RALOXIFENE EXELTIS 60 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

RaloxifeneExeltis60 mg film-coated tablets EFG

raloxifene hydrochloride

Read this leaflet carefully before you start taking this medicine, as 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 others, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Raloxifene Exeltis is and what it is used for
2. What you need to know before taking Raloxifene Exeltis
3. How to take Raloxifene Exeltis
4. Possible side effects
5. Storage of Raloxifene Exeltis
6. Contents of the pack and further information

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

Raloxifene Exeltis contains the active substance raloxifene hydrochloride.

Raloxifene is used for the treatment and prevention of osteoporosis in postmenopausal women. Raloxifene Exeltis reduces the risk of vertebral fractures in postmenopausal women with osteoporosis. It has not been shown to reduce the risk of hip fractures.

How Raloxifene Exeltis works:

Raloxifene Exeltis 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 Exeltis produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes your bones to thin and become fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not cause 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 Exeltis

Do not takeRaloxifene Exeltis:

• 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 medicine (listed in section 6).

• If you may 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. Your doctor should investigate this.
• 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

Talk to your doctor or pharmacist before taking Raloxifene Exeltis:

• 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 replacement therapy.

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 change triglycerides or HDL ("good") cholesterol. However, if you have taken estrogens before and they have excessively increased your triglycerides, do not fail to mention this to your doctor before taking Raloxifene Exeltis.

Other medicines and Raloxifene Exeltis

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

If you are taking a medicine containing digoxin 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 levels, as it may decrease the effectiveness of raloxifene.

Pregnancy and breastfeeding

Raloxifene should only be used by postmenopausal women and should not be used by women who may become pregnant. Raloxifene may harm the fetus.

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

Driving and using machines

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

Raloxifene Exeltis contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Raloxifene Exeltis

Follow the instructions for taking this medicine exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended 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 taken 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 how long you should take Raloxifene Exeltis. Your doctor may advise you to take calcium and vitamin D supplements.

If you take moreRaloxifeneExeltisthan 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 medicine and the amount taken.

If you forget to takeRaloxifeneExeltis

Take a tablet as soon as you remember and continue as before. Do not take a double dose to make up for the forgotten tablet.

If you stop takingRaloxifeneExeltis

Consult your doctor beforehand.

It is important that you continue taking raloxifene for as long as your doctor prescribes it. Raloxifene can only treat or prevent your osteoporosis 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 side effects

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

If you experience any of the following serious side effects, stop taking raloxifene and inform your doctor immediately.

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

• Blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism). Symptoms are: shortness of breath, chest pain, numbness, heat, or swelling of the legs.
• Blood clots in an artery (such as stroke, including an increased risk of dying from a stroke). Symptoms include severe headache, loss of vision, loss of coordination, difficulty speaking.

Tell your doctor if you experience any of the following side effects:

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

??? Loss of vision in one eye, which may be due to a blood clot in an ocular vein (retinal vein thrombosis).

??? More frequent bleeding or bruising than usual, which may be due to a decrease in the number of platelets in the blood.

Other side effects:

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

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

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

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

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

• Redness and painful skin around a vein (superficial venous thrombophlebitis).

Rarely, liver enzyme levels may increase during treatment with Raloxifene Exeltis.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Raloxifene Exeltis

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

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

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofRaloxifene Exeltis

• 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:

Tablet core: sodium carboxymethylcellulose (Primogel), citric acid monohydrate, microcrystalline cellulose, dibasic calcium phosphate, poloxamer 407, and magnesium stearate.

Tablet coating: hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E-171), and macrogol/PEG 400 (see section 2 'Raloxifene Exeltis contains lactose and sodium').

Appearance of the product and pack contents

The film-coated tablets are white and elliptical in shape.

Raloxifene Exeltis is available in blister packs containing 14, 28, 30, 84, or 90 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Exeltis Healthcare S.L.

Avenida de Miralcampo, 7.

Polígono Industrial Miralcampo.

19200 Azuqueca de Henares.

Guadalajara, Spain.

Manufacturer

Pharmathen International, S.A.

Industrial Park Sapes, Rodopi Prefecture, Block No 5

Rodopi 69300

Greece

or

Pharmathen S.A.

6 Dervenakion Str.

153 51 Pallini Attikis

Greece

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This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain Raloxifene Exeltis 60 mg film-coated tablets EFG

France Raloxifène Mylan Pharma 60 mg, film-coated tablet

Portugal Raloxifene Exeltis

Date of last revision ofthis leaflet:February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/