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ENTECAVIR CIPLA 1.0 MG FILM COATED TABLETS

Active substance(s): ENTECAVIR

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Package leaflet: Information for the user
Entecavir Cipla 0.5 mg film-coated tablets
Entecavir Cipla 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 Cipla is and what it is used for
2. What you need to know before you take Entecavir Cipla
3. How to take Entecavir Cipla
4. Possible side effects
5. How to store Entecavir Cipla
6. Contents of the pack and other information

1. What Entecavir Cipla is and what it is used for
Entecavir Cipla contains the active substance entecavir and belongs to a group of medicines
called anti-viral. It is used to treat chronic (long term) hepatitis B virus (HBV) infection in adults.
Entecavir Cipla 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 Cipla is also used to treat chronic (long term) HBV infection in children and
adolescents. Entecavir Cipla 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 Cipla 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 Cipla
Do not take Entecavir Cipla
 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 Cipla
 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 Cipla without your doctor’s advice since your hepatitis may
worsen after stopping treatment. When your treatment with Entecavir Cipla 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 Cipla 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 Cipla will not control your HIV infection.
 taking Entecavir Cipla 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 Cipla 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 Cipla.
 if you have previously received treatment for chronic hepatitis B, please inform your doctor.
Children and adolescents
Entecavir Cipla should not be used for children below 2 years of age or weighing less than 10 kg.
Other medicines and Entecavir Cipla
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Entecavir Cipla with food and drink
In most cases you may take Entecavir Cipla 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 Cipla because the treatment with
lamivudine was not successful, you should take Entecavir Cipla on an empty stomach once daily.
If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Cipla
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 Cipla 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 Cipla is safe to use during pregnancy. Entecavir Cipla
must not be used during pregnancy unless specifically directed by your doctor. It is important that
women of childbearing age receiving treatment with Entecavir Cipla use an effective method of
contraception to avoid becoming pregnant.
You should not breast-feed during treatment with Entecavir Cipla . It is not known whether
entecavir, the active ingredient in Entecavir Cipla, 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 Cipla contain 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 Cipla
Not all patients need to take the same dose of Entecavir Cipla.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctoror 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), Entecavir Cipla 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. 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 Cipla 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.
Entecavir Cipla should not be used for children weighing less than 32.6 kg and if you or your
child are unable to swallow tablets. In such cases you may check with your doctor for the
availability of entecavir oral solution.
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 Cipla 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 Cipla on an empty stomach (see Entecavir Cipla with food and
drink in Section 2). If your doctor instructs you to take Entecavir Cipla 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 Cipla than you should
Contact your doctor at once.
If you forget to take Entecavir Cipla
It is important that you do not miss any doses. If you miss a dose of Entecavir Cipla, 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 Cipla
Some people get very serious hepatitis symptoms when they stop taking Entecavir Cipla. 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 Cipla have reported the following side effects:
Common (may affect up to 1 in 10 people)
 headache
 insomnia (inability to sleep)
 fatigue (extreme tiredness)
 dizziness
 somnolence (sleepiness)
 vomiting
 diarrhea
 nausea
 dyspepsia (indigestion)
 increased blood levels of liver enzymes
Uncommon (may affect up to 1 in 100 people)
 rash
 hair loss
Rare (may affect up to 1 in 1,000 people)
 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; 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 Cipla
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions
Do not use this medicine after the expiry date which is stated on the carton and label after “EXP”.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicine you no longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Entecavir Cipla contain
 The active substance is entecavir.
Entecavir Cipla 0.5 mg film-coated tablets
Each film-coated tablet contains 0.5 mg of entecavir
Entecavir Cipla 1 mg film-coated tablets
Each film-coated tablet contains 1 mg of entecavir

 The other ingredients are
Tablet core: Lactose monohydrate, microcrystalline cellulose (E460), crospovidone (E1202),
hydroxyl propyl cellulose (E463), magnesium stearate (E470b).
Film-coat:
Hypromellose (E464), titanium dioxide (E171), macrogol (E1521).
Entecavir Cipla 1 mg film-coated tablets additionally contains iron oxide red (E172).
What Entecavir Cipla looks like and contents of the pack
The Entecavir Cipla 1 mg film-coated tablets are pink coloured, triangular shaped, biconvex, film
coated tablets, debossed with “E” on one side and “1” on the other side. Length 11.00 ± 0.20 and
breadth 10.60 ± 0.20.
The Entecavir Cipla 0.5 mg film-coated tablets are white to off-white, triangular shaped
biconvex, film coated tablet, debossed with “E” on one side and plain on other side. Length 8.70
± 0.20 and breadth 8.40 ± 0.20.
Each carton contains either:


30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu
blisters,
or



90 x 1 film-coated tablet; 9 blister cards of 10 x 1 film-coated tablet each in Alu/
Alu blisters.

Not all pack sizes and container types may be marketed.
Marketing Authorisation Holder
Cipla (EU) Limited,
Dixcart House,
Addlestone Road,
Bourne Business Park,
Addlestone,
Surrey, KT15 2LE,
United Kingdom.
Manufacturer:
CIPLA (EU) Limited,
Dixcart House,
Addlestone Road,
Bourne Business Park,
Addlestone,
Surrey, KT15 2LE,
United Kingdom.
Cipla Europe NV,
De Keyserlei 58-60,
Box-19, 2018 Antwerp,
Belgium

This leaflet was last revised in
08/2017

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