Active ingredient
- raloxifene hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/98/073/004, EU/1/98/073/002, EU/1/98/073/003, EU/1/98/073/001.
Evista 60mg film-coated tablets
Package leaflet: Information for the user
Evista 60 mg film coated tablets
raloxifene hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
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
1. What Evista is and what it is used for
Evista contains the active substance raloxifene hydrochloride.
Evista is used to treat and prevent osteoporosis in postmenopausal women. Evista reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
How Evista works
Evista belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Evista mimics some of the helpful effects of oestrogen after the menopause.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
2. What you need to know before you take Evista
Do not take Evista:
Warnings and precautions
Talk to your doctor or pharmacist before you take Evista.
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.
3. How to take Evista
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The dose is one tablet a day. It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.
The tablets are for oral use.
Swallow the tablet whole. If you wish you may take a glass of water with it. Do not break or crush the tablet before taking it. A broken or crushed tablet may taste bad and there is a possibility that you will receive an incorrect dose.
Your doctor will tell you how long you should continue to take Evista. The doctor may also advise you to take calcium and vitamin D supplements.
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.
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. The majority of side effects seen with Evista have been mild.
The most common side effects (affects more than 1 user in 10) are:
Common side effects (affects 1 to 10 users in 100) are:
Uncommon side effects (affects 1 to 10 users in 1000) are:
In rare cases, blood levels of liver enzymes may increase during treatment with Evista.
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.
5. How to store Evista
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.
Store in the original package. Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Evista contains
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in October 2017.
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
2 Eastbourne Terrace, London, W2 6LG
+44 (0)1223 395 301
+44 (0)1223 395 301
+44 (0)1223 395 301