Fareston
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
03-12-2021
Karatteristiċi tal-prodott
(SPC)
03-12-2021
Rapport ta 'Valutazzjoni Pubblika
(PAR)
02-04-2009
Ingredjent attiv:
toremifene
Disponibbli minn:
Orion Corporation
Kodiċi ATC:
L02BA02
INN (Isem Internazzjonali):
toremifene
Grupp terapewtiku:
Endocrine therapy
Żona terapewtika:
Breast Neoplasms
Indikazzjonijiet terapewtiċi:
First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.Fareston is not recommended for patients with estrogen receptor negative tumours.
Sommarju tal-prodott:
Revision: 25
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
1996-02-14
Fuljett ta 'informazzjoni
17
B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
FARESTON 60 MG TABLETS
toremifene
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fareston is and what it is used for
2.
What you need to know before you take Fareston
3.
How to take Fareston
4.
Possible side effects
5.
How to store Fareston
6.
Contents of the pack and other information
1.
WHAT FARESTON IS AND WHAT IT IS USED FOR
Fareston contains the active substance toremifene, an anti-estrogen.
Fareston is used for the treatment
of a certain type of breast tumour in women who have had their
menopause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FARESTON
DO NOT TAKE FARESTON
-
if you are allergic to toremifene or any of the other ingredients of
this medicine (listed in
section 6).
-
if you have a thickening of the womb lining
-
if you have severe liver problems
-
if you were born with or have had any condition which causes certain
abnormal changes in the
electrical recording of the heart (electrocardiogram or ECG)
-
if you have a salt imbalance in the blood, especially low
concentrations of potassium in the
blood (hypokalaemia) which are currently not corrected by treatment
-
if you have a very slow heart rate (bradycardia)
-
if you have a heart failure
-
if you have a history of abnormal heart rhythms (arrhythmias)
-
if you are taking other medicines that m
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Fareston 60 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 60 mg toremifene (as citrate).
Excipient with known effect
One tablet contains 28.5 mg of lactose (as monohydrate). For the full
list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round, flat, bevelled edge tablet with TO 60 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
First line hormone treatment of hormone-dependent metastatic breast
cancer in postmenopausal
patients.
Fareston is not recommended for patients with estrogen receptor
negative tumours.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 60 mg daily.
_Renal impairment_
No dose adjustment is needed in patients with renal insufficiency.
_Hepatic impairment_
Toremifene should be used cautiously in patients with liver impairment
(see section 5.2).
_Pediatric population_
There is no relevant use of Fareston in the paediatric population.
Method of administration
Toremifene is administered orally. Toremifene can be taken with or
without food.
4.3
CONTRAINDICATIONS
-
Pre-existing endometrial hyperplasia and severe hepatic failure are
contra-indications in long-
term use of toremifene.
-
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
-
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
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