SILDATIO PHT sildenafil (as citrate) 20 mg film-coated tablets blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

sildenafil citrate, Quantity: 28.1 mg (Equivalent: sildenafil, Qty 20 mg)

Предлага се от:

Arrotex Pharmaceuticals Pty Ltd

INN (Международно Name):

Sildenafil citrate

Лекарствена форма:

Tablet, film coated

Композиция:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; calcium hydrogen phosphate; hypromellose; croscarmellose sodium; titanium dioxide; lactose monohydrate; triacetin

Начин на приложение:

Oral

Броя в опаковка:

90 Tablets in blister pack

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Used to treat patients with pulmonary arterial hypertension classified as WHO functional classes II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. The efficacy of sildenafil Citrate 20 mg has not been evaluated in patients currently on bosentan therapy.

Каталог на резюме:

Visual Identification: White to off white, round shaped, biconvex, film coated tablets, debossed with '20' on one side and plain on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Registered

Дата Оторизация:

2012-09-10

Листовка

_ _
_SILDENAFIL AN PHT 20_ -
_CONSUMER MEDICINE INFORMATION_
Sildenafil AN PHT v2.0
SILDATIO PHT
_SILDENAFIL (AS CITRATE) 20 MG FILM-COATED TABLETS _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildatio PHT.
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 your taking Sildatio PHT
against
the
benefits
they
expect
it
will have for you.
It should be used only under strict
medical supervision.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SILDATIO PHT IS
USED FOR
Sildatio
PHT
is
used
to
treat
pulmonary
arterial
hypertension
(high
blood
pressure
in
the
blood
vessels in the lungs). Sildatio PHT
brings down the blood pressure by
relaxing these vessels. Sildatio PHT
tablet contain the active ingredient
sildenafil
(present
as
sildenafil
citrate) which belongs to a group of
medicines
called
phosphodiesterase
type 5 inhibitors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SILDATIO PHT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE SILDATIO
PHT
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SILDATIO PHT IF:
1. YOU ARE BEING TREATED FOR
ANGINA (CHEST PAIN), OR OTHER
HEART CONDITIONS, WITH CERTAIN
MEDICINES CALLED NITRATES
Nitrate
medicines
include
glyceryl
trinitrate (also called nitroglycerin).
Common tradenames include tablets;
such as Anginine and Tridil; patches
such
as
Nitro-Dur,
Nitradisc,
Transiderm-Nitro,
Nitrocor,
Nitroderm TTS and Minitran; sprays
such as Nitrolingual and injections
such as Nitronal.
Common
tradenames
for
other
nitrate
preparations
include
tablets
such
as
Imdur
Durule,
Sorbidin,
Isordil,
Carvasin,
Corangin,
ISMO
20, Imtrate, Coronex, Duride, Ikorel
and Sodium Nitroprusside.
There may be other tradenames not
listed here.
2. YOU ARE

Данни за продукта

1
AUSTRALIAN PRODUCT INFORMATION – SILDATIO PHT SILDENAFIL (AS
CITRATE) FILM COATED TABLET
1
NAME OF THE MEDICINE
Sildenafil (as citrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg sildenafil (as citrate).
Sildenafil 20 mg, an oral therapy for pulmonary arterial hypertension,
is the citrate salt of sildenafil, a
selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific
phosphodiesterase type-5
(PDE5).
Sildenafil citrate is an off-white, crystalline powder. Its aqueous
solubility is equivalent to 2.6 mg
sildenafil per mL at 25°C.
_Excipients with known effect:_ This product contains lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SILDATIO PHT are white to off white, round shaped, biconvex,
film-coated tablets, debossed with
‘20’ on one side and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SILDATIO PHT tablets are for the treatment of patients with pulmonary
arterial hypertension classified
as WHO functional classes II and III, to improve exercise capacity.
Efficacy has been shown in primary
pulmonary hypertension and pulmonary hypertension associated with
connective tissue disease.
The efficacy of sildenafil has not been evaluated in patients
currently on bosentan therapy.
4.2
D
OSE AND METHOD OF ADMINISTRATION
TREATMENT SHOULD ONLY BE INITIATED AND MONITORED BY A PHYSICIAN
EXPERIENCED IN THE TREATMENT OF
PULMONARY ARTERIAL HYPERTENSION. IN CASE OF CLINICAL DETERIORATION IN
SPITE OF SILDENAFIL TREATMENT,
ALTERNATIVE THERAPIES SHOULD BE CONSIDERED.
USE IN ADULTS (≥ 18 YEARS)
The recommended dose for sildenafil is 20 mg three times a day (TID).
Sildenafil tablets should be
taken approximately 6-8 hours apart, with or without food.
2
No greater efficacy was achieved with doses higher than 20 mg TID
therefore treatment with doses
higher than 20 mg TID is not recommended (See section 5.1
PHARMACODYNAMIC PROPERTIES).
Dosages lower than 20 mg TID have not been examined and the efficacy
of these