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AstraZeneca

Celsentri
maraviroc

Package leaflet: Information for the user


CELSENTRI 25 mg film-coated tablets CELSENTRI 75 mg film-coated tablets CELSENTRI 150 mg film-coated tablets CELSENTRI 300 mg film-coated tablets maraviroc


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


effects not listed in this leaflet. See Section 4.


What is in this leaflet


  1. What CELSENTRI is and what it is used for

  2. What you need to know before you take CELSENTRI

  3. How to take CELSENTRI

  4. Possible side effects

  5. How to store CELSENTRI

  6. Contents of the pack and other information


1. What CELSENTRI is and what it is used for


CELSENTRI contains a medicine called maraviroc. Maraviroc belongs to a group of medicines called CCR5 antagonists. CELSENTRI works by blocking a receptor called CCR5 which HIV uses to enter and infect your blood cells.


CELSENTRI is used to treat Human Immunodeficiency Virus type-1 (HIV-1) in adults, adolescents and children of 2 years and older, and weighing at least 10 kg.


CELSENTRI must be taken in combination with other medicines which are also used to treat the HIV infection. These medicines are all called anti-HIV medicines or antiretrovirals.


CELSENTRI, as part of combination therapy, reduces the amount of virus in your body, and keeps it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection.


2 What you need to know before you take CELSENTRI Do not take CELSENTRI


Reporting of side effects

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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.


  1. How to store CELSENTRI


    Keep this medicine out of the sight and reach of children.


    Do not use CELSENTRI after the expiry date which is stated on the carton, blister or bottle label. The expiry date refers to the last day of that month.


    This medicine does not require any special storage conditions.


    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 to protect the environment.


  2. Contents of the pack and other information What CELSENTRI contains


Tablet core: cellulose microcrystalline, calcium hydrogen phosphate anhydrous, sodium starch glycolate, magnesium stearate


Film-coat: poly (vinyl alcohol), titanium dioxide (E171), macrogol 3350, talc, soya lecithin, indigo carmine aluminium lake (E132).


What CELSENTRI looks like and contents of the pack


CELSENTRI film-coated tablets are blue coloured with “MVC 25”, “MVC 75”, “MVC 150” or “MVC 300”.


CELSENTRI 25 mg and 75 mg film-coated tablets are supplied in bottles of 120 tablets. CELSENTRI 150 mg and 300 mg film-coated tablets are supplied in bottles of 180 tablets or in blister packs of 30, 60, 90 film-coated tablets and multipacks containing 180 (2 packs of 90) film- coated tablets.


Not all pack sizes may be marketed in all countries.


Marketing Authorisation Holder


ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands.


Manufacturer


Pfizer Manufacturing Deutschland GmbH, Betriebsstātte 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 ViiV Healthcare srl/bv Tél/Tel: + 32 (0) 10 85 65 00

Lietuva

ViiV Healthcare BV Tel: +370 80000334


България

ViiV Healthcare BV

Teл.: +359 80018205

Luxembourg/Luxemburg ViiV Healthcare srl/bv Belgique/Belgien

Tél/Tel: + 32 (0) 10 85 65 00


Česká republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 111

cz.info@gsk.com

Magyarország ViiV Healthcare BV Tel.: +36 80088309


Danmark

GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

ViiV Healthcare BV Tel: +356 80065004


Deutschland

ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10

viiv.med.info@viivhealthcare.com

Nederland

ViiV Healthcare BV Tel: + 31 (0)33 2081199


Eesti

ViiV Healthcare BV Tel: +372 8002640

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00


Ελλάδα

GlaxoSmithKline Μονοπρόσωπη A.E.B.E.

Τηλ: + 30 210 68 82 100

Österreich

GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0

at.info@gsk.com


España

Laboratorios ViiV Healthcare, S.L.

Tel: +34 900 923 501

es-ci@viivhealthcare.com

Polska

GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000


France

ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969

Infomed@viivhealthcare.com

Portugal

VIIVHIV HEALTHCARE, UNIPESSOAL, LDA. Tel: + 351 21 094 08 01

viiv.fi.pt@viivhealthcare.com

Hrvatska

ViiV Healthcare BV Tel: +385 800787089

România

ViiV Healthcare BV Tel: +40 800672524


Ireland

GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000

Slovenija

ViiV Healthcare BV Tel: +386 80688869


Ísland

Vistor hf.

Sími: + 354 535 7000

Slovenská republika ViiV Healthcare BV Tel: +421 800500589


Italia

ViiV Healthcare S.r.l. Tel: + 39 (0)45 7741600

Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30

Finland.tuoteinfo@gsk.com


Κύπρος

ViiV Healthcare BV

Τηλ: +357 80070017

Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com


Latvija

ViiV Healthcare BV Tel: +371 80205045

United Kingdom (Northern Ireland)

ViiV Healthcare BV Tel: + 44 (0)800 221441

customercontactuk@gsk.com


This leaflet was last revised in {MM/YYYY}

.eu.