OPTRUMA 60 mg Coated Tablet

Зміст інструкції

1. Optruma 60 mg film-coated tablets
   1. What Optruma is and what it is used for
   2. What you need to know before taking Optruma
   3. How to take Optruma
   4. Possible side effects
   5. How to store Optruma
   6. Package Contents and Other Information

Optruma 60 mg film-coated tablets

raloxifene hydrochloride

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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.

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 women after menopause. Optruma reduces
the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of
femoral fractures has not been demonstrated.
How Optruma works
Optruma belongs to a group of non-hormonal medicines called Selective Estrogen Receptor
Modulators (SERM). When a woman reaches menopause, the level of the female sex hormone,
estrogen, decreases. Optruma reproduces some of the beneficial effects of estrogen after
menopause.
Osteoporosis is a disease that causes bones to become thin and fragile - this disease is
particularly common in women after menopause. Although in the early stages the disease may
not be accompanied by symptoms, osteoporosis predisposes to fractures, especially of the
spine, hips and wrists and can cause back pain, loss of height and a curved back.

2. What you need to know before taking Optruma

Do not take Optruma:

• If you are being treated or have been treated for the formation of 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 may become pregnant, Optruma could cause harm to the unborn child.
• If you have a liver disease (examples of liver disease are cirrhosis, moderate hepatic insufficiency or cholestatic jaundice).
• If you have severe kidney problems.
• If you have unexplained vaginal bleeding. In this case, consult your doctor for investigations.
• If you have an active malignant tumor of the uterus, because there is insufficient 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 immobilised for a certain period of time, for example if you are confined to a wheelchair, if you need to be hospitalised or stay in bed during post-operative recovery or an unexpected illness, as these conditions may increase the risk of thrombosis (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
• If you have had a stroke, or if your doctor has told you that you are at high risk of having one.
• If you have liver diseases.
• If you have a malignant breast tumor, because there is insufficient experience with the use of Optruma in women with this disease.
• If you are receiving oral estrogen therapy.

It is unlikely that Optruma will cause vaginal bleeding. Therefore, vaginal bleeding is not expected to occur when you take Optruma. Consult your doctor for investigations.
Optruma does not relieve post-menopausal symptoms, such as hot flashes.
Optruma lowers total cholesterol and LDL cholesterol (the "bad" cholesterol). Generally, it does not change
triglyceride or HDL cholesterol (the "good" cholesterol) levels. However, if you have taken estrogens in the
past and have had high increases in triglyceride levels, consult your doctor before taking
Optruma.

Optruma contains lactose
If your doctor has told you that you have lactose intolerance, a type of sugar, 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 available without a prescription.
If you are taking digitalis medicines for the heart or anticoagulants such as warfarin to improve
blood fluidity, your doctor may need to adjust the dosage of these medicines.
Tell your doctor if you are taking cholestyramine, which is mainly used as a medicine
that reduces fat in the blood, as Optruma may not work optimally.

Pregnancy and breastfeeding
Optruma is used exclusively in women after menopause and should not be taken by women
who may still be able to have children. Optruma could cause harm to the unborn child.
Do not take Optruma if you are breastfeeding as the medicine may pass into breast milk.

Driving and using machines
Optruma has no effects, or negligible effects, on driving vehicles or using machines.

3. How to take Optruma

Take this medicine following the instructions of your doctor exactly. If you have any doubts, you should
consult your doctor or pharmacist.
The dose is one tablet a day. It does not matter at what time of day you take the
tablet, but taking the tablet at the same time each day will help you remember to take it.
You can take it independently of meals.
The tablets are for oral use.
Swallow the tablet whole. If you prefer, you can swallow it with a glass of water. Do not cut or
crush the tablet before taking it. A cut or crushed tablet may have a bad
taste and there is a possibility that you may take an incorrect dose.
Your doctor will tell you how long you will need to continue taking Optruma. Your doctor may also
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 one tablet as soon as you remember and then continue as usual. Do not take a
double dose to make up for a forgotten tablet.

If you stop taking Optruma
Consult your doctor first.
It is important that you take Optruma for the entire time prescribed by your doctor, Optruma can treat or
prevent osteoporosis only if you continue to take the tablets.
If you have any further questions about 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 of the side effects observed with Optruma have been mild.
Very common side effects (which may affect more than 1 in 10 treated patients) are:

• Hot flushes (vasodilation)
• Flu-like syndrome
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and digestive disorders
• Increased blood pressure

Common side effects (which may affect up to 1 in 10 treated patients) are:

• Headache, including migraine
• Leg cramps
• Swelling of the hands, feet and legs (peripheral edema)
• Gallstones
• Skin rash
• Mild breast symptoms such as pain, enlargement and tension

Uncommon side effects (which may affect up to 1 in 1,000 treated patients) are:

• Increased risk of blood clot formation in the veins of the legs (deep vein thrombosis)
• Increased risk of blood clot formation in the lungs (pulmonary embolism)
• Increased risk of blood clot formation in the eyes (retinal vein thrombosis)
• Red and painful skin around the vein (superficial venous thrombophlebitis)
• Formation of a blood clot in an artery (for example stroke, including increased risk of dying from stroke)
• Decreased number of platelets in the blood

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed in Annex V. By reporting side effects you can help
to provide more information on the safety of this medicine.

5. How to store Optruma

Keep this medicine out of sight and reach of children.
Do not use Optruma after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Store in the original packaging. Do not freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Optruma Contains

• The active ingredient is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg of raloxifene.
• The excipients are:

Tablet core: Povidone, polysorbate 80, lactose, lactose monohydrate, crospovidone,
magnesium stearate.
Tablet coating: Titanium dioxide (E 171), polysorbate 80, methylhydroxypropylcellulose,
macrogol 400, carnauba wax.
Printing inks: Shellac, propylene glycol, indigo carmine (E 132).

Description of Optruma’s Appearance and Package Contents
Optruma are film-coated tablets, white, oval-shaped, with the number 4165 imprinted on them.
They are packaged in blisters or plastic bottles. The blister packs 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, Netherlands.

Manufacturer
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas (Madrid), Spain.
For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Eli Lilly Benelux S.A./N.V.
Tel: + 32-(0)2 548 84 84

Lietuva
Eli Lilly Lietuva
Tel. +370 (5) 2649600

България
TP "Eli Lilly Nederland" B.V. - България
tel. + 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 Nederland B.V.
Tel: +372 6 817 280

Norge
Eli Lilly Norge A.S.
Tlf: + 47 22 88 18 00

Ελλάδα
PHARMASERV-LILLY A.E.B.E.
Tel: +30 210 629 4600

Österreich
Eli Lilly Ges.m.b.H.
Tel: + 43-(0) 1 711 780

España
Lilly S.A.
Tel: +34-91-663 50 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/FinlandOy 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 (Suisse) S.A Pārstāvniecība Latvijā
Tel: +371 67364000

United Kingdom (Northern Ireland)
Eli Lilly and Company (Ireland) Limited
Tel: + 353-(0) 1 661 4377
Detailed information on this medicine is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu