Efavirenz 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Efavirenz

Available from:

Mylan

ATC code:

J05AG03

INN (International Name):

Efavirenz

Dosage:

600mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100; GTIN: 5016695005331

Patient Information leaflet

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ 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, 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 is and what it is used for
2.
What you need to know before you take Efavirenz
3.
How to take Efavirenz
4.
Possible side effects
5.
How to store Efavirenz
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ IS AND WHAT IT IS USED FOR
Efavirenz contains the active substance efavirenz, which 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. It
is used by adults, adolescents and children 3 months of age and older
and weighing at least 3.5 kg.
Your doctor has prescribed Efavirenz for you because you have HIV
infection. Efavirenz 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
DO NOT TAKE EFAVIRENZ:

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 are currently taking any of the following medicines:

astemizole or terfenadine (used to treat allergy symptoms

Summary of Product characteristics

OBJECT 1
EFAVIRENZ MYLAN 600 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 17-Jul-2017 | Generics UK
T/A Mylan
1. Name of the medicinal product
Efavirenz 600 mg 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 128 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
Yellow capsule shaped, biconvex, bevelled-edge film-coated tablet
debossed with “M” on one side and
“EV6” 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 months of age and older
and weighing at least 3.5 kg.
Efavirenz has not been adequately studied in patients with advanced
HIV disease, namely in patients with
CD4 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 efavirenz
form