TADALAFIL LUPIN tadalafil 20 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 20 mg

Available from:

AdiraMedica Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

8, 4, 2, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

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

Authorization status:

Registered

Authorization date:

2020-05-12

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
TADALAFIL LUPIN
(TADALAFIL) TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tadalafil Lupin. 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
Tadalafil Lupin 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 LUPIN IS
USED FOR
Tadalafil Lupin 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 Lupin
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 Lupin 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.
Your doctor may have
prescribed you Tadalafil Lupin
to treat this condition.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
TADALAFIL LUPIN HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
Tadalafil Lupin is available only
with a doctor's prescription.
Tadalafil Lupin is not intended
for use by women, or by children
under the age of 18 years.
The active ingredient in Tadalafil
Lupin tablets, tadalafil, belongs
to a group of medicines called
phosphodiesterase type 5
inhibitors.
_____________________
BEFORE YOU TAKE
TADALAFIL LUPIN
_____________________
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TADALAFIL LUPIN 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.
Tadalafil Lupin h

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – TADALAFIL LUPIN
(tadalafil) tablet
1
NAME OF THE MEDICINE
Tadalafil.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg or 20 mg tadalafil as the active
ingredient. Excipients
with known effect: Tadalafil Lupin tablets contain lactose
monohydrate. For the full
list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Tadalafil Lupin 10 mg tablets are yellow coloured, ‘oval’ shaped
tablets, marked with “10’’on one side
and plain on the other side.
Tadalafil Lupin 20 mg tablets are yellow coloured, ‘oval’ shaped
tablets, marked with “20’’ on one side
and plain on the other side.
TADALAFIL LUPIN 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
Tadalafil Lupin is indicated for the treatment of:
erectile dysfunction (ED) in adult males;
4.2 Dose and Method of Administration
Tadalafil Lupin is for oral use.
Tadalafil Lupin can be taken with or without food.
For Erectile Dysfunction in Adult Males - On-demand Dosing
The recommended dose of Tadalafil Lupin 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 Lupin v0.2
(tadalafil) tablet
Page 2 of 27
once per day. Tadalafil Lupin 10 mg and 20 mg is intended for use
prior to anticipated sexual activity and
is not for continuous daily use.
Tadalafil Lupin 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 Tadalafil Lupin (ie. at
least twice weekly), a once daily
regimen with the lowest dose of Tadalafil Lupin might be considered
su