Lamivudine Accord 100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Lamivudina Accord 100 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What is Lamivudina Accord and what is it used for?

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

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

The hepatitis B virus infects the liver, causes long-term (chronic) infection, and may lead to liver damage. Lamivudina Accord may 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 Lamivudina Accord may reduce the amount of hepatitis B virus in your body. This may result in reduced liver damage and improvement in liver function. Not everyone responds to treatment with Lamivudina Accord in the same way. Your doctor will monitor the effectiveness of the treatment.

2. What you need to know before starting to take Lamivudina Accord

Your healthcare provider should offer you counseling and HIV testing before starting lamivudine treatment for hepatitis B infection, and during treatment. If you have or develop HIV infection, see section 3.

Do not take Lamivudina Accord:

• If you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you think this applies to you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Lamivudina Accord.

Some people who take Lamivudina Accord or similar medicines are at increased risk of serious side effects. You should know that the risk is higher:

• If you have ever had other types of liver disease, such as hepatitis C

• If you are significantly overweight (especially if you are female)

• Talk to your doctor if you have any of these conditions. You may need additional tests, such as blood tests, while taking this medicine. For more information, see Section 4.

Do not stop taking Lamivudina Accord without your doctor's advice, as there is a risk that your hepatitis may worsen. After stopping Lamivudina Accord, your doctor will monitor you for at least four months to check for any problems. This will involve blood tests to check for abnormalities in liver enzymes indicating liver damage. See section 3 for more information on how to take Lamivudina Accord.

Protecting others

Hepatitis B is spread through sexual contact with someone who has the disease or through transfer of infected blood (for example, by sharing needles). Lamivudina Accord does not prevent the spread of hepatitis B to others. To prevent others from becoming infected with hepatitis B:

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

Taking Lamivudina Accord with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal preparations or over-the-counter medicines.

Remember to inform your doctor or pharmacist if you start taking any other medicine while you are taking Lamivudina Accord.

The following medicines should not be taken with Lamivudina Accord:

• Medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• Other medicines containing lamivudine used to treat HIV infection (sometimes also called the AIDS virus).
• Emtricitabine used to treat HIV or hepatitis B infection.
• Cladribine used to treat hairy cell leukemia.

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, think you might be pregnant, or are planning to become pregnant:

• Talk to your doctor immediately about the risks and benefits of taking Lamivudina Accord during pregnancy.

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

Breastfeeding

Components of Lamivudina Accord may pass into breast milk. If you are breastfeeding or considering breastfeeding:

• Talk to your doctor before taking Lamivudina Accord.

Driving and using machines

Lamivudina Accord may make you feel tired, which could affect your ability to drive or operate machinery.

• Do not drive or operate machinery unless you are sure it does not affect you.

Lamivudina Accord contains isomalt

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lamivudina Accord

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

Keep in regular contact with your doctor

Lamivudina Accord helps control your hepatitis B infection. You need to keep taking it every day to maintain control of the infection and prevent it from worsening.

• Stay in contact with your doctor and do not stop taking Lamivudina Accord without your doctor's advice.

How much to take

The recommended dose is one tablet (100 mg of lamivudine) once daily.

Your doctor may prescribe a lower dose if you have kidney problems. Oral lamivudine solution is available for patients who require a lower than usual dose or who cannot take tablets.

• Speak with your doctor if you are in this situation.

Patients who also have or may acquire HIV infection

If you have or develop untreated HIV infection while taking lamivudine for the treatment of hepatitis B, the HIV virus may develop resistance to certain anti-HIV drugs, making the infection harder to treat. Lamivudine can also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may prescribe another medicine containing a higher dose of lamivudine, usually 150 mg twice daily, as the lower 100 mg dose of lamivudine is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, discuss this with your doctor first.

• Speak with your doctor if you are in this situation.

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

If you take more Lamivudina Accord than you should

If you accidentally take too much Lamivudina Accord, contact your doctor or pharmacist, or go immediately to the nearest hospital emergency department for advice. If possible, show them the Lamivudina Accord packaging. You may also call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Lamivudina Accord

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

If you stop taking Lamivudina Accord

Do not stop taking Lamivudina Accord without consulting your doctor. There is a risk that your hepatitis may worsen (see "Warnings and precautions" in section 2). After stopping Lamivudina Accord, your doctor will monitor you for at least four months to check for any problems. This includes taking blood samples to monitor liver enzyme levels, as elevated levels may indicate liver damage.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The most commonly reported adverse effects in clinical trials with Lamivudine Accord were fatigue, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting, and diarrhea, increased liver enzymes and increased enzymes produced in the muscles (see below).

Allergic reaction

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

• swelling of the eyelids, face, or lips

• difficulty swallowing or breathing

• Contact a doctor immediately if you experience these symptoms. Stop taking Lamivudine Accord.

Adverse effects believed to be caused by Lamivudine Accord:

A very common adverse effect (may affect more than 1 in 10 people) that may be observed in blood tests is:

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

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

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

A common adverse effect that may be observed in blood tests is:

• an increase in the level of an enzyme produced in the muscles (creatine phosphokinase), which may be a sign of body tissue damage.

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

• lactic acidosis (excess lactic acid in the blood)

Other adverse effects

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

• muscle rupture
• worsening of liver disease if the hepatitis B virus becomes resistant to Lamivudine Accord or if treatment is interrupted. This may be fatal in some people.

An adverse effect that may appear in blood tests is:

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

If you experience adverse effects

?Talk to your doctor or pharmacist. This includes any possible adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, www.notificaRAM.es. By reporting adverse 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 use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamivudina Accord

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

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

Appearance of the product and contents of the pack

Lamivudina Accord 100 mg film-coated tablets EFG is supplied in Alu/PVC-Alu-OPA blisters containing 28 or 84 tablets.

The tablets are pink, film-coated, 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.

Only some 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, 6th floor

08039 Barcelona, Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW 20A - Kordin Industrial Park

PLA 3000 Paola

Malta

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

Date of the last revision of this leaflet: June 2025

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