20 mg film-coated tablets
Bazedoxifene
1. What CONBRIZA is and what it is 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 to treat osteoporosis in women who have reached menopause and who therefore have an increased risk of fractures. The drug works by slowing down or stopping the thinning of bones in these women. This medicine should not be used to treat osteoporosis in men
2. What you need to know before using CONBRIZA
Do not use CONBRIZA
- if you are allergic (hypersensitive) 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 a blood vessel in your legs, lungs, or eyes).
- if you are pregnant or may become pregnant. This medicine can harm the fetus if taken during pregnancy.
- if you have unexplained vaginal bleeding. This must be examined by a doctor.
- if you have uterine cancer.
Warnings and cautions
Talk to your doctor or pharmacist before taking CONBRIZA
- as the medicine may increase the risk of you getting a blood clot. Blood clots occur very rarely but can cause serious health problems, disability, or death. Talk to your doctor to determine if you have an increased risk of blood clots.
- if you have difficulty moving for a long period of time, for example, if you are in a wheelchair, have to sit down most of the time or lie in bed while you recover from an operation or illness. If you are traveling long distances, get up and move or move your legs and feet regularly. If you sit still in the same position for a long time, the blood circulation can be affected and the risk of blood clots increases. If you have to stay still for a long time, for example, to have surgery soon, it is important that you talk to your doctor about how you can reduce the risk of blood clots.
- if you have not yet reached menopause. CONBRIZA has only been studied in women who have reached menopause, and can therefore not be recommended to others.
- if you have previously had elevated levels of triglycerides (a type of fat found in the blood).
- if you have liver problems or severe kidney problems.
- if you bleed from your vagina while taking CONBRIZA, talk to your doctor.
- if you have breast cancer because there is not enough experience with the use of this medicine among women with this disease.
Due to, among other things, the conditions described above, this medicine may not be suitable for you. If you have any of the problems described, talk to your doctor before taking the medicine.
Other medicines and CONBRIZA
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Pregnancy, breastfeeding, and fertility
CONBRIZA is intended for use only among men who have reached menopause. It must not be taken by women who are pregnant or who may still be pregnant. Do not take this medicine if you are breast-feeding, as it is unclear whether the medicine can pass into breast milk.
Driving and using machines
If you feel drowsy after taking this medicine, do not drive or use machines.
You may have some vision problems, such as blurred vision, such as blurred vision while taking this medicine. If this happens, do not drive or use machines until your doctor tells you it’s safe to do so.
CONBRIZA contains lactose and sodium
This medicine contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
3. How to use CONBRIZA
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure. You should continue to take this medicine for as long as your doctor tells you to. You must take this medicine every day for the treatment to work.
- The recommended dose is one tablet (orally) daily. More than one tablet a day does not give an increased effect and it can be associated with an increased risk.
- You can take the tablet at any time of the day with or without food.
- This medicine should be taken with enough calcium and vitamin D. Talk to your doctor to find out if your calcium and vitamin D intake is already sufficient or if you need calcium and/or vitamin D supplements. You can take the supplements at the same time as the medicine.
If you use more CONBRIZA than you should
Talk to your doctor or pharmacist if you have accidentally taken too much CONBRIZA.
If you forget to use CONBRIZA
If you forget to take a tablet at the usual time, take it as soon as you remember. If it is almost time for your next dose of this medicine, skip the dose you missed and take your next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using CONBRIZA
If you decide to stop taking this medicine before the end of the prescribed treatment period, talk to your doctor first.
If you have any further questions on the use of this product, or on stopping the use of this medicine, contact 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 are – Stop taking CONBRIZA and see a doctor immediately
Uncommon (may affect up to 1 in 100 people):
- If you get signs of blood clots in your legs or lungs, such as painful swelling or redness on your legs, sudden chest pain, or difficulty breathing.
- If you have signs of a blood clot in your eye ( retinal vein), such as unilateral vision disorder, impaired vision, blurred vision, or loss of vision in one eye.
- If you get any of the problems listed in the “Do not take CONBRIZA” section
No known frequency (occurs in an unknown number of users):
- If you experience other side effects that affect the eye and/or vision (see sparks or flashes of light, get narrowing fields of vision, and swelling of the eye or eyelids).
