EFAMAT Tablets 200mg

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

EFAVIRENZ

Disponibil de la:

PAHANG PHARMACY SDN. BHD.

INN (nume internaţional):

EFAVIRENZ

Unități în pachet:

30 Tablets

Produs de:

Mylan Laboratories Limited

Prospect

_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

Caracteristicilor produsului

LABEL CLAIM
EFAMAT
TABLETS
200
MG
Each film coated tablet contains
Efavirenz USP
200 mg
EFAMAT 200
(EFAVIRENZ TABLETS 200MG)
PRODUCT DESCRIPTION:
Peach colored oval shaped, film coated tablets, debossed with ‘3X’
on one side and ‘M’ on other side.
LIST OF EXCIPIENTS:
Cellulose Microcrystalline, Croscarmellose sodium, Hydroxypropyl
cellulose, Sodium lauryl Sulfate,
Lactose monohydrate, Magnesium Stearate, Film coat {Hypromellose,
Titanium dioxide, Polyethylene
glycol 400, Iron oxide yellow, Iron oxide red}.
THERAPEUTIC INDICATIONS
Efavirenz is indicated in antiviral combination treatment of HIV 1
infected adults, adolescents and children.
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dosage of Efavirenz in combination with a protease
inhibitor and/or
nucleoside analogue reverse transcriptase inhibitors (NRTIs) is 600 mg
orally, once daily. Efavirenz may
be taken with or without food, as desired.
In order to improve the tolerability of nervous system side effects,
bedtime dosing is recommended during
the first two to four weeks of therapy and in patients who continue to
experience these symptoms. (see
SIDE EFFECTS).
CONCOMITANT ANTIRETROVIRAL THERAPY:
Efavirenz must be given in combination with other antiretroviral
medications.
ADOLESCENTS AND CHILDREN (17 YEARS AND UNDER):
The recommended dose of Efavirenz incombination
with a protease inhibitor and/or NRTIs for patients 17 years of age
and under is described in Table 1.
Efavirenz tablets should only be administered to children who are able
to reliably swallow tablets.
Efavirenz tablets may be taken with or without food, as desired.
Efavirenz has not been adequately
studied in children under the age of 3 years or children weighing less
than 13 kg.
TABLE 1 PEDIATRIC DOSE TO BE ADMINISTERED ONCE DAILY
BODY WEIGHT
(Kg)
EFAVIRENZ
TABLETS
DOSE (MG)
13 to <15
200
15 to < 20
250
20 to < 25
300
25 to < 32.5
350
32.5 to < 40
400
≥40
600
Efamat Tablets are available in two strengths of 200mg and 600mg. They
are not able to deliver all
approved dose