ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
Fareston 60 mg tablets
2.
Each tablet contains 60 mg toremifene (as citrate).
Excipients: 30 mg lactose per tablet.
For a full list of excipients, see section 6.1.
3.
Tablet.
White, round, flat, bevelled edge tablet with TO 60 on one side.
4.
First line hormone treatment of hormone-dependent metastatic breast cancer in postmenopausal patients.
Fareston is not recommended for patients with estrogen receptor negative tumours.
Posology
The recommended dose is 60 mg daily.
Renal impaiment
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 use
There is no relevant indication for use of Fareston in children.
Method of administration
Toremifene is administered orally. Toremifene can be taken with or without food.
-
Pre-existing endometrial hyperplasia and severe hepatic failure are contra-indications in long-term use
of toremifene.
-
Hypersensitivity to toremifene or to any of the excipients.
-
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
- Clinically relevant heart failure with reduced left-ventricular ejection fraction
2
- Previous history of symptomatic arrhythmias.
Toremifene should not be used concurrently with other drugs that prolong the QT interval (see also section
4.5).
Gynaecological examination should be performed before treatment administration, closely looking at
pre-existing endometrial abnormality. Afterwards gynaecological examination should be repeated at
least once a year. Patients with additional risk of endometrial cancer, e.g. patients suffering from
hypertension or diabetes, having high BMI (>30) or history of hormone replacement therapy should be
closely monitored (see also section 4.8).
Patients with a history of severe thromboembolic disease should generally not be treated with toremifene
(see also section 4.8).
Fareston has been shown to prolong the QTc interval on the electrocardiogram in some patients in a dose-
related manner. The following information regarding QT-prolongation is of special importance (for
contraindications see section 4.3).
A QT clinical study with a 5-arm parallel design (placebo, moxifloxacin 400 mg, toremifene 20 mg, 80 mg,
and 300 mg) has been performed in 250 male patients to characterize the effects of toremifene on the QTc
interval duration. The results of this study show a clear positive effect of toremifene in the 80 mg group with
mean prolongations of 21 - 26 ms. Regarding the 20 mg group, this effect is significant as well, according to
ICH guidelines, with upper confidence interval of 10 - 12 ms. These results strongly suggest an important
dose-dependent effect. As women tend to have a longer baseline QTc interval compared with men, they may
be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-
associated effects on the QT interval.
Fareston should be used with caution in patients with ongoing proarrhythmic conditions (especially elderly
patients) such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for
ventricular arrhythmias (incl. Torsade de pointes) and cardiac arrest (see also section 4.3).
If signs or symptoms that may be associated with cardiac arrhythmia occur during treatment with Fareston,
treatment should be stopped and an ECG should be performed.
If the QTc interval is > 500 ms, Fareston should not be used.
Patients with non-compensated cardiac insufficiency or severe angina pectoris should be closely monitored.
Hypercalcemia may occur at the beginning of toremifene treatment in patients with bone metastasis and
thus these patients should be closely monitored.
There are no systematic data available from patients with labile diabetes, from patients with severely
altered performance status or from patients with cardiac failure.
Fareston tablets contain lactose (30 mg/tablet). Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
An additive effect on QT interval prolongation between Fareston and the following drugs and other
medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased
risk of ventricular arrhythmias, including Torsade de pointes. Therefore co-administration of Fareston with
any of the following medicinal products is contraindicated (see also section 4.3):
-
antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or
-
neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride),
3
-
antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide),
-
certain antimicrobials agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly
halofantrine),
-
certain antihistaminics (terfenadine, astemizole, mizolastine),
-
others (cisapride, vincamine IV, bepridil, diphemanil).
Drugs which decrease renal calcium excretion, e.g. thiazide diuretics, may increase the risk of
hypercalcaemia.
Enzyme inducers, like phenobarbital, phenytoin and carbamazepine, may increase the rate of toremifene
metabolism thus lowering the steady-state concentration in serum. In such cases doubling of the daily
dose may be necessary.
There is a known interaction between anti-estrogens and warfarin-type anticoagulants leading to a
seriously increased bleeding time. Therefore, the concomitant use of toremifene with such drugs should
be avoided.
Theoretically the metabolism of toremifene is inhibited by drugs known to inhibit the CYP 3A enzyme
system which is reported to be responsible for its main metabolic pathways. Examples of such drugs are
ketoconazole and similar antimycotics, erythromycin and troleandomycin. Concomitant use of those
drugs with toremifene should be carefully considered.
