Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - optruma

Document Subject

Generated Narrative: MedicinalProductDefinition mp3fb39d4138ab0b1b436f7dc265a1c128

identifier: http://ema.europa.eu/identifier/EU/1/98/074/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Optruma 60 mg film coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3fb39d4138ab0b1b436f7dc265a1c128

identifier: http://ema.europa.eu/identifier/EU/1/98/074/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - optruma

Attesters

What is in this leaflet

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

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.

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.

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.

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.

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.

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, 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 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:

Belgi /Belgique/Belgien Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 Lietuva Eli Lilly Lietuva
Tel. +370 (5) 2649
" " . . -
. + 359 2 491 41 Luxembourg/Luxemburg Eli Lilly Benelux S.A./N.V. T l/Tel: + 32-(0)2 548 84 esk republika ELI LILLY R, s.r.o. Tel: + 420 234 664 Magyarorsz g Lilly Hung ria Kft. Tel: + 36 1 328 5Danmark Eli Lilly Danmark A/S Tlf: +45 45 26 60 Malta Charles de Giorgio Ltd. Tel: + 356 25600 Deutschland Lilly Deutschland GmbH
Tel. + 49-(0) 6172 273 2Nederland Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 Eesti Eli Lilly Nederland B.V. Tel: +372 6 817 Norge Eli Lilly Norge A.S. Tlf: + 47 22 88 18

• . . . .
  : +30 210 629 4 sterreich Eli Lilly Ges.m.b.H.
  Tel: + 43-(0) 1 711 Espa a Lilly S.A. Tel: +34-91-663 50 Polska Eli Lilly Polska Sp. z o.o. Tel: +48 22 440 33 France Pierre Fabre M dicament T l: + 33-(0) 1 49 10 80 Portugal Lilly Portugal Produtos Farmac uticos, Lda Tel: + 351 21412 66 Hrvatska Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 Rom nia Eli Lilly Rom nia S.R.L. Tel: + 40 21 4023Ireland Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4Slovenija Eli Lilly farmacevtska dru ba, d.o.o. Tel: +386 (0)1 580 00 sland Icepharma hf. S mi + 354 540 8Slovensk republika Eli Lilly Slovakia s.r.o. Tel: + 421 220 663 Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39-055 56Suomi/Finland Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45
  Phadisco Ltd
  : +357 22 715Sverige Eli Lilly Sweden AB Tel: + 46-(0) 8 7378Latvija Eli Lilly (Suisse) S.A P rst vniec ba Latvij
  Tel: +371 67364United Kingdom (Northern Ireland) Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4This 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