Label: information for the user

Entecavir SUN 1 mg film-coated tablets EFG

entecavir

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isEntecavirSun and what it is used for

2. What you need to know before starting to takeEntecavirSun

3. How to takeEntecavirSun

4. Possible side effects

5. Storage ofEntecavirSun

6. Contents of the pack and additional information

Entecavirisamedicationthatisusedtotreatchronic(long-term)infectioncausedbythehepatitisBvirus(VHB)inadults.

Entecavir maybeusedinpatientswhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease)andinpatientswhoseliverisdamagedanddoesnotfunctionadequately(decompensatedliverdisease).

Entecavirisalsousedtotreatchronic(long-term)infectioncausedbyVHBinchildrenandadolescentsfrom2yearstolessthan18yearsold.

Entecavir maybeusedinchildrenwhoseliverisdamagedbutstillfunctionsadequately(compensatedliverdisease).

TheinfectioncausedbythehepatitisBvirusmaydamagetheliverEntecavir reducestheamountofvirusinthebodyandimprovestheconditionoftheliver.

Do not take Entecavir Sun

• if you are allergicto entecavir or 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 if you interrupt 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. Do not take entecavir for the treatment of your hepatitis B infection unless you are also taking medications for the treatment of HIV infection, as 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 available to protect individuals at risk of HBV infection.

• Entecavir belongs to a class of medicines that can cause lactic acidosis(excess 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 serious 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.

Entecavir Sun with other medicines

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

Entecavir Sun 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 at least 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 except when 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 treatment with entecavir. 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 reduce your ability to drive and operate machinery. If you have any doubts, consult your doctor.

Entecavir Sun contains lactose

This medicine contains lactose. If your doctor has told you 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.

Entecavir oral solution is recommended for patients with a weight between 10 kg and 32.5 kg. Children weighing at least 32.6 kg can take the oral solution or 0.5 mg tablets. 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 tablets 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 Sun 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 forget to take Entecavir Sun

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 Sun without consulting your doctor

Some people develop severe hepatitis symptoms when stopping entecavir. 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 will experience them.

Patients treated with entecavir have reported the following adverse effects:

Adults:

• frequent (in at least 1 in 100 patients):
• • headache,
  • insomnia (inability to sleep),
  • fatigue (extreme tiredness),
  • dizziness, somnolence (drowsiness),
  • vomiting, diarrhea, nausea, dyspepsia (indigestion) –
  • 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 above, 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).

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 Medicines for Human Use:https://www.notificaram.es. 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 label and on the packaging after CAD. The expiration date refers to the last day of the month.

This medication does not require special storage conditions.

Bottle: use within 30 days following the opening of the bottle.

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

Composition of Entecavir Sun

The active ingredient is entecavir.

Entecavir Sun 1 mg:Each film-coated tablet contains 1 mg of entecavir.

The other components are:

Core tablet:lactose monohydrate, povidone K30, crospovidone, microcrystalline cellulose PH 102, and magnesium stearate.

Film coating:

Opadry 13B84610 Pink (contains HPMC 2910/Hypromellose (E464), titanium dioxide (E171), Macrogol 400 (E1521), polisorbate 80 (E433), and iron oxide red (E172))

Appearance of Entecavir Sun and packaging contents

Entecavir SUN 1 mg film-coated tablets

Pink or light pink, triangular-shaped tablets, 10.90 mm x 10.60 mm in size, marked with “RL2” on one side and flat on the other side.

Film-coated tablets are available in HDPE bottles, in blisters containing 30 or 90 film-coated tablets, and in single-dose blisters containing 30 or 90 film-coated tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Alkaloida Chemical Company Zrt

Kabay János u. 29

Tiszavasvári, H-4440

Hungary

S.C. Terapia S.A.

Str. Fabricii nr. 124

Cluj-Napoca, 400632

Romania

For more information about this medication, please contact the local representative of the marketing authorization holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Phone:+34 93 342 78 90

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

GermanyENTECAVIR BASICS1 mg, Filmtabletten

ItalyEntecavir SUN 1 mg compresse rivestite con film

PolandEntecavir Ranbaxy

RomaniaEntecavir Terapia 1 mg comprimate filmate

SpainEntecavir SUN 1 mg comprimidos recubiertos con película EFG

United KingdomEntecavir SUN 1 mg film-coated tablets

Last review date of this leaflet:January 2022