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ENTECAVIR TEVA 0.5 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR MONOHYDRATE / ENTECAVIR MONOHYDRATE

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PANTONE® GREEN C
BLACK

Package leaflet: Information for the user

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 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

1 What Entecavir is and what it is used
for

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Entecavir tablets are anti-viral medicines, used to
treat chronic (long term) hepatitis B virus (HBV)
infection in adults. This medicine 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 to less than 18 years. This
medicine can be used in children whose liver is
damaged but still functions properly
(compensated liver disease).

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 this
medicine.
• 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 32.6 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 this medicine 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 this medicine because the treatment with
lamivudine was not successful, you should take
this medicine on an empty stomach once daily. If
your liver disease is very advanced, your doctor
will also instruct you to take this medicine 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 this medicine 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 is safe to use during pregnancy.
This medicine must not be used during pregnancy
unless specifically directed by your doctor. It is
important that women of childbearing age
Infection by the hepatitis B virus can lead to
receiving treatment with this medicine use an
damage to the liver. Entecavir reduces the amount effective method of contraception to avoid
of virus in your body, and improves the condition becoming pregnant.
of the liver.
You should not breast-feed during treatment with
Entecavir. Tell your doctor if you are
2 What you need to know before you
breast-feeding. It is not known whether entecavir,
take Entecavir
the active substance in this medicine, is excreted
Do not take Entecavir if you:
in human breast milk.
• are allergic (hypersensitive) to entecavir or any
of the other ingredients of this medicine (listed Driving and using machines
Dizziness, tiredness (fatigue) and sleepiness
in section 6).
(somnolence) are common side effects which may
Warnings and precautions
impair your ability to drive and use machines. If
Talk to your doctor or pharmacist before taking
you have any concerns consult your doctor.
Entecavir:
• if you have ever had problems with your
3 How to take Entecavir
kidneys, tell your doctor. This is important
because Entecavir is eliminated from your body Not all patients need to take the same dose of
through the kidneys and your dose or dosing
Entecavir.
schedule may need to be adjusted.
Always take this medicine exactly as your doctor
• do not stop taking Entecavir without your
doctor’s advice since your hepatitis may worsen has told you. Check with your doctor or
after stopping treatment. When your treatment pharmacist if you are not sure.
with this medicine is stopped, your doctor will
continue to monitor you and take blood tests for For adults the recommended dose is either
0.5 mg or 1 mg once daily orally (by mouth).
several months.
• discuss with your doctor whether your liver
Your dose will depend on:
functions properly and, if not, what the possible • whether you have been treated for HBV
effects on your Entecavir treatment may be
infection before, and what medicine you
• if you are also infected with HIV (human
received
immunodeficiency virus) be sure to tell your
• whether you have kidney problems. Your doctor
doctor. You should not take Entecavir to treat
may prescribe a lower dose for you or instruct
your hepatitis B infection unless you are taking
you to take it less often than once a day.
medicines for HIV at the same time, as the
• the condition of your liver.
effectiveness of future HIV treatment may be
reduced. This medicine will not control your HIV For children and adolescents (from 2 to less than
infection.
18 years of age), your child's doctor will decide
• taking Entecavir will not stop you from infecting the right dose based on your child's weight.
other people with hepatitis B virus (HBV)
Children weighing at least 32.6 kg may take the
through sexual contact or body fluids (including 0.5 mg tablet or an entecavir oral solution may be
blood contamination). So, it is important to take available. For patients weighing from 10 kg to
appropriate precautions to prevent others from 32.5 kg, an entecavir oral solution is
becoming infected with HBV. A vaccine is
recommended. All dosing will be taken once daily
available to protect those at risk from becoming orally (by mouth). There are no recommendations
infected with HBV.
for entecavir in children less than 2 years of age
• Entecavir belongs to a class of medicines that
or weighing less than 10 kg.
can cause lactic acidosis (excess of lactic acid in
Your child's doctor will decide the right dose
your blood) and enlargement of the liver.
based on your child's weight.
Symptoms such as nausea, vomiting and

2696

ENTECAVIR 0.5 mg AND 1 mg
FILM-COATED TABLETS

For children and adolescents weighing less than
32.6 kg and for dosages below 0.5 mg an
entecavir oral solution may be available.

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

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Your child's doctor will decide the right dose
based on your child's weight.

