OPTRUMA 60 mg film coated tablets

OPTRUMA belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.

OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women. OPTRUMA reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.

Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.

Do not take OPTRUMA:

• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of OPTRUMA.
• If there is still a possibility that you can get pregnant, OPTRUMA could harm your unborn child.
• If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
• If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
• If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• If you have active uterine cancer, as there is insufficient experience of OPTRUMA use in women with this disease.
• If you have severe kidney problems.

Take special care with OPTRUMA

The following are reasons why this product may not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine.

• If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness.
• If you are receiving oral oestrogen therapy
• If you are suffering from breast cancer, as there is insufficient experience of OPTRUMA use in women with this disease.
• If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you are at high risk of having one.

It is unlikely that OPTRUMA will cause vaginal bleeding. So any vaginal bleeding while you take OPTRUMA is unexpected. You should have this investigated by your doctor.

OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.

OPTRUMA lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking OPTRUMA.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.

Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.

Pregnancy and breast-feeding

OPTRUMA is for use only by postmenopausal women and must not be taken by women who could still have a baby. Optruma could harm your unborn child.
Do not take OPTRUMA if you are breast-feeding as it might be excreted in mother's milk.

Driving and using machines:
OPTRUMA has no known effects on driving or using machines.

Important information about some ingredients of OPTRUMA:
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product..

Always take this product exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose is one tablet a day. It does not matter what time of day you take your tablet but taking the tablet at the same time each day will help you remember to take it. You may take it with or without food.

The tablets are for oral use.

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

Your doctor will tell you how long you should continue to take OPTRUMA. The doctor may also advise you to take calcium and vitamin D supplements.

If you stop taking OPTRUMA:

You should talk to your doctor first.

If you have the impression that the effect of this product is too strong or too weak, talk to your doctor or pharmacist.

If you forget to takeOPTRUMA:
Take a tablet as soon as you remember and then continue as before.

If you take more tablets than your doctor prescribed:
Tell your doctor or pharmacist.

Like all medicines, OPTRUMA can cause side effects although not everybody gets them. The majority of side effects seen with OPTRUMA have been mild.

The most common side effects (affects more than 1 user in 10) are:

• Hot flushes (vasodilatation)
• Flu syndrome

Common side effects (affects 1 to 10 users in 100) are:

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

Uncommon side effects (affects 1 to 10 users in 1000) 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)
• Skin around the vein is red and painful (superficial vein thrombophlebitis)

Very rare side effects (affects less than 1 user in 10,000) are:

• Rash
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure
• Decrease in the number of the platelets in the blood
• Blood clot in an artery (for example stroke)
• Headache including migraine
• Mild breast symptoms such as pain, enlargement and tenderness

In rare cases, blood levels of liver enzymes may increase during treatment with OPTRUMA.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the pack.

Store in the original package. Do not freeze.
This medicinal product does not require any special storage conditions.

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 to protect the environment.

What OPTRUMA contains

• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
• The other ingredients of OPTRUMA tablets are: Tablet Core: Povidone, polysorbate 80, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate. Tablet coating: Titanium dioxide (E 171), polysorbate 80, hypromellose, macrogol 400, carnauba wax. Ink: Shellac, propylene glycol, indigo carmine (E 132).

What OPTRUMA looks like and contents of the pack

OPTRUMA are white, oval, film coated tablets which are marked with the number 4165. They are packed in blisters or in plastic bottles. The blister boxes contain 14, 28, or 84 tablets. The bottles contain 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.

Manufacturer

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

For any information about this medicinal product, please contact the representative of Eli Lilly in your country:

BelgiqueBelgiëBelgien Eli Lilly Benelux S.A.N.V. TélTel 32-02 548 84 84 LuxembourgLuxemburg Eli Lilly Benelux S.A.N.V. TélTel 32-02 548 84 84

.. - . 359 2 491 41 40 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100

eská republika Eli Lilly R, s.r.o. Tel 420 234 664 111 Malta Charles de Giorgio Ltd. Tel 356 25600 500

Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800

Deutschland Daiichi Sankyo Deutschland GmbH Tel. 49-0 89 78080 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00

Eesti Eli Lilly Holdings Limited. Eesti filiaal Tel 3726441100 Österreich Eli Lilly Ges. m.b.H. Tel 43-0 1 711 780

- .... 30 210 629 4600 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00

España Laboratorios Dr. Esteve, S.A. Tel 34-93 446 60 00 Portugal Laboratórios Vitória S.A. Tel 351- 21 4758300

France Pierre Fabre Médicament Tél 33-0 1 49 10 80 00 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Eli Lilly and Company Ireland Limited. Tel 353-0 1 661 4377 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250 Italia A Menarini Industrie Farmaceutiche Riunite s.r.l Tel 39-055 56801

Phadisco Ltd 357 22 715000 Sverige Eli Lilly Sweden AB Tel 46 0 8 7378800

Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315999

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600

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