Edurant

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

rilpivirine hydrochloride

Saatavilla:

Janssen-Cilag International N.V.   

ATC-koodi:

J05AG05

INN (Kansainvälinen yleisnimi):

rilpivirine

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

HIV Infections

Käyttöaiheet:

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 patients 12 years of age and older with a viral load ≤ 100,000 HIV‑1 RNA copies/ml. As with other antiretroviral medicinal products, genotypic resistance testing should guide the use of Edurant.,

Tuoteyhteenveto:

Revision: 20

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-11-28

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
EDURANT 25 MG FILM-COATED TABLETS
rilpivirine
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What EDURANT is and what it is used for
2.
What you need to know before you take EDURANT
3.
How to take EDURANT
4.
Possible side effects
5.
How to store EDURANT
6.
Contents of the pack and other information
1.
WHAT EDURANT IS AND WHAT IT IS USED FOR
EDURANT contains rilpivirine that is used for the treatment of Human
Immunodeficiency Virus
(HIV) infection. It belongs to a group of HIV medicines called
non-nucleoside reverse transcriptase
inhibitors (NNRTIs). EDURANT works by reducing the amount of HIV in
your body.
EDURANT IS USED IN COMBINATION WITH OTHER HIV MEDICINES to treat
adolescents and adults
12 years of age and older who are infected with HIV and who have never
been treated before with
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 EDURANT
DO NOT TAKE EDURANT if you are allergic to rilpivirine or any of the
other ingredients of this
medicine (listed in section 6).
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, pantopr

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
EDURANT 25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains rilpivirine hydrochloride equivalent
to 25 mg rilpivirine.
Excipient with known effect
Each film-coated tablet contains 56 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex, film-coated tablet with a
diameter of 6.4 mm, debossed with
“TMC” on one side and “25” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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 patients
12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA
copies/ml.
Genotypic resistance testing should guide the use of EDURANT (see
sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
The recommended dose of EDURANT is one 25 mg tablet taken once daily.
EDURANT MUST BE
TAKEN WITH A MEAL (see section 5.2).
_Dose adjustment_
For patients concomitantly receiving rifabutin, the EDURANT dose
should be increased to 50 mg (two
tablets of 25 mg each) taken once daily. When rifabutin
co-administration is stopped, the EDURANT
dose should be decreased to 25 mg once daily (see section 4.5).
_Missed dose_
If the patient misses a dose of EDURANT within 12 hours of the time it
is usually taken, the patient
must take the medicine with a meal as soon as possible and resume the
normal dosing schedule. 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.
If a patient vomits within 4 hours of taking the medicine, another
EDURANT tablet should be taken
with a meal. If a patient vomits more than 4 hours a