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Raloxifene 60 Mg Film-Coated Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Raloxifene 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.


In this leaflet:

1.    What Raloxifene is and what it is used for

2.    What you need to know before you take Raloxifene

3.    How to take Raloxifene

4.    Possible side effects

5.    How to store Raloxifene

6.    Contents of the pack and other information


A SANDOZ


What Raloxifene is and what it is used for


Raloxifene contains the active substance raloxifene hydrochloride.

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.

How Raloxifene works

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.

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.


What you need to know before you take Raloxifene


Do not take Raloxifene:

•    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 are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine (listed in section 6).

•    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 or pharmacist before taking

Raloxifene.

   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 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 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.

Raloxifene 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

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, breast-feeding and fertility

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 or negligible effects on driving or using machines.


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3 How to take Raloxifene


Always take this medicine exactly as your doctor 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. The doctor may also advise you to take calcium and vitamin D supplements.

If you take more Raloxifene than you should

Tell your doctor or pharmacist. If you take more Raloxifene than you should, you could have leg cramps and dizziness.


levels of liver enzymes may increase during treatment with Raloxifene.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (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


Keep this medicine out of the sight and reach of 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 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.


If you forget to take Raloxifene

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

You should talk to your doctor first.

It is important that you continue taking Raloxifene for as long as your doctor prescribes the medicine.

Raloxifene 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.


Contents of the pack and other information


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.


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, 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.


Very common side effects (may affect more than 1 in 10

people):

•    Hot flushes (vasodilation)

•    Flu syndrome

•    Gastrointestinal symptoms such as feeling sick (nausea), vomiting, abdominal pain and indigestion (dyspepsia)

•    Increased blood pressure

Common side effects (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 side effects (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)

•    Reduction in blood platelets, which increases risk of bleeding or bruising


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


In rare cases (may affect up to 1 in 1,000 people), blood

This leaflet was last revised in 07/2015


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SZ00000LT000


a> "co -S JS £


Artwork Proof Box

Ref: V009 - Update in line with reference product

Proof no.

Date prepared:

Font size:

003.0

14/07/2015

10pt

Colours:

Fonts:

Black

Helvetica

Black 20%

Dimensions: 200 x 400 mm

_y