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ZEFFIX 5 mg/ml ORAL SOLUTION

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About the medicine

How to use ZEFFIX 5 mg/ml ORAL SOLUTION

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 Patient

Zeffix 5mg/ml Oral Solution

lamivudine

Read all of this leaflet carefully before you start taking this medicine.

  • Keep this leaflet, as 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 Zeffix is and what it is used for
  2. What you need to know before you take Zeffix
  3. How to take Zeffix
  4. Possible side effects
  5. Storage of Zeffix
  6. Contents of the pack and other information

1. What Zeffix is and what it is used for

The active substance of Zeffix is lamivudine.

Zeffix is used to treat long-term (chronic) hepatitis B infection in adults.

Zeffix is an antiviral medicine that stops the hepatitis B virus from multiplying and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

The hepatitis B virus infects the liver and can cause long-term (chronic) infection, which can lead to liver damage. Zeffix can be used in patients whose liver is damaged but still works normally (compensated liver disease) and in combination with other medicines in patients whose liver is damaged and does not work normally (decompensated liver disease).

Treatment with Zeffix can reduce the amount of hepatitis B virus in your body. This can lead to a reduction in liver damage and an improvement in the functioning of your liver. Not everyone responds to treatment with Zeffix in the same way. Your doctor will monitor the effectiveness of your treatment with regular blood tests.

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 Zeffix

Your doctor should offer you advice and testing for HIV infection before you start treatment with lamivudine for hepatitis B infection and during treatment. If you have or get HIV infection, see section 3.

Do not take Zeffix

  • if you are allergicto lamivudine or any of the other ingredients of this medicine (listed in section 6).
  • Consult your doctorif you think this applies to you.

Warnings and precautions

Some people who take Zeffix or similar medicines have a higher risk of serious side effects. You need to know that there is a higher risk:

  • if you have ever had other types of liver disease, such as hepatitis C
  • if you are significantly overweight(especially if you are a woman)
  • Tell your doctorif you have any of these conditions. You may need extra checks, such as blood tests, while you are taking this medicine. For more information on the risks, see Section 4.

Do not stop taking Zeffixwithout your doctor's advice, as there is a risk that your hepatitis may get worse. When you stop taking Zeffix, your doctor will monitor you for at least four months to check for any problems. This will involve taking blood samples to check for increases in liver enzyme levels that may indicate liver damage. See section 3 for more information on how to take Zeffix.

Protect others

Hepatitis B is spread by having sexual contact with someone who has the disease or by transferring infected blood (for example, by sharing needles). Zeffix does not prevent the risk of passing on hepatitis B infection to others. To prevent others from getting hepatitis B:

  • Use a condomwhen you have oral or penetrative sex.
  • Avoid the risk of blood transfer— for example, do not share needles.

Other medicines and Zeffix

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those with herbal medicines or medicines without a prescription.

Remember to tell your doctor or pharmacist if you start taking any other medicine while you are taking Zeffix.

These medicines must not be taken with Zeffix:

  • medicines, if taken regularly, (usually liquids) that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol)
  • other medicines that contain lamivudine, used to treat HIV infection(sometimes also called AIDS virus)
  • emtricitabine, used to treat HIV infectionor hepatitis B
  • cladribine, used to treat hairy cell leukemia
  • Tell your doctorif you are being treated with any of these medicines.

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to have a baby:

  • Talk to your doctorabout the risks and benefits of taking Zeffix during pregnancy.

Do not stop taking Zeffix without your doctor's advice.

Breast-feeding

Zeffix can pass into breast milk. If you are breast-feeding or thinking of breast-feeding:

  • Talk to your doctorbefore taking Zeffix.

Driving and using machines

Zeffix can make you feel tired, which could affect your ability to drive or use machines.

  • Do not drive or use machines unless you are sure it won't affect you.

Zeffix contains sugar, preservatives, propylene glycol, and sodium

If you are diabetic, note that each dose of Zeffix (100 mg – 20 ml) contains 4 g of sugar.

Zeffix contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking Zeffix. Sucrose may be harmful to your teeth.

Zeffix contains preservatives (parahydroxybenzoates) that may cause allergic reactions (possibly delayed).

This medicine contains 400 mg of propylene glycol in each 20 ml.

This medicine contains 58.8 mg of sodium (a major component of table/cooking salt) in each 20 ml. This is equivalent to 2.9% of the maximum recommended daily intake of sodium for an adult.

3. How to take Zeffix

Always take this medicine exactly as your doctor has told you.If you are not sure, check with your doctor or pharmacist.

Keep in regular contact with your doctor

Zeffix helps control your hepatitis B infection. You need to keep taking it every day to control the infection and prevent it from getting worse.

  • Stay in touch with your doctor and do not stop taking Zeffixwithout your doctor's advice.

