Prospecto: Information for the User

Raloxifeno Teva 60mg Film-Coated Tablets EFG

Hydrochloride of Raloxifeno

Read this entire prospect carefully before starting to take the 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 should not be given to other people 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 Teva and for what it is used

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

3.How to take Raloxifeno Teva

4.Possible adverse effects

5Storage of Raloxifeno Teva

6.Contents of the package and additional information

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

How Raloxifeno Teva works

Raloxifeno Teva 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 Teva 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 Teva

• If you are allergic to raloxifeno or any of the other components of this medication (listed in section 6).
• If you may become pregnant, as Raloxifeno Teva could harm the fetus.
• If you are or have been treated for blood clotting problems (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. Your doctor must investigate it..
• If you have active uterine cancer, as there is not enough experience with the use of Raloxifeno Teva in women with this disease.
• If you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Raloxifeno Teva:

• If you will be immobilized for a certain period of time, such as being in a wheelchair, in a hospital, or recovering from surgery or an unexpected illness.
• If you are taking oral estrogen therapy.
• If you have breast cancer, as there is not enough experience with the use of Raloxifeno Teva in women with this disease.
• If you have had a stroke (e.g., cerebral hemorrhage) or if your doctor has told you that you are at high risk of having one.
• If you have liver problems, as there is not enough experience in people with liver disease. If you have liver problems and your doctor continues to recommend treatment, you may need to have some blood tests during treatment.

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

Raloxifeno Teva does not treat menopausal symptoms, such as hot flashes.

Raloxifeno Teva reduces total cholesterol and LDL ("bad") cholesterol. In general, it does not modify triglycerides or HDL ("good") cholesterol. However, if you have taken estrogens in the past and they have excessively increased your triglycerides, do not forget to tell your doctor before taking Raloxifeno Teva.

Taking Raloxifeno Teva with other medications

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 fluidity, 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

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

Do not take Raloxifeno Teva during breastfeeding because it may be excreted in breast milk.

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

Driving and operating machinery

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

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 desired, you can take it with a glass of water.

Your doctor will tell you for how long you should take Raloxifeno Teva. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifeno Teva than you should

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

If you forgot to take Raloxifeno TevaRaloxifeno Teva

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

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Raloxifeno Teva

Consult your doctor beforehand.

It is essential that you continue taking Raloxifeno Teva for as long as your doctor prescribes the medication. Raloxifeno Teva 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 medicinecan cause side effects, although not everyone will experience them.Most of the side effects observed withRaloxifenoTeva have been mild.

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

1. Hot flashes (vasodilation).
2. Flu-like syndrome.
3. Symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort.
4. Increased blood pressure

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

1. Headache, including migraines
2. Leg cramps.
3. Swelling of hands, feet, and legs (peripheral edema).
4. Gallstones.
5. Rash.
6. Mild symptoms in the breast, such as pain, enlargement, or sensitivity

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

1. Increased risk of blood clots in the legs (deep vein thrombosis).
2. Increased risk of blood clots in the lungs (pulmonary embolism).
3. Increased risk of blood clots in the eyes (retinal vein thrombosis).
4. Skin around a vein more red and painful (superficial venous thrombophlebitis).
5. Blood clots in an artery (e.g., stroke, including increased risk of death from stroke)
6. Decreased number of platelets in the blood

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

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 that does not appear in this leaflet. You can also report them directly through the national notification system included in theAnnex V. By reporting side effects, you can contribute to providing more information about 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 or blister after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Raloxifeno Teva Composition

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

- The other components are:

Tablet core: pregelatinized cornstarch, magnesium stearate, povidone (K30), anhydrous colloidal silica, and microcrystalline cellulose.

Tablet coating: Polydextrose (E1200), titanium dioxide (E171), hypromellose (E464), and macrogol 4000.

Product appearance and packaging contents

The film-coated tablets are white to almost white, oval-shaped, and engraved with the number "60" on one side and "N" on the other side.

Raloxifeno Teva 60 mg is available in packaging of 14, 28, and 84 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Responsible manufacturers:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information regarding this medication, please contact the local representative of the Marketing Authorization Holder.