil
which belongs to a group
of medicines called
phosphodiesterase type
5 (PDE 5) inhibitors. It
works by helping to relax
the blood vessels in your
penis, allowing blood to
flow into your penis when
you get sexually excited.
Sildenafil will only help
you to get an erection
if you are sexually
stimulated.
Sildenafil is a treatment
for adult men with erectile
dysfunction, sometimes
known as impotence. This
is when a man cannot
get, or keep a hard, erect
penis suitable for sexual
activity. 2.
WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE SILDENAFIL
DO NOT TAKE SILDENAFIL:
-
if you are allergic to
sildenafil or any of
the other ingredients
of this medicine
(listed in section 6).
-
If you are taking
medicines called
nitrates, as the
combination may
lead to a dangerous
fall in your blood
pressure. Tell your
doctor if you are
taking any of these
medicines which are
often given for relief
of angina pectoris
(or “chest pain”). If
you are not certain,
ask your doctor or
pharmacist.
-
If you are using any
of the medicines
known as nitric oxide
donors such as amyl
nitrite (“poppers”)
as the combination
may also lead to a
dangerous fall in your
blood pressur

Vara einkenni

OBJECT 1
SILDENAFIL 50 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 18-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Sildenafil 50 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 50 mg Sildenafil (as sildenafil
citrate).
Excipient with known effect:
Each 50 mg film-coated tablet contains 3.7 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
White to off-white, round (9.6 mm diameter), biconvex film-coated
tablets debossed with “SL” on one
side and 50 on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Sildenafil is indicated in adult men with erectile dysfunction, which
is the inability to achieve or maintain
a penile erection sufficient for satisfactory sexual performance.
In order for Sildenafil to be effective, sexual stimulation is
required.
4.2 Posology and method of administration
Posology
USE IN ADULTS
The recommended dose is 50mg taken as needed approximately one hour
before sexual activity. Based on
efficacy and tolerability, the dose may be increased to 100mg or
decreased to 25mg. The maximum
recommended dose is 100 mg. The maximum recommended dosing frequency
is once per day. If
Sildenafil is taken with food, the onset of activity may be delayed
compared to the fasted state (see
Section 5.2).
_Special populations _
ELDERLY
Dosage adjustments are not required in elderly patients (≥ 65 years
old)..
RENAL IMPAIRMENT
The dosing recommendations described in “Use in adults” apply to
patients with mild to moderate renal
impairment (creatinine clearance = 30-80 ml/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine clearance < 30
ml/min) a 25mg dose should be considered. Based on efficacy and
tolerability, the dose may be increased
step-wise to 50mg and 100mg as necessary.
HEPATIC IMPAIRMENT
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g.