patient information leaflet fareston

PACKAGE LEAFLET: INFORMATION FOR THE USER

Fareston 60 mg tablet

Active substance: Toremifene citrate

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

1. WHAT FARESTON IS AND WHAT IT IS USED FOR

Fareston is an anti-oestrogen. 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.

Take special care with Fareston

if you have heart failure, labile diabetes or your performance status is severely deteriorated.
In case you have a history of deep venous thrombosis or lung embolism, you should generally not take Fareston.

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 with regard to the question whether you should have gynaecological examinations in the beginning and regular intervals while taking Fareston.

Please consult your doctor or pharmacist if you think this applies to you.

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) and certain antibiotics (such as erythromycin and troleandomycin).

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 in one 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.

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

Daily intake is recommended. 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.

4. POSSIBLE SIDE EFFECTS

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

The side effects that are most likely to occur are: hot flushes, sweating, uterine bleeding, white discharge, tiredness, nausea (feeling sick), rash, itching, dizziness and depression.

Other possible side effects are: headache, weight increase, swelling, sleep disorders, shortness of breath, constipation, loss of appetite, reversible sight problems and vomiting.

Rare but serious side effects are; blood clots in veins of legs and/or lung, changes in the lining of the uterus (endometrium) and liver problems. You should 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.

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.

6. FURTHER INFORMATION

What Fareston contains

The active substance is toremifene 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

Tablets are white, round, flat, bevelled edge tablet with TO 60 on one side.

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.

Medicine: fareston