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Fareston 60mg Tablets

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.
  • If you have any further questions, ask your doctor or pharmacist.
  • 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

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.

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 your 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 rhythm 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.

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.

Possible Side Effects

Like all medicines, Fareston can cause side effects, although not everybody gets them.

The 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 electocardiogram 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.

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.

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
Tengstr?minkatu 8
FIN-20360 Turku
Finland

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

United Kingdom
Orion Pharma (UK) Ltd
Oaklea Court
22 Park Street
Newbury
Berkshire
RG14 1EA
Tel.:+ 44 1635 520 300

This leaflet was last approved in January 2009

Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.





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