PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Raloxifene 60 mg Film-coated Tablets

(raloxifene hydrochloride)

Please read this information carefully before you start to take your medicine.

•    Keep this leaflet until you have finished this pack as you may want to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Raloxifene is and what it is used for

2.    Before you take Raloxifene

3.    How to take Raloxifene    A SANDOZ

4.    Possible side effects

5.    How to store Raloxifene

6.    Further information

What Raloxifene is and what it is used for

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 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.

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 Before you take Raloxifene

Do not take Raloxifene:

•    If you are allergic (hypersensitive) to raloxifene or any of the ingredients of Raloxifene Film-coated Tablets.

•    If there is a possibility that you can get pregnant, Raloxifene could harm your unborn baby.

•    If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or 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 Raloxifene use in women with this disease.

•    If you have severe kidney problems.

Take special care with Raloxifene:

The following are reasons why this product may not be

suitable for you. If any of them apply to you, talk to your

doctor before you take the medicine.

•    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.

•    If you are receiving oral oestrogen therapy.

•    If you are suffering from breast cancer, as there is insufficient experience of Raloxifene 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.

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.

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.

Taking other medicines

Please 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.

Pregnancy and breast-feeding

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 known effects on driving or using machines.

Important information about some ingredients of Raloxifene Film-coated Tablets:

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.

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3 How to take Raloxifene

5 How to store Raloxifene

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 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.

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.

If you stop taking Raloxifene

You should talk to your doctor first.

If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.

If you forget to take Raloxifene

Take a tablet as soon as you remember and then continue as before.

If you take more Raloxifene than you should

Tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

4 Possible side effects

Like all medicines, Raloxifene can cause side effects although not everybody gets them. The majority of side effects seen with raloxifene have been mild.

The most common side effects (affects more than 1 user in 10) are:

•    Hot flushes (vasodilation)

•    Flu syndrome.

Common side effects (affects 1 to 10 users in 100) are:

•    Leg cramps

•    Swelling of hands, feet and legs (peripheral oedema)

•    Gallstones.

Uncommon side effects (affects 1 to 10 users in 1,000) 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).

Very rare side effects (affects less than 1 user in 10,000) are:

•    Rash

•    Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset

•    Increased blood pressure

•    Decrease in the number of the platelets in the blood

•    Blood clot in an artery (for example stroke)

•    Headache including migraine

•    Mild breast symptoms such as pain, enlargement and tenderness.

In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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, polyethylene glycol, titanium dioxide (E171) and macrogol/PEG 400.

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.

The blister boxes contain 14, 28, 30, 84, or 90 tablets.

Not all pack sizes may be marketed.

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

or

Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben,

Germany

or

Lek Pharmaceuticals d.d.,

Verovskova 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

This leaflet was last revised in 05/2014

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