TADALIS 20 tadalafil 20 mg film-coated tablet blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

tadalafil, Quantity: 20 mg

Tersedia dari:

Cipla Australia Pty Ltd

INN (Nama Internasional):

Tadalafil

Bentuk farmasi:

Tablet

Komposisi:

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

Rute administrasi :

Oral

Unit dalam paket:

28, 14, 56, 60

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

TADALIS is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

Ringkasan produk:

Visual Identification: Brown coloured, capsule shaped, biconvex film coated tablets with "T20" debossed on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status otorisasi:

Licence status A

Tanggal Otorisasi:

2017-03-27

Selebaran informasi

Version 1.0
‐ 1 ‐
TADALIS 20
_tadalafil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
TADALIS 20. 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 TADALIS 20 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 TADALIS 20 IS USED FOR
TADALIS 20 is used in adults as
a treatment for pulmonary
arterial hypertension.
TADALIS 20 belongs to a group
of medicines called
phosphodiesterase type 5
(PDE5) inhibitors which work
by helping the blood vessels
around your lungs relax,
improving the flow of blood into
your lungs. The result of this is
an improved ability to do
physical activity.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
TADALIS 20 HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another
reason.
TADALIS 20 is available only
with a doctor's prescription.
TADALIS 20 is not intended for
use by children under the age of
18 years.
BEFORE YOU TAKE TADALIS 20
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TADALIS 20 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.
TADALIS 20 has been shown to
increase the effects of these
medicines.
If you are taking any form of
nitrate or are unsure talk to your
doctor.
DO NOT TAKE TADALIS 20:

IF YOU HAVE SUFFERED A HEART
ATTACK IN THE LAST 3 MONTHS

IF YOU HAVE VISION LOSS IN ONE
EYE BECAUSE OF NON-ARTERITIC
ANTERIOR ISCHAEMIC OPTIC
NEUROPATHY (NAION)

SEVERE HYPOTENSION

IF YOU USE GUANYLATE CYCLASE
STIMULATORS SUCH AS
RIOCIGUAT, USED TO TREAT
PULMONARY ARTERIAL
HYPOTENSION
DO NOT TAKE TADALIS 20 IF YOU
HAVE AN ALLERGY TO:

any of the ingredients listed at
the en

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION
TADALIS 20 (TADALAFIL) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg tadalafil.
Excipient with known effect
Contains sugars as lactose.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
TADALIS 20 film-coated tablets are brown coloured, capsule shaped,
biconvex film coated
tablets with “T20” debossed on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TADALIS 20 is indicated in adults for the treatment of pulmonary
arterial hypertension (PAH)
classified as WHO functional class II and III, to improve exercise
capacity. Efficacy has been
shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular
disease.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of
PAH.
The recommended dose is 40 mg (2 x 20 mg) taken once daily with or
without food.
Patients with renal impairment
In patients with mild to moderate renal impairment a starting dose of
20 mg once per day is
recommended based on data from clinical pharmacology studies. Although
clinical pharmacology
studies in patients with renal impairment have not been performed with
40 mg the dose may be
increased to 40 mg once per day, based on individual efficacy and
tolerability. In patients with
severe renal impairment the use of tadalafil is not recommended due to
limited clinical experience
in these patients (see sections 4.4 Special warnings and precautions
for use and 5.2
Pharmacokinetic properties).
Patients with hepatic impairment
Based on data obtained in a clinical pharmacology study performed
using single doses of 10 mg
in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class
A and B), a starting dose of
20 mg once per day may be considered. If tadalafil is prescribed, a
careful individual benefit/risk
evaluation should be undertaken by the p