Other side effects ar
Some patients have experienced the following side effects while taking CONBRIZA:
Very common (may affect more than 1 user in 10):
- Muscle cramps (including leg cramps)
- Hot flashes
- Swelling of hands, feet, and legs (peripheral edema )
Common (may affect up to 1 in 10 people):
- Allergisk reaktion (inklusive överkänslighet och urtikaria)
- Utslag, klåda
- Muntorrhet
- Ökad mängd triglycerider i blodet (fett som finns i blodet)
- Förhöjt antal leverenzymer
- Sömnighet
Ingen känd frekvens (förekommer hos ett okänt antal användare):
- Hjärtklappning
- Torra ögon, ögonsmärta, minskad synskärpa, nedsatt syn, blefarospasm(onormala oavsiktliga blinkningar eller ögonlocksspasmer).
5. Hur CONBRIZA ska förvaras
Förvara detta läkemedel utom syn- och räckhåll för barn.
Används före utgångsdatum som anges på kartongen och blistret efter EXP.
The expiration date is the last day of the specified month.
Do not store above 25 ° C.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is bazedoxifene. One film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.
- The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinized starch (corn), sodium, sodium, colloidal anhydrous silica, ascorbic acid, hypromellose, titanium dioxide (E171), and macrogol 400 (see section 2 “CONBRIZA contains lactose and sodium”).
What the medicine looks like and the contents of the pack
CONBRIZA is delivered as white to off-white, capsule-shaped, film-coated tablets marked “WY20”. The tablet is approximately 1.5 cm long. They are packaged in PVC / Aclar blisters and are supplied in packs of 7, 28, 30, 84, and 90 tablets.
Not all pack sizes may be marketed.
Marketing Authorization 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.
Contact the representative of the marketing authorization holder to find out more about this medicine: Show larger
| Belgium / Belgique / Belgien Luxembourg / LuxemburgPfizer SA / NVTel: +32 (0) 2 554 62 11 | LatviaPfizer Luxembourg SARL subsidiary LatvijāTel .: + 371 670 35 775 |
| Bulgaria Pfizer of Luxembourg, Clone of BulgariaTel: +359 2 970 4333 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaTel. + 370 52 51 4000 |
| Czech RepublicPfizer sroTel: + 420-283-004-111 | HungaryPfizer Kft Tel: +36 1 488 3700 |
| DenmarkPfizer ApSTel: +45 44 201 100 | MaltaVivian Corporation Ltd.Tel: +35621 344610 |
| GermanyPfizer Pharma PFE GmbHTel: +49 (0) 800 8535555 | The NetherlandsPfizer BVTel: +31 (0) 10 406 43 01 |
| Eesti Pfizer Luxembourg SARL Eesti subsidiaryTel .: +372 666 7500 | NorwayPfizer ASTel: +47 67 526 100 |
| GreecePfizer Hellas AE Τηλ .: +30 210 6785 800 | AustriaPfizer Corporation Austria Ges.mbHTel: +43 (0) 1 521 15-0 |
| SpainPfizer, SLTel: +34 91 490 99 00 | PolandPfizer Polska Sp. z ooTel: +48 22 335 61 00 |
| FrancePfizer PFE France Tel: +33 (0) 1 58 07 34 40 | PortugalPfizer Biopharmaceuticals, Sociedade Unipessoal LdaTel: +351 21 423 5500 |
| CroatiaPfizer Croatia dooTel: + 385 1 3908 777 | RomaniaPfizer Romania SRLTel: +40 (0) 21 207 28 00 |
| IrelandPfizer Healthcare IrelandTel: 1800 633 363 (toll free)+44 (0) 1304 616161 | SloveniaPfizer Luxembourg SARLPfizer, underwriting and dryingpharmacevtske dejavnosti, LjubljanaTel .: + 386 (0) 1 52 11 400 |
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| ItalyPfizer Italia SrlTel: +39 06 33 18 21 | Finland / FinlandPfizer OyPuh / Tel: +358 (0) 9 430 040 |
| United KingdomPfizer Limited,Tel: +44 (0) 1304 616161 |