Edurant 25mg film-coated tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

rilpivirine

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

rilpivirine

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

JANSSEN-CILAG S.P.A.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
EDURANT
® FILM-COATED TABLET
Rilpivirine (25 mg)
1
WHAT IS IN THIS LEAFLET
1.
What EDURANT
®
is used for
2.
How EDURANT
®
works
3.
Before you use EDURANT
®
4.
How to use EDURANT
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
EDURANT
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT EDURANT
® IS USED FOR
EDURANT is a medicine used for
the treatment of Human
Immunodeficiency Virus (HIV)
infection.
EDURANT is always used in
combination with other HIV
medicines. Your doctor will
discuss with you which
combination of medicines is best
for you.
EDURANT in combination with
other HIV medicines is used to
treat adults who are infected by
HIV and who have never been
treated before with HIV medicines.
HOW EDURANT
® WORKS
EDURANT 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.
BEFORE YOU USE EDURANT
®
-
_When you must not use it _
Do not take EDURANT if you are
allergic to rilpivirine or any of the
other ingredients of EDURANT.
These other ingredients are listed
in “Product Description”.
Do not take EDURANT in
combination with any of the
following medicines as they may
affect the way EDURANT or the
other medicine works:
-
carbamazepine, oxcarbazepine,
phenobarbital, phenytoin
(medicines to treat epilepsy
and prevent seizures)
-
rifampicin, rifapentine
(medicines to treat some
bacterial infections such as
tuberculosis)
-
omeprazole, esomeprazole,
lansoprazole, pantoprazole,
rabeprazole (medicines to
prevent and treat stomach
ulcers and heartburn)
-
dexamethasone (a
corticosteroid used in a variety
of conditions such as
inflammation and allergic
reactions) when taken by
mouth or injected, except as a
single dose treatment
-
products that contain St John’s
wort (a herbal product used for
depression)
If you are taking any of the above,
ask your doctor about alternatives.
_Pregnancy and

Ciri produk

PRODUCT NAME
EDURANT
®
25 mg film-coated tablets
DOSAGE FORMS AND STRENGTHS
COMMERCIAL PRODUCT
Dosage Form
White to off-white, film-coated, round, biconvex, tablet of 6.4 mm,
debossed
with “TMC” on one side and “25” on the other side.
Strength
Each film-coated tablet contains rilpivirine hydrochloride equivalent
to 25 mg
rilpivirine.
Excipient: each tablet contains 56 mg lactose monohydrate.
For excipients, see
_List of Excipients_
CLINICAL INFORMATION
INDICATIONS
EDURANT, in combination with other antiretroviral medicinal products,
is indicated for the treatment of
human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral treatment-naïve adult patients
with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
DOSAGE AND ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
EDURANT must always be given in combination with other antiretroviral
medicinal products.
_ _
DOSAGE (ADULTS)
The recommended dose of EDURANT is one 25 mg tablet once daily TAKEN ORALLY WITH A MEAL
(see
_Pharmacological properties – _
_Pharmacokinetic Properties_
).
_Dose adjustment with rifabutin coadministration_
For patients concomitantly receiving rifabutin, the EDURANT dose
should be increased to 50 mg (two
tablets of 25 mg each) once daily, taken with a meal. When rifabutin
co-administration is stopped, the
EDURANT dose should be decreased to 25 mg once daily, taken with a
meal (see
_Interactions_
).
MISSED DOSE(S)_ _
If the patient misses a dose of EDURANT within 12 hours of the time it
is usually taken, the patient should
take EDURANT with a meal as soon as possible and then take the next
dose of EDURANT at the regularly
scheduled time. If a patient misses a dose of EDURANT by more than 12
hours, the patient should not take
the missed dose, but resume the usual dosing schedule.
SPECIAL POPULATIONS
Paediatric(17 years of age and younger)
The
safety
and
efficacy
of
EDURANT
in
adolescents
and
children
are
under
investigation
(see
_Pharmacokinetic Properties)_