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ENTECAVIR SUN 1 mg FILM-COATED TABLETS

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About the medicine

How to use ENTECAVIR SUN 1 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Entecavir SUN 1 mg film-coated tablets EFG

entecavir

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 further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Entecavirisan antiviral medicineusedtotreatchronic(long-term)hepatitisBvirus(HBV)infectioninadults.

Entecavir may be used in patients whose liver is damaged but still works adequately (compensated liver disease) and in patients whose liver is damaged and does not work adequately (decompensated liver disease).

Entecavirisalsousedtotreatchronic(long-term)HBVinfectioninchildrenandadolescentsfrom2tolessthan18yearsofage.

Entecavir may be used in children whose liver is damaged but still works adequately (compensated liver disease).

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

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Entecavir Sun

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

Talk to your doctor or pharmacist before starting entecavir

  • if you have ever had kidney problems, inform your doctor. This is important because entecavir is removed from the body by the kidneys and it may be necessary to adjust your dose or treatment schedule.
  • do not stop taking entecavir without talking to your doctor, as your hepatitis may get worse when treatment is stopped. When you stop your treatment with entecavir, your doctor will monitor you and perform blood tests for several months.
  • ask your doctor if your liver is working properlyand, if not, about the possible effects that your treatment with entecavir may have.
  • (human immunodeficiency virus), make sure to inform your doctor. You should not take entecavir to treat your hepatitis B infection unless you are also taking medicines to treat your 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 body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent others from becoming infected with HBV. There is a vaccine to protect people 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 stomach pain could indicate the development of lactic acidosis. On rare occasions, 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.
  • , 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 Sun with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking 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, you should consider the following. If you have switched to entecavir because lamivudine treatment was not successful, you should take entecavir on an empty stomach, once a day. If your liver disease is very 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 (from 2 to less than 18 years of age) can take entecavir with or without food.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant. The use of entecavir has not been shown to be safe during pregnancy. Entecavir should not be used during pregnancy unless clearly necessary, as determined by your doctor. It is important that women of childbearing age using entecavir use an effective contraceptive method to avoid becoming pregnant.

You should not breastfeed during treatment with entecavir. If you are breastfeeding, tell your doctor. It is not known whether entecavir, the active ingredient of this medicine, is excreted in breast milk.

Driving and using machines

Dizziness, fatigue, and drowsiness are common side effects that may reduce your ability to drive and use machines. If you are unsure, talk to your doctor.

Entecavir Sun contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Entecavir Sun

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

Follow your doctor's instructions for taking this medicine exactly. If you are unsure, talk to your doctor or pharmacist.

For adults, the recommended dose is 0.5 mg or 1 mg once a day (by mouth).

Your dose will depend on:

  • whether you have been treated for HBV infection before, as well as the medicine you received.
  • whether you have kidney problems. Your doctor may prescribe a lower dose or tell you to take it less frequently than once a day.
  • the condition of your liver.

For children and adolescents(from 2 to less than 18 years of age), your pediatrician will decide the appropriate dose based on the child's body weight.

Entecavir oral solution is recommended for patients weighing between 10 kg and 32.5 kg. Children weighing at least 32.6 kg may take the oral solution or the 0.5 mg tablets. All doses should be taken once a day (by mouth). 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 the correct dose for you. Always take the dose recommended by your doctor to ensure that the medicine is fully effective and to reduce the development of resistance to treatment. Take entecavir for as long as your doctor tells you. Your doctor will tell you when to stop treatment.

Some patients need to take this medicine on an empty stomach (see Entecavir tablets with food and drinksin Section 2). If your doctor tells you to take this medicine 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, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Entecavir Sun

It is important that you do not miss any dose. If you miss a dose of Entecavir, take it as soon as possible 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 make up for missed doses.

Do not stop taking Entecavir Sun without talking to your doctor

Some people develop severe hepatitis symptoms when they stop taking entecavir. Tell your doctor immediately if you notice any changes in your symptoms after stopping treatment.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Patients treated with entecavir have reported the following side effects:

Adults:

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

Children and adolescents

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Sun

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

Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Bottle: use within 30 days of opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Entecavir Sun

The active ingredient is entecavir.

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

The other ingredients are:

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

Coating:

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

Appearance of Entecavir Sun and contents of the pack

Entecavir SUN 1 mg film-coated tablets

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

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

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 Barcelona

Spain

Tel.: +34 93 342 78 90

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany ENTECAVIR BASICS 1 mg, Filmtabletten

Italy Entecavir SUN 1 mg compresse rivestite con film

Poland Entecavir Ranbaxy

Romania Entecavir Terapia 1 mg comprimate filmate

Spain Entecavir SUN 1 mg comprimidos recubiertos con película EFG

United Kingdom Entecavir SUN 1 mg film-coated tablets

Date of last revision of this leaflet:January 2022

Online doctors for ENTECAVIR SUN 1 mg FILM-COATED TABLETS

Discuss questions about ENTECAVIR SUN 1 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (29)
Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

  • Test interpretation and guidance on diagnostic plans.
  • Allergic rhinitis, hay fever, bronchial asthma (including severe cases).
  • Food and drug allergies, skin rashes, angioedema.
  • Atopic dermatitis, urticaria, contact allergies.
  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
  • High blood pressure and adjustment of baseline antihypertensive therapy.
  • Hyperlipidaemia and elevated cholesterol.
  • Cough, nasal congestion, fever, sore throat.
  • Anaemia, including iron deficiency and related conditions.
  • Other issues related to allergology and internal medicine.

During consultations, Dr. Nazarchuk takes a thorough, structured approach — analysing symptoms, identifying potential causes, and helping patients make informed decisions. Whether treatment, further investigation, or monitoring is needed, he explains each step clearly so you understand your health and how best to manage it.

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Frequently Asked Questions

Is a prescription required for ENTECAVIR SUN 1 mg FILM-COATED TABLETS?
ENTECAVIR SUN 1 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ENTECAVIR SUN 1 mg FILM-COATED TABLETS?
The active ingredient in ENTECAVIR SUN 1 mg FILM-COATED TABLETS is entecavir. This information helps identify medicines with the same composition but different brand names.
Who manufactures ENTECAVIR SUN 1 mg FILM-COATED TABLETS?
ENTECAVIR SUN 1 mg FILM-COATED TABLETS is manufactured by Sun Pharmaceutical Industries (Europe) B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ENTECAVIR SUN 1 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ENTECAVIR SUN 1 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ENTECAVIR SUN 1 mg FILM-COATED TABLETS?
Other medicines with the same active substance (entecavir) include BARACLUDE 0.05 mg/mL ORAL SOLUTION, BARACLUDE 0.5 mg FILM-COATED TABLETS, BARACLUDE 1 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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