RALOXIFENE AUROVITAS 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Raloxifene Aurovitas 60 mg film-coated tablets EFG

Raloxifene hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Raloxifene Aurovitas and what is it used for
2. What you need to know before taking Raloxifene Aurovitas
3. How to take Raloxifene Aurovitas
4. Possible side effects
5. Storage of Raloxifene Aurovitas
6. Package contents and additional information

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

Raloxifene Aurovitas contains the active substance raloxifene hydrochloride.

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

How Raloxifene Aurovitas works

Raloxifene belongs to a group of non-hormonal medications called Selective Estrogen Receptor Modulators (SERM). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Raloxifene produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes your bones to wear down and become fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not produce symptoms at first, predisposes you to 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 taking Raloxifene Aurovitas

Do not take Raloxifene Aurovitas

• If you are or have been treated for blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal vein thrombosis).
• If you are allergic to raloxifene or any of the other ingredients of this medication (listed in section 6).
• If you may still be able to become pregnant, as raloxifene may harm the fetus.
• If you have liver disease (such as cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).
• If you have severe kidney problems.
• If you experience unexplained vaginal bleeding. If this occurs, contact your doctor for evaluation.
• If you have active uterine cancer, as there is not enough experience with the use of raloxifene in women with this disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Raloxifene Aurovitas.

• If you are to be immobilized for a period of time, such as being in a wheelchair, hospitalized, or bedridden after surgery or an unexpected illness, as the risk of blood clots (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis) may be increased.
• If you have had a stroke (such as a stroke) or if your doctor has told you that you are at high risk of having one.
• If you have liver disease.
• If you have breast cancer, as there is not enough experience with the use of raloxifene in women with this disease.
• If you are taking estrogen therapy orally.

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

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

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

Taking Raloxifene Aurovitas with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

If you are taking digitalis medications for your heart or anticoagulants such as warfarin to increase blood fluidity, your doctor may need to adjust the dose of these medications.

Inform your doctor if you are taking cholestyramine, a medication used to reduce fat content, as it may decrease the effectiveness of raloxifene.

Pregnancy, breastfeeding, and fertility

Only postmenopausal women should use raloxifene. Women who may still become pregnant should not use it. Raloxifene may harm the fetus.

Do not take raloxifene during breastfeeding, as it may be excreted in breast milk.

Driving and using machines

The effects of raloxifene on the ability to drive and use machines are negligible or non-existent.

3. How to take Raloxifene Aurovitas

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist again.

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

The tablets are administered orally.

Swallow the tablet whole. If you wish, you can take it with a glass of water. Do not break or crush the tablet before taking it. A broken or crushed tablet may have an unpleasant taste and you may take an incorrect dose.

Your doctor will indicate how long you should take raloxifene. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifene Aurovitas than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Raloxifene Aurovitas

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 interrupt treatment with Raloxifene Aurovitas

Consult your doctor beforehand.

It is important that you continue taking raloxifene for the time your doctor prescribes the medication.

Raloxifene can only treat or prevent your osteoporosis if you continue taking the tablets.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Most side effects observed with raloxifene have been mild.

The most common side effects (may affect more than 1 in 10 people) are:

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

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

• Headache, including migraines.
• Leg cramps.
• Swelling of hands, feet, and legs (peripheral edema).
• Gallstones.
• Rash.
• Mild breast symptoms, such as pain, increased size, or sensitivity.

Uncommon side effects (may affect up to 1 in 100 people) 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).
• Redness and painful sensation of the skin around a vein (superficial venous thrombophlebitis).
• Blood clots in an artery (such as stroke, including increased risk of death from stroke).
• Decreased platelet count in the blood.

In rare cases, liver enzyme levels may increase during treatment with raloxifene.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Raloxifene Aurovitas

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

Do not use this medication after the expiration date stated on the carton after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Raloxifene Aurovitas

• The active ingredient 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:microcrystalline cellulose, crospovidone (type A), povidone (K30), polysorbate 80, citric acid monohydrate, magnesium stearate.

Coating of the tablet:hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80.

Appearance of the product and package contents

White or off-white film-coated tablets, elliptical in shape, with the mark "X" on one side and "57" on the other.

Raloxifene Aurovitas film-coated tablets are available in blister packs of Polyamide/Aluminum/PVC-Aluminum with 14, 28, 30, 50, 56, and 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication is authorized in the EEA member states under the following names:

Date of the last revision of this package leaflet: September 2016

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).