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ENTECAVIR KENT 1 MG FILM-COATED TABLET

Active substance(s): ENTECAVIR MONOHYDRATE / ENTECAVIR MONOHYDRATE

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150 mm
PHARMA CODE

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTECAVIR 0.5 mg FILM-COATED TABLETS
ENTECAVIR 1 mg FILM-COATED TABLETS
entecavir

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.

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.

If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

WHAT IS IN THIS LEAFLET
1. What Entecavir is and what it is used for
2. What you need to know before you take Entecavir
3. How to take Entecavir
4. Possible side effects
5. How to store Entecavir
6. Contents of the pack and other information

Entecavir tablets are anti-viral medicines, used to
treat chronic (long term) hepatitis B virus (HBV)
infection in adults. Entecavir 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 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 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

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Do not take Entecavir
• if 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
• if you have ever had problems with your
kidneys, tell your doctor. This is important
because Entecavir is eliminated from your body
through the kidneys and your dose or dosing
schedule may need to be adjusted.
• do not stop taking Entecavir without your
doctor’s advice since your hepatitis may worsen
after stopping treatment. When your treatment
with Entecavir is stopped, your doctor will continue
to monitor you and take blood tests for several
months.
• discuss with your doctor whether your liver
functions properly and, if not, what the possible
effects on your Entecavir treatment may be.
• if you are also infected with HIV (human
immunodeficiency virus) be sure to tell your
doctor. You should not take Entecavir 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 will not control your HIV
infection.
• taking Entecavir 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.
• Entecavir belongs 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.
• if you have previously received treatment for
chronic hepatitis B, please inform your doctor.
Children and adolescents
Entecavir should not be used for children below 2
years of age or weighing less than 10 kg.
Other medicines and Entecavir
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Entecavir with food and drink
In most cases you may take Entecavir 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 because the
treatment with lamivudine was not successful, you
should take Entecavir on an empty stomach once
daily. If your liver disease is very advanced, your
doctor will also instruct you to take Entecavir on an
empty stomach. Empty stomach means at least 2
hours after a meal and at least 2 hours before your
next meal.

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

Not all patients need to take the same dose of
Entecavir.
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 0.5 mg
or 1 mg once daily orally (by mouth).
Your dose will depend on:
• whether you have been treated for HBV infection
before, and what medicine you received.
• whether 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.
• the condition of your liver.
For children and adolescents (from 2 to less than
18 years of age), Entecavir 0.5 mg tablets or an oral
solution are available. Your child's doctor will decide
the right dose based on your child's weight. Children
weighing at least 32.6 kg may take the 0.5 mg tablet.
The dose 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 10 kg.
Your doctor will advise you on the dose that is right
for you. 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 as long as your doctor has
told you. Your doctor will tell you if and when you
should stop the treatment.

203.9 mm

1.

WHAT ENTECAVIR IS AND WHAT IT IS
USED FOR

5.

HOW TO STORE ENTECAVIR

KEEP THIS MEDICINE OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use this medicine after the expiry date which
is stated on blister or carton after EXP. That expiry
date refers to the last day of that month.
This medicinal product 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 contains
• The active substance is entecavir. Each
film-coated tablet contains 0.5 mg entecavir.
• The active substance is entecavir. Each
film-coated tablet contains 1 mg entecavir.
• The other ingredients are:
0.5 mg and 1 mg Tablet core: lactose
monohydrate, microcrystalline cellulose,
crospovidone, hypromellose and magnesium
stearate.
0.5 mg Tablet coating: hypromellose, titanium
dioxide (E171), macrogol 400 and polysorbate 80
(E433).
1 mg Tablet coating: hypromellose, titanium
dioxide (E171), macrogol 400 and iron oxide red
(E172).
What Entecavir looks like and contents of the
pack
0.5 mg - White triangular shaped film-coated tablets
debossed 'A' on one side and '88' on the other side.
1 mg - Pink triangular shaped film-coated tablets
debossed 'A' on one side and '89' on the other side.

450 mm

Folding size 28.12 mm

150 mm

Entecavir 0.5 mg film-coated tablets are supplied in
cartons containing 30 or 90 film-coated tablets.
Entecavir 1 mg film-coated tablets are supplied in
cartons containing 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Kent Pharmaceuticals Limited, DCC Vital,
Westminster Industrial Estate, Repton Road,
Measham, DE12 7DT, England.
Manufacturer
Pharmacare, HHF003, Hal Far Industrial Estate,
Hal Far BBG3000, Malta.
Wessling Hungary Kft., Foti ut. 56, 1047 Budapest,
Hungary.
PL 08215/0104
PL 08215/0105
This leaflet was last revised in June 2017.

Some patients must take Entecavir on an empty
stomach (see Entecavir with food and drink in
Section 2). If your doctor instructs you to take
Entecavir 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 than you should
Contact your doctor at once.
If you forget to take Entecavir
It is important that you do not miss any doses. If you
miss a dose of Entecavir, 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 without your doctor’s
advice
Some people get very serious hepatitis symptoms
when they stop taking Entecavir. 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 have reported the
following side effects:
common (at least 1 in 100 patients): headache,
insomnia (inability to sleep), fatigue (extreme

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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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