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RALOXIFENE HYDROCHLORIDE ACTAVIS 60MG FILM-COATED TABLETS

Active substance(s): RALOXIFENE HYDROCHLORIDE

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Package leaflet: Information for the user

Raloxifene Hydrochloride 60mg Film-coated Tablets
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.
• The full name of this medicine is Raloxifene
Hydrochloride 60mg Film-coated Tablets
but within the leaflet it will be referred to as
Raloxifene Tablets.
What is in this leaflet
1. What Raloxifene Tablets are and what they are
used for
2. What you need to know before you take
Raloxifene Tablets
3. How to take Raloxifene Tablets
4. Possible side effects
5. How to store Raloxifene Tablets
6. Contents of the pack and other information

• 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 Tablet use in
women with this disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Raloxifene Tablets
• If you are immobilised for some time such as
being wheelchair 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 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 Tablet use in
women with this disease.
• If you are receiving oral oestrogen therapy.

1. What Raloxifene Tablets are and what they are
used for

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

Raloxifene Tablets contains the active substance
raloxifene hydrochloride.

Raloxifene Tablets do not treat postmenopausal
symptoms, such as hot flushes.

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

Raloxifene Tablets 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 Tablets.

How Raloxifene Tablets work.

Raloxifene Tablets contain 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.

Raloxifene Tablets belong to a group of nonhormonal medicines called Selective Oestrogen
Receptor Modulators (SERMs). When a woman
reaches the menopause, the level of the female sex
hormone oestrogen goes down. Raloxifene Tablets
mimic 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
Raloxifene Tablets
Do not take Raloxifene Tablets:
• If you are allergic to raloxifene or any of the other
ingredients of this medicine (listed in section 6).
• 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 there is still a possibility that you can get
pregnant, Raloxifene Tablets 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.

Other medicines and Raloxifene Tablets
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,
because Raloxifene Tablets may not work as well.
Pregnancy and breast-feeding
Raloxifene Tablets are for use only by
postmenopausal women and must not be taken
by women who could still have a baby. Raloxifene
Tablets could harm your unborn child.
Do not take Raloxifene Tablets if you are breastfeeding as it might be excreted in mother’s milk.
Driving and using machines
Raloxifene Tablets has no or negligible effects on
driving or using machines.
3. How to take Raloxifene Tablets
Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.

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Raloxifene 60mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAH5476

dimensions:

print proof no:

4

pharmacode:

origination date: 31.12.14
approved for print/date

min pt size:

200 x 400

2.
3.
4.

11.5

5.
6.

originated by:

jh

revision date:

07.01.15

Technical Approval

revised by:

jh

date sent:

supplier:

Pharmathen

technically app. date:

31.12.14

Non Printing Colours
1.
2.
3.

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.

By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Raloxifene Tablets

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.

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

This medicinal product does not require any special
storage conditions.

If you take more Raloxifene Tablets than you
should
Tell your doctor or pharmacist. If you take more
Raloxifene Tablets than you should you could have
leg cramps and dizziness.
If you forget to take Raloxifene Tablets
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 Raloxifene Tablets
You should talk to your doctor first.
It is important that you continue taking Raloxifene
Tablets for as long as your doctor prescribes the
medicine, Raloxifene Tablets 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 Raloxifene Tablets
have been mild.
The most common side effects (affects more than 1
user in 10) are:
• Hot flushes (vasodilatation)
• Flu syndrome
• Gastrointestinal symptoms such as nausea,
vomiting, abdominal pain and stomach upset
• Increased blood pressure
Common side effects (affects 1 to 10 users in 100)
are:
• Headache including migraine
• Leg cramps
• Swelling of hands, feet and legs (peripheral
oedema)
• Gallstones
• Rash
• Mild breast symptoms such as pain, enlargement
and tenderness
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)
• Blood clot in an artery (for example stroke,
including an increased risk of dying from stroke)
• Decrease in the number of the platelets in the
blood

Do not use this medicine after the expiry date
which is stated on the carton and blister after EXP.
The expiry date refers to the last day of that month.

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 Raloxifene Tablets contain
- The active substance is raloxifene hydrochloride.
Each tablet contains 60mg of raloxifene
hydrochloride, which is equivalent to 56mg
raloxifene.
- The other ingredients are:
Tablet core: Sodium starch glycolate (primogel)
type A, citric acid monohydrate, microcrystalline
cellulose, dibasic calcium phosphate 2-hydrate,
poloxamer 407, magnesium stearate.
Tablet coating: Titanium dioxide E171, lactose
monohydrate, hypromellose 2910/ hypromellose
15 c PE464, macrogol 4000, hypromellose 2910/
hypromellose 3cP E464, hypromellose 2910/
hypromellose 50cP E464.
What Raloxifene Tablets look like and contents
of the pack
Elliptically shaped (12.6 mm x 6.6 mm), white filmcoated tablets. They are packed in blisters in boxes
of 28 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78
220 Hafnarfjordur
Iceland
Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki
Greece
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture
Block No 5
Rodopi 69300
Greece
This leaflet was last revised in December 2014

If you would like a
leaflet with larger text,
please contact
01271 385257.

In rare cases, blood levels of liver enzymes may
increase during treatment with Raloxifene Tablets.
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 Website:
www.mhra.gov.uk/yellowcard
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Actavis, Barnstaple, EX32 8NS, UK

AAAH5476

Raloxifene 60mg tablet leaflet - UK

colours/plates:
1. Black

item no:

AAAH5476

dimensions:

print proof no:

4

pharmacode:

origination date: 31.12.14
approved for print/date

min pt size:

200 x 400

2.
3.
4.

11.5

5.
6.

originated by:

jh

revision date:

07.01.15

Technical Approval

revised by:

jh

date sent:

supplier:

Pharmathen

technically app. date:

31.12.14

Non Printing Colours
1.
2.
3.

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.

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