CIDALA tadalafil 20mg film-coated tablet blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tadalafil, Quantity: 20 mg

Dostupno od:

Arrotex Pharmaceuticals Pty Ltd

INN (International ime):

Tadalafil

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: sodium lauryl sulfate; lactose monohydrate; croscarmellose sodium; magnesium stearate; povidone; hyprolose; silicon dioxide; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000

Administracija rute:

Oral

Jedinice u paketu:

4, 8, 2, 1

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

CIDALA 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

Proizvod sažetak:

Visual Identification: Yellow to light yellow, oval shaped, beveled edge, coated tablets debossed with 'L 339' on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2017-05-26

Uputa o lijeku

CIDALA – Consumer Medicine Information
Page 1 of 5
CIDALA
tadalafil
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CIDALA. 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 CIDALA
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 CIDALA IS USED
FOR
CIDALA 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,
CIDALA 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. CIDALA 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. CIDALA
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 CIDALA to treat either, or both
of these conditions.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CIDALA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason. CIDALA is
available only with a doctor's
prescription.
CIDALA is not intended for use by
women or by children under the
age of 18 years.
The active ingredient in

Svojstava lijeka

1
AUSTRALIAN PRODUCT INFORMATION – CIDALA (TADALAFIL)
TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalafil tablets contain 2.5 mg, 5 mg, 10mg and 20 mg of tadalafil.
Excipient with known effect: Sugars as lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CIDALA, tadalafil 20 mg tablets are yellow to light yellow, oval
shaped, beveled edge, coated tablets
debossed with ‘L 339’ on one side and plain on other side.
CIDALA, tadalafil 10 mg tablets are yellow to light yellow, round
shaped, beveled edge, coated
tablets debossed with ‘338’ on one side and plain on other side.
CIDALA, tadalafil 5 mg tablets are yellow to light yellow, round
shaped, beveled edge, coated tablets
debossed with ‘337’ on one side and plain on other side.
CIDALA, tadalafil 2.5mg are yellow to light yellow, round shaped,
beveled edge, coated tablets
debossed with ‘336’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
CIDALA 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
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
CIDALA is for oral use.
CIDALA can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The recommended dose of CIDALA 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. CIDALA 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