Optruma

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  • Heiti vöru:
  • Optruma
  • Lyf við lungum:
  • Mannfólk
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  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Optruma
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Sex hormones and modulators of the genital system,
  • Lækningarsvæði:
  • Osteoporosis, Postmenopausal
  • Ábendingar:
  • Optruma is indicated for the treatment and prevention of osteoporosis in post-menopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated. When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
  • Vörulýsing:
  • Revision: 22

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000185
  • Leyfisdagur:
  • 04-08-1998
  • EMEA númer:
  • EMEA/H/C/000185
  • Síðasta uppfærsla:
  • 30-03-2019

Opinber matsskýrsla

European Medicines Agency

7 Westferry Circus, Canary Wharf, London E14 4HB, UK

Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16

E-mail: mail@emea.europa.eu http://www.emea.europa.eu

European Medicines Agency, 2008. Reproduction is authorised provided the source is acknowledged.

EMEA/H/C/185

EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)

OPTRUMA

EPAR summary for the public

This document is a summary of the European Public Assessment Report (EPAR). It explains how

the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to

reach their recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the Package

Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more

information on the basis of the CHMP recommendations, read the Scientific Discussion (also part

of the EPAR).

What is Optruma?

Optruma is a medicine containing the active substance raloxifene hydrochloride. It is available as

white, oval tablets (60 mg).

What is Optruma used for?

Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile)

in women who have been through the menopause. Optruma has been shown to significantly reduce

vertebral fractures (breaks in the spine), but not hip fractures.

The medicine can only be obtained with a prescription.

How is Optruma used?

The recommended dose for adults and the elderly is one tablet taken once a day, with or without food.

Patients may also receive calcium and vitamin D supplements if they do not get enough from their

diet. Optruma is intended for long-term use.

How does Optruma work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken

down. Gradually, the bones become thin and fragile, and more likely to break (fracture). Osteoporosis

is more common in women after the menopause, when the levels of the female hormone oestrogen

fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.

The active substance in Optruma, raloxifene, is a selective oestrogen receptor modulator (SERM).

Raloxifene acts as an ‘agonist’ of the oestrogen receptor (a substance that stimulates the receptor for

oestrogen) in some tissues in the body. Raloxifene has the same effect as oestrogen in the bone, but it

does not have an effect in the breast or the womb.

How has Optruma been studied?

Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies.

Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or

placebo (a dummy treatment) for two years. The studies measured the density of the bones.

The fourth study compared the effects of Optruma with those of placebo in the treatment of

osteoporosis in 7,705 women over four years. The main measure of effectiveness was how many

women had vertebral (spine) fractures during the study.

What benefit has Optruma shown during the studies?

Optruma was more effective than placebo in preventing and treating osteoporosis.

In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip

or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%.

When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of

vertebral fractures. Over four years, in comparison with placebo, Optruma decreased the number of

new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had

osteoporosis and an existing fracture. There was no effect of Optruma on hip fractures.

What is the risk associated with Optruma?

The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot

flushes) and flu-like symptoms. For the full list of side effects reported with Optruma, see the Package

Leaflet.

Optruma should not be used in women who:

could become pregnant;

have or have had any blood clot disorders, including deep vein thrombosis and pulmonary

embolism (a blood clot in the lungs);

have liver disease, severe kidney disease, unexplained bleeding from the womb or endometrial

cancer (cancer of the lining of the womb).

Optruma should not be used in people who may be hypersensitive (allergic) to raloxifene or any of the

other ingredients.

Why has Optruma been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown

its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb.

The Committee decided that Optruma’s benefits are greater than its risks for the treatment and

prevention of osteoporosis in postmenopausal women. The Committee recommended that Optruma be

given marketing authorisation.

Other information about Optruma:

The European Commission granted a marketing authorisation valid throughout the European Union

for Optruma to Eli Lilly Nederland B.V. on 5 August 1998. The marketing authorisation was renewed

on 5 August 2003 and on 5 August 2008.

The full EPAR for Optruma is available here

This summary was last updated in 07-2008.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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.

What is in this leaflet

What Optruma is and what it is used for

What you need to know before you take Optruma

How to take Optruma

Possible side effects

How to store Optruma

Contents of the pack and other information

1.