Toremifene is recommended for postmenopausal patients.
There are no adequate data from the use of Fareston in pregnant women. Studies in animals have shown
reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Fareston should not be used during pregnancy.
In rats, decreased body weight gain of the offspring during lactation was observed.
Fareston should not be used during lactation.
Toremifene has no influence on the ability to drive and use machines.
The most frequent adverse reactions are hot flushes, sweating, uterine bleeding, leukorrhea, fatigue,
nausea, rash, itching, dizziness and depression. The reactions are usually mild and mostly due to the
hormonal action of toremifene.
The frequencies of the adverse reactions are classified as follows:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000), not known (cannot be estimated from the available data).
4
System organ
class
Very common
Common
Uncommon
Rare
Very rare
Neoplasms
beningn,
malignant and
unspecified
(including cysts
and polyps)
endometrial
cancer
Metabolism
and nutrition
disorders
loss of appetite
Psychiatric
disorders
depression
insomnia
Nervous system
disorders
dizziness
headache
Eye disorders
transient
corneal
opacity
Ear and
labyrinth
disorders
vertigo
Vascular
disorders
hot flushes
thromboembolic
events
Respiratory,
thoracic and
mediastinal
disorders
dyspnoea
Gastrointestinal
disorders
nausea,
vomiting
constipation
Hepatobiliary
disorders
increase of
transaminases
jaundice
Skin and
subcutaneous
tissue disorders
sweating
rash, itching
alopecia
Reproductive
system and
breast disorders
uterine
bleeding
leukorrhea
endometrial
hypertrophy
endometrial
polyps
endometrial
hyperplasia,
General
disorders and
administration
site conditions
fatigue
oedema
weight increase,
Thromboembolic events include deep venous thrombosis, thrombophlebitis and pulmonary embolism (see
also section 4.4).
Toremifene treatment has been associated with changes in liver enzyme levels (increases of transaminases)
and in very rare occasions with more severe liver function abnormalities (jaundice).
A few cases of hypercalcaemia have been reported in patients with bone metastases at the beginning of
toremifene treatment.
Endometrial hypertrophy may develop during the treatment due to the partial estrogenic effect of toremifene.
There is a risk of increased endometrial changes including hyperplasia, polyps and cancer. This may be due
to the underlying mechanism/estrogenic stimulation (see also section 4.4).
5
Fareston increases the QT interval in a dose-related manner (see also section 4.4).
Vertigo, headache and dizziness were observed in healthy volunteer studies at daily dose of 680 mg. The
dose-related QTc interval prolongation potential of Fareston should also be taken into account in cases of
overdose. There is no specific antidote and the treatment is symptomatic.
5.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Anti-estrogens, ATC code: L02BA02
Toremifene is a nonsteroidal triphenylethylene derivative. As other members of this class, e.g. tamoxifen and
clomifene, toremifene binds to estrogen receptors and may produce estrogenic, anti-estrogenic or both
effects, depending upon the duration of treatment, animal species, gender, target organ and variable selected.
In general, however, nonsteroidal triphenylethylene derivatives are predominantly anti-estrogenic in rats and
man and estrogenic in mice.
In post-menopausal breast cancer patients, toremifene treatment is associated with modest reductions in both
total serum cholesterol and low density lipoprotein (LDL).
Toremifene binds specifically to estrogen receptors, competitively with oestradiol, and inhibits estrogen-
induced stimulation of DNA synthesis and cell replication. In some experimental cancers and/or using high-
dose, toremifene displays anti-tumour effects which are not estrogen-dependent.
The anti-tumour effect of toremifene in breast cancer is mainly due to the anti-estrogenic effect, although
other mechanisms (changes in oncogene expression, growth factor secretion, induction of apoptosis and
influence on cell cycle kinetics) may also be involved in the anti-tumour effect.
5.2 Pharmacokinetic properties
Absorption
Toremifene is readily absorbed after oral administration. Peak concentrations in serum are obtained within 3
(range 2 - 5) hours. Food intake has no effect on the extent of absorption but may delay the peak
concentrations by 1.5 - 2 hours. The changes due to food intake are not clinically significant.
Distribution
The serum concentration curve can be described by a biexponential equation. The half-life of the first
(distribution) phase is 4 (range 2 - 12) hours, and of the second (elimination) phase 5 (range 2 - 10 ) days.
