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ENTECAVIR ARISTO 1 MG FILM-COATED TABLETS

Active substance(s): ENTECAVIR MONOHYDRATE

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

1. What Entecavir Aristo is and what it is used for
Entecavir Aristo tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B virus (HBV)
infection in adults. Entecavir Aristo 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 Aristo tablets are also used to treat chronic (long term) HBV infection in children and
adolescents. Entecavir Aristo 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 Aristo 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 Aristo
Do not take Entecavir Aristo
• 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 Aristo
• if you have ever had problems with your kidneys, tell your doctor. This is important because Entecavir
Aristo is eliminated from your body through the kidneys and your dose or dosing schedule may need to
be adjusted.
• do not stop taking Entecavir Aristo 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 Aristo 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 Aristo will not
control your HIV infection.
• taking Entecavir Aristo 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 Aristo 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 Aristo.
• 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 Aristo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Entecavir Aristo 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 Aristo because the treatment with lamivudine was not successful, you
should take Entecavir Aristo on an empty stomach once daily. If your liver disease is very advanced, your
doctor will also instruct you to take Entecavir Aristo 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 Aristo 0.5 mg tablets
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 Aristo 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 Aristo, 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 Aristo 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 Aristo
Not all patients need to take the same dose of Entecavir Aristo.
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 Aristo 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 Aristo 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 Aristo on an empty stomach (see ‘Entecavir Aristo 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 Aristo than you should
Contact your doctor at once.
If you forget to take Entecavir Aristo
It is important that you do not miss any doses. If you miss a dose of Entecavir Aristo, 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 Aristo
Do not stop Entecavir Aristo 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.
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 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 Tenofovir disoproxil Aristo
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 Aristo contains
• The active substance is entecavir.
Each tablet of Entecavir Aristo 0.5 mg contains entecavir monohydrate equivalent to 0.5 mg of entecavir.
Each tablet of Entecavir Aristo 1.0 mg contains entecavir monohydrate equivalent to 1 mg of entecavir.
• The other ingredients are:
Entecavir Aristo 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 Aristo 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 Aristo looks like and contents of the pack
Entecavir Aristo 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 Aristo 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 Aristo 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)
90 tablets (blister)
30 tablets (bottle)
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aristo Pharma GmbH
Wallenroder Straße 8–10
13435 Berlin
Germany
Manufacutrer
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture
Block No 5
Rodopi 69300
Greece
Or
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki Greece
This leaflet was last revised in July 2017.

GI604000-01/UK/0717

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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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