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ENTECAVIR 1MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR

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Package leaflet: Information for the user

Entecavir 0.5mg and 1mg
Film-coated Tablets
entecavir
Read all of this leaflet carefully before
you start taking this medicine because
it contains important information for
you.
• K
 eep this leaflet. You may need to read
it again.
•  I f 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.
• I f 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.
•  The full name of this medicine is
Entecavir 0.5mg and 1mg Film-coated
Tablets but within the leaflet it will be
referred to as Entecavir Tablets.

What is in this leaflet
1 What Entecavir Tablets are and
what they are used for
2 What you need to know before
you take Entecavir Tablets
3 How to take Entecavir Tablets
4 Possible side effects
5 How to store Entecavir Tablets
6 Contents of the pack and other
information
1 What Entecavir Tablets are and

what they are used for

Entecavir Tablets are anti-viral
medicines, used to treat chronic (long
term) hepatitis B virus (HBV) infection
in adults. Entecavir Tablets can be used
in people whose liver is damaged but
still functions properly (compensated
liver disease) and in people whose liver is
damaged and does not function properly
(decompensated liver disease).
Entecavir Tablets are also used to treat
chronic (long term) HBV infection in
children and adolescents aged 2 years to
less than 18 years. Entecavir Tablets can
be used in children whose liver is damaged
but still functions properly (compensated
liver disease).
Infection by the hepatitis B virus can lead
to damage to the liver. Entecavir Tablets
reduces the amount of virus in your body,
and improves the condition of the liver.

2 What you need to know before

you take Entecavir Tablets

Do not take Entecavir Tablets
• i f you are allergic (hypersensitive) to
entecavir or any of the other ingredients
of this medicine (listed in section 6).

Warning and precautions

Talk to your doctor or pharmacist before
taking Entecavir Tablets

• i f you have ever had problems with

your kidneys, tell your doctor. This is
important because Entecavir Tablets are
eliminated from your body through the
kidneys and your dose or dosing schedule
may need to be adjusted.

•d
 o not stop taking Entecavir Tablets

without your doctor’s advice since your
hepatitis may worsen after stopping
treatment. When your treatment with
Entecavir Tablets is stopped, your doctor
will continue to monitor you and take
blood tests for several months.

•d
 iscuss with your doctor whether your

liver functions properly and, if not, what
the possible effects on your Entecavir
Tablets treatment may be.

• i f you are also infected with HIV (human

immunodeficiency virus) be sure to tell
your doctor. You should not take Entecavir
Tablets to treat your hepatitis B infection
unless you are taking medicines for HIV
at the same time, as the effectiveness of
future HIV treatment may be reduced.
Entecavir Tablets will not control your HIV
infection.

• t aking Entecavir Tablets will not stop

you from infecting other people with
hepatitis B virus (HBV) through sexual
contact or body fluids (including blood
contamination). So, it is important to take
appropriate precautions to prevent others
from becoming infected with HBV. A
vaccine is available to protect those at risk
from becoming infected with HBV.

• E ntecavir Tablets belong to a class of

medicines that can cause lactic acidosis
(excess of lactic acid in your blood) and
enlargement of the liver. Symptoms such
as nausea, vomiting and stomach pain
might indicate the development of lactic
acidosis. This rare but serious side effect
has occasionally been fatal. Lactic acidosis
occurs more often in women, particularly
if they are very overweight. Your doctor
will monitor you regularly while you are
receiving Entecavir Tablets.

• i f you have previously received

treatment for chronic hepatitis B, please
inform your doctor.

Children and adolescents

Entecavir Tablets should not be used for
children below 2 years of age or weighing
less than 10kg.

Other medicines and Entecavir
Tablets

Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.

Entecavir Tablets with food and
drink

In most cases you may take Entecavir
Tablets with or without food. However, if
you have had a previous treatment with a
medicine containing the active substance
lamivudine you should consider the
following. If you were switched over to
Entecavir Tablets because the treatment
with lamivudine was not successful, you
should take Entecavir Tablets on an empty
stomach once daily. If your liver disease
is very advanced, your doctor will also
instruct you to take Entecavir Tablets on
an empty stomach. Empty stomach means
at least 2 hours after a meal and at least 2
hours before your next meal.
Children and adolescents (from 2 to less
than 18 years of age) can take Entecavir
Tablets with or without food.

Pregnancy, breast-feeding and
fertility

Tell your doctor if you are pregnant or
planning to become pregnant. It has
not been demonstrated that Entecavir
Tablets are safe to use during pregnancy.
Entecavir Tablets must not be used during
pregnancy unless specifically directed by
your doctor. It is important that women of
childbearing age receiving treatment with
Entecavir Tablets use an effective method
of contraception to avoid becoming
pregnant.
You should not breast-feed during
treatment with Entecavir Tablets. Tell
your doctor if you are breast-feeding. It is
not known whether entecavir, the active
ingredient in Entecavir Tablets, is excreted
in human breast milk.

Driving and using machines

Dizziness, tiredness (fatigue) and sleepiness
(somnolence) are common side effects
which may impair your ability to drive and
use machines. If you have any concerns
consult your doctor.

