Efavirenz Sandoz 600mg film-coated Tablets

Država: Malta

Jezik: engleski

Izvor: Malta Medicines Authority

Aktivni sastojci:

EFAVIRENZ

Dostupno od:

Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia

ATC koda:

J05AG03

INN (International ime):

EFAVIRENZ 600 mg

Farmaceutski oblik:

FILM-COATED TABLET

Sastav:

EFAVIRENZ 600 mg

Tip recepta:

POM

Područje terapije:

ANTIVIRALS FOR SYSTEMIC USE

Status autorizacije:

Withdrawn

Datum autorizacije:

2013-08-07

Uputa o lijeku

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ SANDOZ 600 MG FILM-COATED TABLETS
efavirenz
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Efavirenz Sandoz is and what it is used for
2.
What you need to know before you take Efavirenz Sandoz
3.
How to take Efavirenz Sandoz
4.
Possible side effects
5.
How to store Efavirenz Sandoz
6.
Contents of the pack and other information
1
WHAT EFAVIRENZ SANDOZ IS AND WHAT IT IS USED FOR
Efavirenz Sandoz 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.
Your doctor has prescribed Efavirenz Sandoz for you because you have
HIV infection. Efavirenz
Sandoz taken in combination with other antiretroviral medicines
reduces the amount of the virus in the
blood.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFAVIRENZ SANDOZ
DO NOT TAKE EFAVIRENZ SANDOZ

IF YOU ARE ALLERGIC (hypersensitive) to efavirenz or any of the other
ingredients of Efavirenz
Sandoz (listed in section 6). Contact your doctor or pharmacist for
advice.

IF YOU HAVE SEVERE LIVER DISEASE.

IF YOU ARE CURRENTLY TAKING any of the following medicines:
-
ASTEMIZOLE OR TERFENADINE (used to treat allergy symptoms)
-
BEPRIDIL (used to treat heart disease)
-
CISAPRIDE (used to treat heartburn)
-
ERGOT ALKALOIDS (for example, ergotamine, dihydroergotamine,
ergonovine, and
methylergono

Svojstava lijeka

Page 1 of 31
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efavirenz Sandoz 600 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz.
Excipient(s) with known effect:
Each film-coated tablet contains 100.3 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow film-coated tablet of capsule shape (9.6 x 19.2 mm) with a
break line on both sides.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz Sandoz is indicated in antiviral combination treatment of
human immunodeficiency virus-
1 (HIV-1) infected adults, adolescents and children weighing 40 kg or
more.
Efavirenz Sandoz 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 Efavirenz Sandoz.
For a summary of clinical and pharmacodynamic information, see section
5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Page 2 of 31
Tablets shall preferably be taken whole but may be divided in equal
doses if dose adjustments are
necessary or in case of difficulty swallowing.
_Concomitant antiretroviral therapy: _Efavirenz Sandoz must be given
in combination with other
antiretroviral medicines (see section 4.5).
It is recommended that Efavirenz Sandoz be taken on an empty stomach.
The increased efavirenz
concentrations observed following administration of Efavirenz Sandoz
with food may lead to an
increase in frequency of adverse reactions (see sections 4.4 and 5.2).
In order to improve the tolerability of nervous system undesirable