How much to take

The usual dose of Zeffix is 20ml(100 mg of lamivudine) once a day.

Your doctor may prescribe a lower dose if you have kidney problems.

  • Talk to your doctorif you are in this situation.

Patients who also have or may get HIV infection

If you have or get HIV infection that is not being treated with medicines while you are taking lamivudine for hepatitis B infection, the HIV virus may become resistant to certain HIV medicines and become difficult to treat. Lamivudine is also used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine that contains a higher dose of lamivudine, usually 150 mg twice a day, as the lower dose of 100 mg is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor before.

  • Talk to your doctorif you are in this situation.

Swallow the tablet whole with water. Zeffix can be taken with or without food.

See the diagram and instructions for measuring and taking a dose of medicine after section 6 of this leaflet.

If you take more Zeffix than you should

If you accidentally take too much Zeffix, talk to your doctor or pharmacist, or go to the nearest hospital emergency department for advice. If possible, show them the Zeffix packaging.

If you forget to take Zeffix

If you miss a dose, take it as soon as you remember. Then continue taking it as before. Do not take a double dose to make up for missed doses.

Do not stop taking Zeffix

Do not stop taking Zeffix without talking to your doctor. There is a risk that your hepatitis may get worse (see section 2). When you stop taking Zeffix, your doctor will monitor you for at least four months to check for any problems. This means you will have blood tests to check for increases in liver enzyme levels that may indicate liver damage.

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.

The most common side effects reported with Zeffix in clinical trials were tiredness, respiratory tract infections, sore throat, headache, stomach discomfort and pain, nausea, vomiting, and diarrhea, increased liver enzymes, and increased muscle enzymes (see below).

Allergic reaction

This is rare (may affect up to 1 in 1,000 people). The signs include:

  • swelling of the eyelids, face, or lips
  • difficulty swallowing or breathing.
  • Contact a doctor immediatelyif you have these symptoms. Stop taking Zeffix.

Side effects that are thought to be caused by Zeffix:

A very common side effect(may affect more than1 in 10people) that may appear in blood tests is

  • an increase in the levels of some liver enzymes (transaminases), which may be a sign of liver inflammation or damage.

A common side effect(may affect up to 1 in 10people) is:

  • muscle cramps and pain
  • skin rash or "hives" anywhere on the body.

A common side effectthat may appear in blood tests is:

  • an increase in the level of a muscle enzyme (creatine phosphokinase) that may be a sign of muscle damage.

A very rare side effect(may affect up to 1 in 10,000 people) is:

  • lactic acidosis (excess lactic acid in the blood).

Other side effects

Other side effects have been reported in a small number of people, but their exact frequency is unknown:

  • muscle breakdown
  • worsening of liver disease if the hepatitis B virus becomes resistant to Zeffix or treatment is stopped. This can be fatal in some people.

A side effect that may appear in blood tests is:

  • a decrease in the number of cells involved in blood clotting (thrombocytopenia).

If you get side effects

  • Talk to your doctor or pharmacisteven if you think the side effects are not listed in this leaflet.

Reporting side effects

If you get 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 via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zeffix

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

Do not take this medicine after the expiry date which is stated on the packaging and bottle.

Do not store above 25°C.

Discard one month after first opening.

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 other information

What Zeffix contains

The active substance is lamivudine. Each ml of oral solution contains 5 mg of lamivudine.

The other ingredients are: sucrose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid, propylene glycol (E1520), sodium citrate, artificial strawberry flavor, artificial banana flavor, purified water.

Appearance and packaging

Zeffix oral solution is available in packs containing a white polyethylene bottle with a child-resistant closure. The solution is clear, colorless, or pale yellow with a strawberry/banana flavor. The bottle contains 240 ml of lamivudine solution (5 mg/ml). The pack includes a graduated oral applicator in ml and an applicator adapter that must be fitted to the bottle before use.

Manufacturer

Marketing Authorization Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk,

Citywest Business Campus

Dublin 24,

Ireland

D24 YK11

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24,

Ireland

D24 YK11

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

Belgium

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Tel: + 32 (0)10 85 52 00

Lithuania

GlaxoSmithKline Trading Services Limited

Tel: + 370 80000334

Text with contact information of GlaxoSmithKline Trading Services Limited and phone number

Luxembourg

GlaxoSmithKline Pharmaceuticals s.a./n.v.

Belgium

Tel: + 32 (0) 10 85 52 00

Czech Republic

GlaxoSmithKline s.r.o.

