TADALACCORD tadalafil 5 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tadalafil, Quantity: 5 mg

Available from:

Pharmacor 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:

28 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TADALACCORD 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

Product summary:

Visual Identification: Light yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with T 5 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 1.1
1
2020
TADALACCORD
_tadalafil _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TADALACCORD. 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
TADALACCORD 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 TADALACCORD IS
USED FOR
TADALACCORD 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,
TADALACCORD 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.
TADALACCORD 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. TADALACCORD 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 TADALACCORD to treat either,
or both of these conditions.
ASK YOUR DOCTOR IF YOU HAVE

Summary of Product characteristics

1 v2
AUSTRALIAN PRODUCT INFORMATION –
TADALACCORD (TADALAFIL) TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalaccord 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
Tadalaccord 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.
Tadalaccord 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.
.
Tadalaccord 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
Tadalaccord 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.
Tadalaccord can be taken with or without food.
Tadalaccord is for oral use.
2 v2
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of Tadalaccord 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. Tadalaccord 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 tadalafil (i.e. at lea