Conbriza - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package Leaflet: Information for the patient

CONBRIZA 20 mg film-coated tablets bazedoxifene

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in 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 substance bazedoxifene, and is a medicine that belongs to a group of non-hormonal medicines called Selective Oestrogen Receptor Modulators (SERMs). It is used for the treatment of osteoporosis in women after they have reached menopause, when they are at an increased risk of fractures. It works by slowing or stopping the thinning of bone 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 in your legs, lungs, or eyes).

• – if you are pregnant or could still become pregnant. This medicine may cause harm to your unborn child 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 taking CONBRIZA

• – as it may increase your risk of getting blood clots. While very infrequent, these clots can cause serious medical problems, disability or death. Speak with your doctor to see if you are at increased risk for blood clots.

• – if you are immobile (unable to move) for some time, such as being wheel-chair bound, sitting for a prolonged period of time or having to stay in bed while recovering from an operation or illness. If you are traveling on long trips, you should walk around or exercise your legs and feet at regular intervals. This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots. If you need to remain immobile for an extended period of time or are scheduled to have surgery, it is important for you to talk to your doctor about ways you can reduce the risk of blood clots.

• – if you are pre-menopausal. CONBRIZA has only been studied in women who have reached menopause, and therefore is not recommended.

• – if you have had increased levels of triglycerides (a type of fat found in your blood) in the past.

• – if you have liver or severe kidney problems.

• – if you have any vaginal bleeding while you take CONBRIZA, you should speak with your doctor.

• – if you are suffering from breast cancer, as there is insufficient experience with this medicine use in women with this disease.

The above are some reasons why this medicine may not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine.

Other medicines and CONBRIZA

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

Pregnancy and breast-feeding

CONBRIZA is for use only by postmenopausal women. It must not be taken by women who are pregnant or who could still have a baby. Do not take this medicine if you are breast-feeding, because it is not known whether it is excreted in mother's milk.

Driving and using machines

If you feel drowsy after taking this medicine, you should avoid driving or operating machines.

You may notice problems with your eyesight such as blurred vision while taking this medicine. If this happens, you should avoid driving or operating machines until your doctor tells you that it is 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, that is to say essentially ‘sodium-free’.

3. How to take CONBRIZA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You should continue taking this medicine as long as your doctor tells you to. In order for this medicine to treat osteoporosis, it must be taken daily.

• – The recommended dose is one tablet by mouth daily. Taking more than one tablet daily is not more effective and may carry additional risks.

• – You can take the tablet at any time of the day, with or without food.

• – This medicine should be taken with an adequate amount of calcium and vitamin D. Consult your doctor to see if your dietary calcium and vitamin D intake is adequate and whether you need calcium and vitamin D supplementation. If you take supplemental calcium and/or vitamin D, it may be taken at the same time as this medicine.

If you take more CONBRIZA than you should

Tell 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 your next dose of this medicine, skip the dose you missed and only take your next scheduled 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 finishing the prescribed course of treatment, you should talk to your doctor first.

If you have any further questions on the use or stopping the use of 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 see a doctor immediately

Uncommon (may affect up to 1 in 100 people):

• – If you have signs of a blood clot in the legs or lungs, such as painful swelling and redness of the legs, sudden chest pain, or difficulty in breathing;

• – If you have signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance or visual impairment or blurring or loss of vision in one eye.

• – If you get any of the problems listed under ‘Do not take CONBRIZA’

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

• – If you have other events affecting the eye and/or vision (seeing sparks or flashes of light, narrowing of visual field, and swelling of 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 (includes leg cramps)

• – Hot flushes

• – Swelling of the 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

• – Increase in blood triglycerides (fat found in your blood)

• – Increase in liver enzymes

• – Drowsiness

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

• – Palpitations (awareness of your heart beat)

• – Dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix 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 carton and blister after EXP. The expiry date refers to the last date of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What CONBRIZA contains

• – The active substance is bazedoxifene. Each film-coated tablet contains bazedoxifene acetate equivalent to 20 mg bazedoxifene.

• – The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch (maize), 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”).

What CONBRIZA looks like and contents of the pack

CONBRIZA is supplied as a white to off-white, capsule-shaped, film-coated tablet marked with “WY20”. The tablet is approximately 1.5 cm in length. 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.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer

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

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Luxembourg/Lu­xemburg Pfizer NV/SA

Latvija Pfizer Luxembourg SARL filiäle Latvijä Tel: +371 670 35 775

Tél/Tel: +32 (0)2 554 62 11

EtarapuH n<|)aÜ3ep ^æKceMÔypr C’AP^. K.toh Eijrapna Ten.: +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
EZZàôa Pfizer EÂÂàc A.E. TnÀ: +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 Polska 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
Ísland Icepharma hf. Sími: +354 540 8000	Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421 2 3355 5500

Suomi/Finland

Pfizer Oy

Puh/Tel: +358 (0)9 430 040

Kunpoç

Pfizer Ez.z.àc A.E. (Cyprus Branch)

Tnk +357 22 817690

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0) 1304 616161

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

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