RALOXIFENE STADA 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Raloxifene Stada 60 mg film-coated tablets EFG

Raloxifene hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Raloxifene Stada and what is it used for
2. What you need to know before taking Raloxifene Stada
3. How to take Raloxifene Stada
4. Possible side effects

5 Storage of Raloxifene Stada

1. Contents of the pack and further information

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

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

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

Osteoporosis is a disease that causes your bones to wear down and become fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not produce symptoms at first, 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.

2. What you need to know before taking Raloxifene Stada

Do not take Raloxifene Stada:

• if you are allergic to the active substance or to any of the other ingredients of this medication (listed in section 6)
• if you may become pregnant, as raloxifene could harm the fetus.
• if you are or have been treated for blood clot problems (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis).
• if you have any liver disease (some examples of liver disease are cirrhosis, mild hepatic failure, or cholestatic jaundice).
• if you notice unexplained vaginal bleeding. If this occurs, contact your doctor for evaluation.
• if you have active uterine cancer, as there is not enough experience with the use of raloxifene in women with this disease.
• if you have severe kidney problems.

Warnings and precautions

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

• need to be immobilized for a certain period, such as being in a wheelchair, hospitalized, or bedridden after surgery or an unexpected illness.
• are undergoing estrogen replacement therapy.
• have breast cancer, as there is not enough experience with the use of raloxifene in women with this disease.
• have had a stroke (e.g., stroke) or if your doctor has told you that you are at high risk of having one.

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

Postmenopausal symptoms (e.g., hot flashes) do not improve with raloxifene.

Raloxifene 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, do not fail to mention this to your doctor before taking this medication.

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

Other medications and Raloxifene Stada

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

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

Tell your doctor if you are taking colestyramine, a medication used to reduce fat content.

Pregnancy and breastfeeding

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

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

Driving and using machines

Raloxifene has no known effects related to driving or using machines.

Raloxifene Stada contains lactose

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

Raloxifene Stada contains sodium

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

3. How to take Raloxifene Stada

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again

Dosage

The recommended dose is one tablet per day. It does not matter 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.

Method of administration

The tablets are taken orally.

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

Duration of treatment

Your doctor will indicate how long you should take raloxifene. You may be advised to take calcium and vitamin D supplements.

If you take more Raloxifene Stada than you should

In case of overdose or accidental ingestion, you may experience leg cramps or dizziness; consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and package leaflet of the medication to the healthcare professional.

If you forget to take Raloxifene Stada

Take a tablet as soon as you remember and continue as before. Do not take a double dose to make up for forgotten doses.

If you stop taking Raloxifene Stada

Consult your doctor beforehand.

It is important that you continue taking raloxifene for as long as your doctor prescribes the medication. Raloxifene 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them. Most of the side effects observed with raloxifene 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.

Uncommon (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 painful sensation of the skin around a vein (superficial venous thrombophlebitis).

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 migraine.
• Mild symptoms in the breast, such as pain, increased size, or sensitivity.

On rare occasions, liver enzyme levels may increase during treatment with raloxifene.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Raloxifene Stada

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

Do not use this medication after the expiration date shown on the package 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Raloxifene Stada:

• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.
• The other ingredients are:

Core of the tablet: Sodium carboxymethyl starch type A (potato), citric acid monohydrate, microcrystalline cellulose, calcium hydrogen phosphate, poloxamer, magnesium stearate.

Tablet coating: Hypromellose, lactose, titanium dioxide (E171), and macrogol/PEG 400.

Appearance of the product and pack contents

Raloxifene 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.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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

Date of the last revision of this package leaflet:August 2020.

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