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ENTECAVIR AMNEAL 0.5 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR MONOHYDRATE / ENTECAVIR MONOHYDRATE

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Entecavir tablets - UK - PIL

Review - 1

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.
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.

Size: 170 x 500 mm (PIL), Pantone: Black, Min. Font Size: 9 pt
Date: 17/07/17

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
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)
• increased blood levels of liver enzymes.

Front

Entecavir tablets - UK - PIL

Review - 1

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 MHRA
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 bottle, blister or box after EXP. The expiry date refers
to the last day of that month.
After first opening of the bottle, the tablets should be used
within 30 days.
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 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)
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)
30 tablets (bottle)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturers
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture
Block No 5
Rodopi
69300 Spain
Pharmathen S.A.
Dervenakion 6
Pallini
Athens
15351 Greece
This leaflet was last revised in July 2017

Size: 170 x 500 mm (PIL), Pantone: Black, Min. Font Size: 9 pt
Date: 17/07/17

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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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