Prospect: Information for the user

Raloxifeno Stada 60 mg film-coated tablets EFG

Raloxifene hydrochloride

Read this prospect carefully before starting to take this medicine, as 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 for you, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

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

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

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

3.How to take Raloxifeno Stada

4.Possible adverse effects

5Storage of Raloxifeno Stada

6.Contents of the package and additional information

Raloxifeno 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 produces some of the beneficial effects of estrogens after menopause.

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

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 Stada:

-if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

-if you may become pregnant, as raloxifeno could harm the fetus.

-if you have or have had a blood clotting disorder (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis).

-if you have any liver disease (some examples of liver disease are cirrhosis, mild liver insufficiency, or cholestatic jaundice).

-if you observe unexplained vaginal bleeding. If this occurs, contact your doctor for further evaluation.

-if you have active uterine cancer, as there is insufficient experience with the use of raloxifeno in women with this condition.

-if you have severe kidney problems.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Raloxifeno Stada, if you:

-are to be immobilized for a certain period of time, such as being bedridden, hospitalized, or recovering from surgery.

-are taking oral estrogen therapy.

-have breast cancer, as there is insufficient experience with the use of raloxifeno in women with this condition.

-have had a stroke (e.g., cerebral hemorrhage) or if your doctor has told you that you are at high risk of having one.

It is unlikely that raloxifenowill cause vaginal bleeding. Any vaginal bleeding that occurs during treatment with raloxifeno should be considered unexpected and should be investigated by your doctor.

Menopausal symptoms (e.g., hot flashes) do not improve with raloxifeno.

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, inform your doctor before taking this medication.

This medication contains raloxifeno, which may produce a positive result in doping control tests.

Other Medications and Raloxifeno Stada

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.

Pregnancy and Breastfeeding

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

Do not take raloxifenoduring breastfeeding because it may be excreted in breast milk.

Driving and Operating Machines

Raloxifeno has no known effects on driving or operating machines.

Raloxifeno Stada contains lactose

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

Raloxifeno Stada 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. In case of doubt, consult your doctor or pharmacist again

Dosage

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

Administration Form

The tablets are administered orally

Swallow the tablet whole. If you wish, you can take it with a glass of water

Treatment Duration

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 Stada than you should

In case of overdose or accidental ingestion, you may experience muscle cramps or dizziness. Consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional

If you forgot to take Raloxifeno Stada

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

If you interrupt treatment with Raloxifeno Stada

Consult your doctor beforehand

It is essential that you continue taking raloxifeno for as long as your doctor prescribes the medication. Raloxifeno 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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. Most of the side effects observed with raloxifeno have been mild.

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

•Hot flashes (vasodilation).

•Flu-like syndrome.

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

•Leg cramps.

•Swelling of hands, feet, and legs (peripheral edema).

•Gallstones.

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

•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 pain around a vein (superficial venous thrombophlebitis).

Very rare (may affect up to 1 in 10,000 people):

•Rash.

•Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort.

•Increased blood pressure.

•Decreased platelet count in the blood.

•Blood clots in an artery (e.g., stroke).

•Headache, including migraines.

•Mild symptoms in the breast, such as pain, swelling, or tenderness.

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

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

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 after CAD. The expiration date is the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light and moisture. Do not freeze.

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 unused medications. By doing so, you will help protect the environment.

Composition of Raloxifeno Stada:

• The active ingredient is hydrochloride of raloxifeno. Each tablet contains 60 mg of hydrochloride of raloxifeno, which are equivalent to 56 mg of raloxifeno.
• The other componentsare:

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

Coating of the tablet: Hypromellose, lactose, titanium dioxide (E171) and macrogol/PEG 400.

Appearance of the product and content of the container

Raloxifeno Stada 60 mg film-coated tablets are white, oval-shaped and film-coated. They are packaged in blisters.

The blister packs contain 10, 14, 28, 30, 84, 90, 100 or 126 tablets.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorio, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Eurogenerics N.V.

Heizel Esplanade B22,

1020 Brussels

Belgium

Or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

Or

STADA Arzneimittel GmbH

Muthgasse 36/2, A-1190 Vienna

Austria

Or

Pharmathen S.A.

6, Dervenakion Str., 153 51 Pallini, Athens

Greece

Or

Pharmaten International, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi

Greece

Last review date of this leaflet:Augustof2020.

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