Conbriza 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

CONBRIZA 20 mg film-coated tablets

bazedoxifene

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents

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

1. What CONBRIZA is and what it is used for

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

2. What you need to know before taking CONBRIZA

Do not take CONBRIZA

• if you are allergic to bazedoxifene or to any of the other components of this medicine (listed in section 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 could become pregnant. This medicine could harm the fetus if taken during pregnancy.
• if you have any unexplained vaginal bleeding. This must be investigated by your doctor.
• if you have active uterine cancer.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take CONBRIZA

• because it may increase your risk of developing blood clots. Although very rare, these clots could lead to serious medical problems, disability, or death. Consult your doctor to determine whether your risk of developing blood clots is increased.
• if you are immobilized (unable to move) for some time, for example, if you need to use a wheelchair, sit for prolonged periods, or remain in bed recovering from surgery or illness. If you are making long journeys, you should walk around or exercise your legs and feet regularly. Remaining seated in the same position for long periods may impair blood circulation and increase the risk of blood clots. If you are going to be immobilized for a prolonged period or have scheduled surgery, it is important to consult your doctor about ways to reduce the risk of blood clots.
• if you are premenopausal. CONBRIZA has only been studied in women who have already reached menopause and is therefore not recommended.
• if you have previously had increased levels of triglycerides (a type of blood lipid).
• if you have significant liver or kidney problems.
• if you experience any vaginal bleeding while taking CONBRIZA, you must speak with your doctor.
• if you have breast cancer, as there is insufficient experience regarding the use of this medicine in women with this condition.

These are some reasons why this medicine may not be suitable for you. If any of these situations apply to you, consult your doctor before taking this medicine.

Other medicines and CONBRIZA

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

CONBRIZA is intended for use only in postmenopausal women. Pregnant women or women who could still have children must not take it. Do not take this medicine 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 medicine, you should avoid driving or operating machinery.

While taking this medicine, you may experience vision problems such as blurred vision. If this occurs, you should avoid driving or operating machinery until your doctor advises that it is safe to do so.

CONBRIZA contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take CONBRIZA

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. You should continue taking this medicine for as long as your doctor recommends. For the treatment of osteoporosis, this medicine must 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 carry additional risks.
• You may take the tablet at any time of day, with or without food.
• This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to determine whether your dietary intake of calcium and vitamin D is sufficient and whether you need calcium and vitamin D supplements. If you are taking calcium and/or vitamin D supplements, you may take them at the same time as this medicine.

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 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 completing the prescribed course, you must first consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects – Stop taking CONBRIZA and contact your doctor immediately

Uncommon (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 changes in vision, unilateral visual disturbances, 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 affecting the eye and/or vision (such as seeing flashes or sparks of light, narrowing of the visual field, or swelling of the eye or eyelid).

Other adverse effects

Some patients have experienced the following adverse 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 oedema)

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of CONBRIZA

• The active substance is bazedoxifene. Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg of bazedoxifene.
• The other components are monohydrate lactose, microcrystalline cellulose, pregelatinized starch (corn), sodium starch glycolate, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171), and macrogol 400 (see section 2 “CONBRIZA contains lactose and sodium”).

Appearance of CONBRIZA and pack contents

CONBRIZA is presented as film-coated, capsule-shaped white or almost white tablets marked with “WY20”. The tablet is approximately 1.5 cm in length. It is packaged in PVC/Aclar blisters and available in pack sizes of 7, 28, 30, 84 or 90 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

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

Manufacturer

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: .

Other sources of information

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