RALOXIFENE TEVA FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Raloxifene Teva 60mg film-coated tablets EFG

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.

Contents of the pack and other information:

1. What is Raloxifene Teva and what is it used for
2. What you need to know before you take Raloxifene Teva
3. How to take Raloxifene Teva
4. Possible side effects

5 Storage of Raloxifene Teva

1. Contents of the pack and further information

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

Raloxifene is used for the treatment and prevention of osteoporosis in postmenopausal women. Raloxifene Teva reduces the risk of vertebral fractures in postmenopausal women with osteoporosis. No reduction in the risk of hip fractures has been demonstrated.

How Raloxifene Teva works

Raloxifene Teva belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Raloxifene Teva produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes your bones to become thin and fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not cause symptoms at first, makes you more likely to have bone fractures, especially of the spine, hip, and wrist, and can cause back pain, loss of height, and curvature of the spine.

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

Do not take Raloxifene Teva

• If you are allergic to raloxifene or any of the other ingredients of this medicine (listed in section 6).
• If you may become pregnant, as Raloxifene Teva may harm the fetus.
• If you are being treated for blood clots (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis).
• If you have any liver disease (some examples of liver disease are cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).
• If you have unexplained vaginal bleeding. Your doctor should investigate this.
• If you have active uterine cancer, as there is not enough experience of the use of Raloxifene Teva in women with this disease.
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Raloxifene Teva:

• If you are to be immobilized for a period of time, such as being in a wheelchair, being hospitalized, or staying in bed recovering from surgery or an unexpected illness.
• If you are taking estrogen replacement therapy.
• If you have breast cancer, as there is not enough experience of the use of Raloxifene Teva in women with this disease.
• If you have had a stroke (e.g., stroke) or if your doctor has told you that you are at high risk of having one.
• If you have liver problems, as there is not enough experience in people with liver problems. If you have liver problems and your doctor still recommends treatment, you may need to have some blood tests during treatment.

It is unlikely that Raloxifene Teva will cause vaginal bleeding. For this reason, any vaginal bleeding that occurs during treatment with Raloxifene Teva should be considered unexpected and should be investigated by your doctor.

Raloxifene Teva does not treat postmenopausal symptoms, such as hot flashes.

Raloxifene Teva lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken estrogens before and they have excessively raised your triglycerides, do not fail to mention this to your doctor before taking Raloxifene Teva.

Taking Raloxifene Teva with other medicines

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 such as warfarin to increase blood fluidity, your doctor may need to adjust the dose of your medication.

Tell your doctor if you are taking colestyramine, a medicine used to reduce fat content.

Pregnancy and breastfeeding

Only postmenopausal women should use Raloxifene Teva and it should not be used by women who may still become pregnant. Raloxifene Teva may harm the fetus.

Do not take Raloxifene Teva during breastfeeding because it may be excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Raloxifene Teva has no or negligible influence on the ability to drive and use machines.

3. How to take Raloxifene Teva

Follow exactly the instructions of administration of this medicine given to you by your doctor. If you are not sure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. It does not matter at what time of day you take the tablet, however, if you take it at the same time every day it will be easier to remember. You can take it with or without food.

The tablets are taken orally.

Swallow the tablet whole. If you wish, you can take it with a glass of water.

Your doctor will tell you how long you should take Raloxifene Teva. You may also be advised to take calcium and vitamin D supplements.

If you take more Raloxifene Teva than you should

Contact your doctor or pharmacist. If you take more Raloxifene Teva than you should, you may experience leg cramps and dizziness.

If you forget to take Raloxifene Teva

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

Do not take a double dose to make up for forgotten doses.

If you stop taking Raloxifene Teva

Consult your doctor before stopping treatment.

It is important that you continue to take Raloxifene Teva for as long as your doctor prescribes it. Raloxifene Teva can only treat or prevent your osteoporosis if you continue to take the tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects seen with Raloxifene Teva have been mild.

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

1. Hot flashes (vasodilation).
2. Flu-like symptoms.
3. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort.
4. Increased blood pressure

Common (may affect up to 1 in 10 people):

1. Headache, including migraines.
2. Leg cramps.
3. Swelling of hands, feet, and legs (peripheral edema).
4. Gallstones.
5. Rash.
6. Mild symptoms in the breast, such as pain, increased size, or tenderness.

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

1. Increased risk of blood clots in the legs (deep vein thrombosis).
2. Increased risk of blood clots in the lungs (pulmonary embolism).
3. Increased risk of blood clots in the eyes (retinal vein thrombosis).
4. Skin around a vein more red and painful (superficial venous thrombophlebitis).
5. Blood clots in an artery (e.g., stroke, including increased risk of death from stroke).
6. Decreased platelet count in the blood.

In rare cases, liver enzyme levels in the blood may increase during treatment with Raloxifene Teva.

Reporting of side effects

If you experience 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 national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Raloxifene Teva

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 carton or blister after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package to protect from moisture.

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 protect the environment.

6. Contents of the pack and further information

Composition of Raloxifene Teva

• The active substance is raloxifene hydrochloride. Each film-coated tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.
• The other ingredients are:

Core of the tablet: Pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica, microcrystalline cellulose silicified.

Coating of the tablet: Polydextrose (E1200), titanium dioxide (E171), hypromellose (E464), and macrogol 4000.

Appearance of the product and pack size

The film-coated tablets are white to almost white, oval, and engraved with the number "60" on one side and "N" on the other side.

Raloxifene Teva 60 mg is available in packs of 14, 28, and 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

Manufacturers:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

Date of last revision of this leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/