Spedra 50mg Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Avanafil

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

Avanafil

Units in package:

4 Tablets; 8 Tablets; 12 Tablets; 2 Tablets

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
SPEDRA
_®_ TABLET
_ _
Avanafil 50 mg, 100 mg, 200 mg
1
WHAT IS IN THIS LEAFLET
1. What Spedra is used for
2. How Spedra works
3.
Before you use Spedra
4.
How to use Spedra
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Spedra
8.
Product Description
9.
Manufacturer
and
Product
Registration holder
10.
Date of revision
11.
Serial Number
WHAT SPEDRA IS USED FOR
Spedra contains the active substance
avanafil.
It
belongs
to
a
group
of
medicines
called
phosphodiesterase
type 5 (PDE5) inhibitors.
Spedra is a
treatment
for
adult
men
suffering
from erectile dysfunction (also known
as
impotence).
This
is
when
you
cannot get, or keep a hard, erect penis
suitable for sexual activity.
Spedra will not help you if you do not
have erectile dysfunction. Spedra is
not for women.
HOW SPEDRA WORKS
Spedra works by helping the blood
vessels in your penis to relax. This
increases
the
blood
flow
into
your
penis, helping it stay hard and erect
when
you
get
sexually
excited.
Spedra does not cure your condition.
It is important to note that Spedra
only
works
if
you
are
sexually
stimulated. You and your partner will
still need to use foreplay to get ready
for sex – just as you would if you
were not taking a medicine to help
you.
BEFORE YOU USE SPEDRA
_- When you must not use it _
•
If you are allergic to avanafil or
any of the other ingredients of this
medicine.
•
If
you
are
taking
“nitrate”
medicines for chest pain (angina),
such as amyl nitrite or glyceryl
trinitrate. Spedra can increase the
effects
of
these
medicines
and
severely
lower
your
blood
pressure.
•
If
you are
taking
medicines for
HIV or AIDS such as ritonavir,
indinavir, saquinavir, nelfinavir
or atazanavir.
•
If
you are
taking
medicines for
fungal
infections
such
as
ketoconazole, itraconazole or
voriconazole or certain antibiotics
for
bacterial
infections,
such
as
clarithromycin or telithromycin.
•
If
you
have
a
serious
cardiac
problem.
•
If you have had a stroke or heart
attack in the

Summary of Product characteristics

2018MEN-0299-1 Spedra SmPC
SPEDRA®
Tablets
Avanafil
1.
NAME OF THE MEDICINAL PRODUCT
Spedra 50 mg tablets Spedra 100 mg tablets Spedra 200 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Spedra 50 mg tablets:
Each tablet contains 50 mg of avanafil.
Spedra 100 mg tablets:
Each tablet contains 100 mg of avanafil.
Spedra 200 mg tablets:
Each tablet contains 200 mg of avanafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Spedra 50 mg tablets:
Pale yellow oval tablets, debossed with “50” on one side.
Spedra 100 mg tablets:
Pale yellow oval tablets, debossed with “100” on one side.
Spedra 200 mg tablets:
Pale yellow oval tablets, debossed with “200” on one side.
4.
CLINICAL PARTICULARS
4.1.THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult men.
In order for Spedra to be effective, sexual stimulation is required.
4.2.POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Use in adult men_
The recommended dose is 100 mg taken as needed approximately 15 to 30
minutes before sexual activity (see section
5.1). Based on individual efficacy and tolerability, the dose may be
increased to a maximum dose of 200 mg or
decreased to 50 mg. The maximum recommended dosing frequency is once
per day. Sexual stimulation is required
for a response to treatment.
_Special populations_
_ _
_Elderly (_
≥
_65 years old)_
Dose adjustments are not required in elder patients. Limited data are
available in elder patients aged 70 years or
above.
_ _
_Renal impairment_
Dose adjustments are not required in patients with mild to
moderate renal impairment (creatinine clearance ≥
30
mL/min). Spedra is contraindicated in patients with severe
renal impairment (creatinine clearance < 30
mL/min) (see
sections 4.3 and 5.2). Patients with mild or moderate renal impairment
(creatinine clearance ≥30
mL/min but <80
mL/min) who were enrolled in phase 3 studies showed decreased efficacy
compared to
those with normal renal function.
_ _
_Hepatic impairment_
2018MEN-0299-1 Spedra SmPC
Spedra