TADALAFIL SANDOZ 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:

Sandoz 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:

TADALAFIL SANDOZ 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 3
1
2021
TADALAFIL SANDOZ
_tadalafil _
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Tadalafil Sandoz. 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 Tadalafil
Sandoz 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 SANDOZ IS
USED FOR
Tadalafil Sandoz 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 Sandoz 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
Sandoz 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 Sandoz 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 Tadalafil Sandoz to treat either,
or both of th

Summary of Product characteristics

1 v3
AUSTRALIAN PRODUCT INFORMATION –
TADALAFIL SANDOZ (TADALAFIL) TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil Sandoz 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
Tadalafil Sandoz 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.
Tadalafil Sandoz 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.
.
Tadalafil Sandoz 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
Tadalafil Sandoz 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.
Tadalafil Sandoz can be taken with or without food.
Tadalafil Sandoz is for oral use.
2 v3
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of Tadalafil Sandoz 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. Tadalafil Sandoz 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 a