Skip to Content

ENTECAVIR ZENTIVA 0.5 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR / ENTECAVIR

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

FILM TAB.ORTAK TRF(GB)

PM TYPE:
ARTWORK VERSION:
ARTWORK CREATION DATE:
ARTWORK REVISION DATE:
REASON OF REVISION:

LEAFLET
02
24.03.2017
-

PLANT NAME:
ARTWORK BY:

LULEBURGAZ
BG

TECHNICAL INFORMATION

GENERAL INFORMATION

PRODUCT NAME: ENTECAVIR

FORMAT (size):

PM CODE: 11030014479

OLD PM CODE: -

170 x 290 ± 0.5 mm

NUMBER OF COLORS:

1

Black
LEATUS (optical code/pharma code):

(449)

TECHNICAL DRAWING NUMBER:

B10087

MINIMAL SIZE OF TEXT:

9 pt

FONTS:

Helvetica Neue

Package leaflet: Information for the patient Infection by the hepatitis B virus can lead to
damage to the liver. Entecavir reduces the
Entecavir 0.5 mg film-coated tablets amount of virus in your body, and improves
Entecavir 1 mg film-coated tablets the condition of the liver.
Entecavir
2. What you need to know before you take
Entecavir
Read all of this leaflet carefully before you
start taking this medicine because it
Do not take Entecavir
contains important information for you.
• if you are allergic (hypersensitive) to
• Keep this leaflet. You may need to read it again.
entecavir or any of the other ingredients of
• If you have any further questions, ask your
this medicine (listed in section 6).
doctor or pharmacist.
Warning and precautions
• This medicine has been prescribed for you Talk to your doctor or pharmacist before
only. Do not pass it on to others. It may
taking Entecavir
harm them, even if their signs of illness are • if you have ever had problems with your
the same as yours.
kidneys, tell your doctor. This is important
• If you get any side effects, talk to your
because Entecavir is eliminated from your
doctor or pharmacist. This includes any
body through the kidneys and your dose or
possible side effects not listed in this
dosing schedule may need to be adjusted.
leaflet. See section 4.
• do not stop taking Entecavir without
What is in this leaflet
your doctor’s advice since your hepatitis
1. What Entecavir is and what it is used for
may worsen after stopping treatment. When
2. What you need to know before you take
your treatment with Entecavir is stopped,
Entecavir
your doctor will continue to monitor you
3. How to take Entecavir
and take blood tests for several months.
4. Possible side effects
• discuss with your doctor whether your
5. How to store Entecavir
liver functions properly and, if not, what
6. Contents of the pack and other information
the possible effects on your Entecavir
1. What Entecavir is and what it is used for
treatment may be.
• if you are also infected with HIV (human
Entecavir tablets are anti-viral medicines,
immunodeficiency virus) be sure to tell
used to treat chronic (long term) hepatitis
your doctor.
B virus (HBV) infection in adults. Entecavir
You should not take Entecavir to treat your
can be used in people whose liver is damaged
hepatitis B infection unless you are taking
but still functions properly (compensated liver
medicines for HIV at the same time, as the
disease) and in people whose liver is
effectiveness of future HIV treatment may
damaged and does not function properly
be reduced. Entecavir will not control your
(decompensated liver disease).
HIV infection.
Entecavir, the active ingredient in
Entecavir film-coated tablets, is also used • taking Entecavir will not stop you from
infecting other people with hepatitis B
to treat chronic (long term) HBV infection
virus (HBV) through sexual contact or
in children and adolescents aged 2 years
body fluids (including blood
to less than 18 years. Entecavir containing
contamination). So, it is important to take
products can be used in children whose liver
appropriate precautions to prevent others
is damaged but still functions properly
from becoming infected with HBV.
(compensated liver disease).

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 0.5 mg
Entecavir 0.5 mg film-coated tablets should
not be used for children weighing less than
32.6 kg.
Entecavir 1 mg
Entecavir containing products should not be
used for children below 2 years 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.

Entecavir 0.5 mg
Children and adolescents (weighing at least
32.6 kg) can take Entecavir 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. 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.
Use in children and adolescents
Entecavir 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.
Entecavir 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.
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.

Entecavir 1 mg
Reporting of side effects
If you get any side effects, talk to your doctor • The active substance is entecavir. Each
film-coated tablet contains 1 mg entecavir
or pharmacist. This includes any possible
(as monohydrate).
side effects not listed in this leaflet. You can
also report side effects directly via the Yellow • The other ingredients are:
Tablet core: lactose monohydrate,
Card Scheme at:
cellulose microcrystalline (Avicel PH 101 /
www.mhra.gov.uk/yellowcard. By reporting
PH 102), crospovidone (Type B) (E1202)
side effects you can help provide more
and magnesium stearate (E 572).
information on the safety of this medicine.
Tablet coating: opadry white YS-1-7003
(contains macrogol 400, polysorbate 80,
5. How to store Entecavir
hypromellose 3cp, hypromellose 6cp and
Keep this medicine out of the sight and reach
titanium dioxide (E171)).
of children.
What Entecavir looks like and contents of
Do not use this medicine after the expiry date the pack
Entecavir 0.5 mg
which is stated on the blister or carton after
EXP. The expiry date refers to the last day of The film-coated tablets are white to off white,
round, biconvex, plain on both side.
that month.
Entecavir 0.5 mg film-coated tablets are
This medicine does not require any special
supplied in cartons containing 30 or 90
film-coated tablets in blisters.
storage conditions.
Entecavir 1 mg
Do not throw away any medicines via
The film-coated tablets are white to off white,
wastewater or household waste. Ask your
4. Possible side effects
round, biconvex with score line on one side,
pharmacist how to throw away medicines
Like all medicines, this medicine can cause
you no longer use. These measures will help plain on the other side. The score line is not
intended for breaking the tablet.
side effects, although not everybody gets
protect the environment.
Entecavir 1 mg film-coated tablets are
them.
supplied in cartons containing 30 or 90
6. Contents of the pack and other
Patients treated with Entecavir have reported
film-coated tablets in blisters.
information
the following side effects:
Not all pack sizes may be marketed.
What Entecavir contains
Common (may affect up to 1 in 10 people):
Marketing Authorisation Holder
Entecavir 0.5 mg
• insomnia (inability to sleep)
Zentiva
• The active substance is entecavir. Each
• fatigue (extreme tiredness)
One Onslow Street, Guildford,
film-coated tablet contains 0.5 mg
• headache, dizziness, somnolence
Surrey, GU1 4YS, UK
entecavir
(as
monohydrate).
(sleepiness)
Manufacturer
• The other ingredients are:
• vomiting, diarrhoea, nausea, dyspepsia
S.C. ZENTIVA S.A.
Tablet core: lactose monohydrate,
(indigestion)
B-dul Theodor Pallady nr. 50, sector 3,
cellulose
microcrystalline
(Avicel
PH
101
/
• increased blood levels of liver enzymes
Bucureşti, cod 032266,
PH 102), crospovidone (Type B) (E1202)
Romania
Uncommon (may affect up to 1 in 100 people):
and magnesium stearate (E572).
• rash
This leaflet was last revised in March 2017
Tablet coating: opadry white YS-1-7003
• hair loss
(contains macrogol 400, polysorbate 80,
449
Rare (may affect up to 1 in 1,000 people):
hypromellose 3cp, hypromellose 6cp and
170x290
• severe allergic reaction
titanium dioxide (E171)).
11030014479
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.

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.

Hide