CONBRIZA 20 mg Tabletki Powlekane

Treść ulotki

1. CONBRIZA 20 mg film-coated tablets
   1. What CONBRIZA is and what it is used for
   2. What you need to know before you take CONBRIZA
   3. How to take CONBRIZA
   4. Possible side effects
   5. How to store CONBRIZA
   6. Package contents and other information

CONBRIZA 20 mg film-coated tablets

bazedoxifene

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What CONBRIZA is and what it is used for
• 2. What you need to know before you take 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 ingredient bazedoxifene, and is a medicinal product that belongs to
a group of non-hormonal medicines called Selective Estrogen Receptor Modulators
(SERM). It is used for the treatment of osteoporosis in women after they have reached
menopause, when they have an increased risk of fractures. This medicine works by slowing down or
stopping the thinning of the bones in these women. This medicine should not be used for
the treatment of osteoporosis in men.

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 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 might become pregnant. This medicine can cause harm to the unborn child if taken during pregnancy.
• If you have unexplained vaginal bleeding. This must be evaluated by your doctor.
• If you have an existing uterine cancer.

Warnings and precautions
Talk to your doctor or pharmacist before taking CONBRIZA

• because this may increase the risk of developing blood clots. Although very rare, these clots can cause serious medical problems, disability or death. Talk to your doctor to see if you have an increased risk of blood clots.
• if you are immobilised (unable to move) for a long time, such as in a wheelchair, or if you remain seated for a prolonged period of time or if you have to stay in bed

during recovery from surgery or illness. If you are travelling long distances,
you should walk or move your legs and feet at regular intervals. This is because remaining
in the same position for a long time can prevent proper circulation and can increase
the risk of blood clot formation. If you need to remain immobile for a long
period of time or are awaiting surgery, it is important that you talk to your doctor about
how you can reduce the risk of blood clot formation.

• if you are pre-menopausal. CONBRIZA has only been studied in women who have reached menopause and is therefore not recommended.
• if you have had high 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 experience vaginal bleeding while taking CONBRIZA, you should talk to your doctor.
• if you have breast cancer, as there is insufficient experience with the use of this medicine in women with this condition.

The above are some of the reasons why this product may not be suitable for
you. If you fall into any of these categories, 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 and breastfeeding
CONBRIZA must be used exclusively in postmenopausal women. It should not be
taken by pregnant women or those who may still have children. Do not take this medicine if
you are breastfeeding, as it is not known whether this is excreted in breast milk.

Driving and using machines
If you feel sleepy after taking this medicine, you should avoid driving or using
machines.
You may experience vision problems such as blurred vision while taking this medicine.
If this happens, you should avoid driving vehicles or using machinery until your doctor has
told you that it is safe to perform these activities.

CONBRIZA contains lactose and sodium
This medicine contains lactose (a type of sugar). If your doctor has told you that you have
an intolerance to some sugars, contact your doctor before taking the product.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take CONBRIZA

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. You must continue to take this medicine for as long as your doctor tells you. To treat osteoporosis with this medicine, it must be taken every day.

• The recommended dose is one tablet a day by mouth. Taking more than one tablet a day is not more effective and can lead to further risks.
• You can take the tablet at any time of the day, with or without food.
• This medicine must be taken with an adequate amount of calcium and vitamin D. Ask your doctor to check if your intake of calcium and vitamin D with your diet is adequate

and if you need a calcium and vitamin D supplement. If you are also taking calcium and/or vitamin D, these can be taken at the same time as this medicine.

If you take more CONBRIZA than you should
Contact 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 to take the next dose of this medicine, skip the missed dose and take only the next dose scheduled. Do not take a double dose to make up for a forgotten tablet.

If you stop taking CONBRIZA
If you decide to stop treatment with this medicine before completing the treatment cycle, talk to your doctor first.
If you have any questions about the use or discontinuation of this product, 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 consult a doctor immediately
Uncommon(may affect up to 1 in 100 people)

• if you experience signs of blood clots in the legs or lungs, such as pain, swelling or redness in the legs, sudden chest pain, or difficulty breathing;
• if you experience signs of blood clots in the eye (retinal veins), such as visual disturbances or decreased vision in one eye 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

Not known(frequency cannot be estimated from the available data):

• If you experience other events affecting the eye and/or vision (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 spasms (including leg cramps)
• Hot flushes
• Swelling of the hands, feet and legs (peripheral edema)

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

• Allergic reactions (including hypersensitivity and urticaria)
• Rash, itching
• Dry mouth
• Increased triglycerides in the blood (fats found in the blood)
• Increased liver enzymes
• Drowsiness

Not known(frequency cannot be estimated from the available data):

• Palpitations (feeling your heartbeat)
• Dry eyes, eye pain, reduced visual acuity, decreased vision, blepharospasm (abnormal and involuntary blinking, or eyelid spasm).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CONBRIZA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and blister after the
writing EXP. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CONBRIZA contains

• The active ingredient is bazedoxifene. Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg of bazedoxifene.
• The other ingredients are lactose monohydrate, 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 (see section 2 “CONBRIZA contains lactose and sodium”).

Description of the appearance of CONBRIZA and package contents
CONBRIZA is available as film-coated tablets, ranging in color from white to off-white, with a
capsule shape, with “WY20” inscribed. The tablet is approximately 1.5 cm long. They are packaged in
PVC/Aclar blisters and are available in packs of 7, 28, 30, 84 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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.
For further information on this medicine, contact the local representative of the marketing
authorisation holder.

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel:+32 (0)2 554 62 11

Latvijā
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

България
Пфайзер Люксембург САРЛ,
Клон България
Teл.: +359 2 970 4333

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: + 370 52 51 4000

Česká republika
Pfizer, spol. s r.o.
Tel: +420-283-004-111

Magyarország
Pfizer Kft
Tel.: +36 1 488 3700

Danmark
Pfizer ApS
Tlf:+45 44 20 11 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Nederland
Pfizer BV
Tel: +31 (0)10 406 43 01

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Norge
Pfizer AS
Tlf: +47 67 526 100

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Polska
Pfizer Polka Sp. z o.o.
Tel.: +48 22 335 61 00

France
Pfizer
Tél: +33 (0)1 58 07 34 40

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Ireland
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL,
organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
S í mi: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0) 9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Kύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 81769

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu