ENTECAVIR ARISTO

PACKAGE LEAFLET

Package leaflet: Information for the user

Entecavir Aristo 0.5 mg film-coated tablets, 1.0 mg film-coated tablets

Entecavir
Equivalent medicinal product
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Entecavir Aristo is and what it is used for
2. What you need to know before taking 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 an antiviral medicine, used in adults for the treatment of chronic (long-term) hepatitis B virus (HBV) infection. 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 for the treatment of chronic (long-term) hepatitis B virus (HBV) infection in children and adolescents. Entecavir Aristo can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Hepatitis B virus infection can cause liver damage. Entecavir Aristo reduces the amount of virus in the body and improves liver condition.

2. What you need to know before taking Entecavir Aristo

Do not take Entecavir Aristo

• if you are allergic to the active substance or to 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 had kidney problems, inform your doctor. This is important because Entecavir Aristo is eliminated from the body through the kidneys, and you may require a dose adjustment or a different dosing schedule.
• Do not stop taking Entecavir Aristo without medical advice, as hepatitis may worsen after stopping treatment. If treatment with this medicine is discontinued, your doctor will continue to monitor you and perform blood tests for several months.
• Discuss with your doctor whether your liver is functioning properly, and, if not, how this may affect your treatment with Entecavir Aristo.
• If you are also infected with HIV (human immunodeficiency virus), inform your doctor. You should not take this medicine to treat hepatitis B infection unless you are already receiving treatment for HIV, as the effectiveness of future HIV treatment may be reduced. Entecavir Aristo will not control your HIV infection.
• Taking Entecavir Aristo will not prevent you from transmitting the hepatitis B virus (HBV) to others through sexual contact or body fluids (including blood contamination). Therefore, it is important to take precautions to avoid spreading the hepatitis B virus (HBV) to others. A vaccine is available to protect individuals at risk of contracting hepatitis B virus (HBV) infection.
• Entecavir Aristo belongs to a class of medicines that may cause lactic acidosis (excess lactic acid in the blood) and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain may indicate the development of lactic acidosis. This rare but serious side effect has occasionally been fatal. Lactic acidosis occurs more frequently in women, especially those who are significantly overweight. Your doctor will monitor you regularly during treatment with Entecavir Aristo.
• If you have previously received treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
Entecavir must not be given to children under 2 years of age or who weigh less than 10 kg.
Other medicines and Entecavir Aristo
Inform 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 previously been treated with a medicine containing the active substance lamivudine, consider the following. If you have switched to treatment with Entecavir Aristo because lamivudine therapy was not effective, you must take Entecavir Aristo once daily on an empty stomach. If your liver disease is very advanced, your doctor will instruct you to take Entecavir Aristo on an empty stomach. An empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.
Children and adolescents (from 2 to 18 years of age) may take Entecavir Aristo 0.5 mg tablets with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
It has not been established that the use of entecavir during pregnancy is safe. Unless specifically instructed by your doctor, Entecavir Aristo must not be used during pregnancy. It is important that women of childbearing potential use an effective method of contraception during treatment with this medicine to avoid pregnancy.
You must not breastfeed during treatment with this medicine.
It is not known whether entecavir, the active substance in Entecavir Aristo, is excreted in human breast milk.
Driving and using machines
Dizziness, fatigue, and drowsiness are common side effects that may impair your ability to drive or operate machinery. Consult your doctor for any clarification.
Entecavir Aristo contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Entecavir Aristo

Not all patients need to take the same dose of Entecavir Aristo.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
For adults, the recommended dose is 0.5 mg or 1 mg, taken once daily by oral administration (by mouth).
Your dose will depend on:

• whether you have previously received treatment for hepatitis B virus (HBV) infection, and which medicine you were treated with.
• whether you have kidney problems. Your doctor may prescribe a lower dose or advise you to take it less than once daily.
• the condition of your liver.