Tel: + 420 222 001 111

[email protected]

Hungary

GlaxoSmithKline Trading Services Limited

Tel.: + 36 80088309

Denmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

[email protected]

Malta

GlaxoSmithKline Trading Services Limited

Tel: + 356 80065004

Germany

GlaxoSmithKline GmbH & Co. KG

Tel.: + 49 (0)89 36044 8701

[email protected]

Netherlands

GlaxoSmithKline BV

Tel: + 31 (0) 33 2081100

Estonia

GlaxoSmithKline Trading Services Limited

Tel: + 372 8002640

Norway

GlaxoSmithKline AS

Tlf: + 47 22 70 20 00

Greece

GlaxoSmithKline Μονοπρ?σωπη A.E.B.E.

Tel: + 30 210 68 82 100

Austria

GlaxoSmithKline Pharma GmbH

Tel: + 43 (0)1 97075 0

[email protected]

Spain

GlaxoSmithKline, S.A.

Tel: + 34 900 202 700

[email protected]

Poland

GSK Services Sp.zo.o.

Tel.: + 48 (0)22 576 9000

France

Laboratoire GlaxoSmithKline

Tél.: + 33 (0)1 39 17 84 44

[email protected]

Portugal

Glaxo Wellcome Farmacêutica, Lda.

Tel: + 351 21 412 95 00

[email protected]

Croatia

GlaxoSmithKline Trading Services Limited

Tel: + 385 800787089

Romania

GlaxoSmithKline Trading Services Limited

Tel: + 40 800672524

Ireland

GlaxoSmithKline Trading Services Limited

Tel: + 353 (0)1 4955000

Slovenia

GlaxoSmithKline Trading Services Limited

Tel: + 386 80688869

Iceland

Vistor hf.

Phone: + 354 535 7000

Slovak Republic

GlaxoSmithKline Trading Services Limited

Tel: + 421 800500589

Italy

GlaxoSmithKline S.p.A.

Tel: + 39 (0)45 7741 111

Finland

GlaxoSmithKline Oy

Phone/Tel: + 358 (0)10 30 30 30

Cyprus

GlaxoSmithKline Trading Services Limited

Tel: + 357 80070017

Sweden

GlaxoSmithKline AB

Tel: + 46 (0)8 638 93 00

[email protected]

Latvia

GlaxoSmithKline Trading Services Limited

Tel: + 371 80205045

Date of last revision of this leaflet:05/2025

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu

How to measure the dose and take the medication

Transparent 10ml syringe with measurement indicator and vial components labeled with letters and directional arrows

To measure your dose accurately, use the oral applicator included in the packaging (see also Section 3).

When full, the applicator contains 10 ml of solution.

1 Remove the plastic wrapperfrom the applicator/adapter.

  1. Remove the adapter from the applicator.
  2. Remove the child-resistant cap (A) from the bottle. Keep the cap.
  3. Hold the bottle. Insert the plastic adapter (B) into the neck of the bottle as far as it will go.
  4. Insert the applicator (C) firmly into the adapter.
  5. Turn the bottle upside down.
  6. Pull the applicator plunger (D) until the first portion of your full dose is withdrawn.
  7. Return the bottle to its upright position. Remove the applicator from the adapter.
  8. Place the applicator in your mouth, with the tip of the applicator towards the inside of your cheek. Slowly press the plunger, allowing time to swallow. Do not press too hard and pour the liquid towards the back of the throat or you may choke.
  9. Repeat steps 5 to 9 in the same way until you have taken your full dose. For example, if your dose is 20 ml, you need to take 2 complete applicators full of medication.
  10. Remove the applicator from the bottle and wash it well with clean water. Allow it to dry completely before using it again. Leave the adapter in the bottle.
  11. Close the bottle tightly with the cap.

Discard the oral solution one month after it was first opened.

Online doctors for ZEFFIX 5 mg/ml ORAL SOLUTION

Discuss questions about ZEFFIX 5 mg/ml ORAL SOLUTION, 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
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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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:

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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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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:

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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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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:

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  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
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Additional care areas:

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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
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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:

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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
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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:

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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).
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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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Frequently Asked Questions

Is a prescription required for ZEFFIX 5 mg/ml ORAL SOLUTION?
ZEFFIX 5 mg/ml ORAL SOLUTION 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 ZEFFIX 5 mg/ml ORAL SOLUTION?
The active ingredient in ZEFFIX 5 mg/ml ORAL SOLUTION is lamivudine. This information helps identify medicines with the same composition but different brand names.
Who manufactures ZEFFIX 5 mg/ml ORAL SOLUTION?
ZEFFIX 5 mg/ml ORAL SOLUTION is manufactured by Glaxosmithkline Trading Services Limited. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ZEFFIX 5 mg/ml ORAL SOLUTION 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 ZEFFIX 5 mg/ml ORAL SOLUTION 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 ZEFFIX 5 mg/ml ORAL SOLUTION?
Other medicines with the same active substance (lamivudine) include EPIVIR 10 mg/mL ORAL SOLUTION, EPIVIR 150 MG FILM-COATED TABLETS, EPIVIR 150 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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