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The product code(s) for this leaflet is: PL35533/0150 .
Raloxifene hydrochloride 60mg film-coated tablets
Raloxifene hydrochloride 60mg film-coated tablets
raloxifene hydrochloride
The name of your medicine is Raloxifene hydrochloride which will be referred to as "Raloxifene" throughout this leaflet.
1. What Raloxifene is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
This medicine contains the active substance raloxifene hydrochloride.
Raloxifene is used to treat and prevent osteoporosis in post-menopausal women. This medicine reduces the risk of vertebral fractures in women with post-menopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
This medicine 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. This medicine 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.
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).
Talk to your doctor or pharmacist before taking this medicine:
It is unlikely that Raloxifene will cause vaginal bleeding, so any vaginal bleeding that occurs while you are taking this medicine is unexpected. You should have this investigated by your doctor.
This medicine does not treat post-menopausal symptoms, such as hot flushes.
This medicine 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 Raloxifene.
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 digoxin for your heart or anti-coagulants 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 a lipid-lowering medicine. You should not take cholestyramine at the same time as raloxifene because raloxifene may not work as well.
Raloxifene is for use only by post-menopausal women and must not be taken by women who could still have a baby. This medicine could harm your unborn child.
Do not take this medicine if you are breast-feeding as it might be excreted in mother’s milk.
This medicine has no or negligible effects on driving or using machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially “sodium free”.
Always take this medicine exactly as your doctor has told you. 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 it with a glass of water. 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 this medicine. The doctor may also advise you to take calcium and vitamin D supplements.
Tell your doctor or pharmacist. You could have leg cramps and dizziness.
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 dose.
You should talk to your doctor first. It is important that you continue taking Raloxifene for as long as your doctor prescribes the medicine. This medicine can treat or prevent your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of Raloxifene, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The majority of side effects seen with raloxifene have been mild.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the whole body).
Uncommon side effects (may affect up to 1 in 100 people):
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
In rare cases, blood levels of liver enzymes may increase during treatment with this medicine.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).
By reporting side effects you can help provide more information on the safety of this medicine.
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 outer carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Keep the blisters in the outer carton in order to protect from light and moisture. 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.
Raloxifene are white, elliptical, film-coated tablets. They are packed in blisters. Each carton contains 14, 28, 30, 84, or 90 tablets. Not all pack sizes may be marketed.
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This leaflet was last revised in: 05/2019
1010070-P8.5