FARESTON 60 mg Coated Tablet

Зміст інструкції

1. Fareston 60 mg tablets
   1. What is Fareston and what is it used for
   2. What you need to know before you take Fareston
2. Fareston may cause an increase in blood calcium concentration. The doctor
   1. How to take Fareston
   2. Possible side effects
   3. How to store Fareston
   4. Package contents and other information

Fareston 60 mg tablets

toremifene

Read this leaflet carefully before you start to take this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Fareston and what is it used for

Fareston contains the active ingredient toremifene, an anti-estrogen. Fareston is indicated for the
treatment of specific types of breast cancer in women who have already reached
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 uterine walls
• if you have severe liver problems
• if you were born with or have had any condition that causes some abnormal changes in the electrical recording of the heart (electrocardiogram or ECG)
• if you have an altered balance of salts in the blood, especially low potassium levels in the blood (hypokalaemia) at the moment not corrected by treatment
• if you have a very slow heart rate (bradycardia)
• if you suffer from heart failure
• if you have a history of abnormal heart rhythms (arrhythmias)
• if you are taking other medicines that can have effects on the heart (see section 2 “Other medicines and Fareston”). This is because Fareston can affect the heart by delaying the conduction of electrical signals inside the heart (prolongation of the QT interval).

Warnings and precautions
Talk to your doctor or pharmacist before taking Fareston:

• if you suffer from unstable diabetes
• if your general condition has seriously worsened
• if you have had in the past a condition in which blood clots formed in blood vessels, for example in the lungs (pulmonary embolism) or in the veins of the legs (deep vein thrombosis).
• if an abnormal heart rhythm occurs during treatment with Fareston. Your doctor may advise you to stop taking Fareston and have a test to see how your heart is working (ECG). (see section 2 “Do not take Fareston”).
• if you suffer from any heart condition, including chest pain (angina)
• if the cancer has spread to the bones (bone metastases), as at the beginning of treatment with

Fareston may cause an increase in blood calcium concentration. The doctor

will perform regular medical check-ups.

• if you have been told by your doctor that you have an intolerance to certain sugars, such as lactose (see section 2 Fareston contains lactose).

You must undergo gynaecological examinations before starting treatment with Fareston and at least once
a year after the start of treatment. The doctor will perform regular medical check-ups if you have high
blood pressure, diabetes, have undergone hormone replacement therapy or if you are obese (BMI over 30).

Other medicines and Fareston
Tell your doctor if you are taking, have recently taken or might take any other
medicines. During treatment with Fareston it may be necessary to adjust the dosage of
some of them. In particular, tell your doctor if you are taking any of the following medicines:

• diuretics (thiazide diuretics)
• medicines to prevent blood clotting, such as warfarin
• medicines used to treat epilepsy, such as carbamazepine, phenytoin, phenobarbital
• medicines used to treat fungal infections, such as ketoconazole, itraconazole, voriconazole, posaconazole
• medicines used to treat bacterial infections, such as erythromycin, clarithromycin and telithromycin
• medicines used to treat viral infections, such as ritonavir and nelfinavir.

Do not take Fareston together with the following drugs as there is an increased risk that the
heartbeat may be altered (see section 2 “Do not take Fareston”):

• medicines used to treat abnormal heart rhythms (antiarrhythmics) such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide
• medicines used to treat mental or behavioural disorders (neuroleptics) such as phenothiazines, pimozide, sertindole, haloperidol and sulpiride
• medicines used to treat infections (antimicrobials) such as moxifloxacin, erythromycin (infusion), pentamidine and antimalarials (in particular halofantrine)
• some medicines to treat allergies such as terfenadine, astemizole and mizolastine
• others such as cisapride, intravenous vincamine, bepridil, difemanil.

If you are admitted to hospital or are prescribed a new medicine, tell your doctor that you
are taking Fareston.

Pregnancy and breastfeeding
Do not use Fareston during pregnancy or breastfeeding.

Driving and using machines
Fareston does not alter the ability to drive vehicles or use machines.

Fareston contains lactose
Fareston contains 28.5 mg of lactose (as monohydrate) per tablet. If your doctor has
diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Other excipients
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially
‘sodium-free’.

3. How to take Fareston

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult
your doctor or pharmacist. The usual dose is one 60 mg oral tablet once a day.
Fareston can be taken with or without food.

If you take more Fareston than you should
Contact your doctor, pharmacist or the nearest hospital immediately. Symptoms of overdose
may be dizziness and headache.

If you forget to take Fareston
If you forget to take a dose, take the next tablet as usual and continue the
treatment as recommended. Do not take a double dose to make up for a missed
tablet. If you have forgotten several doses, contact your doctor and follow their instructions.

If you stop taking Fareston
Treatment with Fareston must only be stopped when advised by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common ( affects more than 1 in 10 people):

• hot flushes, sweating.

