Raloxifene Cinfamed 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

raloxifeno cinfamed 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 you should not give it to others, 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.

Leaflet contents

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

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

Raloxifeno cinfamed contains the active substance raloxifene hydrochloride.

Raloxifene is used for the treatment and prevention of osteoporosis in postmenopausal women. This medicine 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 cinfamed works

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

Osteoporosis is a disease that causes bones to become thin and fragile; this condition is particularly common in women after menopause. Osteoporosis, although it may not initially cause symptoms, increases the risk of bone fractures (especially in 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 cinfamed

Do not take raloxifeno cinfamed

• If you are allergic to raloxifene hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• 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 could still become pregnant, as raloxifeno may harm the unborn baby.
• If you have liver disease (examples of liver disease include cirrhosis, mild liver 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 raloxifeno in women with this condition.

Warnings and precautions

Consult your doctor or pharmacist before starting to take raloxifeno.

• 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., 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 raloxifeno in women with this condition.
• If you are taking oral estrogen therapy.

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

Postmenopausal symptoms (e.g., hot flushes) do not improve with raloxifeno.

Raloxifeno 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.

Use in athletes:

This medicine contains raloxifeno, which may result in a positive doping test (see references in section 4.4 of the summary of product characteristics).

Other medicines and raloxifeno cinfamed

Tell 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 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 raloxifeno.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Raloxifeno should only be used by postmenopausal women. It must not be used by women who could still become pregnant. Raloxifeno may harm the unborn baby.

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

Driving and using machines

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

raloxifeno cinfamed contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

raloxifeno cinfamed contains sodium

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

3. How to take raloxifeno cinfamed

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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. However, taking it at the same time every day may help you remember more easily. 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 advise you how long you should take raloxifeno. Your doctor may recommend that you take calcium and vitamin D supplements.

If you take more raloxifeno cinfamed than you should

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.

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

If you forget to take raloxifeno cinfamed

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 cinfamed

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.

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

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

Common adverse effects (may affect up to 1 in 10 patients):

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

Uncommon adverse 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 venous thrombosis).
• Reddened, painful skin 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, blood levels of liver enzymes 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 may 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 cinfamed

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Raloxifeno cinfamed

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

Tablet core: sodium carboxymethylstarch (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 contents of the pack

White, elliptical tablets measuring 12.6 mm by 6.6 mm.

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

The packs 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 most recent revision of this leaflet: May 2022

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. 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