Leaflet: Information for the user

Lamivudine Accord 300 mg film-coated tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on 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.

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

2.What you need to know before you start taking Lamivudine Accord

3.How to take Lamivudine Accord

4.Possible side effects

5.Storage of Lamivudine Accord

6.Contents of the pack and additional information

Lamivudina Accordis used in the treatment of the infection caused by the HIV (human immunodeficiency virus) in adults and children.

The active ingredient ofLamivudinaAccordis lamivudina.LamivudinaAccordis a type of medication known as an antiretroviral. It belongs to a group of medications calledinhibitors of reverse transcriptase analogs of nucleosides(INTIs).

LamivudinaAccorddoes not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that plays an important role in helping the body fight infection.

Not everyone responds to treatment withLamivudinaAccordin the same way. Your doctor will monitor the effectiveness of your 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 may affect 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 ever 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 may 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,orbybloodtransfer (forexample,bysharingneedles). LamivudinaAccorddoes not prevent the risk of hepatitis B infection 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 transfers— 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 plants 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) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly.
• other medications containing 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 planning to breastfeed:

• 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 will 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.

Followexactlytheinstructionsfortheadministrationofthismedicationasindicatedbyyourpharmacist.Consultyourdoctor or pharmacist if you are in doubt.

Swallow the tablet whole with water. Lamivudine AccordAccordcan 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.

Maintain regular contact with your doctor

Lamivudine AccordAccordhelps control your condition. You will need to take it every day to prevent your condition from worsening. You may continue to develop other infections and diseases associated with HIV infection.

Remain in contact with your doctor and do not stop taking Lamivudine Accordwithout first speaking with your doctor.

How much to take

Adults, adolescentsand children weighing at least 25 kg:

The usual dose of Lamivudine Accord is 300 mg per day.

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 require a lower dose than usual.

If you or your child has a kidney problem,your dose may be adjusted.

Consult your doctorif this affects you or your child.

If you take more Lamivudine Accord than you should

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

For 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 amount ingested.

If you forget to take Lamivudine AccordAccord

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 the missed dose.

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

During treatment for HIV, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to recovery of health and lifestyle, and in the case of lipids in the blood, sometimes to the HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can produce side effects, although not all people will experience them.

When you are on treatment for HIV, it may be difficult to distinguish whether a symptom is a side effect of Lamivudina Accord or of other medications you are taking, or is due to an effect of the disease caused by HIV itself.Therefore, it is very important that you inform your doctor about any change in your health.

In addition to the side effects listed below for Lamivudina Accord, other disorders may develop during HIV combination treatment.

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

Common side effects

May affectup to 1 in 10patients:

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

Rare side effects

May affectup to 1 in 100patients:

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

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

Uncommon side effects

May affectup to 1 in 1,000patients:

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

An uncommon side effect that may appear in blood tests is:

• increase in an enzyme called amylase.

Very rare side effects

May affectup to 1 in 10,000patients:

• lactic acidosis (excess lactic acid in the blood)

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

An uncommon side effect that may appear in blood tests is:

• failure of the bone marrow to produce new red blood cells (aplastic anemia).

If you experience side effects

Inform your doctor or pharmacistif you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet.

Other possible side effects of HIV combination therapy

HIV combination therapies, such as Lamivudina Accord, may cause other disorders to develop during HIV treatment.

Exacerbation of old infections

People with advanced HIV infection (AIDS) have weakened immune systems and a higher risk of developing severe infections (opportunistic infections). When these people start treatment, they may find that old infections, which were previously hidden, 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 these infections.

In addition to these opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you have started taking medications for your HIV infection. Autoimmune disorders may occur many months after the start of 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 body trunk, palpitations, tremors, or hyperactivity; please inform your doctor immediately to receive the necessary treatment.

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

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

You may have bone problems

Some patients receiving HIV combination therapy 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 suffer from this disease:

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

The 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:Inform your doctor..

Reporting side effects

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

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

Do not use 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 trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of 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

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