CONBRIZA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CONBRIZA 20 mg film-coated tablets

Bazedoxifene

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.

Contents of the pack:

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

1. What is CONBRIZA and what is it used for

CONBRIZA contains the active substance bazedoxifene, and 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 the menopause, when they have an increased risk of fractures. It works by slowing down or stopping the thinning of the bones in these women. This medicine should not be used for the treatment of osteoporosis in men.

2. What you need to know before you take CONBRIZA

Do not take CONBRIZA

• if you are allergic to bazedoxifene or any of the other ingredients of this medicine (listed in section 6).
• if you have or have had a blood clot (for example, in the veins of the legs, lungs or eyes).
• if you are pregnant or may become pregnant. This medicine could harm your unborn child if you take it during pregnancy.
• if you have any unexplained vaginal bleeding. This should be investigated by your doctor.
• if you have active cancer of the uterus.

Warnings and precautions

Talk to your doctor or pharmacist before taking CONBRIZA

• as it may increase the risk of you developing blood clots. Although they are very rare, these clots could cause serious medical problems, disability or death. Talk to your doctor to see if you have an increased risk of developing blood clots.
• if you are immobilized (unable to move) for a period of time, such as having to be in a wheelchair, sitting for a long period of time or in bed recovering from an operation or illness. If you are taking long trips, you should walk or exercise your legs and feet at regular intervals. This is because being seated for long periods of time in the same position can prevent good blood circulation and may increase the risk of blood clots. If you have to remain immobilized for a long period of time or are scheduled for an operation, it is important that you talk to your doctor about how to reduce the risk of blood clots.
• if you are premenopausal. CONBRIZA has only been studied in women who have reached the menopause and is therefore not recommended.
• if you have previously had high levels of triglycerides (a type of blood lipid).
• if you have liver or kidney problems.
• if you experience any vaginal bleeding while taking CONBRIZA, you should talk to your doctor.
• if you have breast cancer, as there is not enough experience with the use of this medicine in women with this disease.

These are some of the reasons why this medicine may not be suitable for you. If you find yourself in any of these situations, talk to your doctor before taking this medicine.

Using CONBRIZA with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy and breast-feeding

CONBRIZA should only be used by postmenopausal women. Pregnant or potentially pregnant women should not take it. Do not take this medicine if you are breast-feeding, as it is not known if it is excreted in breast milk.

Driving and using machines

If you feel drowsy after taking this medicine, you should avoid driving or using machines.

When taking this medicine, you may notice problems with your vision such as blurred vision. If this happens, you should avoid driving or operating machinery until your doctor tells you it is safe to do so.

CONBRIZA contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, talk to them before taking this medicine.

3. How to take CONBRIZA

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. You should continue taking this medicine as long as your doctor tells you to. For the treatment of osteoporosis, this medicine should be taken daily.

• The recommended dose is one tablet per day by mouth. Taking more than one tablet per day is not more effective and may involve additional risks.
• You can take the tablet at any time of the day, with or without food.
• This medicine should be taken with an adequate amount of calcium and vitamin D. Talk to your doctor to see if your dietary intake of calcium and vitamin D is adequate and if you need calcium and vitamin D supplements. If you take calcium and/or vitamin D supplements, you can take them at the same time as this medicine.

If you take more CONBRIZA than you should

Talk to your doctor or pharmacist if you accidentally take more CONBRIZA than you should.

If you forget to take CONBRIZA

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

If you stop taking CONBRIZA

If you decide to stop taking this medicine before finishing the prescribed treatment, you should talk to your doctor first.

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.

Serious side effects - Stop taking CONBRIZA and see a doctor immediately

Uncommon(may affect up to 1 in 100 people):

• If you have signs of a blood clot in your legs or lungs, such as painful swelling and redness of the legs, sudden chest pain or difficulty breathing.
• If you have signs of a blood clot in the eye (retinal vein), such as visual disturbance or unilateral visual disturbance or blurred vision or loss of vision in one eye.
• If you experience any of the problems listed in the section “Do not take CONBRIZA”.

Frequency not known(cannot be estimated from the available data):

• If you have other events that affect the eye and/or vision (see flashes of light, narrowing of the visual field and swelling of the eye or eyelid)

Other side effects

Some patients have experienced the following side effects while taking CONBRIZA:

Very common (may affect more than 1 in 10 people):

• Muscle cramps (such as leg cramps)
• Hot flushes
• Swelling of hands, feet and legs (peripheral edema)

Common(may affect up to 1 in 10 people):

• Allergic reaction (including hypersensitivity and urticaria)
• Rash, itching
• Dry mouth
• Increased triglycerides in blood (a type of blood lipid)
• Increased liver enzymes
• Drowsiness

Frequency not known(cannot be estimated from the available data):

• Palpitations (perception of heartbeats)
• Dry eye, eye pain, decreased visual acuity, visual disturbance, blepharospasm (abnormal and involuntary blinking or spasms of the eyelids).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CONBRIZA

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of CONBRIZA:

• The active substance is bazedoxifene. Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg of bazedoxifene.

• The other ingredients are: lactose monohydrate (see section 2 “CONBRIZA contains lactose”), microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.

Appearance of CONBRIZA and pack contents

CONBRIZA is presented as film-coated tablets, capsule-shaped and white or almost white in color, marked with “WY20”. It is packaged in PVC/Aclar blisters and is 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 Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.

Manufacturer:

Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.