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ENTECAVIR DR. REDDYS 1 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR MONOHYDRATE / ENTECAVIR MONOHYDRATE

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Package leaflet: Information for the user

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).
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 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.
- 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.
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.
Children and adolescents (from 2 to less than 18 years of age) 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 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
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.
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.
Your child's doctor will decide the right dose based on your child's weight.
Entecavir 1 mg:
For children and adolescents (from 2 to less than 18 years of age), weighing at least 32.6 kg and requiring a dose
of 0.5 mg (= halve a tablet of 1 mg), Entecavir 0.5 mg tablets are also available.
All dosing will be taken once daily orally (by mouth).
For children and adolescents weighing less than 32.6 kg and for dosages below 0.5 mg 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.
The 1 mg tablet can be divided into equal doses.
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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this
leaflet.
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 at 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 blister or carton after EXP. That expiry date
refers to the last day of that month.
Do not store above 30°C. Store in the original package.
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 tablets contain
Entecavir 0.5 mg:
The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate corresponding to 0.5 mg
entecavir.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch pregelatinised, crospovidone (Type A)
(E1202) and magnesium stearate.
Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521) and polysorbate 80 (E433).
Entecavir 1 mg:
The active substance is entecavir. Each film-coated tablet contains entecavir monohydrate corresponding to 1 mg
entecavir.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, maize starch pregelatinised, crospovidone (Type A)
(E1202) and magnesium stearate.
Tablet coating: titanium dioxide (E171), hypromellose (E464), macrogol 400 (E1521), polysorbate 80 (E433) and
red iron oxide (E172)
What Entecavir tablets look like and contents of the pack
Entecavir 0.5 mg:
Entecavir film-coated tablets are white and oval-shaped with a break line on both sides.
Entecavir 1 mg:
Entecavir film-coated tablets are pink and oval-shaped with a break line on both sides.
Entecavir film-coated tablets are supplied in cartons containing 10 x 1, 30 x 1, 60 x 1 or 90 x 1 film-coated tablet in
unit-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
Medis International a.s., výrobní závod Bolatice, Průmyslová 961/16, 74723 Bolatice, Czech Republic
This leaflet was last revised in 04/2017

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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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