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ENTECAVIR 1 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR / ENTECAVIR MONOHYDRATE / ENTECAVIR / ENTECAVIR MONOHYDRATE

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Package leaflet: Information for the user
Entecavir 0.5 mg film-coated tablets
Entecavir 1.0 mg film-coated tablets
Entecavir
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
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. 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
Do not take Entecavir
• if you are allergic to entecavir or any of the
other ingredients of this medicine (listed in
section 6).
Warnings 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 this medicine 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 this medicine 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
taking 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 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 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.
Children and adolescents (from 2 to less than 18
years of age) can take Entecavir 0.5 mg tablets
with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
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 this
medicine use an effective method of contraception
to avoid becoming pregnant.
You should not breast-feed during treatment with
this medicine.
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 medicine 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), your child’s doctor will
decide the right dose based on your child’s weight.
For 0.5 mg tablet: Children weighing at least
32.6 kg may take the 0.5 mg tablet or an entecavir
oral solution may be available. For patients
weighing from 10 kg to 32.5 kg, 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 10 kg. Your
child’s doctor will decide the right dose based on
your child’s weight.
For 1 mg tablet: Entecavir 0.5 mg tablets are
available or an entecavir oral solution may be
available. Your child’s doctor will decide the right
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 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 on an empty
stomach (see Entecavir with food and drink in
Section 2). If your doctor instructs 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.
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.
If you stop taking Entecavir
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

What Entecavir looks like and contents of the
pack
Entecavir 0.5 mg film coated tablets are presented
as white to off white triangular-shaped tablets
debossed with “0.5” on one side, with the following
dimensions median 8.4mm±0.2 mm and thickness
3.7mm±0.3 mm.
Entecavir 1.0 mg film coated tablets are presented
as pink triangular-shaped tablets debossed with “1”
on one side, with the following dimensions median
10.6mm±0.2 mm and thickness 4.5mm±0.3 mm.
Entecavir is supplied in a cardboard box containing
OPA/ALU/PVC - Aluminium foil blisters or a white
HDPE bottle with PP child resistant cap and
induction sealing.
Pack sizes
30 tablets (blister)
90 tablets (blister)
30 tablets (bottle)

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Not all pack sizes may be marketed.
Patients treated with entecavir 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)
• 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.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court,
Eastgate Way
Manor Park, Runcorn, Cheshire, WA7 1NT, UK
Manufacturer:
Pharmathen SA
6 Dervenakion Str
Pallini, 15351
Greece

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 Cheme at:
www.mhra.gov.uk/yellowcard. By reporting side
affects you can help provide more information on
the safety of this medicine.

Or

5. How to store Entecavir

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
Nürnberg, 90449
Germany

Keep this medicine out of the sight and reach of
children.

Pharmathen Internaational S.A
Industrial Park Sapes, Rodopi Prefecture,
Block No 5
Rodopi, 69300,
Greece
Or

Do not use this medicine after the expiry date
which is stated on the bottle, blister or box after
EXP. The expiry date refers to the last day of that
month.

This medicinal product is authorised in
the Member States of the EEA under the
following names:

After first opening of the bottle, the tablets should
be used within 30 days.

Denmark
Germany

This medicine does not require any special storage
conditions.

Italy
Spain

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 of Entecavir 0.5 mg
contains entecavir monohydrate equivalent to
0.5 mg of entecavir.
Each film-coated tablet of Entecavir 1.0 mg
contains entecavir monohydrate equivalent to
1 mg of entecavir.


The other ingredients are:
Entecavir 0.5 mg
Tablet core: Lactose monohydrate, Cellulose
Microcrystalline, Crospovidone (type A),
Hydroxypropyl cellulose (type L) and
Magnesium stearate
Coating medium (white): Titanium dioxide
(E171), Lactose monohydrate, Hypromellose,
Macrogol 4000
Entecavir 1.0 mg
Tablet core: Lactose monohydrate, Cellulose
Microcrystalline, Crospovidone (type A),
Hydroxypropyl cellulose (type L) and
Magnesium stearate
Coating medium (pink): Hypromellose, Titanium
dioxide (E171), Polydextrose, Talc, Maltodextrin,
Triglycerides, medium chain, Iron oxide red
(E172), Iron oxide yellow (E172)

Romania

Poland
France

Entecavir Pharmathen
Entecavir Heumann 0,5 mg & 1 mg
Filmtabletten
Entecavir Kabi
Entecavir Kabi 0,5 mg comprimidos
recubiertos con película EFG
Entecavir Kabi 1,0 mg comprimidos
recubiertos con película EFG
Entecavir Pharmathen 0,5 mg
comprimate filmate
Entecavir Pharmathen 1 mg comprimate
filmate
Entecavir Synoptis
ENTECAVIR PHARMATHEN 0,5 mg,
comprimé pelliculé
ENTECAVIR PHARMATHEN 1 mg,
comprimé pelliculé

This leaflet was last revised in July 2017

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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