Viread 245mg tablets

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Tenofovir disoproxil

Disponible des:

Gilead Sciences International Ltd

Codi ATC:

J05AF07

Designació comuna internacional (DCI):

Tenofovir disoproxil

Dosis:

245mg

formulario farmacéutico:

Tablet

Vía de administración:

Oral

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05030100; GTIN: 5391507145444

Informació per a l'usuari

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIREAD 245 MG FILM-COATED TABLETS
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 Viread is and what it is used for
2.
What you need to know before you take Viread
3.
How to take Viread
4.
Possible side effects
5.
How to store Viread
6.
Contents of the pack and other information
IF VIREAD HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL THE
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT VIREAD IS AND WHAT IT IS USED FOR
Viread contains the active substance _tenofovir disoproxil_. This
active substance is an _antiretroviral_ or
antiviral medicine which is used to treat HIV or HBV infection or
both. Tenofovir is a _nucleotide reverse _
_transcriptase inhibitor_, generally known as an NRTI and works by
interfering with the normal working of
enzymes (in HIV _reverse transcriptase_; in hepatitis B _DNA
polymerase_) that are essential for the viruses
to reproduce themselves. In HIV Viread should always be used combined
with other medicines to treat
HIV infection.
VIREAD 245 MG TABLETS ARE A TREATMENT FOR HIV (Human Immunodeficiency
Virus) infection. The
tablets are suitable for:

ADULTS

ADOLESCENTS AGED 12 TO LESS THAN 18 YEARS WHO HAVE ALREADY BEEN
TREATED with other HIV
medicines which are no longer fully effective due to development of
resistance, or have caused side
effects.
VIREAD 245 MG TABLETS ARE ALSO A TREATMENT FOR CHRONIC HEPATITI

Fitxa tècnica

OBJECT 1
VIREAD 245 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 08-Jun-2017 | Gilead
Sciences Ltd
1. Name of the medicinal product
Viread 245 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
fumarate).
Excipient with known effect
Each tablet contains 164 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
Light blue, almond-shaped, film-coated tablets, of dimensions 16.8 mm
x 10.3 mm, debossed on one side
with “GILEAD” and “4331” and on the other side with “300”.
4. Clinical particulars
4.1 Therapeutic indications
_HIV-1 infection_
Viread 245 mg film-coated tablets are indicated in combination with
other antiretroviral medicinal
products for the treatment of HIV-1 infected adults.
In adults, the demonstration of the benefit of Viread in HIV-1
infection is based on results of one study in
treatment-naïve patients, including patients with a high viral load
(> 100,000 copies/ml) and studies in
which Viread was added to stable background therapy (mainly
tritherapy) in antiretroviral pre-treated
patients experiencing early virological failure (< 10,000 copies/ml,
with the majority of patients having <
5,000 copies/ml).
Viread 245 mg film-coated tablets are also indicated for the treatment
of HIV-1 infected adolescents, with
NRTI resistance or toxicities precluding the use of first line agents,
aged 12 to < 18 years.
The choice of Viread to treat antiretroviral-experienced patients with
HIV-1 infection should be based on
individual viral resistance testing and/or treatment history of
patients.
_Hepatitis B infection_
Viread 245 mg film-coated tablets are indicated for the treatment of
chronic hepatitis B in adults with:
• compensated liver disease, with evidence of active viral
replication, persistently elevated serum alanine
aminotransferase (ALT) levels and histological evidence of active
inflammation and/or fibrosis (