TADALAFIL GH tadalafil10 mg film-coated tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

tadalafil, Quantity: 10 mg

Διαθέσιμο από:

Lupin Australia Pty Limited

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; sodium lauryl sulfate; croscarmellose sodium; pregelatinised maize starch; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

8's, 4's, 2's

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

TADALAFIL GH (tadalafil 10 mg tablets) are indicated for the treatment of: ? erectile dysfunction (ED) in adult males.

Περίληψη προϊόντος:

Visual Identification: Yellow coloured, round shaped, biconvex film coated tablets debossed with 'T10' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2018-06-07

Φύλλο οδηγιών χρήσης

TADALAFIL GH CMI V2
Page 1 of 5
CONSUMER MEDICINE INFORMATION
TADALAFIL GH
_tadalafil_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TADALAFIL GH. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date shown on
the final page. More recent
information on this medicine may
be available. Make sure you speak
to your pharmacist, nurse or doctor
to obtain the most up to date
information on this medicine. You
can also download the most up to
date leaflet from
www.generichealth.com.au. The
updated leaflet may contain
important information about
TADALAFIL GH and its use that you
should be aware of.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking TADALAFIL
GH against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT TADALAFIL GH IS USED
FOR
TADALAFIL GH is used to treat:
•
erectile dysfunction, also known
as impotence, in men. This is
when a man cannot get, or
maintain, a hard erect penis
suitable for sexual activity.
Following sexual stimulation,
TADALAFIL GH 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. TADALAFIL
GH will only treat erectile
dysfunction if you are sexually
aroused. You and your partner
will need to engage in foreplay,
just as you would if you were
not taking a medicine for
erectile dysfunction.
•
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 urine, a feeling
of not completely emptying the
bladder and a more frequent
need to pass urine even at
night. TADALAFIL GH improves
blood flow to, and relaxes the
muscles of

Αρχείο Π.Χ.Π.

AUSTRALIAN PRODUCT INFORMATION – TADALAFIL GH
(TADALAFIL) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Tadalafil.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient in Tadalafil GH tablets is tadalafil. Three
strengths are available, containing 5 mg,
10 mg and 20 mg of tadalafil.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Tadalafil GH 5 mg tablets are yellow coloured, round shaped, biconvex
film-coated tablets debossed
with ‘T5’ on one side and plain on other side.
Tadalafil GH 10 mg tablets are yellow coloured, round shaped, biconvex
film-coated tablets debossed
with ‘T10’ on one side and plain on other side.
Tadalafil GH 20 mg tablets are yellow coloured, round shaped, biconvex
film-coated tablets debossed
with ‘T20’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tadalafil GH is indicated for the treatment of:
•
erectile dysfunction (ED) in adult males; and
•
moderate
to
severe
lower
urinary
tract
symptoms
(LUTS)
associated
with
benign
prostatic
hyperplasia (BPH) in adult males.
4.2 DOSE AND METHOD OF ADMINISTRATION
Tadalafil GH is for oral use. Tadalafil GH can be taken with or
without food.
Tadalafil GH does not include 2.5 mg strength. If a patient requires a
2.5 mg dose then other brands of
tadalafil are available.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of Tadalafil GH is either 10 mg or 20 mg, taken
prior to anticipated sexual
activity. The maximum recommended dose is 20 mg. The maximum
recommended dosing frequency is
Tadalafil GH v2
Page 2 of 27
(Tadalafil) film-coated tablets
once per day. Tadalafil GH 10 mg and 20 mg is intended for use prior
to anticipated sexual activity and
is not for continuous daily use.
Tadalafil has been proven effective up to 36 hours after dosing and,
in some patients, as early as
16 minutes after dosing. Patients may initiate sexual activity at
varying time poi