ADIRA TADALAFIL tadalafil 20 mg film-coated tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

tadalafil, Quantity: 20 mg

Dostupné s:

AdiraMedica Pty Ltd

Léková forma:

Tablet, film coated

Složení:

Excipient Ingredients: croscarmellose sodium; sodium lauryl sulfate; lactose monohydrate; copovidone; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin; iron oxide yellow

Podání:

Oral

Jednotky v balení:

2, 8, 1, 4

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Tadalafil is indicated for the treatment of erectile dysfunction (ED) in adult males

Přehled produktů:

Visual Identification: Yellow coloured oval shaped tablets marked with "20" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Registered

Datum autorizace:

2020-05-12

Informace pro uživatele

ADIRA TADALAFIL
_tadalafil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about Adira
Tadalafil. It does not contain all
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Adira Tadalafil 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 ADIRA TADALAFIL
IS USED FOR
Adira Tadalafil 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,
Adira Tadalafil 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. Adira Tadalafil 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.
Y o u r
d o c t o r
may
have
prescribed
you
Adira
Tadalafil
to treat this condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADIRA
TADALAFIL HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason. Adira
Tadalafil is available only with a
doctor's prescription.
Adira Tadalafil is not intended for
use by women, or by children
under the age of 18 years.
The active ingredient in Adira
Tadalafil tablets, tadalafil,
belongs to a group of medicines
called phosphodiesterase type 5
inhibitors.
BEFORE YOU TAKE ADIRA
TADALAFIL_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADIRA TADALAFIL IF
YOU ARE CURRENTLY TAKING ANY
NITRATES OR AMYL NITRITE.
Nitrates
are medicines used for the
treatment of angina ("chest pain")
or other heart conditions. Adira
Tadalafil has been shown to
increase the effects of

Charakteristika produktu

Adira Tadalafil tablets Version 1.0
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
ADIRA TADALAFIL (TADALAFIL)
1.
NAME OF THE MEDICINE
Tadalafil.
2.
QUALITATIVE AND QUATITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg tadalafil as the active
ingredient. Excipient with
known effect: ADIRA TADALAFIL tablets contain lactose monohydrate. For
the full
list of excipients, see 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ADIRA TADALAFIL 20 mg tablets are Yellow coloured, ‘Oval’ shaped,
tablets, marked with “20’’ on one
side and plain on other side.
ADIRA TADALAFIL 10 mg tablets are yellow coloured, ‘Oval’ shaped,
tablets, marked with “10’’on one
side and plain on other side.
ADIRA TADALAFIL is unavailable in 2.5 mg or 5 mg tablet strengths. For
patients requiring treatment
with lower strengths, other brands are available.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADIRA TADALAFIL is indicated for the treatment of:
•
erectile dysfunction (ED) in adult males
4.2
DOSE AND METHOD OF ADMINISTRATION
ADIRA TADALAFIL is for oral use.
ADIRA TADALAFIL can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of ADIRA TADALAFIL 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
once per day. ADIRA TADALAFIL 10 and 20 mg is intended for use prior
to anticipated sexual activity and
is not for continuous daily use.
ADIRA 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 points relative to dosing
in order to determine their own optimal window of responsiveness.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ONCE-A-DAY DOSING
In patients who anticipate a frequent use of ADIRA Tadalafil (i.e. at
least twice weekly), a once daily
regimen with the lowest dose of ADIRA TADALAFIL might be considered
suitable, based on patient
c