Common ( affects up to 1 in 10 people):

• fatigue, dizziness, depression
• nausea (feeling sick), vomiting
• skin rash, itching, edema (swelling)
• uterine bleeding, whitish discharge.

Uncommon ( affects up to 1 in 100 people):

• headache, sleep disorders
• weight gain, constipation, loss of appetite
• thickening of the uterine lining (endometrial hypertrophy)
• blood clot for example in the lung (thromboembolic events)
• shortness of breath.

Rare ( affects up to 1 in 1,000 people):

• feeling of spinning (vertigo)
• growth of the uterine lining (endometrial polyps)
• increased liver enzymes (increased hepatic transaminases).

Very rare ( affects up to 1 in 10,000 people):

• changes in the uterine lining (endometrium), cancer of the uterine lining (endometrial cancer)
• hair loss (alopecia)
• clouding of the surface of the eye (transient corneal opacity)
• yellowing of the skin or whites of the eyes (jaundice).

Not known ( frequency cannot be estimated from available data):

• low number of white blood cells, which are important for fighting infections (leukopenia)
• low number of red blood cells (anemia)
• low number of platelets (thrombocytopenia)
• inflammation of the liver (hepatitis)
• high levels of triglycerides, a type of fat, in the blood.

You should contact your doctor immediately if you notice:

• Swelling or pain in the calves
• shortness of breath or sudden chest pain
• vaginal bleeding or changes in vaginal discharge.

Fareston causes some abnormal changes in the electrical recording of the heart
(electrocardiogram or ECG). See section 2 “Warnings and precautions”.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V *.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Fareston

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. This medicine does not require any particular
storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fareston contains

• The active ingredient is toremifene; each tablet contains 60 mg (as citrate).
• The excipients are corn starch, lactose monohydrate, povidone, sodium starch glycolate, microcrystalline cellulose, anhydrous colloidal silica and magnesium stearate.

Description of the appearance of Fareston and package contents
White, round, flat tablet, beveled at the edges with the inscription TO 60 on one side.
30 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Orion Corporation
Tél/Tel: +358 10 4261

Lietuva
Orion Corporation
Tel: +358 10 4261

България
Orion Corporation
Tel: +358 10 4261

Luxembourg/Luxemburg
Orion Corporation
Tél/Tel: +358 10 4261

Česká republika
Orion Corporation
Tel: +358 10 4261

Magyarország
Orion Corporation
Tel.: +358 10 4261

Danmark
Orion Corporation
Tlf: +358 10 4261

Malta
Orion Corporation
Tel: +358 10 4261

Deutschland
Orion Corporation
Tel: +358 10 4261

Nederland
Orion Corporation
Tel: +358 10 4261

Eesti
Orion Corporation
Tel: +358 10 4261

Norge
Orion Corporation
Tlf: +358 10 4261

Ελλάδα
Orion Corporation
Τηλ: +358 10 4261

Österreich
Orion Corporation
Tel: +358 10 4261

España
Orion Corporation
Tel: +358 10 4261

Polska
Orion Corporation
Tlf: +358 10 4261

France
Orion Pharma
Tel: +33 (0) 1 85 18 00 00

Portugal
Orion Corporation
Tel: +358 10 4261

România
Orion Corporation
Tel: +358 10 4261

Hrvatska
Orion Corporation
Tel.: +358 10 4261

Ireland
Orion Corporation
Tlf: +358 10 4261

Slovenija
Orion Corporation
Tel: +358 10 4261

Ísland
Orion Corporation
Sími: +358 10 4261

Slovenská republika
Orion Corporation
Tel: +358 10 4261

Italia
Orion Pharma S.r.l.
Tel: + 39 02 67876111

Suomi/Finland
Orion Corporation
Puh./Tel: +358 10 4261

Κύπρος
Orion Corporation
Τηλ: +358 10 4261

Sverige
Orion Pharma AB
Tel: +46 8 623 6440

Latvija
Orion Corporation
Tel: +358 10 4261
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND MOTIVATIONS FOR THE VARIATION OF
THE TERMS OF MARKETING AUTHORISATIONS
Scientific conclusions
Taking into account the evaluation by the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Reports (PSUR) for toremifene, the scientific conclusions of the
PRAC are as follows:
In light of the available data on hypertriglyceridaemia from the literature and spontaneous reports, including
some cases with a close temporal relationship, a de-challenge and/or a positive re-challenge and considering a
plausible mechanism of action, the PRAC considers that there may be a reasonable possibility of a causal
relationship between toremifene and hypertriglyceridaemia. The PRAC concluded that the product information
for medicinal products containing toremifene should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
(CHMP) agrees with the overall conclusions and the motivations of the recommendation.

Motivations for the variation of the terms of the marketing authorisation
Based on the scientific conclusions on toremifene, the CHMP considers that the benefit/risk ratio of the
medicinal product containing toremifene remains unchanged, subject to the proposed amendments to the
product information.
The CHMP recommends the variation of the terms of the marketing authorisation.