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Entecavir Tablets contain lactose

If you have been told by your doctor that
you have an intolerance to some sugars,
contact your doctor before taking this
medicinal product.

3 How to take Entecavir Tablets
Not all patients need to take the same
dose of Entecavir Tablets.
Always take this medicine exactly as your
doctor has told you. Check with your
doctor or pharmacist if you are not sure.
For adults the recommended dose is either
0.5mg or 1mg once daily orally (by mouth).
Your dose will depend on:
•w
 hether you have been treated for HBV
infection before, and what medicine you
received.
•w
 hether you have kidney problems. Your
doctor may prescribe a lower dose for you
or instruct you to take it less often than
once a day.
• t he condition of your liver.
For children and adolescents
(from 2 to less than 18 years of age), your
child’s doctor will decide the right dose
based on your child’s weight.
Children weighing at least 32.6kg may
take the 0.5mg tablet or an entecavir oral
solution may be available. For patients
weighing from 10kg to 32.5kg, an entecavir
oral solution is recommended. All dosing
will be taken once daily orally (by mouth).
There are no recommendations for
entecavir in children less than 2 years of
age or weighing less than 10kg.
Your child`s doctor will decide the correct
dose based on your child`s weight.
Always take the dose recommended by
your doctor to ensure that your medicine
is fully effective and to reduce the
development of resistance to treatment.
Take Entecavir Tablets as long as your
doctor has told you. Your doctor will tell
you if and when you should stop the
treatment.
Some patients must take Entecavir Tablets
on an empty stomach (see Entecavir
Tablets with food and drink in Section
2). If your doctor instructs you to take
Entecavir Tablets on an empty stomach,
empty stomach means at least 2 hours
after a meal and at least 2 hours before
your next meal.

If you take more Entecavir Tablets
than you should
Contact your doctor at once.

If you forget to take Entecavir
Tablets

It is important that you do not miss any
doses. If you miss a dose of Entecavir
Tablets, take it as soon as possible, and
then take your next scheduled dose at its
regular time. If it is almost time for your
next dose, do not take the missed dose.
Wait and take the next dose at the regular
time. Do not take a double dose to make
up for a forgotten dose.

Do not stop Entecavir Tablets
without your doctor’s advice

Some people get very serious hepatitis
symptoms when they stop taking Entecavir
Tablets. Tell your doctor immediately about
any changes in symptoms that you notice
after stopping treatment.
If you have any further questions on the
use of this medicine, ask your doctor or
pharmacist.

4 Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
Patients treated with Entecavir Tablets have
reported the following side effects:
common (at least 1 in 100 patients):
headache, insomnia (inability to sleep),
fatigue (extreme tiredness), dizziness,
somnolence (sleepiness), vomiting,
diarrhoea, nausea, dyspepsia (indigestion),
and increased blood levels of liver
enzymes.
uncommon (at least 1 in 1,000 patients):
rash, hair loss.
rare (at least 1 in 10,000 patients):
severe allergic reaction.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
United Kingdom
Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard or search for
MHRA Yellow Card in the Google Play or
Apple App Store.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5 How to store Entecavir Tablets
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the blister or carton
after EXP.
That expiry date refers to the last day of
that month.
This medicine does not require any special
storage conditions.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other

information

What Entecavir Tablets contain
• T he active substance is entecavir. Each

film-coated tablet contains either 0.5mg
or 1mg entecavir.
• T he other ingredients are:
Tablet core: lactose monohydrate 200 M,
microcrystalline cellulose PH102,
crospovidone (type A), magnesium
stearate.
Tablet coating:
0.5mg tablets: Opadry II white 85F28751
containing: polyvinyl alcohol partially
hydrolyzed (E1203), titanium dioxide
(E171), macrogol/PEG 3000 (E1521), talc
(E553b).
1mg tablets: Opadry II pink 85F24151
containing: polyvinyl alcohol partially
hydrolyzed (E1203), titanium dioxide
(E171), macrogol/PEG 3000 (E1521), talc
(E553b), red iron oxide (E172).

What Entecavir Tablets look like and
contents of the pack

Entecavir 0.5mg Film-coated Tablets are
white to off-white, triangular-shaped,
coated tablets. They are marked with “ENT”
on one side and “0.5” on the other.
Entecavir 1mg Film-coated Tablets are pink,
triangular-shaped, coated tablets. They are
marked with “ENT” on one side and “1” on
the other.
Entecavir Film-coated Tablets are supplied
in blister packs containing 30 tablets.
Marketing Authorisation Holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Pharmascience International Ltd
1st Floor, Jacovides Tower
81-83 Grivas Digenis Avenue
Nicosia 1090
Cyprus
This leaflet was last revised in August
2017.

If you would like a
leaflet with larger text,
please contact
+44 (0) 1271 385257

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Entecavir 0.5mg & 1mg 30 Tablets PIL - UK/IE
approved for print/date

Proof Round

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Item no:

BBBA1158

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
14.08.17
30.08.17
S.Anson

Date sent:
14.08.17
Date received: 16.08.17

Dimensions:
148 x 420
Min Body Text Size: 9pts
Supplier:
Pharmascience

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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