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AstraZeneca

Tracleer
bosentan

Package leaflet: Information for the user


Tracleer 62.5 mg film-coated tablets

bosentan


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

(E172), iron oxide red (E172) and ethylcellulose.


What Tracleer looks like and contents of the pack


Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.

PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated tablets (Tracleer 62.5 mg film-coated tablets).


White high-density polyethylene bottles with a silica gel desiccant containing 56 film-coated tablets. Cartons contain 56 film-coated tablets (Tracleer 62.5 mg film-coated tablets).

Do not swallow the desiccant.


Not all pack sizes may be marketed.


Marketing authorisation holder: Janssen-Cilag International NV Turnhoutseweg 30

B-2340 Beerse Belgium


Manufacturer:

Janssen Pharmaceutica NV Turnhoutseweg 30

B-2340 Beerse

Belgium


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


België/Belgique/Belgien Janssen-Cilag NV Tel/Tél: +32 14 64 94 11

janssen@jacbe.jnj.com

Lietuva

UAB "JOHNSON & JOHNSON" Tel: +370 5 278 68 88

lt@its.jnj.com


България

„Джонсън & Джонсън България” ЕООД Тел.: +359 2 489 94 00

jjsafety@its.jnj.com

Luxembourg/Luxemburg

Janssen-Cilag NV Tél/Tel: +32 14 64 94 11

janssen@jacbe.jnj.com


Česká republika Janssen-Cilag s.r.o. Tel: +420 227 012 227


Danmark

Janssen-Cilag A/S Tlf: +45 4594 8282

jacdk@its.jnj.com

Magyarország Janssen-Cilag Kft. Tel.: +36 1 884 2858

janssenhu@its.jnj.com

Malta

AM MANGION LTD Tel: +356 2397 6000


Deutschland

Janssen-Cilag GmbH Tel: +49 2137 955 955

jancil@its.jnj.com

Nederland

Janssen-Cilag B.V. Tel: +31 76 711 1111

janssen@jacnl.jnj.com


Eesti

UAB "JOHNSON & JOHNSON" Eesti filiaal Tel: +372 617 7410

ee@its.jnj.com

Norge

Janssen-Cilag AS Tlf: +47 24 12 65 00

jacno@its.jnj.com

Ελλάδα

Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε. Tηλ: +30 210 80 90 000

Österreich

Janssen-Cilag Pharma GmbH Tel: +43 1 610 300


España

Janssen-Cilag, S.A. Tel: +34 91 722 81 00

contacto@its.jnj.com

France

Janssen-Cilag

Tél: 0 800 25 50 75 / +33 1 55 00 40 03

medisource@its.jnj.com

Hrvatska

Johnson & Johnson S.E. d.o.o. Tel: +385 1 6610 700

jjsafety@JNJCR.JNJ.com

Polska

Janssen-Cilag Polska Sp. z o.o. Tel.: +48 22 237 60 00


Portugal

Janssen-Cilag Farmacêutica, Lda. Tel: +351 214 368 600


România

Johnson & Johnson România SRL Tel: +40 21 207 1800


Ireland

Janssen Sciences Ireland UC Tel: +353 1 800 709 122

Slovenija

Johnson & Johnson d.o.o. Tel: +386 1 401 18 00

Janssen_safety_slo@its.jnj.com


Ísland

Janssen-Cilag AB c/o Vistor hf.

Sími: +354 535 7000

janssen@vistor.is

Slovenská republika Johnson & Johnson, s.r.o. Tel: +421 232 408 400


Italia

Janssen-Cilag SpA

Tel: 800.688.777 / +39 02 2510 1

janssenita@its.jnj.com

Suomi/Finland

Janssen-Cilag Oy

Puh/Tel: +358 207 531 300

jacfi@its.jnj.com


Κύπρος

Βαρνάβας Χατζηπαναγής Λτδ Τηλ: +357 22 207 700

Sverige

Janssen-Cilag AB Tfn: +46 8 626 50 00

jacse@its.jnj.com


Latvija

UAB "JOHNSON & JOHNSON" filiāle Latvijā Tel: +371 678 93561

lv@its.jnj.com

United Kingdom (Northern Ireland)

Janssen Sciences Ireland UC Tel: +44 1 494 567 444


This leaflet was last revised in


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