The basal disposition parameters (CL and V) could not be estimated due to the lack of intravenous study.
Toremifene binds extensively ( > 99.5 %) to serum proteins, mainly to albumin. Toremifene obeys linear
serum kinetics at oral daily doses between 11 and 680 mg. The mean concentration of toremifene at steady-
state is 0.9 (range 0.6 - 1.3) µg/ml at the recommended dose of 60 mg per day.
Metabolism
Toremifene is extensively metabolised. In human serum the main metabolite is N-demethyltoremifene with
mean half-life of 11 (range 4 - 20) days. Its steady-state concentrations are about twice compared to those of
the parent compound. It has similar anti-estrogenic, albeit weaker anti-tumour activity than the parent
compound.
It is bound to plasma proteins even more extensively than toremifene, the protein bound fraction being >
99.9 %. Three minor metabolites have been detected in human serum: (deaminohydroxy)toremifene, 4-
6
hydroxytoremifene, and N,N-didemethyltoremifene. Although they have theoretically interesting hormonal
effects, their concentrations during toremifene treatment are too low to have any major biological
importance.
Elimination
Toremifene is eliminated mainly as metabolites to the faeces. Enterohepatic circulation can be expected.
About 10 % of the administered dose is eliminated via urine as metabolites. Owing to the slow elimination,
steady-state concentrations in serum are reached in 4 to 6 weeks.
Characteristics in patients
Clinical anti-tumour efficacy and serum concentrations have no positive correlation at the recommended
daily dose of 60 mg.
No information is available concerning polymorphic metabolism. Enzyme complex, known to be responsible
for the metabolism of toremifene in humans, is cytochrome P450-dependent hepatic mixed function oxidase.
The main metabolic pathway, N-demethylation, is mediated mainly by CYP 3A.
Pharmacokinetics of toremifene were investigated in an open study with four parallel groups of ten subjects:
normal subjects, patients with impaired (mean AST 57 U/L - mean ALT 76 U/L - mean gamma GT 329 U/L)
or activated liver function (mean AST 25 U/L - mean ALT 30 U/L - mean gamma GT 91 U/L - patients
treated with antiepileptics) and patients with impaired renal function (creatinine: 176 µmol/L). In this study
the kinetics of toremifene in patients with impaired renal function were not significantly altered as compared
to normal subjects. The elimination of toremifene and its metabolites was significantly increased in patients
with activated liver function and decreased in patients with impaired liver function.
5.3 Preclinical safety data
The acute toxicity of toremifene is low with LD-50 in rats and mice of more than 2000 mg/kg. In repeated
toxicity studies the cause of death in rats is gastric dilatation. In the acute and chronic toxicity studies most
of the findings are related to the hormonal effects of toremifene. The other findings are not toxicologically
significant. Toremifene has not shown any genotoxicity and has not been found to be carcinogenic in rats. In
mice, estrogens induce ovarian and testicular tumours as well as hyperostosis and osteosarcomas. Toremifene
has a species-specific estrogen-like effect in mice and causes similar tumours. These findings are postulated
to be of little relevance for the safety in man, where toremifene acts mainly as an anti-estrogen.
Non clinical
in vitro
and
in vivo
studies have evidenced the potential of toremifene and its metabolite to
prolong cardiac repolarisation and this can be attributed to the blockade of hERG channels.
In vivo
, high plasma concentrations in monkeys caused a 24 % prolongation in QTc, which is in line with
QTc findings in humans.
It is also to be noted that the C
max
observed in the monkeys (1800 ng/ml) is two-fold compared to the mean
C
max
observed in humans at a daily dose of 60 mg.
Action potential studies in isolated rabbit heart have shown that toremifene induce cardiac
electrophysiological changes which start to develop at concentrations approximately 10 fold compared to the
calculated free therapeutic plasma concentration in human.
7
6.
6.1 List of excipients
Maize starch
Lactose
Povidone
Sodium starch glycolate
Magnesium stearate
Cellulose, microcrystalline
Silica, colloidal anhydrous.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5
Nature and contents of container
Green PVC foil and aluminium foil blister in a cardboard box.
Package sizes: 30 and 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7.
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Finland
8.
MARKETING AUTHORISATION NUMBERS
EU/1/96/004/001
EU/1/96/004/002
8
9.
14 February 1996 / 2 February 2006
{MM/YYYY}
Detailed information on this medicinal product is available on the website of the European Medicines
Agency (EMEA)
http://www.emea.europa.eu/
9
ANNEX II
A.
