FARESTON toremifene (as citrate) 60mg tablet

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

toremifene citrate, Quantity: 88.5 mg

זמין מ:

Orion Pharma (AUS) Pty Limited

טופס פרצבטיות:

Tablet, uncoated

הרכב:

Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; sodium starch glycollate; microcrystalline cellulose; magnesium stearate; povidone; maize starch

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

sample packs of 5,7,10, 15 tablets, 30, 60, 90, 100, 120

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

For the first line treatment of hormone-dependent metastatic breast cancer in postmenopausal women. It is not recommended for patients with oestrogen receptor negative tumours.

leaflet_short:

Visual Identification: White, flat, round, uncoated tablets with bevelled edges and embossed with "T060" on one side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

1997-06-06

עלון מידע

FARESTON
®
1
FARESTON
®
_Toremifene _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
The name of your medicine is
FARESTON. It contains an active
ingredient called toremifene.
This leaflet answers some common
questions about FARESTON.
It does not contain all of 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 FARESTON
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT FARESTON IS
USED FOR
FARESTON is used to treat
hormone-sensitive breast cancer in
women who have had their
menopause.
It belongs to the group of medicines
known as anti-oestrogens. It helps to
stop the tumour cells from growing
and multiplying.
A doctor's prescription is required for
FARESTON.
Your doctor, however, may prescribe
FARESTON for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY FARESTON
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU TAKE
FARESTON
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE FARESTON IF:
•
you have endometrial hyperplasia
(an overgrowth in the lining of
the uterus)
•
you have severe liver failure
•
you are pregnant or breastfeeding
•
you have a heart condition called
QT prolongation, where the heart
muscle takes longer to contract
and then recover due to a disorder
involving electrical impulses.
•
you have other heart conditions
including bradycardia (slow heart
rhythm), symptomatic
arrhythmias (irregular heart
rhythm) or heart failure.
•
you have electrolyte disturbances
including uncorrected
hypokalaemia (low blood
potassium levels; which can in
turn cause heart arrhythmia
disorders).
FARESTON is for use by women
who have had their menopause and
should not be used by pregnant or
breastfeeding women.
DO NOT TAKE FARESTON AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK.
DO NOT TAKE FARESTON IF T

מאפייני מוצר

PI – Fareston (toremifene)
1 of 10
AUSTRALIAN PRODUCT INFORMATION –
FARESTON (TOREMIFENE AS CITRATE) TABLETS
1
NAME OF THE MEDICINE
Toremifene citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each FARESTON Tablet contains toremifene citrate equivalent to
toremifene 60 mg.
Excipients with known effects: lactose
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Tablet
FARESTON Tablets are white or almost white, round, flat, uncoated
tablets with bevelled
edges, embossed with “TO60” on one side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FARESTON is indicated for first line treatment of hormone-dependent
metastatic breast
cancer in postmenopausal patients. FARESTON is not recommended for
patients with
oestrogen receptor negative tumours.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose is one tablet (60 mg) daily.
No dose adjustment is needed in renal insufficiency. FARESTON should
be used cautiously
in
patients
with
hepatic
impairment
(see
_section _
_5.2 _
_Pharmacokinetic properties _
_- _
_Characteristics in patients_).
4.3 CONTRAINDICATIONS
Pregnancy (see _section 4.6 Fertility, pregnancy and lactation - Use
in Pregnancy_).
Pre-existing endometrial hyperplasia and severe hepatic failure are
contraindications for long-
term use of toremifene.
Both in preclinical investigations and in humans, changes in cardiac
electrophysiology have
been observed following exposure to toremifene, in the form of QT
prolongation. For reasons
of drug safety, toremifene is therefore contraindicated in patients
with:
•
Congenital or documented acquired QT prolongation
•
Electrolyte disturbances, particularly in uncorrected hypokalaemia
•
Clinically relevant bradycardia
PI – Fareston (toremifene)
2 of 10
•
Clinically relevant heart failure with reduced left-ventricular
ejection fraction
•
Previous history of symptomatic arrhythmias
Toremifene should not be used concurrently with other drugs that
prolong the QT interval.
4.4 SPECIAL WARNINGS AND PRECAUTI