APO-TADALAFIL tadalafil 10 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 10 mg

Available from:

Accord Healthcare Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; hypromellose; sorbitan stearate; magnesium stearate; titanium dioxide; purified talc; triacetin; iron oxide yellow

Administration route:

Oral

Units in package:

4 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

APO-TADALAFIL is indicated for the treatment of erectile dysfunction (ED) in adult males

Product summary:

Visual Identification: Light yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with T 10 on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2018-01-15

Patient Information leaflet

Version 2
1
2020
APO-TADALAFIL
_tadalafil _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-Tadalafil. 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.
_ _
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking APO-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 APO-TADALAFIL IS
USED FOR
APO-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,
APO-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. APO-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.
•
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. APO-Tadalafil improves
blood flow to, and relaxes the
muscles of, the prostate and
bladder which may reduce
symptoms of benign prostatic
hyperplasia.
Your doctor may have prescribed
you APO-Tadalafil to treat either, or
both of these conditions.
ASK YOUR DO

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
APO-TADALAFIL (TADALAFIL) TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Tadalafil 5 mg, 10 mg, and 20 mg.
Excipients with Known effect: Lactose monohydrate
For the full list of excipients, see _SECTION 6.1 LIST OF EXCIPIENTS_.
3
PHARMACEUTICAL FORM
APO-Tadalafil 20 mg tablets are yellow, capsule shaped, biconvex,
bevel-edged, film-coated tablets,
debossed with "T 20" on one side and plain on the other side.
APO-Tadalafil 10 mg tablets are light yellow, capsule shaped,
biconvex, bevel-edged, film-coated
tablets, debossed with "T 10" on one side and plain on the other side.
.
APO-Tadalafil 5 mg tablets are light yellow, capsule shaped, biconvex,
bevel-edged, film-coated
tablets, debossed with "T 5" on one side and plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-Tadalafil is indicated for the treatment of:
•
erectile dysfunction (ED) in adult males
•
moderate to severe lower urinary tract symptoms (LUTS) associated with
benign prostatic
hyperplasia (BPH) in adult males
4.2
D
OSE AND METHOD OF ADMINISTRATION
Note that 2.5 mg tablets can be available from other brand/s.
APO-Tadalafil can be taken with or without food.
APO-Tadalafil is for oral use.
2
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of APO-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. APO-Tadalafil 10 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 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 tadalafi