For children and adolescents (from 2 to 18 years of age), your child's doctor will determine the appropriate dose based on your child's weight.
0.5 mg tablet: children weighing at least 32.6 kg may take the 0.5 mg tablet, or an oral solution of entecavir may be available. An oral solution of entecavir is recommended for patients weighing between 10 kg and 32.5 kg. Each dose will be administered once daily by oral route (by mouth). There are no recommendations for entecavir in children under 2 years of age or with body weight below 10 kg. The paediatrician will determine the appropriate dose based on your child's weight.
1 mg tablet: Entecavir Aristo 0.5 mg tablets are available or an oral solution of entecavir may be available. Your child's doctor will determine the appropriate dose based on your child's weight.
To ensure the medicine is fully effective and to reduce the development of resistance to therapy, always take the dose recommended by your doctor. Take Entecavir Aristo for the entire duration indicated by your doctor. Your doctor will inform you whether and when to stop treatment.
Some patients must take Entecavir Aristo on an empty stomach (see Entecavir Aristo with food and
drink in section 2). If your doctor has told you to take this medicine on an empty stomach, this means at least 2 hours after a meal and at least 2 hours before the next meal.
If you take more Entecavir Aristo than you should
Contact your doctor immediately.
If you forget to take Entecavir Aristo
It is important that you do not miss any doses. If you forget a dose of Entecavir Aristo, take it as soon as possible, then take the next dose at the scheduled time. If it is almost time for the next dose, do not take the missed dose. Wait and take the next dose at the scheduled time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Entecavir Aristo
Do not stop treatment with Entecavir Aristo without consulting your doctor. Many people experience very severe symptoms of hepatitis when they stop taking entecavir.
Inform your doctor immediately if you notice any changes in your symptoms after stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Patients treated with entecavir have reported the following side effects:
Common (affects at least 1 in 100 patients):

• headache, insomnia (inability to sleep), fatigue (excessive tiredness), dizziness, drowsiness (somnolence),
• vomiting, diarrhoea, nausea, dyspepsia (indigestion),
• increased levels of liver enzymes in the blood.

Uncommon (affects at least 1 in 1,000 patients):

• skin rash,
• hair loss.

Rare (affects at least 1 in 10,000 patients):

• severe allergic reaction.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir 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 pack or
carton after Exp.
The expiry date refers to the last day of that month.
After first opening the bottle, the tablets must be used within 30 days.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Entecavir Aristo contains

• The active substance is entecavir. Each film-coated tablet of Entecavir Aristo 0.5 mg contains entecavir monohydrate equivalent to 0.5 mg of entecavir. Each film-coated tablet of Entecavir Aristo 1.0 mg contains entecavir monohydrate equivalent to 1.0 mg of entecavir.
• Other components are:
  Entecavir Aristo 0.5 mg
  Tablet core: Lactose monohydrate, Microcrystalline cellulose, Crospovidone (type A), Hydroxypropylcellulose (type L) and Magnesium stearate.
  Film coating (white): Titanium dioxide (E171), Lactose monohydrate, Hypromellose, Macrogol 4000.

Entecavir Aristo 1.0 mg
Tablet core: Lactose monohydrate, Microcrystalline cellulose, Crospovidone (type A),
Hydroxypropylcellulose (type L) and Magnesium stearate.
Film coating (pink): Hypromellose, Titanium dioxide (E171), Polydextrose, Talc,
Maltodextrin, Medium-chain triglycerides, Iron oxide red (E172), Iron oxide yellow (E172).

Description of the appearance of Entecavir Aristo and contents of the pack
Entecavir Aristo 0.5 mg film-coated tablets are white to almost white, triangular-shaped tablets, marked with "0.5" on one side, with average dimensions of 8.4 mm ± 0.2 mm and thickness 3.7 mm ± 0.3 mm.
Entecavir Aristo 1.0 mg film-coated tablets are pink, triangular-shaped tablets, marked with "1" on one side, with average dimensions of 10.6 mm ± 0.2 mm and thickness 4.5 mm ± 0.3 mm.
Entecavir Aristo is available in cardboard cartons containing OPA/ALU/PVC – aluminium foil blisters or white HDPE bottles with child-resistant PP cap and induction sealing.
Pack sizes:
30 tablets (blister)
90 tablets (blister)
30 tablets (bottle)
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Entecavir Aristo 0.5 mg & 1 mg filmovertrukket tablet
United Kingdom: Entecavir Aristo 0.5 & 1 mg film-coated tablets
Germany: Entecavir Aristo 0,5 & 1 mg Filmtabletten
Italy: Entecavir Aristo 0,5 mg & 1 mg compresse rivestite con film
Spain: Entecavir Aristo 0,5 mg & 1 mg comprimido recubierto con película EFG