MANUFACTURING AUTHORISATION HOLDER(S)
RESPONSIBLE FOR BATCH RELEASE
B.
CONDITIONS OF THE MARKETING AUTHORISATION
10
A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
RELEASE
Name and address of the manufacturer(s) responsible for batch release
Orion Corporation Orion Pharma
Tengströminkatu 8
FIN-20360 Turku
Finland
B. CONDITIONS OF THE MARKETING AUTHORISATION
•
Medicinal product subject to medical prescription.
•
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
EFFECTIVE USE OF THE MEDICINAL PRODUCT
Not applicable.
•
OTHER CONDITIONS
11
ANNEX III
LABELLING AND PACKAGE LEAFLET
12
A. LABELLING
13
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON 30 TABLETS
1.
Fareston 60 mg tablets
toremifene
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 60 mg toremifene (as citrate)
3.
LIST OF EXCIPIENTS
Excipients: contains lactose. See package leaflet for further information.
4.
30 tablets
100 tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP:
9.
SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
14
ORION CORPORATION
Orionintie 1
FIN-02200 ESPOO
FINLAND
EU/1/96/004/001
EU/1/96/004/002
13. BATCH NUMBER
Batch number:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Fareston 60 mg
15
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE
PACKAGING
OUTER CARTON 100 TABLETS
1.
Fareston 60 mg tablets
toremifene
2.
STATEMENT OF ACTIVE SUBSTANCE(S)
Each tablet contains 60 mg toremifene (as citrate)
3.
LIST OF EXCIPIENTS
Excipients: contains lactose. See package leaflet for further information
4.
30 tablets
100 tablets
5.
METHOD AND ROUTE(S) OF ADMINISTRATION
Read the package leaflet before use.
6.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
THE REACH AND SIGHT OF CHILDREN
Keep out of the reach and sight of children.
7.
OTHER SPECIAL WARNING(S), IF NECESSARY
8.
EXPIRY DATE
EXP:
9.
SPECIAL STORAGE CONDITIONS
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
16
ORION CORPORATION
Orionintie 1
FIN-02200 ESPOO
FINLAND
EU/1/96/004/001
EU/1/96/004/002
13. BATCH NUMBER
Batch number:
14. GENERAL CLASSIFICATION FOR SUPPLY
Medicinal product subject to medical prescription.
15. INSTRUCTIONS ON USE
16. INFORMATION IN BRAILLE
Fareston 60 mg
17
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER
1.
Fareston 60 mg toremifene
2.
ORION CORPORATION
3.
EXPIRY DATE
EXP:
4.
BATCH NUMBER
Batch number:
5.
OTHER
18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
Fareston 60 mg tablets
Toremifene
Read all of this leaflet carefully before you start using this medicine.
-
Keep this leaflet. You may need to read it again.
-
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet
:
1. What Fareston is and what it is used for
2. Before you take Fareston
3. How to take Fareston
4. Possible side effects
5.
How to store Fareston
6.
Further 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.
BEFORE YOU TAKE FARESTON
Do not take Fareston
- if you are allergic (hypersensitive) to toremifene or any of the other ingredients of Fareston
-
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 with certain abnormal electrocardiogram (ECG,
electrical recording of the heart) changes,
-
have salt imbalance in the blood, especially low concentrations of potassium in the blood
(hypokalaemia) which are currently not corrected by treatment,
-
have a very slow heart rate (bradycardia),
-
have a heart failure,
.
have a history of abnormal heart rhythms (arrhythmias),
.
or you are taking other medicines that result in certain abnormal ECG changes (see section “Taking
other medicines”).
This is because Fareston can cause a certain change on the ECG, which is a prolongation of the QT-
interval i.e. delayed conduction of electrical signals.
Take special care with Fareston
-
if you have labile diabetes or your performance status is severely deteriorated.
-
In case you have a history of deep venous thrombosis or lung embolism or certain heart rhytm
abnormalities (see “Do not take Fareston”), you should generally not take Fareston.
Please consult your doctor before treatment with Fareston
-
if you have bone metastasis hypercalcemia (increased concentration of calcium in the blood, may
occur at the beginning of the treatment), thus calcium level has to be controlled.
Please contact your doctor whether you should have gynaecological examinations in the beginning and at
regular intervals while taking Fareston.
