Stocrin

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

efavirenz

Available from:

Merck Sharp & Dohme B.V.

ATC code:

J05AG03

INN (International Name):

efavirenz

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

Stocrin is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Stocrin has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Stocrin.

Product summary:

Revision: 49

Authorization status:

Authorised

Authorization date:

1999-05-28

Patient Information leaflet

85
B. PACKAGE LEAFLET
86
PACKAGE LEAFLET: INFORMAT
ION FOR THE USER
STOCRIN 30 MG/ML ORAL SOLUTION
efavirenz
READ ALL OF T
HIS LEAFLET C
AREFULLY BEFORE Y
OU START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMP
ORTANT INFORMATION FOR YOU
.

Keep this leaf
let. You may need to read it again.

If you have any furt
her
questions, ask y
o
ur doctor, pharmacist or n
urse.

This medicine has bee
n 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, phar
maci
st or nurse. Thi
s
includes any possible
sid
e effects not listed in thi
s leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Stocrin is and what it is used for
2.
What you need to know
before
you take Stocrin
3.
How to take Stocrin
4.
Possible side effects
5.
How to s
tore Stocrin
6.
Contents o
f the pack and other inform
ation
1.
WH
AT STOCRIN IS AND WHAT IT IS USED FOR
Stocrin, which contains the act
ive substance efavirenz,
belongs to a class
of antiretroviral medicines
called non-
nucleoside rever
se t
ranscriptase inh
i
bitors (NNRTIs).
It is
AN
ANTIRETROVIRAL MEDICINE THA
T
FIGHTS HUMA
N IMMUNODEFICIENC
Y VIRUS (HIV)
infection by reducing the amount of the
virus in blood.
It is used by adults
, adol
escents and children 3
years of age and older.
Your doctor
has prescribed S
t
ocrin for you because you
have HIV infection. Stocrin
taken in
com
bination with oth
er antiretroviral medicines reduces the amount of the
virus in the blood.
This will
strengthen y
our immune system and reduce the risk of developing illn
esse
s linked to HIV
infection.
2.
WHAT YOU NE
ED TO KNOW BEFORE YOU TAKE
STOCRIN
DO N
OT TAKE STOCRIN

IF YOU ARE ALLERGIC
to efavirenz or any of the other
ingredients of this medicine (listed i
n
section 6).
Contact your doctor or pharmacist for advice.

IF Y
OU HAVE SEVERE LI
VER DISEASE.

IF YOU HAVE
A HEART CONDITION, SUCH AS
CHANGES IN TH
E RHYTHM OR RATE
OF THE HEART BEAT, A
SLOW HEART BEAT, OR SEVE

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF T
HE MEDICINAL P
RODUCT
STOCRIN 30
mg/mL oral solution
2.
QUALITATIVE AND Q
UANTITATIVE C
OMPOSITIO
N
Each mL contains 30 mg of efavirenz.
Excipients w
ith known effect
Each mL contains 1 mg of benzoic acid (E210).
Each mL contains up to 0.816 mg of benzyl alcohol (E1519).
For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL F
ORM
Oral solution
Colourless to sl
ight
ly yellow cle
ar liquid.
4.
CLINICAL PART
ICULARS
4.1
THERAPEUTIC INDI
CATIONS
STOCRIN oral solution is indicated
in antiviral
combination tr
eatment of human immunodeficiency
virus-1 (HIV-
1) infected adults, adolesc
ents and children 3
years of age and
old
er, who are u
nable to
swallow the film
-coated tablets.
STOCRIN has not
bee
n adequately studied in patients with a
dvanced HIV
di
sease, namely
in patients
with CD4 counts <
50 cells/mm
3
,
or after failure of protease i
nhibitor (PI
) containing regimens.
Although cross-resistance o
f efavirenz with PIs
has
not been documented, the
re a
re at present
insufficient data on the
efficacy of su
bsequent use o
f PI based combination therapy after fa
ilure of
regimens containing STOCRI
N.
For a su
mmary of clinical and ph
arma
codynamic inf
ormation, see section 5.1.
4.2
P
OSOLOGY AND METHOD OF ADM
INISTRATION
Therapy should be initiated by
a physician e
xperienced in
the management of HIV infection.
Posology
Efavirenz
must be given in com
bination wit
h other antiretroviral m
edicines (see
section
4.5).
Efavirenz oral soluti
on may be taken with or w
itho
ut food (see
section 5.2).
In order to
improve the
t
olerability of
nervous system
adverse reactions, bedt
ime dosing is
recommended during th
e first two
to four weeks of therapy
and
in patients
who conti
nue to experience
these
symptoms (see
section
4.8).
Adults
T
he recommended dose of
efavirenz in combinati
on with nucleo
side analogue reverse transcriptase
inh
ibitors (NRTIs) with or without a P
I (see section 4.5) is 24 mL orally, once daily.
3
Dose adjustment
If efaviren