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ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS

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About the medicine

How to use ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS

Translated with AI

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 Kern Pharma 0.5 mg film-coated tablets EFG

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

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

Entecavir is an antiviral medicine used to treat long-term (chronic) hepatitis B virus (HBV) infection 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 long-term (chronic) HBV infection in children and adolescents from 2 to less than 18 years of age.Entecavir may be used in children whose liver is damaged but still functions properly (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 Kern Pharma

Do not take Entecavir Kern Pharma

  • to entecavir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before you start taking entecavir.

  • If you have ever had problems with your kidneys,tell 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 if you stop treatment. When you stop 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 treatment with entecavir could have.
  • If you are also infected with HIV (human immunodeficiency virus),make sure to tell 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 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 other people with hepatitis B virus (HBV)through sexual contact or body fluids (including blood contamination). Therefore, it is important that you take appropriate precautions to prevent other people 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 the blood)and liver enlargement. Symptoms such as nausea, vomiting, and stomach pain could indicate the development of lactic acidosis. On rare occasions, this serious side effect has been fatal. Lactic acidosis occurs more frequently in women, especially in those who are overweight. Your doctor will monitor you regularly 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

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

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, you should consider the following. If you have switched to entecavir because treatment with lamivudine 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 to take entecavir on an empty stomach. An empty stomach means at least 2 hours after and 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. It has not been shown that the use of entecavir is 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 method of contraception 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 affect your ability to drive and use machines. If you are unsure, talk to your doctor.

Entecavir Kern Pharma 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 Kern Pharma

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

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, talk to your doctor or pharmacist again.

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

Your dose will depend on:

  • whether you have been treated before for HBV infection,as well as the medicine you received.
  • whether you have kidney problems.Your doctor may prescribe a lower dose or indicate that you 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.

Children with a weight of at least 32.6 kg can take the oral solution or the 0.5 mg tablet. Entecavir oral solution is recommended for patients with a weight between 10 kg and 32.5 kg. 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 you should stop treatment.

Some patients must take this medicine on an empty stomach (see Entecavir with food and drinksin Section 2). If your doctor tells you to take this medicine on an empty stomach, an 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, 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 Kern Pharma

It is important that you do not miss any dose. If you miss a dose of entecavir, you should 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 Kern Pharma without talking to your doctor

Some people develop very 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 on 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, fatigue, dizziness, drowsiness, vomiting, diarrhea, nausea, dyspepsia, and increased liver enzyme levels in 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 in children and adolescents are similar to those experienced in 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 for fighting infections).

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 through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Entecavir Kern Pharma

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

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

Blister: This medicine does not require any special storage conditions.

Bottle: This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

What Entecavir Kern Pharma contains

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

Tablet core: 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 and packaging

Entecavir Kern Pharma 0.5 mg film-coated tablets are white or almost white, triangular tablets. They are marked with “ENT” on one side and with “0.5” on the other side.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer:

PHARMASCIENCE INTERNATIONAL LIMITED

1st floor Iacovides Tower

81-83 Griva Digeni Avenue,

1090 Nicosia, Cyprus

This medicine is authorised in the Member States of the European Economic Area under 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 last revision of this leaflet: July 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

Online doctors for ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS

Discuss questions about ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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€58
5.0 (3)
Doctor

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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€80
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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€70
5.0 (760)
Doctor

Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including:

  • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs.
  • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis.
  • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation.
  • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea.
  • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections.
  • Chronic diseases: hypertension, elevated cholesterol, weight management.
  • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness.
  • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance.

She also provides:

  • IMT medical certificates for driving licence exchange in Portugal.
  • Personalised preventive care and wellness consultations.
  • Interpretation of test results and medical reports.
  • Follow-up care and medication review.
  • Support in managing multiple coexisting conditions.
  • Remote prescription management and medical documentation.

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

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€55
5.0 (140)
Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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€50

Frequently Asked Questions

Is a prescription required for ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS?
ENTECAVIR KERN PHARMA 0.5 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 KERN PHARMA 0.5 mg FILM-COATED TABLETS?
The active ingredient in ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS is entecavir. This information helps identify medicines with the same composition but different brand names.
Who manufactures ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS?
ENTECAVIR KERN PHARMA 0.5 mg FILM-COATED TABLETS is manufactured by Kern Pharma S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ENTECAVIR KERN PHARMA 0.5 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 KERN PHARMA 0.5 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 KERN PHARMA 0.5 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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