Efavirenz Teva

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

efavirenz

Saatavilla:

Teva B.V.

ATC-koodi:

J05AG03

INN (Kansainvälinen yleisnimi):

efavirenz

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

HIV Infections

Käyttöaiheet:

Efavirenz is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children 3 years of age and older.Efavirenz 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 protease inhibitors (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.

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2012-01-09

Pakkausseloste

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFAVIRENZ TEVA 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Efavirenz Teva is and what it is used for
2.
What you need to know before you take Efavirenz Teva
3.
How to take Efavirenz Teva
4.
Possible side effects
5.
How to store Efavirenz Teva
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ
TEVA IS AND WHAT IT IS USED FOR
Efavirenz Teva, 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-1) infection by reducing the amount of
the virus in blood. It is used by adults, adolescents and children 3
years of age and older.
Your doctor has prescribed Efavirenz Teva for you because you have HIV
infection. Efavirenz Teva
taken in combination with other antiretroviral medicines reduces the
amount of the virus in the blood.
This will strengthen your immune system and reduce the risk of
developing illnesses linked to HIV
infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EFAVIRENZ
TEVA
DO NOT TAKE EFAVIRENZ TEVA
-
IF YOU ARE 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,

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz Teva 600 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg efavirenz.
Excipients with known effect
Each film-coated tablet contains 9.98 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Yellow, capsule-shaped, film-coated tablet debossed with “Teva” on
one side and “7541” on the other
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz is indicated in antiviral combination treatment of human
immunodeficiency virus-1 (HIV-1)
infected adults, adolescents and children 3 years of age and older.
Efavirenz has not been adequately studied in patients with advanced
HIV disease, namely in patients
with CD
4
counts < 50 cells/mm
3
, 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.
For a summary of clinical and pharmacodynamic information, see section
5.1.
_ _
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 and adolescents over 40 kg _
The recommended dose of efavirenz in combination with nucleoside
analogue reverse transcriptase
inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg
orally, once daily.
Efavirenz film-coated tablets are not suitable for children weighing
less than 40 kg. Other
formulations are available for these patients.
3
_Dose adjustment _
If efavirenz is co-administered with voriconazole, the voriconazole
m