CONBRIZA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

CONBRIZA 20 mg film-coated tablets

Bazedoxifene

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is CONBRIZA and what is it used for
2. What you need to know before taking CONBRIZA
3. How to take CONBRIZA
4. Possible side effects
5. Storage of CONBRIZA
6. Package contents and additional information

1. What is CONBRIZA and what is it used for

CONBRIZA contains the active ingredient bazedoxifene, and it 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 have an increased risk of fractures. It works by slowing down or stopping the thinning of bones in these women. This medication should not be used to treat osteoporosis in men.

2. What you need to know before taking CONBRIZA

Do not take CONBRIZA

• if you are allergic to bazedoxifene or any of the other components of this medication (listed in section 6).
• if you have had a blood clot (e.g., in the blood vessels of the legs, lungs, or eyes).
• if you are pregnant or may become pregnant. This medication may 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 can cause serious medical problems, disability, or death. Consult 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 being in a wheelchair, sitting for a long period, or in bed recovering from surgery 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 a long time in the same position can impede good blood circulation and increase the risk of blood clots. If you need to remain immobilized for a long period or have scheduled surgery, it is essential that you consult 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 menopause, and therefore, it is not recommended.
• if you have had a previous increase in triglyceride levels (a type of blood lipid).
• if you have significant 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 medication in women with this disease.

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

Using CONBRIZA with other medications

Tell your doctor or pharmacist if you are using or have recently used any other medications.

Pregnancy and breastfeeding

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

Driving and using machines

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

When taking this medication, 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 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.

3. How to take CONBRIZA

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

• The recommended dose is one tablet per day orally. 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 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 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 already close to the 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 stop taking CONBRIZA

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Serious side effects - Stop taking CONBRIZA and consult your doctor immediately

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

• If you experience 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 experience signs of a blood clot in the eye (retinal vein), such as visual disturbance or unilateral visual disturbance, 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 available data):

• If you experience other events that affect the eye and/or vision (seeing 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 flashes
• 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 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of CONBRIZA

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

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of CONBRIZA:

• The active ingredient 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 starch (corn), sodium starch glycolate, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171), and macrogol 400.

Appearance of CONBRIZA and package contents

CONBRIZA is presented in 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 authorization holder and manufacturer

Marketing authorization 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 medication from the local representative of the marketing authorization holder:

Spain

Pfizer, S.L.

Tel: +34 91 490 99 00

Date of the last revision of this package leaflet:

Other sources of information

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