Taking other medicines
20
-
If you have any further questions, ask your doctor or pharmacist.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription. The dose of some of these may have to be adjusted while you are on
Fareston.
These include: diuretics of thiazide type, anticoagulants (to prevent blood clotting) of warfarin type, certain
anti-epileptics (medicines used to treat epilepsy e.g. carbamazepine, phenytoin, phenobarbital), certain anti-
mycotics (used to treat fungal infections such as ketoconazole), certain antibiotics (such as erythromycin and
troleandomycin).
For Fareston be aware of the following:
If you are taking Fareston and other medicines that affect your heart there is an increased risk for altering
your heartbeat. Therefore, do not take Fareston together with the following medicines:
-
antiarrhythmics like quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide,
-
neuroleptics like phenothiazines, pimozide, sertindole, haloperidol, sultopride
-
certain antimicrobials agents (moxifloxacin, erythromycin IV, pentamidine, antimalarials particularly
halofantrine),
-
certain antihistaminics (terfenadine, astemizole, mizolastine),
-
others (cisapride, intravenous vincamine, bepridil, diphemanil.
If you are admitted to the hospital or if you are prescribed a new medicine, please tell your doctor that you
are taking Fareston.
Pregnancy and breast-feeding
Fareston is recommended for women who have had their menopause. It should not be used during pregnancy
or breast-feeding.
Driving and using machines
Toremifene has no influence on the ability to drive and use machines.
Important information about some of the ingredients of Fareston
Fareston contains lactose (30 mg per tablet). If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.
3.
HOW TO TAKE FARESTON
Always take Fareston exactly as your doctor has told you. You should check with your doctor if you are not
sure. The usual dose is 60 mg tablet taken orally, once daily. Fareston can be taken with or without food.
If you take more Fareston than you should
Contact your doctor immediately. Symptoms of overdose may be dizziness and headache.
If you forget to take Fareston
If you miss one dose take the next tablet as usual and continue treatment as recommended. Do not take a
double dose to make up for a forgotten tablet. If you have missed several doses, please inform your doctor
and follow his instructions.
If you stop taking Fareston
The treatment with Fareston should only be stopped when advised by your doctor.
If you have any further questions on the use of this product, ask your doctor.
21
4.
POSSIBLE SIDE EFFECTS
Like all medicines, Fareston can cause side effects, although not everybody gets them.
Side effects may occur with certain frequencies, which are defined as follows:
-
very common: affects more than 1 user in 10
-
uncommon: affects 1 to 10 users in 1,000
-
rare: affects 1 to 10 users in 10,000
-
very rare: affects less than 1 user in 10,000
-
not known: frequency cannot be estimated from the available data.
Very common side effects
Hot flushes, sweating.
Common side effects
Fatigue, oedema (swelling), nausea (feeling sick), vomiting, rash, itching, dizziness, depression, uterine
bleeding, white discharge.
Uncommon side effects
Headache, weight increase, sleep disorders, shortness of breath, constipation, loss of appetite, endometrial
hypertrophy, thromboembolic events.
Rare side effects
Vertigo, endometrial polyps, increase of liver transaminases.
Very rare side effects
Changes in the lining of the uterus (endometrium), endometrial cancer, alopecia, transient corneal opacity,
jaundice.
You should immediately contact your doctor if you notice any of the following symptoms: swelling or
tenderness in your calf, unexplained shortness of breath or sudden chest pain, vaginal bleeding or changes in
vaginal discharge.
Fareston increases the QTc interval in a dose-related manner. Thus electrocardiogram changes (QTc interval
prolongation, arrhythmias) are possible side effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5.
HOW TO STORE FARESTON
Keep out of the reach and sight of children.
Do not use Fareston after the expiry date which is stated on the label. The expiry date refers to the last day of
that month.Fareston does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
22
-
common: affects 1 to 10 users in 100
6.
FURTHER INFORMATION
What Fareston contains
-
The active substance is toremifene; each tablet contains 60 mg (as citrate).
-
The other ingredients are maize starch, lactose, povidone, sodium starch glycolate, microcrystalline
cellulose, colloidal anhydrous silica and magnesium stearate.
What Fareston looks like and contents of the pack
White, round, flat, bevelled edge tablet with TO 60 on one side.
