Evista 60mg film-coated tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Evista is and what it is used for
2. What you need to know before you take Evista
3. How to take Evista
4. Possible side effects
5. How to store Evista
6. Contents of the pack and other information

Do not take Evista:

• If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism) or in the eyes (retinal vein thrombosis).
• If you are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine (listed in section 6).
• If there is still a possibility that you can get pregnant, Evista could harm your unborn child.
• If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
• If you have severe kidney problems.
• If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• If you have active uterine cancer, as there is insufficient experience of Evista use in women with this disease.

Warnings and precautions

Talk to your doctor or pharmacist before you take Evista.

• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness as these may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
• If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.
• If you have liver disease
• If you are suffering from breast cancer, as there is insufficient experience of Evista use in women with this disease.
• If you are receiving oral oestrogen therapy.

It is unlikely that Evista will cause vaginal bleeding. So any vaginal bleeding while you take Evista is unexpected. You should have this investigated by your doctor.

Evista does not treat postmenopausal symptoms, such as hot flushes.

Evista lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Evista.

Evista contains lactose

If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product.

Other medicines and Evista

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.

Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine, because Evista may not work as well.

Pregnancy and breast-feeding

Evista is for use only by postmenopausal women and must not be taken by women who could still have a baby. Evista could harm your unborn child.

Do not take Evista if you are breast-feeding as it might be excreted in mother's milk.

Driving and using machines

Evista has no or negligible effects on driving or using machines.

If you take more Evista than you should

Tell your doctor or pharmacist. If you take more Evista than you should you could have leg cramps and dizziness.

If you forget to take Evista

Take a tablet as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten tablet dose.

If you stop taking Evista

You should talk to your doctor first.

It is important that you continue taking Evista for as long as your doctor prescribes the medicine.

Evista can treat or prevent your osteoporosis only if you continue to take the tablets.

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:

Ireland:

United Kingdom:

or search for MHRA Yellow Card in the Google Play or Apple App Store,

Malta:

By reporting side effects you can help provide more information on the safety of this medicine.

What Evista contains

• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
• The other ingredients are:
  Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate.
  Tablet coating: Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.
  Ink: Shellac, propylene glycol, indigo carmine (E 132).

What Evista looks like and contents of the pack

Evista are white, oval, film coated tablets which are marked with the number 4165. They are packed in blisters or in plastic bottles. The blister boxes contain 14, 28 or 84 tablets. The bottles contain 100 tablets. Not all pack sizes may be marketed.

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