Sustiva 600mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Efavirenz

Available from:

Bristol-Myers Squibb Pharmaceuticals Ltd

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: 5012712003144

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUSTIVA 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 SUSTIVA is and what it is used for
2.
What you need to know before you take SUSTIVA
3.
How to take SUSTIVA
4.
Possible side effects
5.
How to store SUSTIVA
6.
Contents of the pack and other information
1.
WHAT SUSTIVA IS AND WHAT IT IS USED FOR
SUSTIVA, 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
months of age and older and
weighing at least 3.5 kg.
Your doctor has prescribed SUSTIVA for you because you have HIV
infection.
SUSTIVA 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 SUSTIVA
DO NOT TAKE SUSTIVA

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, A
SLOW HEART BEAT, OR SEVERE HEART DISEASE.
�

Summary of Product characteristics

OBJECT 1
SUSTIVA 600 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 04-Jan-2018 | Bristol-Myers
Squibb Pharmaceuticals
limited
1. Name of the medicinal product
SUSTIVA 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 249.6 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Dark yellow, capsule-shaped, printed with “SUSTIVA” on both sides.
4. Clinical particulars
4.1 Therapeutic indications
SUSTIVA 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.
SUSTIVA 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
SUSTIVA.
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. Efavirenz hard
capsules are available for these patients.
_Dose