EFAMAT Tablets 600mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EFAVIRENZ

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

EFAVIRENZ

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Mylan Laboratories Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
EFAMAT TABLETS
Efavirenz (200mg, 600mg)
1
WHAT IS IN THIS LEAFLET
1.
What Efamat is used for
2.
How Efamat works
3.
Before you use Efamat
4.
How to use Efamat
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Efamat
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT EFAMAT IS USED FOR
Efamat contains an active ingredient
efavirenz which used to treat HIV
infection.
Efamat
taken
in
combination
with
other
antiretroviral
medicines
reduces the amount of the virus in the
blood.
HOW EFAMAT WORKS
Efamat is a member of a class of
antiretroviral medicines called non-
nucleoside
reverse
transcriptase
inhibitors
(NNRTIs).
It
is
an
antiretroviral
medicine
that
fights
HIV
infection
by
reducing
the
amount of virus in blood.
BEFORE YOU TAKE EFAMAT
-
_When you must not use it _
Do not take Efamat if you are allergic
to any of the ingredients in Efamat
tablets.
Efamat
should
not
be
taken
with
some other medicines. (See Taking
other medicines)
-
_Before you start use it _
Inform your doctor about any past or
present medical problems, including:

liver
disease
(for
example,
chronic hepatitis B or C) or

allergies,

seizures,

mental illness, or

substance or alcohol abuse

any
medications,
vitamins,
or
nutritional supplements including
St.
John’s
wort
(Hypericum
perforatum).
Inform your doctor if you are breast-
feeding a baby, pregnant, or intend to
become pregnant. Tell your doctor if
you
are
taking
a
medicine
that
contains efavirenz. Efamat should not
be
taken
together
with
other
medicines that contain efavirenz.
Women should notify their physician
if they become pregnant while taking
Efamat.
If
you
could
get
pregnant
while
receiving Efamat, a reliable form of
barrier contraception should always
be
used
with
other
methods
of
contraception including oral (pill) or
other hormonal contraceptives (e.g.,
implants, injection). Efavirenz, may
remain in your blood for a time after
ther

Ciri produk

LABEL CLAIM
Each film coated tablet contains :
Efavirenz 600 mg
EFAVIRENZ TABLETS 600 MG: Peach coloured capsule shaped, film coated
tablets, debossed with ‘M109’ on one side and plain on the other
side.
DOSAGE FORM: Oral, Film coated tablet
THERAPEUTIC INDICATIONS
Efavirenz is indicated in antiviral combination treatment of HIV-1
infected adults, adolescents and children.
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV infection.
CONCOMITANT ANTIRETROVIRAL THERAPY: Efavirenz must be given in
combination with other antiretroviral medications.
Efavirenz may be taken with or without food. It is recommended that
Efavirenz tablet be taken on an empty stomach. The increased efavirenz
concentrations observed following administration of Efavirenz with
food may lead to an increase in frequency of adverse events.
In order to improve the tolerability of nervous system undesirable
effects, bedtime dosing is recommended during the first 2-4 weeks of
therapy and in patients who continue to experience adverse events.
ADULTS: The recommended dosage of Efavirenz in combination with
nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or
without a protease inhibitor (PI) is 600 mg orally, once daily.
Efavirenz film-coated tablets are not suitable for children <3years or
weighing less than 40 kg.
CONTRAINDICATIONS
Hypersensitivity to Efavirenz or to any of the excipients.
Efavirenz must not be used in patients with severe hepatic impairment
(Child Pugh Grade C).
Efavirenz must not be administered concurrently with terfenadine,
astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or
ergot
alkaloids (for example, ergotamine, dihydroergotamine,ergonovine, and
methylergonovine) because competition for CYP3A4 by efavirenz
could result in inhibition of metabolism and create the potential for
serious and/or life-threatening undesirable effects [for example,
cardiac
arrhythmias, prolonged sedation or respiratory depression].
Herbal prepa