APO-SILDENAFIL PHT sildenafil (as citrate) 20mg tablet bottle

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:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

Sildenafil citrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: macrogol 8000; microcrystalline cellulose; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; hypromellose; titanium dioxide; hyprolose

Administration route:

Oral

Units in package:

90

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sildenafil is 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 has not been evaluated in patients currently on bosentan therapy.

Product summary:

Visual Identification: White to off white, round biconvex, film coated tablets, engraved "APO" on one side and "SIL" over "20" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2011-01-12

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-SILDENAFIL PHT (SILDENAFIL CITRATE) FILM
COATED TABLETS
1
NAME OF THE MEDICINE
Sildenafil citrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg sildenafil as the active ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APO-Sildenafil PHT 20 mg tablets are white to off-white round,
biconvex, film coated tablets,
engraved “APO” on one side and “SIL” over “20” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil is indicated 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 established in patients
currently on bosentan therapy
(see section 4.4 SPECIAL PRECAUTIONS AND WARNINGS FOR USE).
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Sildenafil PHT tablets are intended for oral administration.
DOSAGE
Treatment should only be initiated and monitored by a health care
professional 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 CHILDREN (< 18 YEARS)
Sildenafil is not indicated for use in children < 18 years of age.
2
DISCONTINUATION OF TREATMENT
Limited data suggests that the abrupt discontinuation of s