OLTAD 20MG FILM COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Tadalafil

Boleh didapati daripada:

KOMEDIC SDN BHD

INN (Nama Antarabangsa):

Tadalafil

Unit dalam pakej:

1 x 4 (4 tablets) Tablets; 2 x 4 (8 tablets) Tablets

Dikeluarkan oleh:

MEDOCHEMIE LTD (CENTRAL FACTORY)

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
OLTAD FILM-COATED TABLETS
_Tadalafil 20mg _
1
WHAT IS IN THIS LEAFLET
1.
What Oltad is used for
2.
How it works
3.
Before you use Oltad
4.
How to use Oltad
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Oltad
8.
Product description
9.
Manufacturer
and
Product
registration holder
10.
Date of revision
WHAT OLTAD IS USED FOR
Oltad
contains
the
active
substance
tadalafil which belongs to a group of
medicines
called
phosphodiesterase
type 5 inhibitors.
Oltad is used to treat adult men with
erectile dysfunction. This is when a man
cannot get, or keep a hard erect penis
suitable for sexual activity
HOW OLTAD WORKS
Erectile dysfunction
Following
sexual
stimulation
Oltad
works by helping the blood vessels in
your penis to relax, allowing the flow of
blood into your penis. It is important to
note that Oltad does not work if there is
no sexual stimulation. You and your
partner will need to engage in foreplay,
just as you would if you were not taking
a medicine for erectile dysfunction.
BEFORE YOU USE OLTAD
_- When you must not use it _
Do not take Oltad:
-
If you are allergic to tadalafil or any
of
the
other
ingredients
in
this
medicine
(see
section
_8. _
_Product _
_description_
).
-
If you are taking any form of nitrates
such as amyl nitrite. This is a group
of medicines used in the treatment of
angina pectoris (chest pain). Oltad
has
been
shown
to
increase
the
effects of these medicines. If you are
taking any form of nitrate or are
unsure, tell your doctor.
-
If you have serious heart disease or
recently had a heart attack within the
last 3 months.
-
If you recently had a stroke within
the last 6 months
-
If you have low blood pressure or
uncontrolled high blood pressure.
-
If
you
ever
had
loss
of
vision
because
of
non-arteritic
anterior
ischemic
optic
neuropathy
(NAION), a condition described as
“stroke of the eye”
-
If you are taking riociguat. This
drug
is
used
to
treat
pulmonary
arterial hypertension (i.e. high blood
pressure in the lungs) a

Ciri produk

1
PACKAGE INSERT - OLTAD
1.
NAME OF THE MEDICINAL PRODUCT
Oltad 20mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20mg film coated tablet contains 20mg tadalafil
Excipient with known effect: lactose

Each 20 mg film coated tablet contains 245.5mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
The 20mg tablets are yellow, round, convex film coated tablets, plain
on both sides, with diameter of nucleus 10.3mm
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
OLTAD IS INDICATED FOR:
Treatment of erectile dysfunction in adult males. In order for
tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is required.
Oltad is not indicated for use by women.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ADULT MEN _
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg might be tried. It may be taken
at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 20 mg is intended for use prior to anticipated sexual
activity and it is not recommended for continuous daily
use.
In patients who anticipate a frequent use of tadalafil (i.e., at least
twice weekly), a once daily regimen with the lowest
doses of tadalafil might be considered suitable, based on patient
choice and the physician's judgement.
In these patients, the recommended dose is 5 mg taken once a day at
approximately the same time of day. The dose may
be decreased to 2.5 mg once a day based on individual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_ _
SPECIAL POPULATION:
_Elderly patients _
Dose adjustments are not required in elderly patients.
_Men with renal impairment _
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients with severe renal
i