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Razylan 60mg Film Coated Tablets

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Package leaflet: information for the user

Razylan 60mg 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 oestrogen goes down. Razylan 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 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.

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 (eg. 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 oestrogen 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 digoxin 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. You should not take cholestyramine at the same time as raloxifene as it may reduce the absorption of raloxifene.

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.

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 ask your 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 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.    P

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.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting the

whole body).

If you experience any of the following serious side effects, contact your doctor immediately or go to the nearest hospital

accident and emergency department:

Uncommon side effects (may affect up to 1 in 100 people):

Swelling, warmth, redness and pain in the legs, these are signs and symptoms associated with blood clots in the legs (deep vein thrombosis).

Chest pain and shortness of breath, these are signs and symptoms associated with blood clots in the lungs (pulmonary embolism).

Blurring, loss of vision or patchiness of images, these are signs and symptoms associated with blood clots in the eye (retinal vein thrombosis)

Pain, whitening of the limbs, weakness, loss of sensation or paralysis, these are signs and symptoms of blood clots in an artery (for example stroke).

The following side effects have also been reported:

Very common

•    asodilation)

•    Flu syndrome

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

•    Increased blood pressure

Common    :

•    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

•    Sk

•    Decrease in the number of 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 (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 60mg of raloxifene hydrochloride, which is equivalent to 56mg 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,    . 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

Pharmathen SA

6, Dervenakion Str., 153 51, Pallini, Attiki, Greece, or

Pharmathen International SA

Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece Distributor:

Aspire Pharma Limited

Unit 4, Rotherbrook Court, Bedford Road, Petersfield, Hampshire, GU32 3QG, United Kingdom This leaflet was last revised on: 10/2016

P1010070-5.1