What Entecavir contains

Do not stop Entecavir without your doctor’s
advice
Some people get very serious hepatitis symptoms
when they stop taking this medicine. Tell your
doctor immediately about any changes in symptoms
that you notice after stopping treatment.

Entecavir 0.5 mg Film-coated Tablets are white to
off white, round shaped tablet, debossed with
"05" on one side of the tablet and with "E" on the
other side of the tablet with diameter of
approximately 5.96 - 6.26 mm.

• The active substance is entecavir.
• Each 0.5 mg film-coated tablet contains 0.5 mg
Your doctor will advise you on the dose that is
entecavir.
right for you. Always take the dose recommended
• The other ingredients are:
by your doctor to ensure that your medicine is
Tablet Core: mannitol (E421), cellulose
fully effective and to reduce the development of
microcrystalline (E460), maize starch
resistance to treatment. Take Entecavir as long as
pregelatinized, crospovidone type A (E1202),
your doctor has told you. Your doctor will tell you
magnesium stearate.
if and when you should stop the treatment.
Tablet Coating: poly(vinyl alcohol) partially
Some patients must take Entecavir on an empty
hydrolyzed (E1203), titanium dioxide (E171),
stomach (see Entecavir with food and drink in
macrogol 3350 (polyethylene glycol), talc
Section 2). If your doctor instructs you to take this
(E553b).
medicine on an empty stomach, empty stomach
• Each 1 mg film-coated tablet contains 1 mg
means at least 2 hours after a meal and at least
entecavir.
2 hours before your next meal.
• The other ingredients are:
If you take more Entecavir than you should
Tablet Core: mannitol (E421), cellulose
Contact your doctor at once.
microcrystalline (E460), maize starch
pregelatinized, crospovidone type A (E1202),
If you forget to take Entecavir
magnesium stearate.
It is important that you do not miss any doses. If
Tablet Coating: poly(vinyl alcohol) partially
you miss a dose of this medicine, take it as soon as
hydrolyzed (E1203), titanium dioxide (E171),
possible, and then take your next scheduled dose
macrogol 3350 (polyethylene glycol), talc
at its regular time. If it is almost time for your next
(E553b), iron oxide red (E172).
dose, do not take the missed dose. Wait and take
the next dose at the regular time. Do not take a
What Entecavir looks like and contents of the
double dose to make up for a forgotten dose.
pack

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
• inability to sleep (insomnia)
• extreme tiredness (fatigue)
• dizziness
• sleepiness (somnolence)
• vomiting
• diarrhoea
• nausea
• indigestion (dyspepsia)
• 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 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.

5 How to store Entecavir

Entecavir 1 mg Film-coated Tablets are light pink
to pink, round shaped tablet with deep score line,
debossed with "1" on one side of the tablet and
with "E/E" on the other side of the tablet with
diameter of approximately 8.42 - 8.86 mm. The
tablet can be divided into equal doses.
The 0.5 mg and 1 mg film-coated tablets are
supplied in:
• PVC/PVdC – Aluminium blisters in cartons
containing 10, 30, 60 or 90 tablets.
• PVC/PVdC – Aluminium unit-dose blisters in
cartons containing 30x1 tablets.
• Aluminium/OPA/PVC – Aluminium blisters in
cartons containing 10, 30, 60 or 90 tablets.
• Aluminium/OPA/PVC – Aluminium unit-dose
blisters in cartons containing 30x1 tablets.
• HDPE bottles with polypropylene child resistant
caps in cartons containing 30 or 100 tablets.
• HDPE bottles with polypropylene child resistant
caps and silica gel desiccants in cartons
containing 30 or 100 tablets.
The 1 mg film-coated tablets are also supplied in:
• PVC/PVdC – Aluminium unit-dose blisters in
cartons containing 60x1 or 90x1 tablets.
• Aluminium/OPA/PVC – Aluminium unit-dose
blisters in cartons containing 60x1 or 90x1
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz
baruna Filipovića 25, 10000 Zagreb, Croatia
This leaflet was last revised in 02/2017
PL 00289/2078
PL 00289/2079

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 bottle, blister or carton after
EXP. The expiry date refers to the last day of that
month.

70894-B

322K508200217

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For children and adolescents (from 2 to less than
18 years of age), weighing at least 32.6 kg and
requiring a dose of 0.5 mg (=halve a tablet of
1 mg), Entecavir 0.5 mg tablets are also available.
All dosing will be taken once daily orally (by
mouth).

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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