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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

90 Tablets in blister pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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.

Product summary:

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

Authorization status:

Registered

Authorization date:

2012-09-10

Patient Information leaflet

SILDENAFIL SANDOZ PHT 20
1
SILDENAFIL SANDOZ PHT
20
_sildenafil (as citrate) 20 mg film-coated Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sildenafil Sandoz
PHT 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 your taking Sildenafil
Sandoz PHT 20 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
SANDOZ PHT 20 IS
USED FOR
Sildenafil Sandoz PHT 20 is used to
treat pulmonary arterial hypertension
(high blood pressure in the blood
vessels in the lungs). Sildenafil
Sandoz PHT 20 brings down the
blood pressure by relaxing these
vessels. Sildenafil Sandoz PHT 20
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 SILDENAFIL
SANDOZ PHT 20 HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
SILDENAFIL SANDOZ PHT
20
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE SILDENAFIL SANDOZ PHT
20 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 Nitropr

Summary of Product characteristics

1 v2.2
AUSTRALIAN PRODUCT INFORMATION –
SILDENAFIL SANDOZ PHT 20 (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 188702).
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SILDENAFIL SANDOZ PHT 20 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 v2.