Fareston 60 mg tablets

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.

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

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.

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.

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
• common: affects 1 to 10 users in 100
• 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.

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.

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

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Baxter Belgium SPRL Bd de la PlainePleinlaan 5 B-1050 BrusselBruxellesBrüssel Tel 32 2 650 1711 LuxembourgLuxemburg Baxter Belgium SPRL Bd de la PlainePleinlaan 5 B-1050 Brussel BruxellesBrüssel Tel 32 2 650 1711

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

eská republika Orion-yhtymä Oyj Zelen pruh 9597 140 00 Praha Tel 420 227 027 263 Malta Orion Corporation Orionintie 1 FIN-02200 Espoo Tel 358 10 4261

Danmark Orion Pharma AS 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

63 GR-174 55 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

Portugal Rue Agualva dos Açores 16 PT-2735-557 Agualva Cacem Tel 351 21 433 9300 España Schering-Plough, S.A. Edificio Amura CCantabria, 2-3a Planta E-28108 Alcobendas Madrid Tel 34 91 567 3000

France Centre Specialites Pharmaceutiques 76-78 avenue du Midi F-63800 Cournon dAuvergne Tél 33 1 47 04 80 46 România Orion Corporation Orionintie 1 FIN-02200 Espoo Tel 358 10 4261

Slovenija Orion Corporation Orionintie 1 FIN-02200 Espoo Tel 358 10 4261 Ireland Orion Pharma Ireland Ltd co Allphar Services Ltd. 4045 Kingswood Road Citywest Business Campus IRL- Co. Dublin Tel 353 1 468 7500

Ísland Vistor hf. Hörgatún 2 IS-210 Garðabær Tel 354 535 7000 Slovenská republika Orion-yhtymä Oyj Ruová dolina 6 821 08 Bratislava 2 Tel. 421 2 5022 1215

SuomiFinland Orion Corporation Orionintie 1 FIN-02200 EspooEsbo Tel 358 10 4261 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

.. 8, CY-1055 . 357-22 757.188 Sverige Orion Pharma AB Box 520 SE-192 05 Sollentuna Tfn 46 8 623 6440

Latvija Orion Corporation Orion Pharma prstvniecba Bauskas iela 58-244 LV-1004 Rga 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}.