Raloxifene Teva 60 mg film-coated tablets

Raloxifene Teva 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. Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.

Raloxifene Teva is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Teva 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 Raloxifene Teva

• If you are allergic (hypersensitive) to raloxifene or any of the ingredients of Raloxifene Teva.
• If there is still a possibility that you can get pregnant, Raloxifene Teva 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 Raloxifene Teva use in women with this disease.
• If you have severe kidney problems.

Take special care with Raloxifene Teva

The following are reasons why this medicine may not be suitable for you. If any of them apply to you, talk to your doctor before you take this 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 Raloxifene Teva 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.
• If you have liver problems, as there is insufficient experience in people with liver problems. If you do have liver problems and your doctor still recommends treatment, then you may need some blood tests during treatment.

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

Raloxifene Teva does not treat postmenopausal symptoms, such as hot flushes.

Raloxifene Teva 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 Raloxifene Teva.

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

Raloxifene Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby. Raloxifene Teva could harm your unborn child.

Do not take Raloxifene Teva if you are breast-feeding as it might be excreted in mother's milk.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines
Raloxifene Teva has no known effects on driving or using machines.

Always take Raloxifene Teva 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 at what time of the 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 Raloxifene Teva. The doctor may also advise you to take calcium and vitamin D supplements.

If you take more Raloxifene Teva than you should
Tell your doctor or pharmacist.

If you forget to take Raloxifene Teva
Take a tablet as soon as you remember and then continue as before.

If you stop taking Raloxifene Teva

You should talk to your doctor first.

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

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

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), very rare (affects less than 1 user in 10,000) and not known (frequency cannot be estimated from the available data).

Very common (affects more than 1 user in 10)

• Hot flushes (vasodilatation).
• Flu syndrome.

Common (affects 1 to 10 users in 100)

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

Uncommon (affects 1 to 10 users in 1,000)

• 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).

Rare (affects 1 to 10 users in 10,000)

• Swelling of hands, feet and legs (peripheral oedema).
• Blood clot, usually in a leg, which causes pain, swelling or redness (venous thromboembolic reaction).

Very rare (affects less than 1 user in 10,000)

• 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 Raloxifene Teva.

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 Raloxifene Teva after the expiry date which is stated on the outer carton or foil. The expiry date refers to the last day of that month.

This medicine 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 Raloxifene Teva contains

• The active substance is raloxifene hydrochloride. Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
• The other ingredients are: Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified. Tablet coating: polydextrose (E1200), titanium dioxide (E171), hypromellose (E464) and macrogol 4000.

What Raloxifene Teva looks like and contents of the pack

The film-coated tablets are white to off-white, oval shaped and debossed with the number ?60? on one side and ?N? on the other side.

Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Teva Pharma B.V.
Computerweg 10
3542 DR Utrecht
The Netherlands

Manufacturers:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
Debrecen H-4042
Hungary

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllö

Táncsics Mihály út 82

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG UK

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TelTél 32 3 820 73 73 LuxembourgLuxemburg Teva Pharma Belgium S.A. TélTel 32 3 820 73 73

Te 359 2 489 95 82 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00

eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Malta Teva .. el 30 210 72 79 099

Danmark Teva Denmark AS Tlf 45 44 98 55 11 Nederland Teva Nederland B.V. Tel 31 0 800 0228400

Deutschland Teva Generics GmbH Tel 49 351 834 0 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva Generics GmbH Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409

Teva .. 30 210 72 79 099 Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel. 48 22 345 93 00

España Teva Genéricos Española, S.L.U Tél 34 91 387 32 80 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910

France Teva Santé Tél 33 1 55 91 7800 România Teva Pharmaceuticals S.R.L Tel 4021 230 65 24

Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390

Ísland Teva UK Limited Sími 44 1323 501 111. Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911

Italia Teva Italia S.r.l. Tel 39 0289179805 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00

Teva .. 30 210 72 79 099 Sverige Teva Sweden AB Tel 46 42 12 11 00

Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 United Kingdom Teva UK Limited Tel 44 1323 501 111

Lietuva

UAB ?Sicor Biotech?
Tel: +370 5 266 02 03

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