What Optruma is and what it is used for

Optruma contains the active substance raloxifene hydrochloride.

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.

How Optruma works

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.

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.

2.

What you need to know before you take Optruma

Do not take Optruma:

If you are being treated or have been treated for blood clots in the legs (deep vein thrombosis),

in the lungs (pulmonary embolism) or in the 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 there is still a possibility that you can get pregnant, Optruma could harm your unborn child.

If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment

or cholestatic jaundice).

If you have severe kidney problems.

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.

Warnings and precautions

Talk to your doctor or pharmacist before you take Optruma.

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 as these may increase your risk of blood clots (deep vein thrombosis, pulmonary

embolism or retinal vein thrombosis).

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.

If you have liver disease

If you are suffering from breast cancer, as there is insufficient experience of Optruma use in

women with this disease.

If you are receiving oral oestrogen therapy.

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.

Optruma contains lactose

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.

Other medicines and Optruma

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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,

because Optruma may not work as well.

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 or negligible effects on driving or using machines.

3.

How to take Optruma

Always take this medicine 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. Do not break or crush the

tablet before taking it. A broken or crushed tablet may taste bad and there is a possibility that you will

receive an incorrect dose.

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 take more Optruma than you should

Tell your doctor or pharmacist. If you take more Optruma than you should you could have leg cramps

and dizziness.

If you forget to take

Optruma

Take a tablet as soon as you remember and then continue as before. Do not take a double dose to

make up for a forgotten tablet dose.

If you stop taking Optruma

You should talk to your doctor first.

It is important that you continue taking Optruma for as long as your doctor prescribes the medicine,

Optruma can treat or prevent your osteoporosis only if you continue to take 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. 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

Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset

Increased blood pressure

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

Headache including migraine

Leg cramps

Swelling of hands, feet and legs (peripheral oedema)

Gallstones

Rash

Mild breast symptoms such as pain, enlargement and tenderness

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)

Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)

Decrease in the number of the platelets in the blood

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

Reporting of side effects

If you get 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.

How to store Optruma

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

Do not use after the expiry date which is stated on the pack after EXP. The expiry date refers to the

last day of the month.

Store in the original package. Do not freeze.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

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 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 B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė

Tel. +370 (5) 2649600

България

ТП "Ели Лили Недерланд" Б.В. - България

те

л. + 359 2 491 41 40

Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

Česká republika

ELI LILLY ČR, s.r.o.

Tel: + 420 234 664 111

Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Danmark

Eli Lilly Danmark A/S

Tlf: +45 45 26 60 00

Malta

Charles de Giorgio Ltd.

Tel: + 356 25600 500

Deutschland

Daiichi Sankyo Deutschland GmbH

Tel. +49-(0) 89 78080

Nederland

Eli Lilly Nederland B.V.

Tel: + 31-(0) 30 60 25 800

Eesti

Eli Lilly Holdings Limited Eesti filiaal

Tel: +372 6 817 280

Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.

Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges.m.b.H.

Tel: + 43-(0) 1 711 780

España

Laboratorios Dr. Esteve, S.A.

Tel: + 34-93 446 60 00

Polska

Eli Lilly Polska Sp. z o.o.

Tel: +48 22 440 33 00

France

Pierre Fabre Médicament

Tél: + 33-(0) 1 49 10 80 00

Portugal

Laboratórios Vitória S.A.

Tel: + 351- 21 4758300

Hrvatska

Eli Lilly Hrvatska d.o.o.

Tel: +385 1 2350 999

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 družba, d.o.o.

Tel: +386 (0)1 580 00 10

Ísland

Icepharma hf.

Sími + 354 540 8000

Slovenská republika

Eli Lilly Slovakia, s.r.o.

Tel: + 421 220 663 111

Italia

A. Menarini

Industrie Farmaceutiche Riunite s.r.l.

Tel: +39-055 56801

Suomi/Finland

Oy Eli Lilly Finland Ab

Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

Eli Lilly Sweden AB

Tel: + 46-(0) 8 7378800

Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā

Tel: +371 67364000

United Kingdom

Eli Lilly and Company Limited

Tel: + 44-(0) 1256 315000

This leaflet was last revised in month YYYY.

Detailed information on this medicine is available on the European Medicines Agency (EMA) web

site: http://www.ema.europa.eu