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RALOXIFENE 60 MG FILM-COATED TABLETS

Active substance: RALOXIFENE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Raloxifene 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 is and what it is used for
2. Before you take Raloxifene
3. How to take Raloxifene
4. Possible side effects
5. How to store Raloxifene
6. Further information

1

• 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.

What Raloxifene is and what it is used
for

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

Raloxifene 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 mimics some of the
helpful effects of estrogen after the menopause.

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

Raloxifene is used to treat and prevent osteoporosis in
postmenopausal women. Raloxifene reduces the risk of
vertebral fractures in women with postmenopausal
osteoporosis. A reduction in the risk of hip fractures has
not been shown.

Raloxifene 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.

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

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.

Before you take Raloxifene

Tell your doctor if you are taking cholestyramine which
is mainly used as lipid-lowering medicine.

Do not take Raloxifene:
• If you are allergic (hypersensitive) to raloxifene or any
of the ingredients of Raloxifene Film-coated Tablets.
• If there is a possibility that you can get pregnant,
Raloxifene 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 use in women
with this disease.
• If you have severe kidney problems.

Pregnancy and breast-feeding
Raloxifene is for use only by postmenopausal women
and must not be taken by women who could still have a
baby. Raloxifene could harm your unborn child.
Do not take Raloxifene if you are breast-feeding as it
might be excreted in mother's milk.

Driving and using machines
Raloxifene has no known effects on driving or using
machines.

Important information about some ingredients of
Raloxifene Film-coated Tablets:
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.

Take special care with Raloxifene:
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 use in women
with this disease.

Continued on the next page >>

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3

5

How to take Raloxifene

Always take this product exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the
pack.

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.

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.

The tablets are for oral use.
Swallow the tablet whole. If you wish you may take a
glass of water with it.

Your doctor will tell you how long you should continue to
take Raloxifene. The doctor may also advise you to take
calcium and vitamin D supplements.

6

If you stop taking Raloxifene
You should talk to your doctor first.

Further information

What Raloxifene 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 tablets 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.

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
Take a tablet as soon as you remember and then
continue as before.
If you take more Raloxifene than you should
Tell your doctor or pharmacist.

4

How to store Raloxifene

What Raloxifene looks like and contents of the pack
Raloxifene 60 mg Film-coated Tablets are white
elliptical, film-coated tablets. They are packed in
blisters.

Possible side effects

Like all medicines, Raloxifene can cause side effects
although not everybody gets them. The majority of side
effects seen with raloxifene have been mild.

The blister boxes contain 14, 28, 30, 84, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The most common side effects (affects more than 1
user in 10) are:
• Hot flushes (vasodilation)
• Flu syndrome.

Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Common side effects (affects 1 to 10 users in 100) are:
• Leg cramps
• Swelling of hands, feet and legs (peripheral oedema)
• Gallstones.

Manufacturer:
Pharmathen S.A.,
6 Dervenakion Str., 153 51, Pallini, Attikis,
Greece

Uncommon side effects (affects 1 to 10 users in 1,000)
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).

or

Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany
or

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia

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.

or

Lek Pharmaceuticals d.d.,
Trimlini 2D , 9220 Lendava,
Slovenia.
This leaflet was last revised in 03/2013.

In rare cases, blood levels of liver enzymes may
increase during treatment with Raloxifene.

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.

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Ref: Licence application
Proof no.
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Date prepared:
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Colours:
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Dimensions: 200 x 400 mm

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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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