TADALCA tadalafil 20 mg film-coated tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

tadalafil, Quantity: 20 mg

থেকে পাওয়া:

Pharmacor Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Tablet, film coated

রচনা:

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

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

56 tablets, 8 tablets, 4 tablets

প্রেসক্রিপশন টাইপ:

(S4) Prescription Only Medicine

থেরাপিউটিক ইঙ্গিত:

Tadalafil 20 mg tablets 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.

পণ্য সারাংশ:

Visual Identification: Yellow, capsule shaped, biconvex, bevel-edged, film-coated tablets, debossed with T 20 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

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2018-01-15

তথ্য লিফলেট

Version 1.1
2018 1
TADALCA
_tadalafil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Tadalca. 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
Tadalca 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 TADALCA IS
USED FOR
Tadalca is used in adults as a
treatment
for
pulmonary
arterial hypertension.
Tadalca 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
TADALCA
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have
prescribed it for another reason.
Tadalca is available only with a
doctor's prescription.
Tadalca is not intended for use by
children under the age of 18
years.
BEFORE YOU TAKE
TADALCA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TADALCA 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.
Tadalca 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 TADALCA:
•
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 TADALCA IF YOU HAVE
AN ALLERGY TO:
•
any of the ingredients listed
at the end of this leaflet
Some of the symptoms of an
alle

পণ্য বৈশিষ্ট্য

AUSTRALIAN PRODUCT INFORMATION –
TADALCA (TADALAFIL) TABLETS
1
NAME OF THE MEDICINE
Tadalafil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tadalca 20 mg.
Excipients with Known effect: Lactose monohydrate
For the full list of excipients, see _SECTION 6.1 LIST OF EXCIPIENTS_.
3
PHARMACEUTICAL FORM
Tadalca 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. The
active ingredient in Tadalca
tablets is tadalafil.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Tadalafil 20 mg tablets 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
D
OSE 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.
_Use in 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 _ SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE,
USE IN RENAL IMPAIRMENT and _
_SECTION 5.2 PHARMACOKINETIC PROPERTIES. _
_ _
_Use in 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