Entecavir Aurobindo

Package leaflet: Information for the user

Entecavir Aurobindo 0.5 mg film-coated tablets, 1 mg film-coated tablets

Equivalent medicine
Please 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 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, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

What this leaflet contains:

1. What Entecavir Aurobindo is and what it is used for
2. What you need to know before taking Entecavir Aurobindo
3. How to take Entecavir Aurobindo
4. Possible side effects
5. How to store Entecavir Aurobindo
6. Contents of the pack and other information

1. What Entecavir Aurobindo is and what it is used for

Entecavir Aurobindo tablets are an antiviral medicine used in adults for the treatment of chronic (long-term) hepatitis B virus infection. Entecavir Aurobindo can be used in patients whose liver is damaged but still functions properly (compensated liver disease) and in patients whose liver is damaged and does not function properly (decompensated liver disease).
Entecavir Aurobindo tablets are also used for the treatment of chronic (long-term) hepatitis B virus infection in children and adolescents from 2 to less than 18 years of age. Entecavir Aurobindo 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 Aurobindo reduces the amount of virus in the body and improves liver condition.

2. What you need to know before taking Entecavir Aurobindo

Do not take Entecavir Aurobindo

• if you are allergic to entecavir 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 Aurobindo.

• If you have ever had kidney problems, inform your doctor. This is important because Entecavir Aurobindo is eliminated from the body through the kidneys, and you may need a dose adjustment or a different dosing schedule.
• Do not stop taking Entecavir Aurobindo without consulting your doctor, as hepatitis may worsen after stopping treatment. If treatment with Entecavir Aurobindo 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 Aurobindo.
• If you are also infected with HIV (human immunodeficiency virus), inform your doctor. You should not take Entecavir Aurobindo to treat hepatitis B infection unless you are already taking medicines for HIV, as the effectiveness of future HIV treatment may be reduced. Entecavir Aurobindo will not control your HIV infection.
• Taking Entecavir Aurobindo will not prevent you from transmitting the hepatitis B virus (HBV) to others through sexual contact or bodily 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 people at risk of contracting hepatitis B virus (HBV) infection.
• Entecavir Aurobindo belongs to a class of medicines that can cause lactic acidosis (excess lactic acid in the blood) and enlargement of the liver. 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 Aurobindo.
• If you have previously received treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
Entecavir Aurobindo must not be given to children under 2 years of age or who weigh less than 10 kg.

Other medicines and Entecavir Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Entecavir Aurobindo with food and drink
In most cases, you can take Entecavir Aurobindo 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 Entecavir Aurobindo because lamivudine treatment was not successful, you must take Entecavir Aurobindo once daily on an empty stomach. If your liver disease is in a very advanced stage, your doctor will prescribe that you take Entecavir Aurobindo on an empty stomach. An empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal.
0.5 mg:
Children and adolescents (from 2 up to less than 18 years of age) may take entecavir with or without food.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. It has not been proven that using Entecavir Aurobindo during pregnancy is safe. Unless specifically instructed by your doctor, Entecavir Aurobindo must not be used during pregnancy. It is important that women of childbearing age use an effective method of contraception during treatment with Entecavir Aurobindo to avoid pregnancy.
You must not breastfeed during treatment with Entecavir Aurobindo. Inform your doctor if you are breastfeeding. It is not known whether entecavir, the active substance in Entecavir Aurobindo, is excreted in human breast milk.

Driving and using machines
Dizziness, tiredness (fatigue), and drowsiness are common side effects that may affect your ability to drive or operate machinery. Consult your doctor for any clarification.

Entecavir Aurobindo contains lactose monohydrate. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Entecavir Aurobindo

Not all patients need to take the same dose of Entecavir Aurobindo.
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 was used.
• 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.

0.5 mg:
For children and adolescents (from 2 up to less than 18 years of age), your child’s doctor will determine the correct dose based on the child’s body weight. Children weighing at least 32.6 kg may take the 0.5 mg tablets, or entecavir oral solution may be available. Each dose should be administered once daily by oral route (by mouth). There are no recommendations for entecavir use in children under 2 years of age or weighing less than 10 kg.
Your child’s doctor will determine the correct dose based on the child’s body weight.

1 mg:
For children and adolescents (from 2 to less than 18 years of age), Entecavir Aurobindo 0.5 mg tablets or entecavir oral solution are available.
Your child’s doctor will determine the correct dose based on the child’s body weight.
Your doctor will advise you on the correct dosage for you. To ensure the medicine is fully effective and to reduce the risk of developing resistance to treatment, always take the dose recommended by your doctor. Take Entecavir Aurobindo for the entire duration prescribed by your doctor. Your doctor will inform you whether and when to stop treatment.

Some patients must take Entecavir Aurobindo on an empty stomach (see Entecavir Aurobindo with food and drink in section 2). If your doctor has instructed you to take Entecavir Aurobindo 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 Aurobindo than you should
Contact your doctor immediately.

If you forget to take Entecavir Aurobindo
It is important not to miss any doses. If you forget a dose of Entecavir Aurobindo, take it as soon as possible, then continue with your next dose at the usual time. If it is almost time for your 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 missed dose.

Do not stop treatment with Entecavir Aurobindo without consulting your doctor
Some people develop very severe hepatitis symptoms when they stop taking Entecavir Aurobindo. Inform your doctor immediately if you notice any changes in your symptoms after stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients treated with Entecavir Aurobindo:
Common (affects at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (drowsiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased liver enzyme levels 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 effect, 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton, the blister or the bottle after EXP. The expiry date refers to the last day of that month.
Blister pack: Store below 30°C.
HDPE container: This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Aurobindo Contains

• The active substance is entecavir. Each film-coated tablet contains 0.5 mg of entecavir (as monohydrate). Each film-coated tablet contains 1 mg of entecavir (as monohydrate).
• The other components are: Tablet core: lactose monohydrate, microcrystalline cellulose (E460), crospovidone (E1202), magnesium stearate. Tablet coating: hypromellose (E464), macrogol 400, titanium dioxide (E171).

Description of the Appearance of Entecavir Aurobindo and Contents of the Package
Film-coated tablet.
Entecavir Aurobindo 0.5 mg film-coated tablets:
White, triangular-shaped, biconvex, film-coated tablet, marked with “ET” on one side and “0\ 5” on the other side.
Entecavir Aurobindo 1 mg film-coated tablets:
White, round-shaped, biconvex, film-coated tablet, marked with “ET” on one side and “1” on the other side.
Entecavir Aurobindo film-coated tablets are available in blister packs and in HDPE bottles with polypropylene caps.
Pack sizes:
Blister packs: 30 and 90 film-coated tablets.
HDPE bottles: 30, 100 and 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy
Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6Qd
United Kingdom
Arrow Génériques - Lyon
26 avenue Tony Garnier, 69007 Lyon
France
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: Entecavir Aurovitas
France: Entecavir Arrow 0.5 mg/1 mg, comprimé pelliculé
Germany: Entecavir PUREN 0.5 mg/1 mg Filmtabletten
Italy: Entecavir Aurobindo
Netherlands: Entecavir Aurobindo 0.5 mg/1 mg, filmomhulde tabletten
Poland: Entecavir Aurovitas
Portugal: Entecavir Generis
Romania: Entecavir Aurobindo 0.5 mg/1 mg comprimate filmate
Spain: Entecavir Aurovitas 0.5 mg/1 mg comprimidos recubiertos con película EFG
United Kingdom: Entecavir Milpharm 0.5 mg/1 mg film-coated tablets