CONBRIZA 20 mg. 28 tablets
CONBRIZA contains the active substance bazedoxifene and is a drug that belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). It is used to treat osteoporosis in women after they have reached menopause, when an increased risk of fractures. It works by slowing or stopping the thinning of bone in these women.
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 in 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 or still can become pregnant. This medicine may harm your unborn child if taken during pregnancy;
if you have any unexplained vaginal bleeding. It should be examined by your doctor;
if you have active uterine cancer.
Warnings and Precautions
Talk to your doctor or pharmacist before taking CONBRIZA.
as it can increase the risk of blood clots in the blood. Very rarely they can cause serious medical problems, disability or death. Talk to your doctor to find out if you have an increased risk of developing such clots;
if you are immobile (unable to move) for some time, for example if you are confined to a wheelchair, stay seated for long periods of time or should rest while recovering from surgery or illness. If you have a long journey, you can walk or to move your legs and feet at regular intervals. This is because standing in the same position for a long time may prevent good blood circulation and may increase your risk of blood clots in the blood. If you need to remain immobile for an extended period of time or have scheduled surgery, it is important to talk to your doctor about ways you can reduce the risk of clots in the blood;
if you are premenopausal. CONBRIZA has only been studied in women who are in menopause, and therefore is not recommended;
if you have or have had increased levels of triglycerides (a type of fat found in your blood) in the past;
if you have liver problems or severe kidney problems;
if you have any vaginal bleeding while you take CONBRIZA, you should talk to your doctor;
if you suffer from breast cancer, as experience with the use of this medicine in women with this disease is insufficient.
The above are some reasons why this product may not be suitable for you. If any of these apply to you, talk to your doctor before taking this medicine.
Other medicines and CONBRIZA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Pregnancy and lactation
CONBRIZA is for use in postmenopausal women. It should not be taken by women who are pregnant or may still born. Do not take CONBRIZA, if breast-feeding because it is not known whether it is excreted in human milk.
Driving and using machines
If you feel drowsy after taking CONBRIZA, you should avoid driving and operating machinery.
You may notice problems with your vision, such as blurred vision while taking this medicine. 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, contact him before taking this medicine.
3. How to take CONBRIZA
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist. You should continue taking this medicine unless your doctor tells you. To treat osteoporosis, CONBRIZA should be taken daily.
The recommended dose is one tablet daily by mouth. Taking more than one tablet a day reinforce the effect and may cause additional risks.
You can take the tablet at any time of day with or without food.
CONBRIZA should be taken with enough calcium and vitamin D. Consult your doctor to check whether the intake of calcium and vitamin D in your food is sufficient and whether you need a supplement of calcium and vitamin D. If you are taking a supplement of calcium and / or vitamin D, it can be administered concurrently with this drug.
If you take more dose of CONBRIZA
Tell your doctor or pharmacist.
If you forget to take CONBRIZA
If you miss a dose, take it as soon as you remember. If, however, almost the time is ripe to take your next dose of CONBRIZA, skip the dose you missed and take only your next dose. Do not take a double dose to make up for a forgotten tablet.
If you stop taking CONBRIZA
If you decide to stop taking this medicine before you finish the prescribed course of treatment, you should first talk to your doctor.
If you have any further questions on the use or stopping 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 immediately go to the doctor
Uncommon: If you have signs of a blood clot, such as painful swelling or redness in the legs, sudden chest pain or difficulty breathing;
Rare: Unilateral visual impairment, including blurring or loss of vision;
If any of the problems listed in the "Do not take CONBRIZA".
Other side effects
Some patients experienced the following side effects while taking CONBRIZA:
Very common (may affect more than 1 in 10 people):
Muscle cramps (including leg cramps);
Common (may affect up to 1 in 10 people):
Allergic reaction (including hypersensitivity and urticaria);
Increases in blood triglycerides (fat found in your blood);
Increase in liver enzymes;
Swelling of the hands, feet and legs (peripheral edema);
Uncommon (may affect up to 1 in 100 people):
Blood clot in the leg;
Blood clot in the lungs.
Rare (may affect up to 1 in 1000 people):
Blood clot in the eye (retinal vein).
If you get any side effects, tell your doctor or pharmacist. This includes any not listed in this leaflet.
5. How to store CONBRIZA
Keep out of the reach and sight 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 that month.
Do not store above 25 ° C.
6. Contents of the pack and further information
The active substance is bazedoxifene. Each tablet contains bazedoxifene acetate, which is equivalent to 20 mg bazedoxifene.
The other ingredients are lactose monohydrate (see. Point 2 "CONBRIZA contains lactose"), microcrystalline cellulose, pregelatinized starch (maize), sodium starch glycolate, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, ascorbic acid, hypromellose, titanium dioxide (E171) and macrogol 400.
CONBRIZA looks like and contents of the pack
CONBRIZA is available as a white to off-white capsule-shaped capsule with the inscription "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.