EVISTA. 60 mg. 28 tablets
Evista is used for the treatment and prevention of osteoporosis in postmenopausal women. Evista reduces the risk of fracture of the vertebrae of the spine in women with postmenopausal osteoporosis. There is no evidence that the drug can reduce the risk of breaking bones of the pelvis.
EVISTA. 60 mg. 28 tablets
What is Evista and what it is used?
Evista contains active raloxifene hydrochloride.
Evista is used for the treatment and prevention of osteoporosis in postmenopausal women . Evista reduces the risk of fracture of the vertebrae of the spine in women with postmenopausal osteoporosis . There is no evidence that the drug can reduce the risk of breaking bones of the pelvis.
How does Evista?
Evista belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators ( SERMs ) . When a woman reaches the menopause, levels of the female sex hormone estrogen decreases. Evista mimics some of the beneficial effects of estrogen after menopause .
Osteoporosis is a disease in which bones become thin and fragile - this disease is most common in postmenopausal women. Although initially may have no symptoms , if you have osteoporosis, your bones become more susceptible to fractures, most often in your spine , hips and wrists and it can cause pain and back, height loss and a curved back .
2 . What you should know before taking Evista?
Do not take E -vista:
• If you are being treated or have been treated for blood clots in the legs ( deep vein thrombosis) , the lungs (pulmonary embolism ) , or eyes ( thrombosis, retinal vein ) .
If you are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine (listed in Section 6) .
If you still could get pregnant , Evista may harm your unborn child.
If you have liver disease (eg cirrhosis, mild hepatic impairment or cholestatic jaundice) . If you have severe kidney problems.
If you have vaginal bleeding of unknown origin. This should be investigated by your doctor.
• If you have active uterine cancer , as experience in the application of Evista in women with these diseases is insufficient.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Evista.
• If you are temporarily immobilized . For example, if you move a wheelchair or when needing to be admitted to a hospital or having to stay in bed while recovering from surgery or an unexpected illness , as this may increase the risk of blood clots ( deep vein thrombosis , pulmonary embolism , thrombosis, retinal vein ) .
• If you had a cerebrovascular accident (eg stroke) , or if your doctor has told you that there is a high risk for it.
• If you have liver disease
• If you suffer from breast cancer , as there is insufficient experience of the use of Evista in women with this disease.
• If you are on oral estrogen therapy .
Evista probably will not cause vaginal bleeding , so if vaginal bleeding occurs during treatment with Evista, is unexpected . You must be investigated by your doctor.
Evista does not treat postmenopausal symptoms such as hot flashes .
Evista reduces total cholesterol and LDL (" bad" ) cholesterol. Generally it does not change triglycerides or HDL ( good) cholesterol . However, if you have previously taken estrogen and had a significant increase in triglycerides, you should talk to your doctor before you start taking Evista.
Evista contains lactose
If your doctor has told you that you have an intolerance to lactose , a type of sugar , contact your doctor before taking this medicine.
Other medicines and Evista
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If for heart disease are treated with digitalis or anticoagulants such as warfarin to prevent blood clots , you may need your doctor to change the dose of these drugs .
Tell your doctor if you are taking cholestyramine, which is mainly used as lipid-lowering medication as Evista may not work well enough.
Pregnancy and lactation
Evista is intended for use only by postmenopausal women and should not be used by women who may not yet have children. Evista may harm your unborn child. Do not take Evista if you are breastfeeding , as it might be excreted in breast milk.
Driving and using machines
Evista or no influence imperceptible ability to drive or operate machinery.
3 . How to take Evista?
Always take this medicine exactly as your doctor tells you . Consult your doctor or pharmacist if you are unsure.
The daily dose is one tablet . No matter what time of day you take your tablet but taking the same time to help you to remember to take it . You can take it with a meal or without food.
The tablets are for oral use.
Swallow the tablet whole . If you wish, you can take a glass of water. Do not break or crush the tablet before you accept it. Broken or crushed tablets can have a bad taste and be able to get the wrong dose.
Your doctor will determine how long to continue treatment with Evista. It may also advise you to take calcium and vitamin D
If you take more than the amount of Evista
Tell your doctor or pharmacist. If you take more Evista, than you need , you can get 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.
If you stop taking Evista
You should talk to your doctor.
It is very important to continue taking Evista as long as prescribed by your doctor . Evista can heal or protect you from osteoporosis only if you continue to take the tablets .
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them . Most adverse reactions observed with Evista, were minor.
Very common side effects ( affects more than 1 user in 10 ) are:
• Hot flashes ( vasodilation )
• Gastrointestinal symptoms such as nausea , vomiting , abdominal pain and indigestion
• Increased blood pressure
Common side effects ( affects 1 to 10 users in 100 ) are:
• Headache including migraine
• Leg cramps
• Swelling of the hands, feet and legs ( peripheral edema)
• Mild breast symptoms such as pain, enlargement and
Uncommon side effects ( affects 1 to 10 of 1000 users) are:
• Increased risk of blood clots in the legs (deep vein thrombosis)
• Increased risk of blood clots in the lungs (pulmonary embolism)
• Increased risk of blood clots in the eyes ( retinal vein thrombosis )
• Skin around the vein is red and painful ( superficial vein thrombophlebitis )
• Blood clot in an artery (eg, stroke, including increased risk of death from stroke)
• Reducing the number of platelets in the blood
In rare cases during treatment with Evista may increase liver enzyme levels in the blood.
If you get any side effects, tell your doctor or pharmacist. This includes all listed in this leaflet .
5 . How to store Evista?
Keep out of reach of children.
Do not use after the expiry date stated on the carton. Store in original container. Do not freeze.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Package Contents and more information
What does Evista?
- The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg of raloxifene .
- The other ingredients are:
Tablet core : povidone, polysorbate 80 , lactose anhydrous , lactose monohydrate, crospovidone, magnesium stearate.
Tablet coating : Titanium dioxide ( E171 ), polysorbate 80 , hypromellose, macrogol 400, karnubski wax.
Ink : shellac, propylene glycol, indigo carmine ( E132 ) .
Evista looks like and contents of the pack ?
Evista is a white, oval film-coated tablets marked with the number 4165 . They are packed in blisters or bottles. Blister boxes contain 14 , 28 or 84 tablets. Bottles containing 100 tablets. Not all pack sizes may be marketed .