Package Leaflet: Information for the User

Entecavir Accord 0.5 mg Film-Coated Tablets

Entecavir Accord 1 mg Film-Coated Tablets

entecavir

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package leaflet, as 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Entecavir Accord tablets are an antiviral medication used to treat chronic (long-term) infection by the hepatitis B virus (HBV) in adults. Entecavir Accord may be used in patients whose liver is damaged but still functioning properly (compensated liver disease) and in patients whose liver is damaged and not functioning properly (decompensated liver disease).

Entecavir Accord tablets are also used to treat chronic (long-term) infection by HBV in children and adolescents from 2 years to less than 18 years. Entecavir Accord may be used in children whose liver is damaged but still functioning properly (compensated liver disease).

Hepatitis B infection can damage the liver. Entecavir Accord reduces the amount of virus in your body and improves liver condition.

Do not take Entecavir Accord

if you are allergic (hypersensitive)to entecavir or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Entecavir Accord

• if you have ever had problems with your kidneys,inform your doctor. This is important because Entecavir Accord is eliminated from the body through the kidneys and it may be necessary to adjust your dose or treatment schedule.

• do not stop taking Entecavir Accord without consulting your doctor, as your hepatitis may worsen by interrupting treatment. When your treatment with Entecavir Accord is interrupted, your doctor will continue to monitor you and make blood tests for several months.

• ask your doctor if your liver is functioning properlyand if not, about the possible effects that your treatment with Entecavir Accord may have.

• if you are also infected with HIV(human immunodeficiency virus), make sure to inform your doctor. Do not take Entecavir Accord for the treatment of your hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as otherwise, the effectiveness of future HIV treatments may be reduced. Entecavir Accord will not control your HIV infection.

• taking Entecavir Accord will not prevent you from infecting others with the hepatitis B virus (HBV)through sexual contact or bodily fluids (including blood contamination). Therefore, it is essential to take the necessary precautions to prevent others from becoming infected with HBV. There is a vaccine to protect individuals at risk of HBV infection.

• Entecavir Accord belongs to a class of medicines that can cause lactic acidosis(excess of lactic acid in your blood) and liver enlargement. Symptoms such as nausea, vomiting, and abdominal pain may indicate the development of lactic acidosis. In some cases, this rare but severe side effect has been fatal. Lactic acidosis occurs more frequently in women, especially those who are overweight. Your doctor will monitor you periodically while you are taking Entecavir Accord.

• if you have received previous treatment for chronic hepatitis B, please inform your doctor.

Children and adolescents

Entecavir Accord should not be used in children under 2 years of age or weighing less than 10 kg.

Taking Entecavir Accord with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Taking Entecavir Accord with food and drinks

In most cases, you can take Entecavir Accord with or without food. However, if you have received previous treatment with another medicine containing lamivudine as the active ingredient, consider the following. If you have switched to Entecavir Accord because lamivudine treatment was unsuccessful, take Entecavir Accord on an empty stomach, once a day. If your liver disease is advanced, your doctor will also instruct you on taking Entecavir Accord on an empty stomach. Empty stomach means at least 2 hours after and 2 hours before the next meal.

Children and adolescents (2 to less than 18 years of age) can take Entecavir Accord with or without food.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or intend to become pregnant. The use of Entecavir Accord has not been proven to be safe during pregnancy. Do not use Entecavir Accord during pregnancy except when clearly necessary, according to your doctor. It is essential for women of childbearing age who are being treated with Entecavir Accord to use an effective contraceptive method to avoid becoming pregnant.

Do not breastfeed during treatment with Entecavir Accord. If you are doing so, inform your doctor. The excretion of entecavir, the active ingredient of Entecavir Accord, in breast milk is unknown.

Driving and operating machinery

Dizziness, fatigue, and drowsiness are common side effects that may impair your ability to drive and operate machinery. If you have any doubts, consult your doctor.

Entecavir Accord contains soy polysaccharides and sodium

This medicine contains soy polysaccharide. If you are allergic to soy, do not use this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Not all patients need to take the same dose of Entecavir Accord.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For adultsthe recommended dose is 0.5 mg or 1 mg once a day (oral administration).

