Odefsey® (200mg Emtricitabine25mg Rilpivirine25mg Tenofovir alafenamide) film coated tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EMTRICITABINE; Rilpivirine HCl; Tenofovir alafenamide fumarate

Boleh didapati daripada:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

EMTRICITABINE; Rilpivirine HCl; Tenofovir alafenamide fumarate

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

PATHEON INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ODEFSEY
® FILM-COATED TABLETS
EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE
200 MG/25 MG/25 MG FILM-COATED TABLETS
1
WHAT IS IN THIS LEAFLET?
1. What Odefsey is used for
2. How Odefsey works
3. Before you use Odefsey
4. How to use Odefsey
5. While you are using
Odefsey.
6. Side effects
7. Storage and Disposal of
Odefsey
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
1.
WHAT ODEFSEY IS USED FOR
Odefsey is an antiviral
medicine used to treat infection
by the Human
Immunodeficiency Virus
(HIV). Odefsey is used in
adults and adolescents aged
12 years and older, who weigh
at least 35 kg.
2. HOW ODEFSEY WORKS
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.
3. BEFORE YOU USE ODEFSEY
_-When you must not use it _
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 8).
•
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 (used to treat
some bacterial infections
such as tuberculosis)
-
omeprazole,
dexlansoprazole,
lansoprazole, rabeprazole,
pantoprazole and
esomeprazole (used to
prevent and treat stomach
ulcers, heartburn, acid
reflux disease)
-
dexamethasone (a
corticosteroid medicine
used to treat inflammation
and suppress the immune
system) when taken by
mouth or injected (except
as a single dose treatment)
-
products that contain
St. John’s wort
(
_Hypericum perforatum_
) (a
herbal remedy used for
depression and anxiety)
→
If this applies to you, do not
take Odefsey and tell your
doctor immediately.
_-Before you start to use it _
_Warnings and precautions _
You must remain under the
care of your doctor while
taking Odefsey.
You can still pass on HIV

Ciri produk

1
1. NAME OF THE MEDICINAL PRODUCT
Odefsey 200 mg/25 mg/ 25 mg film -coated tablet s
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 2 5 mg of tenofovir alafenamide .
Excipient s with known effect
Each tablet contains 189.8 mg lactose monohydrate .
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film -coated tablet.
Grey, capsule -shaped, film -coated tablets, 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/m L (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
Adults and adolescents aged 12 years and older, weighing at least 35 kg
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 Odefse y they do not need to take another dose of
Odefsey until the next regularly scheduled dose.
Elderly
No dose adjustment of Odefs