CALIBERI ORODISPERSIBLE FILM 5MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TADALAFIL

Boleh didapati daripada:

ABBOTT LABORATORIES (M) SDN. BHD.

INN (Nama Antarabangsa):

TADALAFIL

Unit dalam pakej:

2 Sachets; 15 Sachets

Dikeluarkan oleh:

CTCBIO Inc

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
CALIBERI
®
ORODISPERSIBLE FILM
Tadalafil (5mg and 20mg)
1
WHAT IS IN THIS LEAFLET
1. What Caliberi
®
is used for
2. How Caliberi
®
works
3. Before you use Caliberi
®
4. How to use Caliberi
®
5. While you are using it
6. Side effects
7. Storage and Disposal of
Caliberi
®
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT CALIBERI
® IS USED FOR
_CALIBERI_
_®_
_ 5MG AND 20MG_
are
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.
Caliberi
®
has been shown to
significantly improve the
ability of obtaining a hard
erect penis suitable for
sexual activity.
_CALIBERI_
_®_
_ 5MG_
is used to treat
adult men with:
•
urinary symptoms associated
with a common condition
called
BENIGN PROSTATIC
HYPERPLASIA
. This is when
the prostate gland gets bigger
with age. Symptoms include
difficulty in starting to pass
water, a feeling of not
completely emptying the
bladder and a more frequent
need to pass water even at
night.
HOW CALIBERI
® WORKS
Caliberi
®
contains the active
ingredient tadalafil which
belongs to a group of medicines
called phosphodiesterase type 5
inhibitors (PDE 5 inhibitors).
Following sexual stimulation
Caliberi
®
works by helping the
blood vessels in your penis to
relax, allowing the flow of blood
into your penis. The result of
this is improved erectile
function. Caliberi
®
will not help
you if you do not have erectile
dysfunction. It is important to
note that Caliberi
®
for the
treatment of erectile dysfunction
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.
Caliberi
®
improves blood flow
to, and relaxes, the muscles of,
the prostate and bladder which
may reduce symptoms of benign
prostatic hyperplasia. Caliberi
®
has been shown to improve
these urinary symptoms as early
as 1-2 w

Ciri produk

CALIBERI
®
ORODISPERSIBLE FILM 5MG
CALIBERI
®
ORODISPERSIBLE FILM 20MG
1. NAME OF THE MEDICINAL PRODUCT
Caliberi® Orodispersible Film 5mg
Caliberi
®
Orodispersible Film 20mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Caliberi
®
Orodispersible Film 5mg contains 5mg tadalafil
Each Caliberi
®
Orodispersible Film 20mg contains 20mg tadalafil
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Orodispersible Film (ODF)
Caliberi
®
Orodispersible Film (ODF) 5mg and 20mg is light yellow, rectangular
orodispersible films.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_CALIBERI_
_® _
_ORODISPERSIBLE FILM (ODF) 5MG AND 20MG_
Treatment of erectile dysfunction (ED) in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is required.
_CALIBERI_
_® _
_ORODISPERSIBLE FILM (ODF) 5MG _
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Caliberi
®
is not indicated for use by women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_CALIBERI_
_® _
_ORODISPERSIBLE FILM (ODF) 5MG AND 20MG _
_Erectile dysfunction (ED)_
_Adult men _
In general, the recommended dose is 10 mg (2 ODF × 5mg) taken prior
to anticipated sexual activity without
food.
In those patients in whom tadalafil 10 mg (2 ODF × 5mg) 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 10mg (2 ODF X 5mg) and 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 Caliberi
®
(i.e., at least twice weekly) a once daily regimen with
the lowest doses of Caliberi
®
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 appropriateness of continued use of the daily regimen should