Raloxifene Stada 60 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Raloxifeno Stada 60 mg film-coated tablets EFG

Raloxifene hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to others even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Raloxifeno Stada is and what it is used for
2. What you need to know before taking Raloxifeno Stada
3. How to take Raloxifeno Stada
4. Possible side effects
5. How to store Raloxifeno Stada
6. Contents of the pack and other information

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

Raloxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). When a woman reaches menopause, the levels of female sex hormones (estrogens) decrease. 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. A reduction in the risk of hip fractures has not been demonstrated.

Osteoporosis is a disease that causes your bones to become thin and fragile; this condition is particularly common in women after menopause. Osteoporosis, although it may not initially cause symptoms, predisposes you to bone fractures, especially in the spine, hip, and wrist, and may cause back pain, loss of height, and curvature of the spine.

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

Do not take Raloxifeno Stada:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6)
• if you could become pregnant, as raloxifeno may harm the fetus.
• if you are or have been receiving treatment for blood clotting problems (deep vein thrombosis, pulmonary embolism, or retinal venous thrombosis).
• if you have any liver disease (some examples of liver disease are cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).
• if you experience unexplained vaginal bleeding. If this occurs, contact your doctor for 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 going to be immobilized for a period of time, such as being confined to a wheelchair, being admitted to hospital, or remaining in bed recovering from surgery or an unexpected illness.
• are undergoing treatment with oral estrogens.
• 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 infarction) or if your doctor has told you that you are at high risk of having one.

Vaginal bleeding is unlikely to occur with raloxifeno. For this reason, any vaginal bleeding occurring during treatment with raloxifeno should be considered unexpected and must be investigated by your doctor.

Postmenopausal symptoms (e.g., hot flushes) do not improve with raloxifeno.

Raloxifeno decreases total cholesterol and LDL cholesterol ("bad" cholesterol). In general, it does not affect triglycerides or HDL cholesterol ("good" cholesterol). However, if you have previously taken estrogens and experienced a marked increase in triglycerides, be sure to inform your doctor before taking this medicine.

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

Other medicines and Raloxifeno Stada

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

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 colestyramine, a medicine used to reduce fat levels.

Pregnancy and breastfeeding

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

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

Driving and using machines

Raloxifeno has no known effects on the ability to drive or operate machinery.

Raloxifeno Stada contains lactose

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

Raloxifeno Stada contains sodium

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

3. How to take Raloxifeno Stada

Follow exactly the instructions given by your doctor for taking this medicine. If in 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 each day, you are more likely to remember. You may take it with or without food.

Method of administration

The tablets are taken orally.

Swallow the tablet whole. If desired, you may take it with a glass of water.

Duration of treatment

Your doctor will tell you how long you should take raloxifene. 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 leg cramps or dizziness. Immediately consult your doctor or pharmacist or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

If you forget to take Raloxifeno Stada

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

If you stop taking Raloxifeno Stada

Consult your doctor first.

It is important that you continue taking raloxifene for as long as your doctor has prescribed it. Raloxifene can only treat or prevent your osteoporosis if you continue taking the tablets.

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

4. Possible adverse effects

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

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

• Hot flushes (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 venous thrombosis).
• Reddened, painful skin 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.
• Increase in blood pressure.
• Decrease in the number of platelets in the blood.
• Blood clots in an artery (e.g., stroke).
• Headache, including migraines.
• Mild breast symptoms such as pain, enlargement or tenderness.

Rarely, blood levels of liver enzymes may increase during treatment with raloxifeno.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Raloxifeno Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Raloxifeno Stada:

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

Tablet core: Sodium carboxymethyl starch type A (from 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 medicinal product and contents of the pack

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

Pack sizes contain 10, 14, 28, 30, 84, 90, 100 or 126 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio 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

Pharmathen International, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

69300 Rodopi

Greece

Date of the most recent revision of this leaflet: August 2020.

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