Odefsey
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
20-02-2023
Fachinformation
(SPC)
20-02-2023
Öffentlichen Beurteilungsberichts
(PAR)
08-07-2016
Wirkstoff:
emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide
Verfügbar ab:
Gilead Sciences Ireland UC
ATC-Code:
J05AR19
INN (Internationale Bezeichnung):
emtricitabine, rilpivirine, tenofovir alafenamide
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
Treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV 1 RNA copies/mL.,
Produktbesonderheiten:
Revision: 20
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2016-06-21
Gebrauchsinformation
42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
ODEFSEY 200 MG/25 MG/25 MG FILM-COATED TABLETS
emtricitabine/rilpivirine/tenofovir alafenamide
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 Odefsey is and what it is used for
2.
What you need to know before you take Odefsey
3.
How to take Odefsey
4.
Possible side effects
5.
How to store Odefsey
6.
Contents of the pack and other information
1.
WHAT ODEFSEY IS AND WHAT IT IS USED FOR
Odefsey is an antiviral medicine used to treat infection by the
HUMAN IMMUNODEFICIENCY
VIRUS (HIV).
It is a single tablet that contains a combination of three active
substances:
EMTRICITABINE, RILPIVIRINE
and
TENOFOVIR ALAFENAMIDE.
Each of these active substances works by
interfering with an enzyme called ‘reverse transcriptase’, which
is essential for the HIV-1 virus to
multiply.
Odefsey reduces the amount of HIV in your body. This will improve your
immune system and reduce
the risk of developing illnesses linked to HIV infection.
Odefsey is used in adults and adolescents aged 12 years and older, who
weigh at least 35 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ODEFSEY
DO NOT TAKE ODEFSEY
•
IF YOU ARE ALLERGIC TO EMTRICITABINE, RILPIVIRINE, TENOFOVIR
ALAFENAMIDE
or any of the other
ingredients of this medicine (listed in section 6).
•
IF YOU ARE CURRENTLY TAKING ANY OF THE FOLLOWING MEDICINES:
-
CARBAMAZEPINE, OXCARBAZEPINE, PHENOBARBITAL AND PHENYTOIN
(used to treat epilepsy
and prevent seizures)
-
RIFABUTIN, RIFAMPICIN AND RIFAPENTINE
(u
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Odefsey 200 mg/25 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine
hydrochloride equivalent to
25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to
25 mg of tenofovir alafenamide.
Excipients with known effect
Each tablet contains 180.3 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Grey, capsule-shaped, film-coated tablet, of dimensions 15 mm x 7 mm,
debossed with “GSI” on one
side of the tablet and “255” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Odefsey is indicated for the treatment of adults and adolescents (aged
12 years and older with body
weight at least 35 kg) infected with human immunodeficiency virus-1
(HIV-1) without known
mutations associated with resistance to the non-nucleoside reverse
transcriptase inhibitor (NNRTI)
class, tenofovir or emtricitabine and with a viral load ≤ 100,000
HIV-1 RNA copies/mL (see
sections 4.2, 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
_ _
One tablet to be taken once daily with food (see section 5.2).
If the patient misses a dose of Odefsey within 12 hours of the time it
is usually taken, the patient
should take Odefsey with food as soon as possible and resume the
normal dosing schedule. If a
patient misses a dose of Odefsey by more than 12 hours, the patient
should not take the missed dose
and simply resume the usual dosing schedule.
If the patient vomits within 4 hours of taking Odefsey another tablet
should be taken with food. If a
patient vomits more than 4 hours after taking Odefsey they do not need
to take another dose of
Odefsey until the next regularly scheduled dose.
_Elderly_
No dose adjustment of Odefsey is required in elderly patients (se
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