Leaflet: Information for the user

Lamivudina Accord 100 mg film-coated tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.Seesection4.

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

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

3.How to take Lamivudina Accord

4.Possible side effects

5.Storage of Lamivudina Accord

6.Contents of the pack and additional information

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

The active ingredient of Lamivudina Accord is lamivudina. Lamivudina Accord is an antiviral drug that inhibits the hepatitis B virus and belongs to a group of medications calledinhibitors of reverse transcriptase analogs of nucleosides (NtIs).

The hepatitis B virus infects the liver, causes a long-term (chronic) infection, and may cause 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 would lead to a reduction in liver damage and an improvement in liver function. Not everyone responds to treatment with Lamivudina Accord in the same way. Your doctor will monitor the effectiveness of treatment.

Do not take Lamivudina Accord:

• If you areallergicto lamivudine or to any of the other components of this medication (see section 6).

Consult your doctorif you think this affects you.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lamivudina Accord

Some people taking Lamivudina Accord and other similar medications have a higher risk of severe side effects. You need to know that there is a higher risk:

• if you have had other types ofliver disease, such as hepatitis C
• if you have asignificant overweight(especially if you are a woman)

• Consult your doctor if you have any of these circumstances.You may need additional tests, such as blood tests, while taking this medication.See Section 4 for more information.

Do not stop taking Lamivudina Accordwithout consulting your doctor, as there is a risk that your hepatitis will worsen. When you stop taking Lamivudina Accord, your doctor will monitor you for at least four months to check if there are any problems. This will involve taking blood samples to check for any abnormalities in liver enzymes indicative of liver damage. See section 3 for more information on how to take Lamivudina Accord.

Protect others

Hepatitis B is transmitted by having sexual contact with someone who has thedisease,orbybloodtransmission(forexample,bysharingneedles). LamivudinaAccorddoes not prevent the risk of hepatitis B transmission to others. To prevent others from becoming infected with hepatitis B:

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

Taking Lamivudina Accord with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those with herbal remedies or over-the-counter medications.

Remember to tell your doctor or pharmacist if you start taking any other medication while taking LamivudinaAccord.

These medications should not be taken with Lamivudina Accord:

• medications (usually liquids) that contain sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• other medications that contain lamivudine, used to treatHIV infection(sometimes also called HIV virus).
• emtricitabine used to treatHIV infection or hepatitis B.
• cladribine, used for the treatment ofhairy cell leukemia.

Inform your doctorif you are being treated with any of these medications.

Pregnancy and breastfeeding

Pregnancy

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

• Talk to your doctor immediatelyabout the risks and benefits of taking LamivudinaAccordduring pregnancy.

Do not stop taking LamivudinaAccordwithout consulting your doctor.

Breastfeeding

The components of LamivudinaAccordmay pass into breast milk. If you are breastfeeding, or thinking of breastfeeding:

• Talk to your doctorbefore takingLamivudina Accord.

Driving and operating machinery

LamivudinaAccord 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 this does not affect you.

Lamivudina Accord contains isomalt

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

Follow exactly the administration instructions of this medication as indicated by your doctor

• Consult your doctor or pharmacist if you have any doubts.

Maintain regular contact with your doctor

Lamivudina 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.

Maintain contact with your doctor and do not stop taking Lamivudina Accordwithout consulting your doctor.

Howto 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. Lamivudina oral solution is available for people who need a lower dose than usual, or who cannot take tablets.

Talk to your doctor if you are in this situation.

If you are already taking another medication that contains lamivudine for the treatment of HIV infection, your doctor will continue to treat you with the higher dose (usually 150 mg twice a day), because the dose of lamivudine in Lamivudina Accord (100 mg) is not sufficient to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor beforehand.

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

If you take too much Lamivudina Accord

If you accidentally take too much Lamivudina Accord, inform your doctor or pharmacist, or go to the nearest hospital emergency department for advice. If possible, show them the Lamivudine Accord packaging.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amountingested.

If you forget to take Lamivudina 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 the missed doses.

If you interrupt treatment with Lamivudina Accord

Do not stop taking Lamivudina Accord without consulting your doctor. There is a risk that your hepatitis will worsen (see “Warnings and precautions” in section 2). When you stop taking Lamivudina 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Allergic reaction

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 Lamivudina Accord.

Side effects believed to be caused by Lamivudina Accord:

A very common side effect(may affect more than 1 in 10 people) that may appear in blood tests is:

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

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

• Muscle cramps and muscle pain.
• Rash or "hives" on any part of the body.

A common side effectthat may appear in blood tests is:

• An increase in the level of an enzyme produced in muscles (creatine phosphokinase) that may be a sign of damaged body tissue.

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 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 Lamivudina Accord or if treatment is interrupted. This can be fatal in some people.

A side effect that may appear in blood tests is;

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

If you have side effects

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not take this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamivudina Accord

The active ingredient 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), iron oxide yellow and red (E172).

Appearance of the product and contents of the packaging

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

The tablets are film-coated with a pink color, capsule-shaped, biconvex, with dimensions of 12.00 x 6.00 mm, scored on both faces with the code "37" on one face and "I" on the other face.

Only some sizes of packaging may be marketed.

Holder of the marketing authorization and Responsible for manufacturing

Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona-Spain

Responsible for manufacturing

Pharmadox Healthcare Ltd.

KW 20A - Kordin Industrial Park

PLA 3000 Paola

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Italy: Lamivudina Accord

Netherlands: Lamivudine Accord 100 mg, filmomhulde tabletten

Spain: Lamivudina Accord 100 mg, film-coated tablets

United Kingdom: Lamivudine 100 mg Film-coated tablets

Last review date of this leaflet:April 2024

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