Darunavir Rowex 600 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Darunavir

Available from:

Rowex Ltd

ATC code:

J05AE; J05AE10

INN (International Name):

Darunavir

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Protease inhibitors; darunavir

Authorization status:

Not marketed

Authorization date:

2017-06-02

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR ROWEX 75 MG FILM-COATED TABLETS
DARUNAVIR ROWEX 600 MG FILM-COATED TABLETS
darunavir
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Darunavir Rowex is and what it is used for
2.
What you need to know before you take Darunavir Rowex
3.
How to take Darunavir Rowex
4.
Possible side effects
5.
How to store Darunavir Rowex
6.
Contents of the pack and other information
1. WHAT DARUNAVIR ROWEX IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR ROWEX
Darunavir
Rowex
contains
the
active
substance
darunavir.
Darunavir
Rowex
is
an
antiretroviral medicine used in the treatment of Human
Immunodeficiency Virus (HIV)
infection. It belongs to a group of medicines called protease
inhibitors. Darunavir Rowex
works by reducing the amount of HIV in your body. This will improve
your immune system
and reduces the risk of developing illnesses linked to HIV infection.
WHAT IS IT USED FOR?
Darunavir Rowex is used to treat adults and children of 3 years of age
and above, and at least
15 kilogram body weight who are infected by HIV and who have already
used other
antiretroviral medicines.
Darunavir Rowex must be taken in combination with a low dose of
ritonavir and other anti-
HIV medicines. Your doctor will discuss with you which combination of
medicines is best for
you.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DARUNAVIR ROWEX
DO NOT TAKE DARUNAVIR ROWEX
-
if you are
ALLERGIC
to darunavir or any of the other ingredients of this medicine (listed
in
section 6)

Summary of Product characteristics

HealthProductsRegulatoryAuthority
13September2019
CRN008V9G
Page1of35
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DarunavirRowex600mgFilm-coatedtablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Eachfilm-coatedtabletcontains600mgdarunavir.
Excipient(s) with known
effect:Eachtabletcontains2.592mgsunsetyellowFCF(E110)
Forthefulllistofexcipients,seesection6.1. 
3 PHARMACEUTICAL FORM
Film-coatedtablet.
Orangeovalshapedfilm-coatedtablet,debossedwith‘600’ononesideandplainontheotherside.
Dimensions:approximately20.1mmx10.1mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DarunavirRowex,co-administeredwithlowdoseritonavirisindicatedincombinationwithotherantiretroviralmedicinal
productsforthetreatmentofpatientswithhumanimmunodeficiencyvirus(HIV-1)infection(seesection4.2).
DarunavirRowextabletsmaybeusedtoprovidesuitabledoseregimens(seesection4.2):

ForthetreatmentofHIV-1infectioninantiretroviraltreatment(ART)-experiencedadultpatients,includingthose
thathavebeenhighlypre-treated.

ForthetreatmentofHIV-1infectioninpaediatricpatientsfromtheageof3yearsandatleast15kgbodyweight.
IndecidingtoinitiatetreatmentwithDarunavirRowexco-administeredwithlowdoseritonavir,carefulconsiderationshouldbe
giventothetreatmenthistoryoftheindividualpatientandthepatternsofmutationsassociatedwithdifferentagents.
Genotypicorphenotypictesting(whenavailable)andtreatmenthistoryshouldguidetheuseofDarunavirRowex(seesection
4.2,4.4and5