Package Leaflet: Information for the User

Raloxifene Cinfamed 60 mg Film-Coated Tablets

Raloxifene Hydrochloride

Read this 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. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

raloxifeno cinfamed contains the active substance hydrochloride of raloxifeno.

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

How raloxifeno cinfamed works

raloxifeno hydrochloride belongs to a group of non-hormonal medications called Selective Estrogen Receptor Modulators (the international acronym is SERM). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Raloxifeno produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes bones to wear away and become fragile; this disease is especially common in women after menopause. Osteoporosis, although initially may not produce symptoms, 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.

Do not take raloxifeno cinfamed

• If you are allergic to hydrochloride raloxifeno or to 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 become pregnant, as raloxifeno could harm the fetus.
• If you have any liver disease (some examples of liver disease are: cirrhosis, mild liver insufficiency, or cholestatic jaundice).
• If you have severe kidney problems.
• If you observe unexplained vaginal bleeding. If this occurs, contact your doctor for further study.
• If you have active uterine cancer, as there is not enough experience with the use of raloxifeno in women with this disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take raloxifeno.

• If you are to be immobilized for a certain period of time, such as being in a wheelchair, hospitalized, or recovering from 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 (for example, cerebral hemorrhage) 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 raloxifeno in women with this disease.
• If you are taking oral estrogen therapy.

It is unlikely that raloxifeno will cause vaginal bleeding. For this reason, any vaginal bleeding that occurs during treatment with raloxifeno should be considered unexpected and should be investigated by your doctor.

Menopausal symptoms (for example, hot flashes) do not improve with raloxifeno.

Raloxifeno 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, inform your doctor before taking raloxifeno.

Use in athletes:

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

Other medications and raloxifeno cinfamed

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

If you are taking digitalis medications for the heart or anticoagulants such as warfarin to increase blood flow, your doctor may need to adjust the dose of your medication.

Inform your doctor if you are taking cholestyramine, which is a medication used to reduce fat content, as it may decrease the effectiveness of raloxifeno.

Pregnancy and lactation

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

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

Do not take raloxifeno during lactation because it may be excreted in breast milk.

Driving and operating machines

Raloxifeno has no effects, or these are insignificant, on the ability to drive or operate machines.

Raloxifeno cinfamed contains lactose

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

Raloxifeno cinfamed contains sodium

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

Follow exactly the administration instructions for this medication 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 at 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 tell you for how long you should take Raloxifeno. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifeno Cinfamed than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 forgot to take Raloxifeno Cinfamed

Take a tablet as soon as you remember and continue as before..Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Raloxifeno Cinfamed

Consult with your doctor beforehand.

It is essential that you continue taking Raloxifeno for as long as your doctor prescribes the medication. Raloxifeno can treat or prevent your osteoporosis only if you continue taking the tablets.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them. Most of the adverse effects observed with raloxifeno have been mild.

The very frequent adverse effects (may affect more than 1 in 10 patients):

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

The infrequent adverse effects (may affect up to 1 in 100 patients):

In rare cases, blood levels of liver enzymes may increase during treatment with raloxifeno.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for conservation.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Raloxifeno cinfamed Composition

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

Tablet core: sodium carboxymethylcellulose (type A) (from potato), citric acid monohydrate, microcrystalline cellulose, calcium dihydrogen phosphate, poloxamer, and magnesium stearate.

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

Product appearance and packaging contents

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

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

The packaging contains 14, 28, or 84 tablets.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Manufacturer responsible

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

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: May 2022

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

You can access detailed and updated information about this medicine by scanning the QR code included in the 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