PACKAGE LEAFLET: INFORMATION FOR THE USER

Raloxifene Hydrochloride Fair-Med 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, pharmacist or nurse.

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Raloxifene Hydrochloride Fair-Med is and what it is used for

2.    What you need to know before you take Raloxifene Hydrochloride Fair-Med

3.    How to take Raloxifene Hydrochloride Fair-Med

4.    Possible side effects

5.    How to store Raloxifene Hydrochloride Fair-Med

6.    Contents of the pack and other information

1. What Raloxifene Hydrochloride Fair-Med is and what it is used for

Raloxifene Hydrochloride Fair-Med contains the active substance raloxifene hydrochloride.

Raloxifene Hydrochloride Fair-Med is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Hydrochloride Fair-Med 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 Fair-Med works

Raloxifene Hydrochloride Fair-Med 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 Fair-Med 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 Fair-Med Do not take Raloxifene Hydrochloride Fair-Med:

•    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 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 use in women with this disease.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you take Raloxifene Hydrochloride Fair-Med.

•    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 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 Hydrochloride Fair-Med use in women with this disease.

•    If you are receiving oral oestrogen therapy.

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

Raloxifene Hydrochloride Fair-Med does not treat postmenopausal symptoms, such as hot flushes.

Raloxifene Hydrochloride Fair-Med 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 Fair-Med.

Other medicines and Raloxifene Hydrochloride Fair-Med

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 may not work as well.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Raloxifene Hydrochloride Fair-Med is for use only by postmenopausal women and must not be taken by women who could still have a baby. Raloxifene Hydrochloride Fair-Med could harm your unborn child.

Do not take Raloxifene Hydrochloride Fair-Med if you are breast-feeding as it might be excreted in mother's milk.

Driving and using machines

Raloxifene Hydrochloride Fair-Med has no or negligible effects on driving or using machines.

3 How to take Raloxifene Hydrochloride Fair-Med

Always take this medicine exactly as your doctor or pharmacist has told you. 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.

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 Fair-Med. The doctor may also advise you to take calcium and vitamin D supplements.

If you take more Raloxifene Hydrochloride Fair-Med than you should

Tell your doctor or pharmacist. If you take more Raloxifene Hydrochloride Fair-Med than you should you could have leg cramps and dizziness.

If you forget to take Raloxifene Hydrochloride Fair-Med

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 dose.

If you stop taking Raloxifene Hydrochloride Fair-Med

You should talk to your doctor first.

It is important that you continue taking Raloxifene Hydrochloride Fair-Med for as long as your doctor prescribes the medicine. Raloxifene Hydrochloride Fair-Med 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, pharmacist or nurse.

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 Hydrochloride Fair-Med have been mild.

Very 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

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

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 Yellow Card Scheme 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 Raloxifene Hydrochloride Fair-Med

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton. 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 Hydrochloride Fair-Med 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 are:

•    Tablet core: Povidone K 30 (E1201), Polysorbate 80 (E 433), Glycine (E640), Crospovidone (E 1202), Microcrystalline cellulose (E460), Silica, colloidal anhydrous, Magnesium stearate (E470b)

•    Tablet coating: Opadry white 12B580000

Consisting of: HPMC 2910/Hypromellose 5cP (E464), Titanium Dioxide (E171), Macrogol /PEG 400 (E1451), Carnauba Wax (E903), Polysorbate 80 (E E433)

What Raloxifene Hydrochloride Fair-Med looks like and contents of the pack

Raloxifene Hydrochloride Fair-Med are white to off-white, oval biconvex film-coated tablets with 'C' on one side and '12' on other side. They are packed in blisters. The blister boxes contain 14, 28 or 84 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Fair-Med Healthcare GmbH Planckstr. 13, 22765 Hamburg Germany

Manufacturer

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

This medicinal product is authorised in the Member States of the EEA under the following names:

Portugal:    Raloxifeno Fair-Med

Germany:    Raloxifen Fair-Med Healthcare 60mg Filmtabletten

Spain:    Raloxifeno Fair-Med 60mg Comprimidos recubiertos con pelicula EFG

France:    RALOXIFENE FAIR-MED 60mg, comprimes pellicule

This leaflet was last revised in 03/2015.

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