Tenofovir 245mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tenofovir disoproxil

Available from:

Lupin Healthcare (UK

ATC code:

J05AF07

INN (International Name):

Tenofovir disoproxil

Dosage:

245mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030100; GTIN: 5060346430249

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TENOFOVIR DISOPROXIL MYLAN 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 Tenofovir disoproxil Mylan is and what it is used for
2.
What you need to know before you take Tenofovir disoproxil Mylan
3.
How to take Tenofovir disoproxil Mylan
4.
Possible side effects
5.
How to store Tenofovir disoproxil Mylan
6.
Contents of the pack and other information
IF THIS MEDICINE 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 TENOFOVIR DISOPROXIL MYLAN IS AND WHAT IT IS USED FOR
Tenofovir disoproxil Mylan 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
Tenofovir disoproxil
Mylan should always be used combined with other medicines to treat HIV
infection.
TENOFOVIR DISOPROXIL MYLAN 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 H

Summary of Product characteristics

OBJECT 1
TENOFOVIR DISOPROXIL LUPIN 245 MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 18-Dec-2017 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Tenofovir disoproxil Lupin 245 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
phosphate).
Excipient(s) with known effect
Each film-coated tablet contains 8.16 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Blue, oval, biconvex film-coated tablets debossed with “T1” on one
side and plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
_HIV-1 infection_
Tenofovir disoproxil Lupin 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 tenofovir disoproxil 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 tenofovir disoproxil phosphate 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).
Tenofovir disoproxil Lupin 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 tenofovir disoproxil 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_
Tenofovir disoproxil Lupin 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
amino