CONBRIZA 20 mg film-coated tablets

CONBRIZA is a medicine that belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures. It works by slowing or stopping the thinning of bone in these women.

Do not take CONBRIZA

- if you are allergic (hypersensitive) to bazedoxifene or any of the other ingredients of CONBRIZA (see section 6).
- if you have or have had a blood clot (for example, in the blood vessels in your legs, lungs, or eyes).
- if you are pregnant or could still become pregnant. This medicine may cause harm to your unborn child if taken during pregnancy.
- if you have any unexplained vaginal bleeding. This must be investigated by your doctor. - if you have active uterine cancer.

Take special care with CONBRIZA

as it may increase your risk of getting blood clots. While very infrequent, these clots can cause serious medical problems, disability or death. Speak with your doctor to see if you are at increased risk for blood clots. if you are immobile unable to move for some time, such as being wheel-chair bound, sitting for a prolonged period of time or having to stay in bed while recovering from an operation or illness. If you are traveling on long trips, you should walk around or exercise your legs and feet at regular intervals. This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots. If you need to remain

immobile for an extended period of time or are scheduled to have surgery, it is important for you to talk to your doctor about ways you can reduce the risk of blood clots. if you are pre-menopausal. CONBRIZA has only been studied in women who have reached menopause, and therefore is not recommended. if you have had increased levels of triglycerides a type of fat found in your blood in the past. if you have liver or severe kidney problems. if you have any vaginal bleeding while you take CONBRIZA, you should speak with your doctor. if you are suffering from breast cancer, as there is insufficient experience with this medicine use in women with this disease.

The above are some 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.

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.

Pregnancy and breast-feeding

CONBRIZA is for use only by postmenopausal women. It must not be taken by women who are pregnant or who could still have a baby. Do not take CONBRIZA if you are breast-feeding, because it is not known whether it is excreted in mother's milk.

Driving and using machines

If you feel drowsy after taking CONBRIZA, you should avoid driving or operating machines.

Important information about some of the ingredients of CONBRIZA

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take CONBRIZA exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. You should continue taking this medicine as long as your doctor tells you to. In order for CONBRIZA to treat osteoporosis, it must be taken daily.

The usual dose is one tablet by mouth daily. Taking more than one tablet daily is not more effective and may carry additional risks.

- You can take the tablet at any time of the day, with or without food.

CONBRIZA should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation. If you take supplemental calcium andor vitamin D, it may be taken at the same time as this medicine.

If you take more CONBRIZA than you should

Tell your doctor or pharmacist.

If you forget to takeCONBRIZA

If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take your next dose of CONBRIZA, skip the dose you missed and only take your next scheduled dose. Do not take a double dose to make up for a forgotten tablet.

If you have any further questions on the use or stopping the use of this product, ask your doctor or pharmacist.

Like all medicines, CONBRIZA can cause side effects, although not everybody gets them.

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)
not known (frequency cannot be estimated from the available data)

Very common side effects:

- Muscle spasms (includes leg cramps)

- Hot flushes

Common side effects:

- Allergic reaction (including hypersensitivity and urticaria)

- Dry mouth

- Increase in blood triglycerides (fat found in your blood)

- Increase in liver enzymes

- Swelling of the hands, feet and legs (peripheral oedema)

- Drowsiness

Uncommon side effects:

- Blood clot in the leg

- Blood clot in the lungs

Rare side effects:

- Blood clot in the eye (retinal vein)

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 CONBRIZA after the expiry date, which is stated on the carton and blister after EXP. The expiry date refers to the last date of that month.

Do not store above 25-C.

What CONBRIZA contains

The active substance is bazedoxifene. Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene. The other ingredients are lactose monohydrate, microcrystalline cellulose, pre-gelatinised starch maize, sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide E171 and macrogol 400.

What CONBRIZA looks like and contents of the pack

CONBRIZA is supplied as a white to off-white, capsule-shaped, film-coated tablet marked with ?WY20?. They are packed in PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom.

Manufacturer: Wyeth Medica Ireland, Little Connell Newbridge, County Kildare, Ireland.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

K Wyeth Hellas Cyprus Branch AEBE T 357 22 817690 BelgiëBelgiqueBelgien LuxembourgLuxemburg Pfizer S.A.N.V. TélTel 32 02 554 62 11

eská Republika Pfizer s.r.o. Tel 420-283-004-111 Magyarország Pfizer Kft Tel 36 1 488 3700

Danmark Pfizer ApS Tlf 45 44 201 100 Malta Vivian Corporation Ltd. Tel 35621 344610

Deutschland Pfizer Pharma GmbH Tel 49 030 550055-51000 Nederland Wyeth Pharmaceuticals B.V. Tel31 23 567 2567

Österreich Pfizer Corporation Austria Ges.m.b.H. Tel 43 01 521 15-0 EestiLatvijaLietuva Slovenija Wyeth-Lederle Pharma GmbH TeTelTãlr 43 1 89 1140

Pfizer Hellas A.E. . 30 210 6785 800 Polska Pfizer Polska Sp. z o.o. Tel48 22 335 61 00

España Pfizer, S.A. Télf 34914909900 Norge Pfizer AS Tlf 47 67 526 100

France Pfizer Tél 33 01 58 07 34 40 Portugal Laboratórios Pfizer, Lda. Tel 351 21 423 55 00

Ireland Wyeth Pharmaceuticals Tel 353 1 449 3500 Slovenská Republika Pfizer Luxembourg SARL, organizaná zloka Tel 421 2 3355 5500

Ísland Icepharma hf Simi 354 540 8000 SuomiFinland Pfizer Oy PuhTel 358 09 430 040

Italia Pfizer Italia S.r.l. Tel 39 06 33 18 21 România Pfizer Romania S.R.L Tel 40 0 21 207 28 00 Sverige Pfizer AB Tel46 08 550 520 00 United Kingdom Wyeth Pharmaceuticals Tel 44 845 367 0098

This leaflet was last approved in {MM/YYYY}.