LAMIVUDINE ACCORD 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Lamivudine Accord 100 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 Lamivudine Accord and what is it used for
2. What you need to know before you take Lamivudine Accord
3. How to take Lamivudine Accord
4. Possible side effects
5. Storage of Lamivudine Accord
6. Contents of the pack and other information

1. What is Lamivudine Accord and what is it used for

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

The active substance of Lamivudine Accord is lamivudine. Lamivudine Accord is an antiviral medicine that inhibits the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

The hepatitis B virus infects the liver, causes long-term infection, and can cause liver damage. Lamivudine Accord can be used in patients whose liver is damaged but still functions normally (compensated liver disease) and in patients whose liver is damaged and does not function normally (decompensated liver disease).

Treatment with Lamivudine Accord may reduce the amount of hepatitis B virus in your body. This can lead to a reduction in liver damage and an improvement in liver function. Not everyone responds to treatment with Lamivudine Accord in the same way. Your doctor will monitor the effectiveness of the treatment.

2. What you need to know before you take Lamivudine Accord

Your healthcare professional should offer you advice and screening for HIV before starting treatment with lamivudine for hepatitis B infection and during treatment. If you have or contract HIV infection, see section 3.

Do not take Lamivudine Accord:

• 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

Consult your doctor or pharmacist before starting treatment with Lamivudine Accord.

Some people taking Lamivudine Accord or similar medicines have a higher risk of experiencing 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 overweight(especially if you are a woman).

• Consult your doctorif you have any of these conditions. You may need additional tests, such as blood tests, while taking this medicine. See section 4 for more information.

Do not stop taking Lamivudine Accordwithout your doctor's advice, as there is a risk that your hepatitis may worsen. When you stop taking Lamivudine Accord, your doctor will monitor you for at least four months to check for any problems. This will involve taking blood samples to check for any abnormal liver enzymes indicating liver damage. See section 3 for more information on how to take Lamivudine Accord.

Protect others

Hepatitis B is transmitted by having sexual contact with someone who has the disease or by transferring infected blood (e.g., by sharing needles). Lamivudine Accord does not prevent the risk of transmitting hepatitis B infection to others. To prevent others from getting infected with hepatitis B:

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

Taking Lamivudine Accord with other medicines

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

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

These medicines must not be taken with Lamivudine Accord:

• medicines (usually liquids) that contain sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• other medicines that contain lamivudine, used to treat HIV infection(sometimes also called AIDS virus).
• emtricitabine used to treat HIV or hepatitis B infection.
• cladribine, used to treat hairy cell leukemia.

Tell your doctorif you are being treated with any of these medicines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, become pregnant, or are planning to become pregnant:

• Talk to your doctor immediatelyabout the risks and benefits of taking Lamivudine Accord during pregnancy.

Do not stop treatment with Lamivudine Accord without your doctor's advice.

Breastfeeding

The components of Lamivudine Accord may pass into breast milk. If you are breastfeeding or thinking of breastfeeding:

• Talk to your doctorbefore taking Lamivudine Accord.

Driving and using machines

Lamivudine Accord may 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 does not affect you.

Lamivudine Accord contains isomalt

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Lamivudine Accord

Follow exactly the instructions for administration of this medicine given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Keep regular contact with your doctor

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

• Keep in touch with your doctor and do not stop taking Lamivudine Accordwithout your doctor's advice.

How much to take

The recommended doseis one tablet (100 mg of lamivudine) once a day.

Your doctor may prescribe a lower dose if you have kidney problems. Lamivudine oral solution is available for people who need a lower dose than usual or who cannot take tablets.

• Talk to your doctorif you are in this situation.

Patients who also have or may contract HIV infection

If you have or contract untreated HIV infection while taking lamivudine for hepatitis B treatment, the HIV virus may develop resistance to certain HIV medicines and become more 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 of lamivudine is not sufficient to treat HIV infection. If you plan to change your HIV treatment, discuss it with your doctor first.

• Talk to your doctorif you are in this situation.

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

If you take more Lamivudine Accord than you should

If you accidentally take too much Lamivudine Accord, contact your doctor or pharmacist, or go to the emergency department of the nearest hospital for advice. If possible, show them the Lamivudine Accord packaging. You can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Lamivudine Accord

If you forget to take 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 forgotten doses.

If you stop taking Lamivudine Accord

Do not stop taking Lamivudine Accord without consulting your doctor. There is a risk that your hepatitis may worsen (see “Warnings and precautions” in section 2). When you stop taking Lamivudine Accord, your doctor will monitor you for at least four months to check for any problems. This means that they will take blood samples to check that the level of any liver enzyme is not elevated, which can indicate liver damage.

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

4. Possible side effects

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

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

Allergic reaction

This is very rare (may affect up to 1 in 1000 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 Lamivudine Accord.

Side effects that are thought to be caused by Lamivudine Accord:

A very common side effect(may affect more than 1 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 10,000people) 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 Lamivudine Accord 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 pharmacist.This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use, www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamivudine Accord

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 after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for disposal. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudine Accord

The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.

The other ingredients are: isomalt (E953), crospovidone, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), and iron oxide yellow and red (E172).

Appearance and packaging of the product

Lamivudine Accord 100 mg film-coated tablets EFG are presented in Alu/PVC-Alu-OPA blisters containing 28 or 84 tablets.

The tablets are film-coated, pink, capsule-shaped, biconvex, with dimensions of 12.00 x 6.00 mm, scored on both sides with the code ''37'' on one side and ''I'' on the other side.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6ª planta

08039 Barcelona-Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW 20A - Kordin Industrial Park

PLA 3000 Paola

Malta

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:June 2025

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