Efavirenz 600mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Efavirenz

Mevcut itibaren:

Milpharm Ltd

ATC kodu:

J05AG03

INN (International Adı):

Efavirenz

Doz:

600mg

Farmasötik formu:

Tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 05030100

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. 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
Efavirenz, 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 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.
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)
-
BEPRIDIL (used to treat heart disease)
-
CISAPRIDE (used to treat heartburn)
-
ERGOT ALKALOIDS (for example, ergotamine,

Ürün özellikleri

OBJECT 1
EFAVIRENZ 600MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 27-Jul-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Efavirenz Milpharm 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 152 mg
of lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
Yellow coloured, oval shaped, beveled edge, biconvex, film-coated
tablets, debossed with 'L' on one side
and '11' on the other side. The size is 20.1 mm X 9.6 mm.
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/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.
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 childr