Package Leaflet: Information for the User

Entecavir Kern Pharma 0.5 mg Film-Coated Tablets

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

• Keep this 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, even if they are not listed in this leaflet. See section 4.

1. What is Entecavir Kern Pharma and what it is used for

2. What you need to know before you start taking Entecavir Kern Pharma

3. How to take Entecavir Kern Pharma

4. Possible side effects

5. Storage of Entecavir Kern Pharma

6. Contents of the pack and additional information

Entecavir is an antiviral medication used to treat chronic (long-term) infection by the hepatitis B virus (HBV) in adults.Entecavir may 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 is also used to treat chronic (long-term) infection by HBV in children and adolescents from 2 years to less than 18 years.Entecavir may be used in children whose liver is damaged but still functions properly (compensated liver disease).

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

Do not take Entecavir Kern Pharma

• 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.

• If you have ever had problems with your kidneys, inform your doctor. This is important because entecavir 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 without consulting your doctor,as your hepatitis may worsen by interrupting treatment. When your treatment with entecavir is interrupted, your doctor will continue to monitor you and perform 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 may have.

• If you are also infected with HIV(human immunodeficiency virus), make sure to inform your doctor.

You should not take entecavir 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 will not control your HIV infection.

• Taking entecavir 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 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 this medicine.

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

Children and adolescents

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

Taking Entecavir Kern Pharma 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 Kern Pharma with food and drinks

In most cases, you can take entecavir 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 because lamivudine treatment was unsuccessful, take entecavir on an empty stomach, once a day. If your liver disease is advanced, your doctor will also instruct you on taking entecavir 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 with or without food.

Pregnancy, breastfeeding, and fertility

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

Do not breastfeed during entecavir treatment. If you are doing so, inform your doctor. It is unknown whether entecavir, the active ingredient of this medicine, is excreted in breast milk.

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 Kern Pharma contains lactose

This medicine contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medicine.

Not all patients need to take the same dose of entecavir.

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 to less than 18 years of age), your pediatrician will decide on the appropriate dose based on the child's body weight.

Children weighing at least 32.6 kg can take the oral solution or 0.5 mg tablet. Entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. 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 for the entire time your doctor has indicated. Your doctor will tell you when to stop treatment

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

If you take more Entecavir Kern Pharma than you should

If you have taken more entecavir than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Entecavir Kern Pharma

It is essential not to forget any dose. If you forget a dose of entecavir, 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 Kern Pharma without consulting your doctor

Some people develop severe hepatitis symptoms when stopping entecavir treatment. 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 have reported the following adverse effects:

Adults

• Common (in at least 1 in 100 patients): headache, insomnia (inability to sleep), extreme fatigue, dizziness, somnolence (drowsiness), vomiting, diarrhea, nausea, indigestion, and increased levels of liver enzymes in the blood.
• Uncommon (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 common (in at least 1 in 10 patients): low levels of neutrophils (a type of white blood cell, which is important for fighting infections).

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 Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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.

Blister: This medication does not require special storage conditions.

Bottle: This medication does notrequire special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Entecavir Kern Pharma

• The active ingredient is entecavir. Each film-coated tablet contains 0.5 mg of entecavir.
• Theother componentsare:

Core of the tablet:lactose monohydrate, microcrystalline cellulose, crospovidone (type A) (E1202), anhydrous ethanol and magnesium stearate.

Film coating: Opadry II white 85F28751 containing polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol/PEG 3000 (E1521) and talc (E553b).

Appearance of the product and contents of the package

Entecavir Kern Pharma 0.5 mg film-coated tablets are white or off-white and triangular in shape. They are marked with “ENT” on one face and with “0.5” on the other face.

They are supplied in boxes containing 30 or 30 x 1 film-coated tablets in Alu/Alu blisters or in single-dose Alu/Alu blisters, respectively, and in bottles containing 30 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing:

PHARMASCIENCE INTERNATIONAL LIMITED

1st floor Iacovides Tower

81-83 Griva Digeni Avenue,

1090 NicosiaCyprus

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain :Entecavir Kern Pharma 0.5 mg film-coated tablets

Bulgaria:?????????Pharmascience International Ltd 0.5 mg ????????? ????????

Hungary:Entecavir Pharmascience International Ltd 0,5 mg filmtabletta

Date of the last review of this leaflet: July 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/