RALOXIFENE CINFAMED 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is raloxifene cinfamed and what is it used for

raloxifene cinfamed contains the active substance raloxifene hydrochloride.

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

How raloxifene cinfamed works

Raloxifene hydrochloride 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 cinfamed

Do not take raloxifene cinfamed

• If you are allergic to raloxifene hydrochloride or any of the other components of this medication (listed in section 6).
• 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 may still be able to become pregnant, as raloxifene could 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.

• If you are to be immobilized for a certain period, 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.

Postmenopausal symptoms (such as hot flashes) do not improve with raloxifene.

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.

Athlete use:

This medication contains raloxifene, which may produce a positive result in doping tests (see references in section 4.4 of the technical data sheet).

Other medications and raloxifene cinfamed

Tell 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 your medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and using machines

Raloxifene has no effects, or they are insignificant, on the ability to drive or use machines.

raloxifene cinfamed contains lactose

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

raloxifene cinfamed contains sodium

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

3. How to take raloxifene cinfamed

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, 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. However, 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 cinfamed than you should

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.

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

If you forget to take raloxifene cinfamed

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

Do not take a double dose to make up for forgotten doses.

If you stop taking raloxifene cinfamed

Consult your doctor beforehand.

It is important that you continue taking raloxifene for as long as 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 will experience them. Most of the side effects observed with raloxifene have been mild.

Very common side effects (may affect more than 1 in 10 patients):

• 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 patients):

• 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 patients):

• 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 in 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.

Rarely, liver enzyme levels in the blood 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 Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of raloxifene cinfamed

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, 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 cinfamed

• The active ingredient is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride.
• The other components are:

Tablet core: sodium carboxymethyl starch (type A) (from potato), citric acid monohydrate, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, poloxamer, and magnesium stearate.

Tablet coating: titanium dioxide (E-171), lactose monohydrate, hypromellose, and macrogol.

Appearance of the product and package contents

White, elliptical tablets, 12.6 mm x 6.6 mm in size.

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters.

The packages contain 14, 28, or 84 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

PHARMATHEN S.A.

Dervenakion 6, Pallini 15351 Attiki Greece

or

PHARMATHEN INTERNATIONAL S.A.

Industrial Park Sapes, Rodopi Prefecture,

Block nº5, Rodopi

69300, Greece

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this package leaflet: May 2022

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/)

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/87122/P_87122.html

QR code to: https://cima.aemps.es/cima/dochtml/p/87122/P_87122.html