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OSTIRAL 60MG FILM COATED TABLETS

Active substance(s): RALOXIFENE HYDROCHLORIDE / RALOXIFENE HYDROCHLORIDE / RALOXIFENE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OSTIRAL 60 mg film coated tablets
(raloxifene hydrochloride)
Read all of this leaflet carefully before you start using
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.
What is in this leaflet:
1. What Ostiral is and what it is used for
2. What you need to know before you take Ostiral
3. How to take Ostiral
4. Possible side effects
5. How to store Ostiral
6. Contents of the pack and other information
1. What Ostiral is and what it is used for
Ostiral contains the active substance raloxifene
hydrochloride.
Ostiral is used to treat and prevent osteoporosis in
postmenopausal women. Ostiral reduces the risk of
vertebral fractures in women with postmenopausal
osteoporosis. A reduction in the risk of hip fractures has
not been shown.
How Ostiral works
Ostiral 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. Ostiral
mimics some of the helpful effects of estrogen 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 Ostiral
Do not take Ostiral:
• If you are allergic to raloxifene or any of the ingredients
of this medicine (listed in section 6).
• If there is still a possibility that you can get pregnant,
Ostiral could harm your unborn child.
• 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 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 womb cancer, as there is insufficient
experience of Ostiral use in women with this disease.
• If you have severe kidney problems.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Ostiral.
• 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 thrombosis,
pulmonary embolism or retinal vein thrombosis).
• If you are receiving oral oestrogen therapy.
• If you are suffering from breast cancer, as there is
insufficient experience of Ostiral 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.
• If you have liver disease
It is unlikely that Ostiral will cause vaginal bleeding. So any
vaginal bleeding while you take Ostiral is unexpected. You
should have this investigated by your doctor.
Ostiral does not treat postmenopausal symptoms, such as
hot flushes.
Ostiral 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 Ostiral.
Other medicines and Ostiral
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 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
Ostiral is for use only by postmenopausal women
and must not be taken by women who could still
have a baby. Ostiral could harm your unborn child.
Do not take Ostiral if you are breast-feeding as it might be
excreted in mother’s milk.
Driving and using machines
Ostiral has no known effects on driving or using machines.
Ostiral 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.
3. How to take Ostiral
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 a glass
of water with it.
Do not break or crush the tablet before taking it.
Your doctor will tell you how long you should continue
to take Ostiral. The doctor may also advise you to take
calcium and vitamin D supplements.
If you stop taking Ostiral
You should talk to your doctor first.
It is important that you continue taking Ostiral for as long
as your doctor prescribes the medicine.
Ostiral 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.
If you forget to take Ostiral
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 take more Ostiral than you should
Tell your doctor or pharmacist. If you take more Ostiral
than you should you could have leg cramps and dizziness.
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 have been mild.
Very common (may affect more than 1 in 10 people):
• Hot flushes (vasodilation)
• Flu syndrome
• Gastrointestinal symptoms such as nausea, vomiting,
abdominal pain and stomach upset
• Increased blood pressure
Common (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
Uncommon (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)
• Decrease in the number of the platelets in the blood
In rare cases, blood levels of liver enzymes may increase
during treatment with Ostiral.

Reporting of side effects
If you get any side effects, talk to your doctor or 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 Webiste: www.mhra.gov.uk/
yellowcard. By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Ostiral
Keep out of the sight and reach of children.
Do not use after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
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
protect the environment.
6. Contents of the pack and other information
What Ostiral 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 Ostiral 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.
What Ostiral looks like and contents of the pack
Ostiral 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
Pharmathen S.A.
6, Dervenakion Str., 153 51
Pallini, Attikis
Greece
Distributed by
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire WA16 0PF
United Kingdom
This leaflet was last revised in 06/2014
Other sources of information
Detailed information on this medicine is available on the
European Medicines Agency web site: http://www.ema.
europa.eu.
Code No. GO/DRUGS/654

Expand Transcript

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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