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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

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

Tilgængelig fra:

Accord Healthcare Pty Ltd

INN (International Name):

Sildenafil citrate

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

90 Tablets in blister pack

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

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

Autorisation status:

Licence status A

Autorisation dato:

2012-09-10

Indlægsseddel

SILDENAFIL PHT APOTEX – CONSUMER MEDICINE INFORMATION
Sildenafil PHT Apotex oct 18 – v1
Page 1 of 4
SILDENAFIL PHT APOTEX
(SILDENAFIL (AS CITRATE) 20 MG FILM COATED TABLETS)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
sildenafil.
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 sildenafil
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 SILDENAFIL PHT IS
USED FOR
Sildenafil PHT is used to treat
P
ulmonary arterial
H
yper
T
ension
(“PHT” - high blood pressure in
the blood vessels in the lungs).
Sildenafil brings down the blood
pressure by relaxing these vessels.
This medicine 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 SILDENAFIL
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only
with a doctor's prescription.
BEFORE YOU TAKE
SILDENAFIL
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE SILDENAFIL 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 trade
nam

Produktets egenskaber

1
AUSTRALIAN PRODUCT INFORMATION –
SILDENAFIL PHT APOTEX (SILDENAFIL CITRATE)
1
NAME OF THE MEDICINE
Sildenafil citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg sildenafil (as citrate)
Ingredients with known effects: lactose
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
20 mg: white to off white, round shaped, biconvex, film coated
tablets, debossed with ‘20’ on
one side and plain on other side (AUST R 188717).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil 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
DOSE 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.
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 – Clinical trials). Dosages lower than 20 mg TID have not
been examined and the
efficacy of these doses is not known.
USE IN THE ELDERLY (OVER 65 YEARS OF AGE)
In general, dose selection of sildenafil for elderly PAH patients
should be undertaken
cautiously due to higher incidence of compromised renal, hepatic or
cardiac function, and of
concomitant disease or drug therapy (see Section 5.2 Pharmacokinetic
Properties – Elderly).
2
USE IN PATIENTS WITH I