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Package Leaflet: Information for the patient Raloxifene Hydrochloride 60 mg Film-coated Tablets

What is in this leaflet:

1.    What Raloxifene Hydrochloride is and what it is used for

2.    What you need to know before you take Raloxifene Hydrochloride

3.    How to take Raloxifene Hydrochloride

4.    Possible side effects

5.    How to store Raloxifene Hydrochloride

6.    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:

•    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 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:

•    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 use in women with this disease.

•    If you are receiving oral oestrogen therapy.

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 digoxin medicine 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.

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.

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):

•    Blood clots in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). Symptoms shortness of breath, chest pain, numbness, heat or swelling in the legs

•    Blood clot in an artery (for example stroke, including an increased risk of dying from stroke).

Symptoms include sudden severe headache, loss of vision, loss of coordination, slurred speech.

Contact your doctor if you notice the following:

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

•    Loss of vision in one eye which may be caused by a blot clot in a vein in the eye (retinal vein thrombosis)

•    Bruising or bleeding more easily that may be caused by a decrease in the number the platelets in the blood.

Other side effects:

Very common (may affect more than 1 in 10 people):

•    Hot flushes (vasodilation)

•    Flu syndrome

•    Gastrointestinal symptoms such as feeling sick (nausea), being sick (vomiting), stomach pain and stomach upset

•    Increased blood pressure

Common (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 (may affect up to 1 in 100 people):

•    Skin around the vein is red and painful (superficial vein thrombophlebitis)

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 after EXP. 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 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

•    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 Hydrochloride 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 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 September 2016

v1/May 2015