30 and 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Finland
Manufacturer
Orion Corporation, Orion Pharma
Tengströminkatu 8
FIN-20360 Turku
Finland
23
For any information about this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:
België/Belgique/Belgien
Baxter Belgium SPRL
Bd de la Plaine/Pleinlaan 5
B-1050 Brussel/Bruxelles/Brüssel
Tel: +32 2 650 1711
Luxembourg/Luxemburg
Baxter Belgium SPRL
Bd de la Plaine/Pleinlaan 5
B-1050 Brussel/ Bruxelles/Brüsse
l
Tel: +32 2 650 1711
България
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Tel: +358 10 4261
Magyarország
Orion Pharma Kft.
Xenter13 Irodaház, Pap Károly u. 4-6 VII. emelet
H-1139 Budapest
Tel: +36 1 239 9095
Česká republika
Orion-yhtymä Oyj
Zelený pruh 95/97
140 00 Praha
Tel: +420 227 027 263
Malta
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Tel: +358 10 4261
Danmark
Orion Pharma A/S
Møllevej 9
DK-2990 Nivå
Tel: + 45 49 12 6600
Nederland
Baxter B.V.
Kobaltweg 49
NL-3542 CE Utrecht
Tel: +31 30 24 88911
Deutschland
Baxter Deutschland GmbH
Edisonstraße 4
85716 Unterschleißheim
Tel: +49 89 31 701 -0
Norge
Orion Pharma AS
Gjerdrumsvei 8
Pb. 4366 Nydalen
NO-0402 Oslo
Tel: + 47 40 00 42 10
Eesti
Orion Pharma Eesti OÜ
Tammsaare str 47
EE-11316 Tallinn
Tel: +372 66 44 550
Österreich
Baxter Healthcare GmbH.
Stella-Klein-Löw-Weg 15
A-1020 Wien
Tel: +43 1 71120-0
Ελλάδα
Αγίου Δημητρίου 63
GR-174 55 Άλιμος
Τηλ: +30 210 98 97300
Polska
Orion Pharma Poland Sp. z o.o.
Przedstawicielstwo w Polsce
Ul. Parandowskiego 19
PL-01-699 Warszawa
Tel: + 48 22 8333177, 8321036
España
Schering-Plough, S.A.
Edificio Amura
C/Cantabria, 2-3
a
Planta
E-28108 Alcobendas (Madrid)
Tel: + 34 91 567 3000
Portugal
Rue Agualva dos Açores 16
PT-2735-557 Agualva Cacem
Tel: +351 21 433 9300
24
France
Centre Specialites Pharmaceutiques
76-78 avenue du Midi
F-63800 Cournon d’Auvergne
Tél: +33 1 47 04 80 46
România
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Tel: +358 10 4261
Ireland
Orion Pharma (Ireland) Ltd
c/o Allphar Services Ltd.
4045 Kingswood Road
Citywest Business Campus
IRL- Co. Dublin
Tel: + 353 1 468 7500
Slovenija
Orion Corporation
Orionintie 1
FIN-02200 Espoo
Tel: +358 10 4261
Ísland
Vistor hf.
Hörgatún 2
IS-210 Garðabær
Tel: +354 535 7000
Slovenská republika
Orion-yhtymä Oyj
Ružová dolina 6
821 08 Bratislava 2
Tel. +421 2 5022 1215
Italia
Schering-Plough S.p.A
Via fratelli Cervi snc
Centro Direzionale Milano Due
Palazzo Borromini
I-20090 Segrate (Milano)
Tel: + 39 02 21018.1
Suomi/Finland
Orion Corporation
Orionintie 1
FIN-02200 Espoo/Esbo
Tel: +358 10 4261
Κύπρος
Μ.Σ. Ιακωβίδης & Σία Λτδ
Οδός Αγίου Νικολάου 8,
CY-1055 Λευκωσία
Τηλ.: +357-22 757.188
Sverige
Orion Pharma AB
Box 520
SE-192 05 Sollentuna
Tfn: + 46 8 623 6440
Latvija
Orion Corporation
Orion Pharma pārstāvniecība
Bauskas iela 58-244
LV-1004 Rīga
Tel.: +371 67455563
United Kingdom
Orion Pharma (UK) Ltd
Oaklea Court
22 Park Street, Newbury
Berkshire, RG14 1EA
Tel.: + 44 1635 520 300
Lietuva
UAB Orion Pharma
Kubiliaus str. 6
LT-08234 Vilnius
Tel. +370 5 276 9499
This leaflet was last approved in
{MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site:
25
Source: European Medicines Agency
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