RALOXIFENE HYDROCHLORIDE 60 MG FILM COATED TABLETS

Active substance: RALOXIFENE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Raloxifene Hydrochloride 60 mg 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 want to read it again.
• If you have any further questions, ask your doctor or pharmacist.
•  his medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if
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their signs of illness are the same as yours.
•  f you get any side effects, talk to your doctor or pharmacist. This includes any possible side
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effects not listed in this leaflet. See section 4.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Raloxifene Hydrochloride is and what it is used for
What you need to know before you take Raloxifene Hydrochloride
How to take Raloxifene Hydrochloride
Possible side effects
How to store Raloxifene Hydrochloride
Contents of the pack and other information

1. What Raloxifene Hydrochloride is and what it is used for
Raloxifene Hydrochloride contains the active substance raloxifene hydrochloride.
Raloxifene Hydrochloride is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Hydrochloride reduces the
risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
How Raloxifene Hydrochloride works:
Raloxifene Hydrochloride 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 Hydrochloride mimics
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 Hydrochloride
Do not take Raloxifene Hydrochloride:
•  f you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism) or
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in the eyes (retinal vein thrombosis).
• If you are allergic to raloxifene or any of the ingredients of this medicine (listed in section 6).
• If there is a possibility that you can get pregnant, Raloxifene Hydrochloride 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 Hydrochloride use in women with this disease.
Warnings and precautions
Talk to your doctor or pharmacist before you take Raloxifene Hydrochloride:
•  f 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
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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).
•  f 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.
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•  f you have liver disease
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•  f you are suffering from breast cancer, as there is insufficient experience of Raloxifene Hydrochloride use in women with this disease.
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•  f you are receiving oral oestrogen therapy.
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It is unlikely that Raloxifene Hydrochloride will cause vaginal bleeding. So any vaginal bleeding while you take Raloxifene Hydrochloride
is unexpected. You should have this investigated by your doctor.
Raloxifene Hydrochloride does not treat postmenopausal symptoms, such as hot flushes.
Raloxifene Hydrochloride 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 Hydrochloride.
Raloxifene Hydrochloride 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
Other medicines and Raloxifene Hydrochloride
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 Hydrochloride may
not work as well.
Pregnancy and breast-feeding
Raloxifene Hydrochloride is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Raloxifene Hydrochloride could harm your unborn child.
Do not take Raloxifene Hydrochloride if you are breast-feeding as it might be excreted in mother's milk.
Driving and using machines
Raloxifene Hydrochloride has no or negligible effects on driving or using machines.
3. How to take Raloxifene Hydrochloride
Always take this product exactly as your doctor has told you. You should 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.

Date: 25 Jun 2014
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 378404

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Superceded Affiliate Item Code 10005286

Vendor Job No. 225008

TrackWise PR No. 378404

Proof No. 6

MA No. 04569/1402

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

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Description Raloxifen 60 mg All

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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. A broken or
crushed tablet may taste bad and there is a possibility that you will receive an incorrect dose.
Your doctor will tell you how long you should continue to take Raloxifene Hydrochloride.
The doctor may also advise you to take calcium and vitamin D supplements.
If you take more Raloxifene Hydrochloride than you should
Tell your doctor or pharmacist. If you take more Raloxifene Hydrochloride than you should you could have leg cramps and dizziness.
If you forget to take Raloxifene Hydrochloride
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 Hydrochloride
You should talk to your doctor first
It is important that you continue taking Raloxifene Hydrochloride for as long as your doctor prescribes the medicine.
Raloxifene Hydrochloride 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 have been mild.
If you get any of the following serious side effects, stop taking Raloxifene Hydrochloride and seek immediate medical help:
Uncommon: may affect up to 1 in 100 people
•  lood clots in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). Symptoms shortness of breath, chest pain,
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numbness, heat or swelling in the legs
•  lood clot in an artery (for example stroke, including an increased risk of dying from stroke). Symptoms include sudden severe
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headache, loss of vision, loss of coordination, slurred speech.
Other side effects include:
Very common: may affect more than 1 in 10 people
•  ot flushes (vasodilation)
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•  lu syndrome
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•  astrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
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• ncreased blood pressure
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Common: may affect up to 1 in 10 people
•  eadache, including migraine
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•  eg cramps
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•  welling of hands, feet and legs (peripheral oedema)
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•  allstones
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•  ash
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•  ild breast symptoms such as pain, enlargement and tenderness
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Uncommon: may affect up to 1 in 100 people
• ncreased risk of blood clots in the eyes (retinal vein thrombosis)
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•  kin around the vein is red and painful (superficial vein thrombophlebitis)
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•  ecrease in the number of the platelets in the blood
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In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Hydrochloride.
Reporting of side effects
If you get any side effects, talk to your doctor, 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 at 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 Raloxifene Hydrochloride
Keep this medicine out of the sight and reach children.
Do not use this medicine after the expiry date which is stated on the pack.
Keep the blister in the outer carton in order to protect from light and moisture. Do not freeze.
Do not throw away 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 Hydrochloride contains
•  he active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg
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raloxifene.
•  he other ingredients of Raloxifene Hydrochloride are:
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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 4000.
What Raloxifene Hydrochloride looks like and contents of the pack
Raloxifene Hydrochloride 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
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Manufacturer
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece


This leaflet was last revised in June 2014

378404
00000000

Date: 25 Jun 2014
Component Type Leaflet

Pharma Code N/A

Affiliate Item Code 378404

SAP No. N/A

Superceded Affiliate Item Code 10005286

Vendor Job No. 225008

TrackWise PR No. 378404

Proof No. 6

MA No. 04569/1402

Client Market UK

Packing Site/Printer N/A

Keyline/Drawing No. N/A

Supplier Code TBC

Barcode Info N/A

Sign-offs

Page Count 2/2

No. of colours 1

Description Raloxifen 60 mg All

Colours

Time: 14:40

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad
Dimensions 200 x 400mm

Body Text Size 9 pt

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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