Entecavir Teva

Package leaflet: Information for the user

Entecavir 0.5 mg film-coated tablets

Entecavir 1 mg film-coated tablets
Generic medicine
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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Entecavir Teva tablets are an antiviral medicine used in adults for the treatment of chronic (long-term) hepatitis B virus infection. Entecavir Teva 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 Teva tablets are also used for the treatment of chronic (long-term) hepatitis B virus infection in children and adolescents from 2 to 18 years of age. Entecavir Teva 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 Teva reduces the amount of virus in the body and improves liver condition.

2. What you need to know before taking Entecavir Teva

Do not take Entecavir Teva

• 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 Teva

• if you have had kidney problems, inform your doctor. This is important because Entecavir Teva is eliminated from the body through the kidneys, and therefore you may need a dose adjustment or different dosing schedule.
• do not stop taking Entecavir Teva 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.
• talk to your doctor to find out if your liver is functioning properly and, if not, ask your doctor how this may affect your treatment with Entecavir Teva.
• if you are also infected with HIV (human immunodeficiency virus), inform your doctor. You must not take Entecavir Teva to treat hepatitis B infection unless you are already receiving HIV treatment, as the effectiveness of future HIV treatment may be reduced. This medicine will not control your HIV infection.
• taking Entecavir Teva will not prevent you from transmitting the hepatitis B (HBV) virus to others through sexual contact or bodily fluids (including blood contamination). Therefore, it is important to take precautions to avoid spreading the hepatitis B (HBV) virus to others. A vaccine is available to protect those at risk of contracting hepatitis B (HBV) virus infection.
• Entecavir Teva 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 this medicine.
• if you have previously received treatment for chronic hepatitis B, inform your doctor.

Children and adolescents
Entecavir Teva must not be given to children under 2 years of age or who weigh less than 32.6 kg.
Other medicines and Entecavir Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Entecavir Teva 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 ingredient lamivudine, you should consider the following. If you have switched to treatment with this medicine because lamivudine therapy was not effective, you must take this medicine once daily on an empty stomach. If liver disease is very advanced, your doctor will instruct you to take this medicine 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 this medicine with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. The use of this medicine during pregnancy has not been proven safe. Unless specifically instructed by your doctor, Entecavir Teva 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 prevent pregnancy.
You must not breastfeed during treatment with Entecavir Teva. Inform your doctor if you are breastfeeding. It is not known whether entecavir, the active substance of this medicine, 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.

3. How to take Entecavir Teva

Not all patients require the same dose of Entecavir Teva.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose for adults is 0.5 mg or 1 mg 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.

Use in children and adolescents
[Entecavir Teva 0.5 mg film-coated tablets]
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 body weight. Children weighing at least 32.6 kg may take the 0.5 mg tablet, or an oral solution of entecavir may be available. For patients weighing between 10 kg and 32.5 kg, the oral solution of entecavir is recommended. Each dose should be administered once daily by oral route (by mouth). There are no recommendations for the use of entecavir in children under 2 years of age or with body weight below 10 kg.
Your child's doctor will determine the correct dose based on your child's weight.
[Entecavir Teva 1 mg film-coated tablets]
For children and adolescents (from 2 to 18 years of age) weighing at least 32.6 kg and requiring a dose of 0.5 mg (= half of the 1 mg tablet), Entecavir Teva 0.5 mg tablets are also available. Each dose should be administered once daily by oral route (by mouth).
For children and adolescents weighing less than 32.6 kg and for doses below 0.5 mg, an oral solution of entecavir may be available.
Your child's doctor will determine the correct dose based on your child's weight.
Your doctor will advise you on the correct dose for you. Always take the dose recommended by your doctor to ensure the medicine is fully effective and to reduce the risk of developing resistance to treatment. Take Entecavir Teva for the duration recommended by your doctor. Your doctor will inform you whether and when you should stop treatment.
Some patients must take Entecavir Teva on an empty stomach (see Entecavir Teva with food and
drink in Section 2). If your doctor tells 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 Teva than you should
Contact your doctor immediately.

If you forget to take Entecavir Teva
It is important not to miss any doses. If you forget to take a dose, take it as soon as you remember, and then take the next dose at your usual time.
If it is almost time for your next dose, do not take the missed dose. Wait and take the next dose at your usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Entecavir Teva
Do not stop taking Entecavir Teva without consulting your doctor. Some people may experience severe worsening of hepatitis after stopping treatment. Contact 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, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Patients treated with Entecavir Teva have reported the following side effects:

Common (may affect up to 1 in 10 people):

• headache
• difficulty sleeping (insomnia)
• extreme tiredness
• dizziness
• sleepiness
• vomiting
• diarrhoea
• nausea
• indigestion (dyspepsia)
• increased levels of liver enzymes in the blood

Uncommon (may affect up to 1 in 100 people):

• skin rash
• hair loss

Rare (may affect up to 1 in 1,000 people):

• severe allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Entecavir Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, blister pack, or carton after EXP. The expiry date refers to the last day of that month.
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 Teva contains

• The active substance is entecavir.
• Each film-coated tablet contains 0.5 mg of entecavir.
• Each film-coated tablet contains 1 mg of entecavir.
• The other components are

Entecavir Teva 0.5 mg film-coated tablets
Tablet core: mannitol (E421), microcrystalline cellulose (E460), pregelatinized maize starch,
crospovidone type A (E1202), magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b).
Entecavir Teva 1 mg film-coated tablets
Tablet core: mannitol (E421), microcrystalline cellulose (E460), pregelatinized maize starch,
crospovidone type A (E1202), magnesium stearate.
Tablet coating: partially hydrolysed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350 (polyethylene glycol), talc (E553b), red iron oxide (E172).

Description of the appearance of Entecavir Teva and contents of the pack
Entecavir Teva 0.5 mg film-coated tablets
White to off-white, round-shaped tablet, marked with "05" on one side and "E" on the other side, with a diameter of approximately 5.96 – 6.26 mm.
Entecavir Teva 1 mg film-coated tablets
Light pink to pink, round-shaped tablet, with a score line, marked with "1" on one side and "E/E" on the other side, with a diameter of approximately 8.42 – 8.86 mm.
The tablet may be divided into two equal doses.
The film-coated tablets are available in:

• PVC/PVdC-Aluminum blisters in packs containing 10, 30, 60 or 90 tablets.
• PVC/PVdC-Aluminum unit dose divisible blisters in packs containing 30x1 tablets.
• Aluminum/OPA/PVC-Aluminum blisters in packs containing 10, 30, 60 or 90 tablets.
• Aluminum/OPA/PVC-Aluminum unit dose divisible blisters in packs containing 30x1 tablets.
• White HDPE bottles with child-resistant closure made of polypropylene, containing 30 or 100 tablets.
• White HDPE bottles with child-resistant closure made of polypropylene and 1 gram of desiccated silica gel in packs containing 300 or 100 tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturers
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4
20123 Milano
Italy
Responsible manufacturers for batch release
Merckle GmbH
Ludwig-Merckle-Strasse 3, 89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovica 25, 10000 Zagreb
Croatia
This medicinal product is authorized in the Member States of the European Economic Area under the following names: