Prospect: Information for the user

Raloxifeno Aurovitas 60 mg film-coated tablets EFG

Hidrocloruro de raloxifeno

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Raloxifeno Aurovitas

3.How to take Raloxifeno Aurovitas

4.Possible adverse effects

5.Storage of Raloxifeno Aurovitas

6.Contents of the package and additional information

Raloxifeno Aurovitas contains the active substance hydrochloride of raloxifeno.

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

How Raloxifeno Aurovitas works

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

Osteoporosis is a disease that causes bones to wear away and become fragile; this disease is especially common in women after menopause. Osteoporosis, although initially may not produce symptoms, 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.

Do not take Raloxifeno 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 raloxifeno or any of the other components of this medication (listed in section 6).

•If you may still be pregnant, as raloxifeno could harm the fetus.

•If you have any liver disease (some examples of liver disease are: cirrhosis, mild liver insufficiency, or cholestatic jaundice).

•If you have severe kidney problems.

•If you observe unexplained vaginal bleeding. If this occurs, contact your doctor for further investigation.

•If you have active uterine cancer, as there is not enough experience with the use of raloxifeno in women with this condition.

Warnings and precautions

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

•If you are to be immobilized for a certain period of time, such as being in a wheelchair, hospitalized, or recovering from 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 (for example, cerebral infarction) 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 raloxifeno in women with this condition.

•If you are taking estrogen therapy by mouth.

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

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

Raloxifeno reduces 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, inform your doctor about this before taking raloxifeno.

Taking Raloxifeno Aurovitas with other medications

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

If you are taking digitalis medications for the 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, which is a medication used to reduce fat content, as it may decrease the effectiveness of raloxifeno.

Pregnancy, lactation, and fertility

Only postmenopausal women should use raloxifeno. Women who may still be pregnant should not use it, as raloxifeno could harm the fetus.

Do not take raloxifeno during lactation, as it may be excreted in breast milk.

Driving and operating machines

The effects of raloxifeno on the ability to drive and operate machines are negligible or insignificant.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one tablet per day. It does not matter at 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 tell you for how long you should take raloxifeno. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifeno Aurovitas than you should

Contact your doctor or pharmacist. If you take more raloxifeno 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Raloxifeno Aurovitas

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Raloxifeno Aurovitas

Consult with your doctor beforehand.

It is essential that you continue taking raloxifeno for the time your doctor prescribes the medication.

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

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

Like all medications,this medicationcan cause side effects, although not everyone will experience them. Most side effects observed with raloxifeno 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.

The 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).

•Formation of gallstones.

•Dermatological eruption.

•Mild symptoms in the breast, such as pain, enlargement, or sensitivity.

The less common 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 pain around a vein (superficial venous thrombophlebitis).

•Blood clots in an artery (e.g., stroke, including increased risk of death from stroke).

•Decreased platelet count in the blood.

In rare cases, blood levels of liver enzymes may increase during treatment with raloxifeno.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Raloxifeno Aurovitas

- The active ingredient is hydrochloride of raloxifeno. Each film-coated tablet contains 60 mg of hydrochloride of raloxifeno, equivalent to 56 mg of raloxifeno.

- The other components are:

Core of the tablet: microcrystalline cellulose, crospovidone (type A), povidone (K30), polisorbate 80, citric acid monohydrate, magnesium stearate.

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

Appearance of the product and contents of the packaging

Film-coated tablets of white or off-white color, elliptical shape, with the mark “X” on one face and “57” on the other.

Raloxifeno Aurovitas film-coated tablets are available in blister packs of Poliamida/Aluminio/PVC-Aluminio with 14, 28, 30, 50, 56, and 90 film-coated tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Tel.: 91 630 86 45

Fax: 91 630 26 64

Responsible for manufacturing:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Last review date of this leaflet: September 2016

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ ).