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ENTECAVIR MILPHARM 1 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR MONOHYDRATE

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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.

Entecavir 0.5 mg
film-coated tablets
Entecavir 1 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 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
Do not take Entecavir
• If you are allergic 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.
Black

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.
0.5 mg:
Children and adolescents (from 2 to less than
18 years of age) can take entecavir 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 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 breastfeeding. 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.
Entecavir contains lactose monohydrate. 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.

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Package leaflet: Information for the user

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.
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
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 the national reporting
system listed in Yellow Card Scheme, Website:
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
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 label, carton, blister or bottle
after EXP. The expiry date refers to the last day of
that month.
Blister Pack: Store below 30°C.
HDPE Pack: 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 contains
• The active substance is entecavir.
Each film-coated tablet contains 0.5 mg
entecavir (as monohydrate).
Each film-coated tablet contains 1 mg entecavir
(as monohydrate).


The other ingredients are
Tablet Core: Lactose monohydrate, cellulose,
microcrystalline (E460), crospovidone(E1202),
magnesium stearate.
Tablet coating: Hypromellose (E464), macrogol
400, titanium dioxide (E 171).

What Entecavir looks like and contents of the
pack
Film coated tablet.
Entecavir 0.5 mg film-coated tablets
White triangular shaped, biconvex, film-coated
tablets, debossed with ‘ET’ on one side and ‘0 5’ on
the other side.
Entecavir 1 mg film-coated tablets
White round shaped, biconvex, film-coated tablets,
debossed with ‘ET’ on one side and ‘1’ on the other
side.
Entecavir film-coated tablets are available in blister
packs and HDPE bottle packs with polypropylene
closure.
Pack sizes:
Blister packs:30 and 90 film-coated tablets
HDPE packs: 30, 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park,
West End Road
South Ruislip, HA46QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park,
West End Road
South Ruislip, HA46QD
United Kingdom
or
Arrow Génériques
Lyon, 26 avenue Tony Garnier,
69007 Lyon
France
or
Generis Farmacêutica,
S.A., Rua João de Deus,
19, 2700-487 Amadora,
Portugal
This leaflet was last revised in 06/2017.

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0.5 mg:
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 32.6 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.
1 mg:
For children and adolescents (from 2 to less than
18 years of age), 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.

+ 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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