Efavirenz 600mg Emtricitabine 200mg Tenofovir disoproxil 245mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine

Available from:

Dr Reddy's Laboratories (UK

ATC code:

J05AR06

INN (International Name):

Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine

Dosage:

600mg ; 245mg ; 200mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100; GTIN: 5036072006980

Patient Information leaflet

Process Black
Die Cut
Guides
Brand:
Dr Reddy’s
Efavirenz/
Emtricitabine/Tenofovir
600mg/ 200 mg/245 mg
Film-Coated Tablets
N/A
UK
23/05/2017
25/10/2017
2
310 x 400 mm
Artwork
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DRXXXXXX
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL 600 MG/200 MG/245 MG
FILM-COATED TABLETS
Efavirenz/Emtricitabine/Tenofovir disoproxil
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/Emtricitabine/Tenofovir disoproxil is and what it is
used for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovir disoproxil
3.
How to take Efavirenz/Emtricitabine/Tenofovir disoproxil
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovir disoproxil
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL IS AND WHAT IT IS
USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL CONTAINS THREE ACTIVE
SUBSTANCES
that are
used to treat human immunodeficiency virus (HIV) infection:
-
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
-
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
-
Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Each of these active substances, also known as antiretroviral
medicines, work by interfering
with an enzyme (reverse transcriptase) that is essential for the virus
to multip

Summary of Product characteristics

OBJECT 1
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL 600
MG/200 MG/245 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 19-Apr-2018 | Dr. Reddy's
Laboratories (UK) Ltd
1. Name of the medicinal product
Efavirenz/Emtricitabine/Tenofovir disoproxil Dr. Reddy's 600 mg/200
mg/245 mg Film-Coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and 245 mg of tenofovir
disoproxil (equivalent to 300.6 mg tenofovir disoproxil succinate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Pink, capsule-shaped film-coated tablets, plain on both sides, with
dimensions 11 mm x 22 mm.
4. Clinical particulars
4.1 Therapeutic indications
Efavirenz/Emtricitabine/Tenofovir disoproxil is a fixed-dose
combination of efavirenz, emtricitabine and
tenofovir disoproxil. It is indicated for the treatment of human
immunodeficiency virus-1 (HIV-1)
infection in adults aged 18 years and over with virologic suppression
to HIV-1 RNA levels of < 50
copies/ml on their current combination antiretroviral therapy for more
than three months. Patients must
not have experienced virological failure on any prior antiretroviral
therapy and must be known not to
have harboured virus strains with mutations conferring significant
resistance to any of the three
components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil
prior to initiation of their first
antiretroviral treatment regimen (see sections 4.4 and 5.1).
The demonstration of the benefit of the fixed-dose combination of
efavirenz/emtricitabine/tenofovir
disoproxil is primarily based on 48-week data from a clinical study in
which patients with stable virologic
suppression on a combination antiretroviral therapy changed to the
fixed-dose combination of
efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No
data are currently available from clinical
studies with the fixed-dose combination of
efavirenz/emtricitabine/tenofovir disoproxil