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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sildenafil citrate

Available from:

Apotex Pty Ltd

INN (International Name):

Sildenafil citrate

Authorization status:

Registered

Patient Information leaflet

APO-SILDENAFIL PHT
_(sildenafil citrate)_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. It does
not contain all the available
information. It does not take the
place of talking to your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
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 THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Sildenafil PHT. It contains the active
ingredient sildenafil citrate.
Sildenafil belongs to a group of
medicines called phosphodiesterase
type 5 inhibitors.
Sildenafil is used to treat pulmonary
arterial hypertension (high blood
pressure in the blood vessels in the
lungs).
Sildenafil brings down pulmonary
arterial blood pressure by relaxing
the blood vessels in the lungs.
Do not give sildenafil to children.
Sildenafil is not indicated for use in
children less than 18 years of age.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE THIS
MEDICINE
YOU MUST NOT TAKE SILDENAFIL IF YOU
ARE TAKING NITRATES OR NITRITE
MEDICATIONS.
IT MAY LEAD TO A SEVERE DROP IN
YOUR BLOOD PRESSURE, WHICH MAY BE
DIFFICULT TO TREAT.
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF:
•
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, Lycinate and
Nitrostat; patches such as Nitro-
Dur, Transiderm-Nitro,
Nitroderm TTS and Minitran;
sprays such as Nitrolingual and
Glytrin and injections such as
Gliceryl trinitrate concentrate.
Common tradenames for other
nitrate preparations includ

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