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AstraZeneca

Bosulif
bosutinib

Package leaflet: Information for the user


Bosulif 100 mg film-coated tablets Bosulif 400 mg film-coated tablets Bosulif 500 mg film-coated tablets bosutinib


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



Sun/UV protection

You may become more sensitive to the sun or UV rays while taking bosutinib. It is important to cover sunlight-exposed areas of skin and use sunscreen with high sun protection factor (SPF).

Children and adolescents

Bosulif is not recommended for people whose age is under 18 years. This medicine has not been studied in children and adolescents.


Other medicines and Bosulif

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, vitamins, and herbal medicines. Some medicines can affect the levels of Bosulif in your body. You should inform your doctor if you are taking medicines containing active substances such as those listed below:


The following active substances may increase the risk of side effects with Bosulif:


What Bosulif looks like and contents of the pack

Bosulif 100 mg film-coated tablets are yellow, oval biconvex, debossed with “Pfizer” on one side and “100” on the other side.

Bosulif 100 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets or 112 film-coated tablets.


Bosulif 400 mg film-coated tablets are orange, oval biconvex, debossed with “Pfizer” on one side and “400” on the other side.

Bosulif 400 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.


Bosulif 500 mg film-coated tablets are red, oval biconvex, debossed with “Pfizer” on one side and “500” on the other side.

Bosulif 500 mg is available in blisters containing either 14 or 15 film-coated tablets in cartons of 28 or 30 film-coated tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17

1050 Bruxelles Belgium


Manufacturer

Pfizer Manufacturing Deutschland GmbH Betriebsstӓtte Freiburg

Mooswaldallee 1

79090 Freiburg Germany


For any information about this medicine, please 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

България

Пфайзер Люксембург САРЛ, Клон България Тел.: +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.: +36-1-488-37-00


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 52 61 00


Ελλάδα

Pfizer Ελλάς A.E.

Τλ: +30 210 6785 800

Österreich

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


España

Pfizer, S.L.

Tél: +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


Italia

Pfizer S.r.l.

Tel: +39 06 33 18 21

Suomi/Finland

Pfizer Oy

Puh./Tel: +358 (0)9 43 00 40


Kύπρος

Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ+357 22 817690

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00


Latvija

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

United Kingdom (Northern Ireland)

Pfizer Limited

Tel: +44 (0) 1304 616161

This leaflet was last revised in


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