Patient leaflet - Fareston
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
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– if you are allergic to toremifene or any of the other ingredients of this medicine (listed in
section 6).
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– if you have a thickening of the womb lining
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– if you have severe liver problems
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– 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)
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– 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
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– if you have a very slow heart rate (bradycardia)
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– if you have a heart failure
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– if you have a history of abnormal heart rhythms (arrhythmias)
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– if you are taking other medicines that may affect your heart (see section 2 Other medicines and
Fareston).
This is because Fareston can affect your heart by delaying the conduction of electrical signals within your heart (prolongation of QT-interval).
Warnings and precautions
Talk to your doctor or pharmacist before taking Fareston:
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– if you have unstable diabetes
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– if your general well-being is severely deteriorated
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– if you have previously had a condition in which blood clots formed in blood vessels, for
example in your lungs (lung embolism) or in the veins of your legs (deep vein thrombosis).
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– if you experience an abnormal heart rhythm whilst taking Fareston. Your doctor may advise
you to stop taking Fareston and perform a medical test to see how your heart is working (ECG). (see section 2 Do not take Fareston)
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– if you have any heart condition, including chest pain (angina)
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– if your cancer has spread to the bones (bone metastasis) as calcium blood levels may increase at
the beginning of treatment with Fareston. Your doctor will conduct regular medical check-ups.
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– if you have been told by your doctor that you have an intolerance to certain sugars, like lactose
(see section 2 Fareston contains lactose).
You should have gynaecological examinations before you start treatment with Fareston and at least once a year following the start of treatment with Fareston. Your doctor will conduct regular medical check-ups if you have high blood pressure, diabetes, have taken 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. The dose of some of these may have to be adjusted while you are on Fareston. In particular please tell your doctor if you are taking any of the following:
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– water tablets (diuretics of thiazide type)
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– medicines to prevent blood clotting such as warfarin
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– medicines used to treat epilepsy such as carbamazepine, phenytoin, phenobarbital
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– medicines used to treat fungal infections such as ketoconazole, itraconazole, voriconazole,
posaconazole
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– medicines used to treat bacterial infections (antibiotics) such as erythromycin, clarithromycin
and telithromycin
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– medicines used to treat viral infection such as ritonavir and nelfinavir.
Do not take Fareston together with the following medicines as there is an increased risk that your heartbeat may be altered (see section 2 Do not take Fareston):
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– medicines used to treat abnormal heart rhythm (antiarrhythmics); such as quinidine,
hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide and ibutilide
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– medicines used to treat mental and behavioral disorders (neuroleptics); such as phenothiazines,
pimozide, sertindole, haloperidol and sultopride
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– medicines used to treat infections (antimicrobials); such as moxifloxacin, erythromycin
(infusion) pentamidine and antimalarials (particularly halofantrine)
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– certain medicines to treat allergies; such as terfenadine, astemizole and mizolastine
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– 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
Do not use Fareston during pregnancy or breast feeding.
Driving and using machines
Fareston has no influence on the ability to drive and use machines.
Fareston contains lactose
Fareston contains 28.5 mg lactose (as monohydrate) 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.
Other excipients
This medicine contains less than 1 mmol (23 mg) sodium per tablet that is to say essentially ‘sodium-free’.
3. How to take Fareston
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is one 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, pharmacist or the nearest hospital 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 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 side effects ( may affect more than 1 in 10 people ): – hot flushes, sweating.
Common side effects ( may affect up to 1 in 10 people ):
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– fatigue, dizziness, depression
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– nausea (feeling sick), vomiting
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– rash, itching, oedema (swelling)
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– uterine bleeding, white discharge.
Uncommon side effects ( may affect up to 1 in 100people
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– headache, sleep disorders
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– weight increase, constipation, loss of appetite
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– thickening of the lining of the womb (endometrial hypertrophy)
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– blood clot for example in the lung (thromboembolic events)
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– shortness of breath.
Rare side effects ( may affect up to 1 in 1,000 people ):
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– a feeling of spinning (vertigo)
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– growth on the lining of the womb (endometrial polyps)
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– increase in liver enzymes (increase of liver transaminases).
Very rare side effects ( may affect up to 1 in 10,000 people ):
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– changes in the lining of the uterus (endometrium), cancer of the lining of the womb
(endometrial cancer)
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– hair loss (alopecia)
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– cloudiness of the eye surface (transient corneal opacity)
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– yellowing of the skin or whites of the eyes (jaundice).
Frequency not known (cannot be estimated from the available data)■.
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– low number of white blood cells, which are important in fighting infection (leukopenia)
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– low number of red blood cells (anaemia)
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– low number of platelets (thrombocytopenia)
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– inflammation of the liver (hepatitis).
You should contact your doctor immediately if you notice any of the following:
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– swelling or tenderness in your calf
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– unexplained shortness of breath or sudden chest pain
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– vaginal bleeding or changes in vaginal discharge.
Fareston causes certain 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 via the national reporting system listed inBy 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 label. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Fareston contains
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– The active substance is toremifene; each tablet contains 60 mg (as citrate).
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– The other ingredients are maize starch, lactose monohydrate, povidone, sodium starch
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
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For any information about this human medicinal product, please contact the local representative of the marketing authorisation holder.
| Belgie/Belgique/Belgien Orion Corporation Tél/Tel: +358 10 4261 | Lietuva Orion Corporation Tel: +358 10 4261 |
| Efc^rapufl Orion Pharma Poland Sp. z o.o. Tel: + 48 22 8 333 177 | 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 |
| EZZáSa Orion Corporation Tql: +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 Tél: +33 (0) 1 85 18 00 00 | Portugal Orion Corporation Tel: +358 10 4261 |
| Hrvatska Orion Corporation Tel.: +358 10 4261 | Romania Orion Pharma Poland Sp. z o.o. Tel: + 48 22 8 333 177 |
| 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 |
Kûnpoç
Orion Corporation
Tql: +358 10 4261
Latvija
Orion Corporation
Tel: +358 10 4261
Sverige
Orion Pharma AB
Tel: +46 8 623 6440
United Kingdom (Northern Ireland)
Orion Corporation
Tel: +358 10 4261
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
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