ADIRAMEDICA TADALAFIL tadalafil 10 mg film-coated tablet blister pack

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

tadalafil, Quantity: 10 mg

Dostupné s:

AdiraMedica Pty Ltd

Léková forma:

Tablet, film coated

Složení:

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

Podání:

Oral

Jednotky v balení:

4, 8, 2

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

Tadalafil is indicated for the treatment of erectile dysfunction (ED) in adult males

Přehled produktů:

Visual Identification: Yellow coloured oval shaped tablets marked with "10" on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Registered

Datum autorizace:

2020-05-12

Informace pro uživatele

ADIRAMEDICA TADALAFIL
_tadalafil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
AdiraMedica Tadalafil. 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
AdiraMedica Tadalafil 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 ADIRAMEDICA
TADALAFIL IS USED FOR
AdiraMedica Tadalafil 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,
AdiraMedica Tadalafil 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.
AdiraMedica Tadalafil 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.
Your doctor may have prescribed you
AdiraMedica Tadalafil to treat this
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ADIRAMEDICA
TADALAFIL HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason. AdiraMedica
Tadalafil is available only with a
doctor's prescription.
AdiraMedica Tadalafil is not intended
for use by women, or by children
under the age of 18 years.
The active ingredient in AdiraMedica
Tadalafil tablets, tadalafil, belongs to
a group of medicines called
phosphodiesterase type 5 inhibitors.
BEFORE YOU TAKE
ADIRAMEDICA
TADALAFIL_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ADIRAMEDICA TADALAFIL
IF YOU ARE CURRENTLY TAKING ANY
NITRATES OR AMYL NITRITE.
Nitrates are
medicines used for the treatment of
angina ("chest pain") or other

Charakteristika produktu

AdiraMedica Tadalafil tablets Version 1.0
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
ADIRAMEDICA TADALAFIL (TADALAFIL)
1.
NAME OF THE MEDICINE
Tadalafil.
2.
QUALITATIVE AND QUATITATIVE COMPOSITION
Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg tadalafil as the
active ingredient.
Excipient with known effect: ADIRAMEDICA TADALAFIL tablets contain
lactose monohydrate.
For the full list of excipients, see 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
ADIRAMEDICA TADALAFIL 20 mg tablets are Yellow coloured, ‘Oval’
shaped, tablets, marked with “20’’ on one
side and plain on other side.
ADIRAMEDICA TADALAFIL 10 mg tablets are yellow coloured, ‘Oval’
shaped, tablets, marked with “10’’on one
side and plain on other side.
ADIRAMEDICA TADALAFIL is unavailable in 2.5 mg or 5 mg tablet
strengths. For patients requiring treatment
with lower strengths, other brands are available.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADIRAMEDICA TADALAFIL is indicated for the treatment of:
•
erectile dysfunction (ED) in adult males
4.2
DOSE AND METHOD OF ADMINISTRATION
ADIRAMEDICA TADALAFIL is for oral use.
ADIRAMEDICA TADALAFIL can be taken with or without food.
FOR ERECTILE DYSFUNCTION IN ADULT MALES - ON-DEMAND DOSING
The
recommended
dose
of
ADIRAMEDICA
TADALAFIL
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. ADIRAMEDICA TADALAFIL 10 and 20 mg
is intended for use prior to
anticipated sexual activity and is not for continuous daily use.
AdiraMedica Tadalafil tablets Version 1.0
Page 2 of 27
ADIRAMEDICA 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 AdiraMedica Ta