Prospect: information for the patient

RaloxifenoViatris60 mg film-coated tablets EFG

hydrochloride of raloxifeno

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2.What you need to know before starting to take Raloxifeno Viatris

3.How to take Raloxifeno Viatris

4.Possible adverse effects

5.Storage of Raloxifeno Viatris

6.Contents of the package and additional information

Raloxifeno Viatris contains the active substance raloxifene hydrochloride.

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

How Raloxifeno Viatris works:

Raloxifeno Viatris belongs to a group of non-hormonal medications called selective estrogen receptor modulators (SERMs). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Raloxifeno Viatris 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 takeRaloxifeno Viatris:

• 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 raloxifeno or any of the other components of this medication (listed in section 6).

-If you can become pregnant, as raloxifeno may 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. Your doctor must investigate it.

-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 Viatris:

-If you will be bedridden for a certain time, such as being in a wheelchair, entering a hospital, or recovering from a surgical operation or 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 have a 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 estrogen therapy by mouth.

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

Raloxifeno does not treat postmenopausal symptoms, such as hot flashes.

Raloxifeno reduces 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 forget to tell your doctor before taking Raloxifeno Viatris.

Other medications and Raloxifeno Viatris

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

If you are taking a heart medication with digoxin or anticoagulants such as warfarin to increase blood fluidity, your doctor may need to adjust the dose of your medication.

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

Pregnancy and lactation

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

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

Driving and operating machinery

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

Raloxifeno Viatris contains lactose and sodium

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

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

Follow exactly the administration instructions for this medication as indicated 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, 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 Viatris. Your doctor may advise you to take calcium and vitamin D supplements.

If you take moreRaloxifenoViatristhan you should

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

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.

If you forgot to takeRaloxifenoViatris

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

If you interrupt treatment withRaloxifenoViatris

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 cause side effects, although not everyone will experience them. Most side effects observed with Raloxifeno Viatris have been mild.

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

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

• Deep vein thrombosis or pulmonary embolism. Symptoms include shortness of breath, chest pain, numbness, warmth, or swelling of the legs.
• Blood clots in an artery (e.g., stroke, including an increased risk of dying from a stroke). Symptoms include severe and sudden headache, loss of vision, loss of coordination, difficulty speaking.

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

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

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

(trombosis de la vena retiniana).

???Increased bleeding or bruising more frequently than normal, 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 (vasodilatación).

-Flu-like symptoms.

-Gastrointestinal symptoms such as 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 edema).

-Galstones.

-Rash.

-Mild symptoms in the breast such as pain, enlargement, or sensitivity.

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

-Redness and pain around a vein, which may be due to superficial venous thrombophlebitis.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side 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.

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

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

Medications should not be disposed of through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofRaloxifeno Viatris

-The active ingredient is hydrochloride of raloxifeno. Each film-coated tablet contains 60 mg of hydrochloride of raloxifeno, which are equivalent to 56 mg of raloxifeno.

-The other components are:

Core of the tablet: carboxymethylcellulose sodium (Primogel), citric acid monohydrate, microcrystalline cellulose, calcium phosphate dibasic, poloxamer 407, and magnesium stearate.

Coating of the tablet: hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (E-171), and macrogol/PEG 400(see section 2 ‘Raloxifeno Viatris contains lactose and sodium’).

Appearance of the product and contents of the package

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

Raloxifeno Viatris is presented in blisters containing 14, 28, 30, 84, or 90 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for Manufacturing

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

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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This medicinal product is authorized in the member states of the European Economic Area with the following names:

SpainRaloxifeno Viatris 60 mg film-coated tablets EFG

FranceRaloxifène Mylan Pharma 60 mg, coated tablet

PortugalRaloxifeno Mylan

United KingdomRaloxifene Hydrochloride 60 mg Film-coated Tablets

Last review date ofthis leaflet:February 2022

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