RALOXIFENE TARBIS 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Raloxifene Tarbis 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

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

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

Raloxifene Tarbis belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERM). When a woman reaches menopause, the level of female sex hormones or estrogens decreases. Raloxifene Tarbis produces some of the beneficial effects of estrogens after menopause.

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

Osteoporosis is a disease that causes your bones to become thin and 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 you take Raloxifene Tarbis

Do not take Raloxifene Tarbis

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

Warnings and precautions

Consult your doctor or pharmacist before taking Raloxifene Tarbis.

This product may not be suitable for you due to various circumstances. If any of these apply to you, talk to your doctor before taking this medicine. These are:

• If you are to be immobilized for a certain period, such as being in a wheelchair, hospitalized, or bedridden after surgery or unexpected illness.
• If you are taking estrogen therapy by mouth.
• If you have breast cancer, as there is not enough experience with the use of Raloxifene Tarbis in women with this disease.
• If you have had a stroke (e.g., stroke) 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 problems. If you have liver problems and your doctor still recommends treatment, you may need to have some blood tests during treatment.

If you have any of these problems, talk to your doctor before taking the medicine.

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

Raloxifene Tarbis does not treat postmenopausal symptoms, such as hot flashes.

Raloxifene Tarbis decreases total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglyceride levels or HDL ("good") cholesterol. However, if you have taken estrogens before and they have excessively increased your triglycerides, do not fail to mention this to your doctor before taking Raloxifene Tarbis.

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

Taking Raloxifene Tarbis with other medicines

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

If you are taking digitalis medicines for the 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 medicine used to reduce fat content.

Pregnancy and breastfeeding

Only postmenopausal women should use Raloxifene Tarbis, and women who may still become pregnant should not use it. Raloxifene Tarbis could harm the fetus.

Do not take Raloxifene Tarbis during breastfeeding because it may be excreted in breast milk.

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

Driving and using machines

Raloxifene Tarbis has no known effects on the ability to drive or use machines.

Raloxifene Tarbis contains lactose, potato starch carboxymethyl starch (Type A).

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Raloxifene Tarbis

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. It does not matter what time of day you take the tablet. However, if you do it every day at the same time, 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.

Your doctor will indicate how long you should take Raloxifene Tarbis. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifene Tarbis than you should

Contact your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Raloxifene Tarbis

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Raloxifene Tarbis

Consult your doctor beforehand.

If you think the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

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

4. Possible side effects

Like all medicines, Raloxifene Tarbis can cause side effects, although not everybody gets them. Most of the side effects observed with Raloxifene Tarbis have been mild.

The very commonside effects (may affect more than 1 in 10 people) are:

• Hot flashes (vasodilation)
• Flu-like syndrome

The commonside effects (may affect up to 1 in 10 people) are:

• Leg cramps
• Swelling of hands, feet, and legs (peripheral edema)
• Gallstones

The uncommonside effects (may affect up to 1 in 100 people) are:

• 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)

The rareside effects (may affect up to 1 in 1,000 people) are:

• Swelling of hands, feet, and legs (peripheral edema)
• Blood clots, usually in the legs, causing pain, swelling, or redness (venous thromboembolic disease)

The very rareside effects (may affect up to 1 in 10,000 people) are:

• Rash
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and indigestion
• Increased blood pressure
• Decreased platelet count in the blood
• Blood clots in an artery (e.g., stroke)
• Headache, including migraine
• Mild breast symptoms, such as pain, increased size, or sensitivity

In rare cases, liver enzyme levels may increase during treatment with Raloxifene Tarbis.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Raloxifene Tarbis

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

Do not use this medicine after the expiration date stated on the blister and carton after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.

• The other ingredients (excipients) are:

• Core of the tablet

Potato starch carboxymethyl starch (Type A)

Citric acid monohydrate

Microcrystalline cellulose

Dicalcium phosphate

Poloxamer 40

Magnesium stearate

Purified water

• Coating of the tablet:

Opadry OY-LS-28908 (II White) which contains (hypromellose, lactose, polyethylene glycol, and titanium dioxide, and macrogol)

Appearance of the product and contents of the pack

Raloxifene Tarbis film-coated tablets are white and elliptical in shape.

Raloxifene Tarbis is available in blister packs of 14, 28, or 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki

Greece

or

Toll Manufacturing Services, S.L.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Spain

or

Pharmathen International, S.A.

Industrial Park Sapes,

Rodopi Prefecture, Block No 5,

Rodopi 69300,

Greece

This leaflet was approved in: January 2013

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