Hepsera 10mg tablets

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Adefovir dipivoxil

Disponibbli minn:

Gilead Sciences International Ltd

Kodiċi ATC:

J05AF08

INN (Isem Internazzjonali):

Adefovir dipivoxil

Dożaġġ:

10mg

Għamla farmaċewtika:

Tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 05030301; GTIN: 5391507146441

Fuljett ta 'informazzjoni

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEPSERA 10 MG TABLETS
Adefovir dipivoxil
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 Hepsera is and what it is used for
2.
What you need to know before you take Hepsera
3.
How to take Hepsera
4.
Possible side effects
5.
How to store Hepsera
6.
Contents of the pack and other information
1.
WHAT HEPSERA IS AND WHAT IT IS USED FOR
WHAT HEPSERA IS
Hepsera belongs to a group of medicines called antiviral medicines.
WHAT IT IS USED FOR
Hepsera is used to treat chronic hepatitis B, an infection with
hepatitis B virus (HBV), in adults.
Infection with the hepatitis B virus leads to damage to the liver.
Hepsera reduces the amount of the
virus in your body, and has been shown to reduce liver damage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HEPSERA
DO NOT TAKE HEPSERA

IF YOU ARE ALLERGIC to adefovir, adefovir dipivoxil or any of the
other ingredients of this
medicine (listed in section 6).

TELL YOUR DOCTOR AT ONCE if you could be allergic to adefovir,
adefovir dipivoxil or any of the
other ingredients of Hepsera.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Hepsera.

TELL YOUR DOCTOR IF YOU HAVE HAD KIDNEY DISEASE, or if tests have
shown problems with your
kidneys. Hepsera can affect the way your kidneys work. The risk of
this occurring is increased
with long-term use of Hepsera. Your doctor should run tests to check
your kidneys and liver are
working properly, before and during your treatment. Depending on the
resu

Karatteristiċi tal-prodott

OBJECT 1
HEPSERA 10 MG TABLETS
Summary of Product Characteristics Updated 19-Aug-2015 | Gilead
Sciences Ltd
1. Name of the medicinal product
Hepsera 10 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 10 mg adefovir dipivoxil.
Excipient(s) with known effect:
Each tablet contains 113 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet.
White to off-white, round, flat-faced, bevelled-edge tablets, 7 mm in
diameter, debossed with
“GILEAD“ and “10“ on one side and a stylised shape of a liver on
the other side.
4. Clinical particulars
4.1 Therapeutic indications
Hepsera is 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
liver inflammation and fibrosis.
Initiation of Hepsera treatment should only be considered when the use
of an alternative antiviral agent
with a higher genetic barrier to resistance is not available or
appropriate (see section 5.1).
• decompensated liver disease in combination with a second agent
without cross-resistance to Hepsera.
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B.
Posology
_Adults:_ The recommended dose of Hepsera is 10 mg (one tablet) once
daily taken orally with or without
food.
Higher doses must not be administered.
The optimum duration of treatment is unknown. The relationship between
treatment response and long-
term outcomes such as hepatocellular carcinoma or decompensated
cirrhosis is not known.
In patients with decompensated liver disease, adefovir should always
be used in combination with a
second agent, without cross-resistance to adefovir, to reduce the risk
of resistance and to achieve rapid
viral suppression.
Patients should be monitored every six months for hepatitis B
biochemical, virological and serological