STOCRIN 600 MG TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EFAVIRENZ

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

J05AG03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

EFAVIRENZ 600 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME B.V, HOLLAND

Therapeutic group:

EFAVIRENZ

Therapeutic area:

EFAVIRENZ

Therapeutic indications:

Stocrin in combination with other antiretroviral agents, is indicated for the treatment of HIV-1-infection .

Authorization date:

2013-10-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine can be sold under doctor’s prescription only
STOCRIN
® 600 MG
TABLETS
Each tablet contains:
Efavirenz 600 mg
For a list of inactive ingredients please refer to section 6.1
"
What STOCRIN contains". See also section 2.8
“Important information about some of the ingredients of STOCRIN".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
This leaflet contains concise information about STOCRIN. If you have
any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
ailment seems similar to yours.
1. WHAT STOCRIN IS INTENDED FOR?
STOCRIN, in combination with other antiretroviral medicines, is used
for the treatment of patients suffering
from human immunodeficiency virus (HIV-1) infection.
THERAPEUTIC GROUP
: STOCRIN, which contains the active substance efavirenz, belongs to a
class of
antiretroviral medicines called non-nucleoside reverse transcriptase
inhibitors (NNRTIs).
It is an antiretroviral medicine that fights human immunodeficiency
virus (HIV) infection by reducing the
amount of the virus in blood.
2. BEFORE USING STOCRIN
2.1 DO NOT USE THE MEDICINE:
•
IF YOU ARE SENSITIVE (ALLERGIC) to efavirenz or any of the other
ingredients of this medicine
(listed in section 6). Contact your doctor or pharmacist for advice.
•
IF YOU HAVE SEVERE LIVER DISEASE.
•
IF YOU HAVE A HEART CONDITION, SUCH AS CHANGES IN THE RHYTHM OR RATE
OF THE HEART BEAT,
A SLOW HEART BEAT, OR SEVERE HEART DISEASE.
•
if any member of your family (parents, grandparents, brothers or
sisters) has died suddenly
due to a heart problem or was born with heart problems.
•
if your doctor has told you that you have high or low levels of
electrolytes such as potassium
or magnesium in your blood.
•
IF YOU ARE PREGNANT OR BREAST-FEEDING (SEE SECTION 2.6 “PREGNANCY,
BREAST-FEEDING AND
FERTILITY”).
•
IF YOU A

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
STOCRIN
®
600 mg Tablets
Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz.
Excipient with known effect: each film-coated tablet contains 249.6 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, capsule-shaped, debossed with “225” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STOCRIN in combination with other antiretroviral agents is indicated
for the treatment of HIV-1
infection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
Efavirenz must be given in combination with other antiretroviral
medicines (see
section
4.5).
In order to improve the tolerability of nervous system adverse
reactions, bedtime dosing is
recommended (see section 4.8).
_Adults_
The recommended dose of efevirenz in combination with nucleoside
analogue reverse transcriptase
inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg
orally, once daily.
_Drug interaction _
As STOCRIN 600 mg tablet is the only dose form available in the local
marketplace, the
recommended dose adjustments for voriconazole and rifampicin are not
possible (see section 4.5)
Special populations
_Renal impairment_
The pharmacokinetics of efavirenz have not been studied in patients
with renal insufficiency; however,
less than 1 % of an efavirenz dose is excreted unchanged in the urine,
so the impact of renal
impairment on efavirenz elimination should be minimal (see section
4.4).
_ _
_Hepatic impairment_
2
Patients with mild liver disease may be treated with their normally
recommended dose of efavirenz.
Patients should be monitored carefully for dose-related adverse
reactions, especially nervous system
symptoms (see sections 4.3 and 4.4).
_ _
_Paediatric population (3 to 17 years)_
Due to the local marketplace availability of 600 mg tablets only, this
medication can onl