Your dose will depend on:

• whether you have been previously treated for a hepatitis B infection, as well as the medication you have received.
• if you have kidney problems. Your doctor may prescribe a lower dose or indicate that you take it less frequently than once a day.
• your liver condition.

For children and adolescents(from 2 years to less than 18 years of age), Entecavir Accord 0.5 mg tablets are available or an oral solution of entecavir may be available.

Your pediatrician will decide on the appropriate dose based on the child's body weight. Children weighing at least 32.6 kg can take 0.5 mg tablets or an oral solution of entecavir may be available. For patients weighing 10 kg to 32.5 kg, an oral solution of entecavir is recommended. All doses should be taken once a day (oral administration). There are no recommendations for entecavir in children under 2 years of age or weighing less than 10 kg.

Your doctor will advise you on what dose is correct for you. Always take the dose recommended by your doctor to ensure the medication is fully effective and to reduce the development of treatment resistance. Take Entecavir Accord for the entire time your doctor has indicated. Your doctor will tell you when to stop treatment.

Some patients must take Entecavir Accord on an empty stomach (seeEntecavir Accord with food and drinksin theSection 2). If your doctor tells you to take Entecavir Accord on an empty stomach, empty stomach means at least 2 hours after a meal and 2 hours before the next meal.

Entecavir Accord is only available as film-coated tablets of 0.5 and 1 mg. For patients who cannot swallow tablets or who are recommended to reduce the dose, other medications containing entecavir with more suitable formulations may be available.

If you take more Entecavir Accord than you should

Contact your doctor immediately.

If you forgot to take Entecavir Accord

It is essential not to forget any dose. If you forget a dose of Entecavir Accord, take it as soon as you remember and then take the next scheduled 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 usual time. Do not take a double dose to compensate for the missed doses.

Do not interrupt treatment with Entecavir Accord without consulting your doctor

Some people develop severe hepatitis symptoms when stopping Entecavir Accord. Inform your doctor immediately of any changes in symptoms you observe after stopping treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Patients treated with Entecavir Accord have reported the following adverse effects:

Adults

• frequent (in at least 1 in 100 patients): headache, insomnia (inability to sleep), extreme fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, indigestion, and increased levels of liver enzymes in the blood.
• infrequent (in at least 1 in 1,000 patients): skin rash, hair loss.
• rare (in at least 1 in 10,000 patients): severe allergic reaction.

Children and Adolescents

The adverse effects experienced by children and adolescents are similar to those experienced by adults as described earlier, with the following difference:

Very frequent (in at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell that is important in fighting infection).

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Use it within 90 days after opening the bottle.

This medication does not require any special storage conditions.

Do not dispose of medications through drains or trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Entecavir Accord

• The active ingredient is entecavir.

Entecavir Accord 0.5 mg film-coated tablets

Each tablet contains entecavir monohydrate equivalent to 0.5 mg of entecavir.

Entecavir Accord 1 mg film-coated tablets

Each tablet contains entecavir monohydrate equivalent to 1 mg of entecavir.

• The other components are:

Tablet core:calcium carbonate, pregelatinized starch, sodium carmellose, soy polysaccharide, citric acid monohydrate, sodium fumarate estearate.

Film coating:

Entecavir Accord 0.5 mg film-coated tablets

hypromellose, titanium dioxide (E171), macrogol, and polisorbate 80.

Entecavir Accord 1 mg film-coated tablets

hypromellose, titanium dioxide (E171), macrogol, red iron oxide (E172),

See section 2 “Entecavir Accord contains soy polysaccharides and sodium”

Appearance of the product and contents of the pack

Entecavir Accord 0.5 mg film-coated tablets: white to off-white, triangular, biconvex with “J” engraved on one face and “110” on the other.

Entecavir Accord 1 mg film-coated tablets: pink, triangular, biconvex, with “J” engraved on one face and “111” on the other.

Entecavir Accord is supplied in boxes containing 30 x 1 or 90 x 1 film-coated tablets (in blister packs) and in bottles containing 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est 6th floor

08039 Barcelona,

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder.

Accord Healthcare Limited, UK

Tel: 0044 208 863 1427

Last review date of this leaflet:{MM/YYYY}

Other sources of information

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu/.