Conbriza

Package leaflet: Information for the user

CONBRIZA 20 mg film-coated tablets

bazedoxifene
Please read all of this leaflet carefully before taking 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, because it may be harmful.
• If you experience any side effects, including 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 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 is a medicinal product belonging to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). It is used for the treatment of osteoporosis in postmenopausal women who are at increased risk of fractures. This medicine works by slowing down or stopping the thinning of the bones in these women. This medicine must not be used for the treatment of osteoporosis in men.

2. What you should know before taking CONBRIZA

Do not take CONBRIZA

• If you are allergic to bazedoxifene or to 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 could become pregnant. This medicine may harm the unborn baby if taken during pregnancy.
• If you have unexplained vaginal bleeding. This must be evaluated by your doctor.
• If you currently have uterine cancer.

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

• because this may increase your risk of developing blood clots. Although very rare, these clots can cause serious medical problems, disability, or death. Speak with your doctor to determine if you have an increased risk of blood clots.

• if you are immobilized (unable to move) for a prolonged period, for example if you are confined to a wheelchair, sitting for long periods, or confined to bed
  during recovery from surgery or illness. If you are traveling long distances,
  you should walk around or move your legs and feet regularly. Remaining
  in the same position for long periods may impair proper circulation and increase
  the risk of blood clots. If you need to remain immobile for a long time or are awaiting surgery, it is important to discuss with your doctor how you can reduce the risk of blood clot formation.

• if you are pre-menopausal. CONBRIZA has only been studied in postmenopausal women and is therefore not recommended.

• if you have previously had high levels of triglycerides (a type of fat in your blood).

• if you have liver problems or severe kidney problems.

• if you experience vaginal bleeding while taking CONBRIZA, you must speak with 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 any of these apply to you, talk to your doctor before taking this medicine.
Other medicines and CONBRIZA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
CONBRIZA should only be used in postmenopausal women. It must not be taken by pregnant women or women who could still have children. Do not take this medicine if you are breastfeeding, as it is not known whether it is excreted in human milk.
Driving and using machines
If you feel drowsy after taking this medicine, you should avoid driving or operating machinery.
You may experience vision problems such as blurred vision while taking this medicine.
If this occurs, you should avoid driving or using machinery until your doctor has advised you that it is safe to perform such activities.
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 your doctor before taking this 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 exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. You must continue taking 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 per day by mouth. Taking more than one tablet per day is not more effective and may lead to additional risks.
• You may take the tablet at any time of day, with or without food.
• This medicine must be taken with an adequate intake of calcium and vitamin D. Consult your doctor to check whether your dietary intake of calcium and vitamin D is sufficient and whether you need a calcium and vitamin D supplement. If you are taking additional calcium and/or vitamin D, these may 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 for your next dose, skip the missed dose and take only the next scheduled dose. Do not take a double dose to make up for the forgotten tablet.

If you stop taking CONBRIZA
If you decide to stop treatment with this medicine before completing the treatment course, speak to your doctor first.

If you have any questions about using or stopping this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects – Stop treatment with CONBRIZA and contact a doctor immediately
Uncommon (may affect up to 1 in 100 patients)

• 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, reduced vision, blurred vision, or loss of vision in one eye;
• if you experience any of the problems listed in section “Do not take CONBRIZA”.

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

• if you experience other events affecting the eye and/or vision (such as seeing flashes of light or sparks, narrowing of the visual field, or 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 oedema)

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 (awareness of your heartbeat)
• Dry eyes, eye pain, reduced visual acuity, vision loss, blepharospasm (abnormal, involuntary blinking or eyelid spasms).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after the word EXP. The expiry date refers to the last day of the month.
Store below 25°C.
Do not dispose of medicines via 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 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 maize starch, 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 pack contents
CONBRIZA is available as a film-coated tablet, white to off-white in colour, capsule-shaped, marked with “WY20”. The tablet is approximately 1.5 cm long. The tablets 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien Latvijā
Luxembourg/Luxemburg Pfizer Luxembourg SARL filiāle Latvijā
Pfizer NV/SA Tel: + 371 670 35 775
Tél/Tel:+32 (0)2 554 62 11

България Lietuva
Пфайзер Люксембург САРЛ, Pfizer Luxembourg SARL filialas Lietuvoje
Клон България Tel: + 370 52 51 4000
Teл.: +359 2 970 4333

Česká republika Magyarország
Pfizer, spol. s r.o. Pfizer Kft
Tel: +420-283-004-111 Tel.: +36 1 488 3700

Danmark Malta
Pfizer ApS Vivian Corporation Ltd.
Tlf:+45 44 20 11 00 Tel: +356 21344610

Deutschland Nederland
PFIZER PHARMA GmbH Pfizer BV
Tel: +49 (0)30 550055-51000 Tel: +31 (0)10 406 43 01

Eesti Norge
Pfizer Luxembourg SARL Eesti filiaal Pfizer AS
Tel: +372 666 7500 Tlf: +47 67 526 100

Ελλάδα Österreich
Pfizer Ελλάς A.E. Pfizer Corporation Austria Ges.m.b.H.
Τηλ: +30 210 6785 800 Tel: +43 (0)1 521 15-0

España Polska
Pfizer, S.L. Pfizer Polka Sp. z o.o.
Tel: +34 91 490 99 00 Tel.: +48 22 335 61 00

France Portugal
Pfizer Laboratórios Pfizer, Lda.
Tél: +33 (0)1 58 07 34 40 Tel: +351 21 423 5500

Hrvatska România
Pfizer Croatia d.o.o. Pfizer Romania S.R.L
Tel: +385 1 3908 777 Tel: +40 (0) 21 207 28 00

Ireland Slovenija
Pfizer Healthcare Ireland Pfizer Luxembourg SARL
Tel: 1800 633 363 (toll free) Pfizer, podružnica za svetovanje s področja
+44 (0)1304 616161 farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Ísland Slovenská republika
Icepharma hf. Pfizer Luxembourg SARL,
S í mi: +354 540 8000 organizačná zložka
Tel: +421 2 3355 5500

Italia Suomi/Finland
Pfizer S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0) 9 430 040

Kύπρος Sverige
Pfizer Ελλάς Α.Ε. (Cyprus Branch) Pfizer AB
Τηλ: +357 22 81769 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 medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu