60 mg tablets 
toremifene

1. What Fareston is and what it is used for

Fareston contains the active substance toremifene, an antiestrogen. Fareston is used to treat a certain type of breast tumor in women who have had their last period.

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 lining.
  • if you have severe liver problems.
  • if you are born with or later have heart problems that cause special changes to appear on charts that show the heart’s electrical activity ( electrocardiogram or ECG )
  • if you have an imbalance in the salinity of the blood, especially if you have too low a concentration of potassium in the blood ( hypokalaemia ) and are not currently being treated for this
  • if your heart beats very slowly ( bradycardia )
  • if you have heart failure
  • if you have a history of abnormal heart rhythm ( arrhythmias )
  • if you are taking other medicines that may affect your heart function (see section 2 Other medicines and Fareston). This is because Fareston can affect your heart by delaying the conduction of certain electrical signals in the heart (an extension of the QT interval ).

Warnings and cautions

Talk to your doctor or pharmacist before taking Fareston.

  • if you have uncontrolled diabetes
  • if you have a severely impaired general condition.
  • if you have previously had blood clots, for example in your lungs ( pulmonary embolism ) or your legs (deep vein thrombosis ).
  • if you get an abnormal heart rhythm while taking Fareston. Your doctor may advise you to stop taking Fareston and perform medical tests to see how your heart is working ( ECG ) (see section 2 Do not take Fareston).
  • If you have any type of heart problem, including chest pain (angina).
  • If you have cancer that has spread to the skeleton (skeletal metastases) because increased calcium levels in the blood may occur at the beginning of treatment with Fareston and your doctor needs to do regular check-ups.
  • If you have been told by your doctor that you have an intolerance to some sugars, such as lactose (see section 2 Fareston contains lactose ).

You will need to undergo a gynecological examination before starting treatment with Fareston and at least once a year during the time you are receiving treatment with Fareston. Your doctor will regularly check if you have high blood pressure, diabetes, have taken hormonal replacement therapy or if are overweight ( BMI over 30).

Other drugs and Fareston

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Dosage one of some of them may need to be changed when you are being treated with Fareston.

This is especially true if you are taking any of the following medicines:

  • diuretics ( thiazide -type diuretics)
  • anticoagulants such as warfarin
  • agents for the treatment of epilepsy e.g. carbamazepine, phenytoin, phenobarbital
  • agents for the treatment of fungal infections such as ketoconazole, itraconazole, voriconazole, and posaconazole
  • drugs used to treat bacterial infections ( antibiotics ) e.g. erythromycin, clarithromycin, and telithromycin.
  • drugs used to treat viral infections such as ritonavir and nelfinavir.

Do not take Fareston with the following medicines as there is an increased risk of changes in your heart rhythm (see section 2- Do not take Fareston):

  • drugs for abnormal heart rhythm ( antiarrhythmics ); such as quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, ibutilide
  • drugs for mental illness and behavioral disorders ( neuroleptics ) such as phenothiazines, pimozide, sertindole, haloperidol, and sultopride
  • medicines for infections (medicines for microorganisms ) such as moxifloxacin, erythromycin ( infusion ), pentamidine, and medicines for malaria, especially halofantrine
  • some medicines for allergies such as terfenadine, astemizole, and mizolastine
  • certain other medicines; cisapride, vincamine intravenously, bepridil, difemanil.

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

Pregnancy and breastfeeding

Do not use Fareston during pregnancy or breast-feeding.

Driving and using machines

Fareston does not affect the ability to drive and use machines.

Fareston contains lactose

Fareston contains lactose (28.5 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 medicine.

How to take Fareston

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. The usual dose is one 60 mg tablet daily. The tablet should be swallowed. Fareston can be taken with or without food.

If you take more Fareston then you should

Contact your doctor, pharmacist, or nearest hospital immediately. Symptoms of overdose may include dizziness and headache.

If you forget to take Fareston

If you forget to take a dose, take the next tablet as usual and continue treatment according to the instructions. Do not take a double dose to make up for a forgotten tablet

If you have missed several doses, contact your doctor and follow his / her instructions.

If you stop taking Fareston

Fareston treatment should only be stopped if your doctor has recommended it. If you have any further questions on the use of this product, 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 flashes, sweating

Common side effects (may affect up to 1 in 10 people):

  • fatigue, dizziness, depression
  • nausea, vomiting
  • skin rash, itching, edema (swelling) bleeding from the uterus, white discharge.

Uncommon side effects (may affect up to 1 in 100 people):

  • headache, sleep disturbances
  • weight gain, constipation, loss of appetite
  • thickening of the uterine lining
  • blood clots eg in the lung (thromboembolic event)
  • shortness of breath,

Rare side effects (may affect up to 1 in 1,000 people):

  • dizziness
  • growth of the uterine lining ( polyps )
  • increase in liver enzymes (increased laboratory values ​​for transaminases in the liver)

Very rare side effects (may affect up to 1 in 10,000 people):

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

Has been reported (occurs in an unknown number of users):

  • low levels of white blood cells, which are important in the immune system ( leukopenia )
  • low level of red blood cells ( anemia )
  • low platelet count ( thrombocytopenia )
  • liver inflammation ( hepatitis ).

You should contact your doctor immediately if you notice any of the following:

  • swelling or tenderness in the calf
  • unexplained shortness of breath or sudden chest pain
  • vaginal bleeding or changes in vaginal discharge.

Fareston causes abnormal changes in charts that show the electrical activity of the heart ( electrocardiogram or ECG ). See section 2- Warnings and Precautions.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via:

The Medical Products Agency

Box 26

SE-751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects, you can help increase drug safety information.

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 expiration date is the last day of the specified month.

This medicine 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. Contents of the packaging and other information

Content declaration

  • The active substance is toremifene; each tablet contains 60 mg (as citrate).
  • The other ingredients are corn starch, lactose monohydrate, povidone, sodium starch glycollate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What the medicine looks like and the contents of the pack

White, round, flat tablets with beveled edges, marked TO 60 on one side.

30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

Muhammad Nadeem

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