Raloxifene Exeltis 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Raloxifeno Exeltis 60 mg film-coated tablets EFG

raloxifene hydrochloride

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Raloxifeno Exeltis contains the active substance raloxifeno hydrochloride.

Raloxifeno is used for the treatment and prevention of osteoporosis in postmenopausal women. Raloxifeno Exeltis 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 Exeltis works:

Raloxifeno Exeltis 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 Exeltis 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 cause symptoms initially, increases your risk of bone fractures, especially in the spine, hip, and wrist, and may lead to back pain, loss of height, and stooping posture.

2. What you need to know before taking Raloxifeno Exeltis

Do not take Raloxifeno Exeltis:

• 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 components of this medicine (listed in section 6).

• If you could become pregnant, as raloxifene may harm the fetus.

  • If you have any liver disease (examples of liver disease include 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 insufficient experience regarding the use of raloxifene in women with this condition.

Warnings and precautions

Talk to your doctor or pharmacist before starting Raloxifeno Exeltis:

• If you are going to be immobilized for a period of time, such as being confined to a wheelchair, being hospitalized, or remaining in bed recovering 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., ischemic 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 insufficient experience with the use of raloxifene in women with this condition.

• If you are currently 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 flashes.

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

Other medicines and Raloxifeno 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 digoxin for heart problems or anticoagulants such as warfarin to thin the blood, your doctor may need to adjust the dose of your medication.

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

Pregnancy and breastfeeding

Raloxifene should only be used by postmenopausal women and must not be used by women who could still 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

Raloxifeno has no effect or negligible effects on the ability to drive or operate machinery.

Raloxifeno Exeltis contains lactose and sodium

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

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

3. How to take Raloxifeno Exeltis

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, 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, taking it at the same time each day may help you remember more easily. You may take it with or without food.

The tablets are taken 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 Exeltis. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifeno Exeltis 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, indicating the medicine and the amount ingested.

If you forget to take Raloxifeno Exeltis

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

If you stop taking Raloxifeno Exeltis

Consult your doctor beforehand.

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 Raloxifeno Exeltis have been mild.

If you experience any of the following serious adverse 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 in the lungs (pulmonary embolism). Symptoms include: shortness of breath, chest pain, numbness, warmth or swelling in the legs.
• Blood clots in an artery (for example, stroke, including an increased risk of death from stroke). Symptoms include sudden, severe headache, vision loss, loss of coordination, difficulty speaking.

Consult your doctor if you experience any of the following adverse 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 eye vein (retinal vein thrombosis).

??? Increased occurrence of bleeding or bruising, which may be due to a reduced number of platelets in the blood.

Other adverse effects:

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

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

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

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

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

• Reddened skin around a vein with a painful sensation (superficial venous thrombophlebitis).

On rare occasions, blood levels of liver enzymes may increase during treatment with Raloxifeno Exeltis.

Reporting of adverse effects

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

5. Storage of Raloxifeno Exeltis

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Raloxifeno 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 components are:

Tablet core: sodium carboxymethyl starch (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, 'Raloxifeno Exeltis contains lactose and sodium').

Appearance of the medicinal product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization 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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain: Raloxifeno Exeltis 60 mg film-coated tablets EFG

France: Raloxifène Mylan Pharma 60 mg, comprimé pelliculé

Portugal: Raloxifeno Exeltis

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date 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/