Skip to Content

UK Edition. Click here for US version.

RALOXIFENE 60 MG FILM-COATED TABLETS

Active substance(s): RALOXIFENE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Raloxifene 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
In this leaflet:
1. What Raloxifene is and what it is used for
2. What you need to know before you take Raloxifene
3. How to take Raloxifene
4. Possible side effects
5. How to store Raloxifene
6. Contents of the pack and other information

What Raloxifene is and what it is used
for



Raloxifene contains the active substance raloxifene
hydrochloride.




1

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.



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.

How Raloxifene works
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
oestrogen goes down. Raloxifene mimics some of the
helpful effects of oestrogen after the menopause.

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

Raloxifene 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.

What you need to know before you take
Raloxifene

Other medicines and Raloxifene
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Do not take Raloxifene:
• 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).
• If you are allergic (hypersensitive) to raloxifene or any
of the other ingredients of this medicine (listed in
section 6).
• If there is still a possibility that you can get pregnant,
Raloxifene could harm your unborn child.
• If you have liver disease (examples of liver disease
include cirrhosis, mild hepatic impairment or
cholestatic jaundice).
• If you have severe kidney problems.
• 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 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
Raloxifene may not work as well.
Pregnancy, breast-feeding and fertility
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 or negligible effects on driving or
using machines.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Raloxifene.
• 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, as these may
increase your risk of blood clots (deep vein

draft: 44052903, 44052902
laetus code: supplier to add
mat.no.: 00000000

thrombosis, pulmonary embolism or retinal vein
thrombosis).
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.
If you have liver disease
If you are suffering from breast cancer, as there is
insufficient experience of Raloxifene use in women
with this disease.
If you are receiving oral oestrogen therapy.

Continued on the next page >>

00000000

Artwork Proof Box
Ref: V009 - Update in line with reference product
Proof no.
003.0

Date prepared:
14/07/2015

Colours:
Black
Black 20%
Dimensions: 200 x 400 mm

Font size:
10pt
Fonts:
Helvetica

3

levels of liver enzymes may increase during treatment
with Raloxifene.

How to take Raloxifene

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 the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of
this medicine

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
The recommended 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.

5

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.

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 pack.

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.

Keep the blister 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 to protect the environment.

If you take more Raloxifene than you should
Tell your doctor or pharmacist. If you take more
Raloxifene than you should, you could have leg cramps
and dizziness.
If you forget to take Raloxifene
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.

6

Contents of the pack and other
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,
titanium dioxide (E171) and macrogol/PEG 400.

If you stop taking Raloxifene
You should talk to your doctor first.
It is important that you continue taking Raloxifene for as
long as your doctor prescribes the medicine.
Raloxifene 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

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, this medicine 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.

Very common side effects (may affect more than 1 in 10
people):
• Hot flushes (vasodilation)
• Flu syndrome
• Gastrointestinal symptoms such as feeling sick
(nausea), vomiting, abdominal pain and indigestion
(dyspepsia)
• Increased blood pressure

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer:
Pharmathen S.A.,
6 Dervenakion Str., 153 51, Pallini, Attikis,
Greece

Common side effects (may affect up to 1 in 10 people):
• Headache including migraine
• Leg cramps
• Swelling of hands, feet and legs (peripheral oedema)
• Gallstones
• Rash
• Mild breast symptoms such as pain, enlargement and
tenderness

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

Uncommon side effects (may affect up to 1 in 100
people):
• 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 (for example stroke, including
an increased risk of dying from stroke)
• Reduction in blood platelets, which increases risk of
bleeding or bruising

Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia
or
Lek Pharmaceuticals d.d.,
Trimlini 2D , 9220 Lendava,
Slovenia.
or
Pharmathen International S.A,
Industrial Park Sapes, Rodopi 69300,
Greece

draft: 44052903, 44052902
laetus code: supplier to add
mat.no.: 00000000

In rare cases (may affect up to 1 in 1,000 people), blood

This leaflet was last revised in 07/2015

Artwork Proof Box
Ref: V009 - Update in line with reference product
Proof no.
003.0

Date prepared:
14/07/2015

Colours:
Black
Black 20%
Dimensions: 200 x 400 mm

Font size:
10pt
Fonts:
Helvetica

00000000
SZ00000LT000

Expand view ⇕

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.

Hide