LAMIVUDINE ACCORD 300 mg FILM-COATED TABLETS

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

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 Lamivudine Accord

Some people taking Lamivudine Accord or other 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 have significant overweight(especially if you are a woman)

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

Do not stop taking Lamivudine Accordwithout your doctor's advice, as there is a risk that your hepatitis may get worse. 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 abnormality in liver enzymes indicating liver damage. See section 3 for more information on how to take Lamivudine Accord.

Protect others

Hepatitis B is spread by having sexual contact with someone who has the disease, or by the transfer of infected blood (for example, by sharing needles). Lamivudine Accord does not prevent the risk of passing on hepatitis B 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.

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 medicines while you are 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, if you become pregnant, or if you are planning to become pregnant:

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

Do not stop taking 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 won't 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

Followexactlytheinstructionsforadministeringthismedicineasindicatedbyyourdoctororpharmacist. In case of doubt, consult your doctor or pharmacist again.

Swallow the tablet whole with water. Lamivudine Accordcan be taken with or without food. If you cannot swallow the tablets whole, you can break them and mix them with a small amount of food or drink; take the entire dose immediately.

Stay in regular contact with your doctor

Lamivudine Accordhelps control your condition. You will need to take it every day to avoid your illness getting worse. You may still develop other infections and illnesses associated with HIV.

Stay in touch with your doctor and do not stop taking Lamivudine Accordwithout talking to your doctor first.

How much to take

Adults, adolescents, and children weighing at least 25 kg:

The usual dose of Lamivudine Accord is 300 mg once daily.

A 150 mg dose of Lamivudine Accord tablets is available for the treatment of children from 3 months of age and weighing less than 25 kg.

It is also available as an oral solution for the treatment of children over 3 months of age and for patients who cannot swallow tablets or who require a lower dose than usual.

If you or your child have kidney problems,your dose may be adjusted.

Consult your doctorif this applies to you or your child.

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 your nearest hospital 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, telephone: 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 and then continue with your usual treatment. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

During treatment for HIV, you may experience an increase in weight and levels of glucose and lipids in the blood. This may be partly due to the recovery of your health and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

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

When you are being treated for HIV, it can be difficult to tell whether a symptom is a side effect of Lamivudine Accord or another medicine you are taking, or a result of the HIV disease itself. It is very important that you inform your doctor about any changes in your health.

In addition to the side effects listed below for Lamivudine Accord, other conditions can develop during combination therapy for HIV.

It is important that you read the information under the heading “Other possible side effects of combination therapy for HIV”.

Common side effects

May affect up to 1 in 10patients:

• headache
• nausea
• vomiting
• diarrhea
• stomach pain
• fatigue, lack of energy
• fever (high temperature)
• general feeling of being unwell
• muscle pain and discomfort
• joint pain
• difficulty sleeping (insomnia)
• cough
• irritated or runny nose
• skin rash
• hair loss (alopecia).

Uncommon side effects

May affect up to 1 in 100patients:

The uncommon side effects that may appear in blood tests are:

• a decrease in the number of cells involved in blood clotting (thrombocytopenia)
• low red blood cell count (anemia) or low white blood cell count (neutropenia)
• an increase in the level of liver enzymes.

Rare side effects

May affect up to 1 in 1,000patients:

• severe allergic reaction that causes swelling of the face, tongue, or throat, which can cause difficulty swallowing or breathing
• inflammation of the pancreas (pancreatitis)
• muscle tissue breakdown
• liver problems, such as jaundice, liver enlargement, fatty liver, inflammation (hepatitis).

A rare side effect that may appear in blood tests is:

• an increase in an enzyme called amylase.

Very rare side effects

May affect up to 1 in 10,000patients:

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

• tingling or numbness of the arms, legs, hands, or feet.

A very rare side effect that may appear in blood tests is:

• failure of the bone marrow to produce new red blood cells (pure red cell aplasia).

If you experience side effects

Tell your doctor or pharmacistif you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapies, such as Lamivudine Accord, can cause other conditions to develop during treatment for HIV.

Worsening of old infections

People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to experience serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably due to an improvement in the body's immune response, which allows it to fight off these infections.

In addition to these opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness in the hands and feet, and ascending to the torso, palpitations, tremors, or hyperactivity; please inform your doctor immediately to receive the necessary treatment.

If you notice any symptoms of infection while taking Lamivudine Accord:

Tell your doctor immediately.Do not take any other medicine for the infection without your doctor's advice.

You may have problems with your bones

Some patients receiving combination therapy for HIV may develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to have this disease:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune system is severely weakened
• if they are overweight

Signs of osteonecrosis include:

• stiffness in the joints
• pain and discomfort (especially in the hip, knee, and shoulder)
• difficulty moving

If you notice any of these symptoms: Tell your doctor.

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. Storage of Lamivudine Accord

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.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. 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

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 A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), and iron oxide yellow and red (E172).

Appearance of the product and pack contents

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 in color, 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 authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Italy: Lamivudina Accord

Netherlands: Lamivudine Accord 100 mg, film-coated tablets

Spain: Lamivudina Accord 100 mg, film-coated tablets EFG

United Kingdom: Lamivudine 100 mg Film-coated tablets

Date of last revision of this leaflet:April 2024

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/).