Prospecto: information for the user

CONBRIZA 20 mg film-coated tablets

Bazedoxifeno

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What CONBRIZA is and for what it is used

2.What you need to know before starting to take CONBRIZA

3.How to take CONBRIZA

4.Possible adverse effects

5.Storage of CONBRIZA

6.Contents of the package and additional information

CONBRIZA contains the active ingredient bazedoxifene, and is a medication that belongs to a group of non-hormonal medications called Selective Estrogen Receptor Modulators (SERMs). It is used in the treatment of osteoporosis in women after they have reached menopause, when they present an increased risk of fractures. It acts by slowing down or stopping the thinning of bones in these women. This medication should not be used for the treatment of osteoporosis in men.

Do not take CONBRIZA

• if you are allergic to bazedoxifene or any of the other ingredients in this medication (listed in thesection 6).
• if you have or have had a blood clot (for example, in the blood vessels of the legs, lungs, or eyes).
• if you are pregnant or may become pregnant. This medication could harm the fetus if taken during pregnancy.
• if you have any unexplained vaginal bleeding. This should be investigated by your doctor.
• if you have active uterine cancer.

Warnings and precautions

Consult your doctor or pharmacist before starting to take CONBRIZA

• as it may increase the risk of developing blood clots. Although rare, these clots could cause serious medical problems, disability, or death. Consult with your doctor to see if you have an increased risk of developing blood clots.
• if you are immobile (incapable of moving) for some time, such as being confined to a wheelchair, sitting for a prolonged 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 sitting for long periods of time in the same position can impede good blood circulation and may increase the risk of blood clots. If you had to remain immobile for a prolonged period of time or had a scheduled operation, it is essential that you consult with your doctor about how to reduce the risk of blood clots.
• if you are in the premenopausal stage. CONBRIZA has only been studied in women who have already reached menopause and is therefore not recommended.
• if you have previously had an increase in triglyceride levels (a type of blood lipid).
• if you have liver problems or significant kidney problems.
• if you have any vaginal bleeding while taking CONBRIZA, you should speak with your doctor.
• if you have breast cancer, as there is not enough experience with the use of this medication in women with this condition.

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

Use of CONBRIZA with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication.

Pregnancy and breastfeeding

CONBRIZA should only be used by postmenopausal women. Pregnant women or those who may still become pregnant should not take it. Do not take this medication if you are breastfeeding your child, as it is unknown whether it is excreted in breast milk.

Driving and operating machinery

If you feel drowsy after taking this medication, you should avoid driving or operating machinery.

When taking this medication, you may experience 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 medication contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist. You should continue taking this medication as long as your doctor tells you to. For the treatment of osteoporosis, this medication should be taken daily.

• The recommended dose is one tablet per day taken orally. Taking more than one tablet per day is not more effective and may pose additional risks.
• You can take the tablet at any time of the day, with or without food.
• This medication should be taken with an adequate amount of calcium and vitamin D. Consult 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 medication.

If you take more CONBRIZA than you should

Consult with your doctor or pharmacist if you accidentally take more CONBRIZA than you should.

If you forgot to take CONBRIZA

If you forgot to take a tablet, take it as soon as you remember. However, if it is almost time for your next dose of this medication, 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 interrupt treatment with CONBRIZA

If you decide to stop taking this medication before completing the prescribed treatment, you should first consult with your doctor.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects - Stop taking CONBRIZA and seek medical attention immediately

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

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

Unknown frequency(cannot be estimated from available data):

• If you experience other eye and/or vision-related events (seeing sparks or 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 the blood (a type of blood lipid)
• Increased liver enzymes
• Drowsiness

Unknown frequency(cannot be estimated from available data):

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25?°C.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacist how to dispose ofthe packaging and the medications that you no longerneed.By doing so, you will help protect the environment.

Composition of CONBRIZA:

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

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

Appearance of CONBRIZA and contents of the packaging

CONBRIZA is presented in film-coated tablets, in capsule shape and white or off-white color, marked with “WY20”. It is packaged in PVC/Aclar blisters and is available in packaging with 7, 28, 30, 84, or 90 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer Europe MA EEIG, Boulevard de la Plaine 17,1050 Brussels, Belgium.

Responsible for manufacturing:

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

For more information about this medication, please contact the local representative of the holder of the marketing authorization:

Spain

Pfizer,S.L.

Phone:+34914909900

Date of the last review of this leaflet:

Other sources of information

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