RALOXIFENE HYDROCHLORIDE 60 MG FILM COATED TABLETS

Active substance: RALOXIFENE HYDROCHLORIDE

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Raloxifene Hydrochloride 60 mg Film-coated Tablets
(raloxifene hydrochloride)
Please read this information carefully before you start to take your medicine.

Keep this leaflet until you have finished this pack as you may want to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Raloxifene Hydrochloride is and what it is used for
2.
Before you take Raloxifene Hydrochloride
3.
How to take Raloxifene Hydrochloride
4.
Possible side effects
5.
How to store Raloxifene Hydrochloride
6.
Further information
1.

WHAT RALOXIFENE HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Raloxifene Hydrochloride 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 estrogen goes down. Raloxifene Hydrochloride mimics some of the helpful effects of
estrogen after the menopause.
Raloxifene Hydrochloride is used to treat and prevent osteoporosis in postmenopausal women.
Raloxifene Hydrochloride reduces the risk of vertebral fractures in women with postmenopausal
osteoporosis. A reduction in the risk of hip fractures has not been shown.
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.
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BEFORE YOU TAKE RALOXIFENE HYDROCHLORIDE

Do not take Raloxifene Hydrochloride:








If you are allergic (hypersensitive) to raloxifene or any of the ingredients of Raloxifene
Hydrochloride.
If there is a possibility that you can get pregnant, Raloxifene Hydrochloride could harm your
unborn baby.
If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary
embolism or retinal vein thrombosis).
If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment
or cholestatic jaundice).
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 Raloxifene
Hydrochloride use in women with this disease.
If you have severe kidney problems.

Take special care with Raloxifene Hydrochloride:

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The following are reasons why this product may not be suitable for you. If any of them apply to you,
talk to your doctor before you take the medicine.






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.
If you are receiving oral oestrogen therapy.
If you are suffering from breast cancer, as there is insufficient experience of Raloxifene
Hydrochloride use in women with this disease.
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.

It is unlikely that Raloxifene Hydrochloride will cause vaginal bleeding. So any vaginal bleeding
while you take Raloxifene Hydrochloride is unexpected. You should have this investigated by your
doctor.
Raloxifene Hydrochloride does not treat postmenopausal symptoms, such as hot flushes.
Raloxifene Hydrochloride lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not
change triglycerides or HDL ("good") cholesterol. However, if you have taken estrogen in the past and
had extreme elevations in triglycerides, you should talk to your doctor before taking Raloxifene
Hydrochloride.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken 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.
Pregnancy and breast-feeding
Raloxifene Hydrochloride is for use only by postmenopausal women and must not be taken by women
who could still have a baby. Raloxifene Hydrochloride harm your unborn child.
Do not take Raloxifene Hydrochloride if you are breast-feeding as it might be excreted in mother's
milk.
Driving and using machines
Raloxifene Hydrochloride has no known effects on driving or using machines.
Important information about some ingredients of Raloxifene Hydrochloride:
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.
3.

HOW TO TAKE RALOXIFENE HYDROCHLORIDE

Always take this product 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.

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Your doctor will tell you how long you should continue to take Raloxifene Hydrochloride. The doctor
may also advise you to take calcium and vitamin D supplements.
If you stop taking Raloxifene HydrochlorideYou should talk to your doctor first
If you have the impression that the effect of this product is too strong or too weak, talk to your doctor
or pharmacist
If you forget to take Raloxifene Hydrochloride
Take a tablet as soon as you remember and then continue as before.
If you take more Raloxifene Hydrochloride than you should
Tell your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Raloxifene Hydrochloride can cause side effects although not everybody gets
them. The majority of side effects seen with raloxifene have been mild.
The most common side effects (affects more than 1 user in 10) are:

Hot flushes (vasodilation)

Flu syndrome
Common side effects (affects 1 to 10 users in 100) are:

Leg cramps

Swelling of hands, feet and legs (peripheral oedema)

Gallstones
Uncommon side effects (affects 1 to 10 users in 1000) 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)
Very rare side effects (affects less than 1 user in 10,000) are:

Rash

Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset

Increased blood pressure

Decrease in the number of the platelets in the blood

Blood clot in an artery (for example stroke)

Headache including migraine

Mild breast symptoms such as pain, enlargement and tenderness
In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene
Hydrochloride.
Reporting of side effects
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
at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

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5.

HOW TO STORE RALOXIFENE HYDROCHLORIDE

Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the pack.
Keep the blister in the outer carton in order to protect from light and moisture. Do not freeze.
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.

FURTHER INFORMATION

What Raloxifene Hydrochloride 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 of Raloxifene Hydrochloride are:
Tablet core: Sodium starch glycolate, citric acid monohydrate, microcrystalline cellulose, dibasic
calcium phosphate, poloxamer 407, magnesium stearate
Tablet coating: Hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E171) and
macrogol/PEG 400.
What Raloxifene Hydrochloride looks like and contents of the pack
Raloxifene Hydrochloride are white elliptical, film coated tablets. They are packed in blisters. The
blister boxes contain 14, 28, 30, 84, or 90 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder

Mylan
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
This leaflet was last approved on: July 2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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