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RAZYLAN 60MG FILM COATED TABLETS

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

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PACKAGE LEAFLET

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Razylan 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.
What is in this leaflet:
1.
What Razylan is and what it is used for
2.
What you need to know before you take Razylan
3.
How to take Razylan
4.
Possible side effects
5.
How to store Razylan
6.
Contents of the pack and other information

1.

What Razylan is and what it is used for

Razylan contains the active substance raloxifene hydrochloride.
Razylan is used to treat and prevent osteoporosis in postmenopausal women. Razylan reduces the risk
of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip
fractures has not been shown.
How Razylan works
Razylan 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. Razylan 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 Razylan

Do not take Razylan:








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, Razylan 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 uterine cancer, as there is insufficient experience of Razylan use in women
with this disease.
If you have severe kidney problems.

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Warnings and precautions
Talk to your doctor or pharmacist before you take Razylan.







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 Razylan 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 Razylan will cause vaginal bleeding. So any vaginal bleeding while you take
Razylan is unexpected. You should have this investigated by your doctor.
Razylan does not treat postmenopausal symptoms, such as hot flushes.
Razylan 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 Razylan.
Other medicines and Razylan
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
Razylan is for use only by postmenopausal women and must not be taken by women who could still
have a baby. Razylan could harm your unborn child.
Do not take Razylan if you are breast-feeding as it might be excreted in mother's milk.
Driving and using machines
Razylan has no known effects on driving or using machines.
Razylan 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 Razylan

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.

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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 Razylan .The doctor may also advise
you to take calcium and vitamin D supplements.
If you stop taking Razylan
You should talk to your doctor first
It is important that you continue taking Razylan for as long as your doctor prescribes the medicine.
Razylan 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, askyour doctor or pharmacist.
If you forget to take Razylan
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 Razylan than you should
Tell your doctor or pharmacist. If you take more Razylan than you should you could have leg cramps
and dizziness.

4.

Possible side effects

Like all medicines, this medicinecan cause side effects although not everybody gets them. The
majority of side effects seen with raloxifene have been mild.
Verycommon (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 Razylan.
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

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(Website: 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 Razylan

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 to protect the environment.

6.

Contents of the pack and other information

What Razylan 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 Razylan 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 Razylan looks like and contents of the pack
Razylan 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
Tel: +30 210 66 65 067
Fax: +30210 66 66 749
Email: info@pharmathen.com
This leaflet was last revisedon: 05/2014

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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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