OPTRUMA 60 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Optruma 60 mg film-coated tablets

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. See section 4.

Contents of the pack

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

1. What is Optruma and what is it used for

Optruma contains the active substance raloxifene hydrochloride.

Optruma is used for the treatment and prevention of osteoporosis in postmenopausal women. Optruma reduces the risk of vertebral fractures in postmenopausal women with osteoporosis. It has not been shown to reduce the risk of hip fractures.

How Optruma works

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

Osteoporosis is a disease that makes your bones waste away and become fragile; this disease is especially common in women after menopause. Osteoporosis, although it may not cause 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 Optruma

Do not take Optruma:

• If you are or have been treated for blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes (retinal vein thrombosis).
• If you are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine (listed in section 6).
• If you may still be able to become pregnant, as Optruma may harm the fetus.
• If you have liver disease (such as cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).
• If you have severe kidney problems.
• If you have unexplained vaginal bleeding. If this happens, contact your doctor for a check-up.
• If you have active uterine cancer, as there is not enough experience with the use of Optruma in women with this disease.

Warnings and precautions

Consult your doctor or pharmacist before taking Optruma.

• If you are going to be immobilized for a period of time, such as being in a wheelchair, hospitalized, or bedridden recovering from surgery or an unexpected illness, as the risk of blood clots (deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis) may be increased.
• If you have had a stroke (such as a stroke) or if your doctor has told you that you are at high risk of having one.
• If you have liver disease.
• If you have breast cancer, as there is not enough experience with the use of Optruma in women with this disease.
• If you are taking estrogen replacement therapy by mouth.

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

Postmenopausal symptoms (such as hot flashes) do not improve with Optruma.

Optruma decreases total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides 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 Optruma.

Optruma contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other medicines and Optruma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

If you are taking digitalis medicines 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 medicine used to reduce fat content, as it may decrease the effectiveness of Optruma.

Pregnancy and breastfeeding

Only postmenopausal women should use Optruma. Women who may still become pregnant should not use it. Optruma may harm the fetus.

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

Driving and using machines

Optruma has no or negligible influence on the ability to drive and use machines.

3. How to take Optruma

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist again.

The 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.

The tablets are taken orally.

Swallow the tablet whole. If you wish, you can take it with a glass of water. Do not break or crush the tablet before taking it. A broken or crushed tablet may have an unpleasant taste and you may take an incorrect dose.

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

If you take more Optruma than you should

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

If you forget to take Optruma

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 Optruma

Consult your doctor beforehand.

It is important that you continue taking Optruma for as long as your doctor prescribes it. Optruma can only treat or prevent your osteoporosis if you continue taking the tablets.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects seen with Optruma have been mild.

The most common side effects (affecting more than 1 in 10 patients) are:

• Hot flashes (vasodilation)
• Flu-like symptoms
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort
• Increased blood pressure

Common side effects (affecting between 1 and 10 in 100 patients) are:

• Headache, including migraines
• Leg cramps
• Swelling of hands, feet, and legs (peripheral edema)
• Gallstones
• Rash
• Mild breast symptoms, such as pain, increased size, or tenderness

Uncommon side effects (affecting between 1 and 10 in 1,000 patients) 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)
• Blood clots in an artery (such as stroke, including increased risk of death from stroke)
• Decreased platelet count in the blood

In rare cases, liver enzyme levels in the blood may increase during treatment with Optruma.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Optruma

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package. Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Optruma

• 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: povidone, polysorbate 80, lactose, lactose monohydrate, crospovidone, magnesium stearate.

Tablet coating: titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax.

Ink: shellac, propylene glycol, and carmine (E 132).

Appearance of the product and pack size

Optruma film-coated tablets are white, oval, and engraved with the number 4165. They are available in blister packs or plastic bottles. The blister packs contain 14, 28, or 84 tablets. The plastic bottles contain 100 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Netherlands.

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.

You can obtain more information on this medicine by contacting the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu