Raloxifene Aurovitas 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Raloxifeno Aurovitas 60 mg film-coated tablets EFG

Hydrochloride raloxifene

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet:

1. What Raloxifeno Aurovitas is and what it is used for
2. What you need to know before taking Raloxifeno Aurovitas
3. How to take Raloxifeno Aurovitas
4. Possible side effects
5. How to store Raloxifeno Aurovitas
6. Contents of the pack and other information

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

Raloxifeno Aurovitas contains the active substance raloxifene hydrochloride.

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. A reduction in the risk of hip fractures has not been demonstrated.

How Raloxifeno Aurovitas works

Raloxifeno belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). When a woman reaches menopause, the levels of female sex hormones (estrogens) decrease. Raloxifeno produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes your bones to become thin and fragile; this condition is particularly common in women after menopause. Osteoporosis, although it may not initially cause symptoms, makes you more prone to bone fractures (especially of the spine, hip, and wrist) and may lead to back pain, loss of height, and curvature of the spine.

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

Do not take Raloxifeno Aurovitas

• If you are or have been receiving treatment for blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in the eyes (retinal venous thrombosis).
• If you are allergic to raloxifene or to any of the other ingredients of this medicine (listed in section 6).
• If you could still become pregnant, as raloxifene could harm the unborn baby.
• If you have liver disease (some examples of liver disease are: 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 insufficient experience with the use of raloxifene in women with this condition.

Warnings and precautions

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

• If you are going to be immobile for a period of time, such as being wheelchair-bound, hospitalised, or confined to bed due to recovery from surgery or an unexpected illness, as this may increase your risk of blood clots (deep vein thrombosis, pulmonary embolism, or retinal venous thrombosis).
• If you have had a stroke (e.g., cerebrovascular accident) 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 insufficient experience with the use of raloxifene in women with this condition.
• If you are undergoing treatment with oral estrogens.

Vaginal bleeding is unlikely to occur with raloxifene. For this reason, any vaginal bleeding that occurs during treatment with raloxifene should be considered unexpected and must be investigated by your doctor.

Raloxifene does not treat postmenopausal symptoms such as hot flushes.

Raloxifene decreases total cholesterol and LDL cholesterol ("bad" cholesterol). In general, it does not affect triglycerides or HDL cholesterol ("good" cholesterol). However, if you have previously taken estrogens and experienced a marked increase in triglycerides, be sure to inform your doctor before taking raloxifene.

Taking Raloxifeno Aurovitas with other medicines

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

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 dosage of these medicines.

Inform your doctor if you are taking colestyramine, a medicine used to reduce fat levels, as it may reduce the effectiveness of raloxifene.

Pregnancy, breastfeeding and fertility

Only postmenopausal women should use raloxifene. Women who could still become pregnant must not use it. Raloxifene could harm the unborn baby.

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 none.

3. How to take Raloxifeno Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The dose is one tablet daily. It does not matter at what time of day you take the tablet, but taking it at the same time each day may help you remember. You may take it with or without food.

The tablets are administered orally.

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

Your doctor will tell you 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested.

If you forget to take Raloxifeno Aurovitas

Take one 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 Raloxifeno Aurovitas

Consult your doctor first.

It is important that you continue taking raloxifeno for as long as your doctor prescribes it.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of the adverse effects observed with raloxifene have been mild.

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

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

The common adverse effects (may affect up to 1 in 10 people) are:

• Headache, including migraines.
• Leg cramps.
• Swelling of the hands, feet, and legs (peripheral oedema).
• Gallstones.
• Skin rash.
• Mild breast symptoms such as pain, enlargement, or tenderness.

The uncommon adverse 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 venous 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 number of platelets in the blood.

Rarely, liver enzyme levels in the blood may increase during treatment with raloxifeno.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Raloxifeno Aurovitas

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

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Raloxifeno Aurovitas

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

Tablet core: microcrystalline cellulose, crospovidone (type A), povidone (K30), polysorbate 80, citric acid monohydrate, magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80.

Appearance of the product and contents of the pack

White or almost white, elliptical, film-coated tablets, marked with "X" on one side and "57" on the other.

Raloxifeno Aurovitas film-coated tablets are available in Poliamide/Aluminum/PVC-Aluminum blister packs containing 14, 28, 30, 50, 56 and 90 film-coated tablets.

Only certain 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

Tel.: 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 medicinal product is authorized in the EEA Member States under the following names:

Date of the last revision of this leaflet: September 2016

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