Label: Information for the User

Epivir 300Film-Coated Tablets

lamivudine

Read this label carefully before starting to take this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonly for you, and you should notgive it to others even if they have the same symptomsas you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1.What Epivir is and how it is used

2.What you need to knowbefore starting to take Epivir

3.How to take Epivir

4.Adverse effects

5.Storage of Epivir

6.Contents of the package and additional information

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

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

Epivir does 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 cellsare a type of white blood cell that plays an important role in helping your body fight infection.

Not everyone responds to Epivir treatment in the same way. Your doctor will monitor the effectiveness of your treatment.

Do not take Epivir

• if you areallergicto lamivudine or any of the other ingredients ofthis medicine(listed in section 6).

Consult your doctorif you think this affects you.

Be especially careful with Epivir

Some people taking Epivir or other combination treatments for HIV infection have a higher risk of serious side effects. You need to know that there is a higher risk:

• if you have ever hadliver disease, including hepatitis B or C (if you have hepatitis B do not stop taking Epivir without consulting your doctor, as it may worsen)
• if you havesignificant overweight(especially if you are a woman)
• if you have kidney disease, your dose may be adjusted.

Consult your doctor ifyou suffer from any of these circumstances.You may need additional tests, including blood tests, while taking this medicine. For more information see section 4.

Be aware of important symptoms

Some people taking HIV medicines develop other disorders, which can be serious. You need to know what signs and symptoms to look out for while taking Epivir.

Read the information on “Other possible side effects of combined HIV treatment” in section 4 of this leaflet.

Other medicines and Epivir

Inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including herbal medicines and those bought without a prescription.

Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Epivir.

The following medicines should not be used with Epivir:

• medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
• other medicines containing lamivudine (used to treatHIV infectionorhepatitis B infection)
• emtricitabine (used to treatHIV infection)
• high doses ofco-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• caldribina (used to treatacute myeloid leukaemia).

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

Pregnancy

If you are pregnant, if you become pregnant, or if you are planning to become pregnanttalk to your doctor about the risks and benefits of taking Epivir for you and your baby.

Epivir and similar medicines may cause side effects in babies during pregnancy.If you have been taking Epivirduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor your child’s development. In children whose mothers took INTIs during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

It is not recommendedthat women with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk.

A small amount of the components of Epivir may also pass into breast milk.

If you are breastfeeding or plan to breastfeed,you should consult your doctor as soon as possible.

Driving and operating machines

It is unlikely that Epivir will affect your ability to drive or operate machines.

Epivir contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist . In case of doubt, consult again with your doctor or pharmacist.

Swallow Epivir tablets with a little water. Epivir can 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

Epivir helps control your disease. You will need to take it every day to prevent your disease from getting worse. There is a possibility that you may develop other infections and diseases associated with HIV infection.

Stay in contact with your doctor and do not stop taking Epivir without first speaking with your doctor.

How much to take

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

The usual dose is one 300 mg tablet once a day.

Epivir is also available in 150 mg tablets for the treatment of children aged 3 months or older weighing less than 25 kg.

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

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

Consult your doctor if this affects you.

If you take too much Epivir

If you take too much Epivir, inform your doctor or pharmacist, or contact the hospital's emergency department for more information. If possible, show them the Epivir packaging.

If you forget to take Epivir

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 doses.

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 medicationcan 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 Epivir or of other medications you are taking, or if it is due to an effect of the disease caused by HIV.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 Epivir, other disorders may develop during combined HIV treatment.

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

Common side effects

May affectup to 1 in 10people:

• headache
• unwellness(nausea)
• vomiting
• diarrhea
• stomach pain
• fatigue, lack of energy
• fever (elevated temperature)
• general feeling of unwellness
• 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 100people:

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

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

Very rare side effects

May affectup to 1 in 1,000people:

• 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 tissue rupture
• inflammation (hepatitis).

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

• increase of an enzyme calledamylase.

Very rare side effects

May affectup to 1 in 10,000people:

• 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 (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 combined HIV treatment

Combined treatments, such as Epivir, 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 serious 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 monthsafter 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 rising to the trunk of the body, palpitations, tremors, or hyperactivity; please inform your doctor immediately to receive the necessary treatment.

If you notice any symptoms of infection while taking Epivir

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

You may have problems with your bones

Some people who receive combined HIV treatment may develop a bone disease calledosteonecrosis. 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 a combined treatment for a long time
• if they also take anti-inflammatory medications called corticosteroids
• if they drink alcohol
• if their immune systemis very weakened
• if they are overweight.

The signs of osteonecrosis include:

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

If you notice any of these symptoms:

Inform your doctor.

Reporting side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect not mentioned in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. 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 box.

Do not store Epivir at a temperature above 30 °C.

Medications should not be disposed of through drains or trash.Ask your pharmacist how to dispose ofthe packaging and medications that you no longerneed.This will help protect the environment.

Composition of Epivir

The active ingredient is lamivudine.

The other components are:

• Core of the tablet : microcrystalline cellulose, sodium carboxymethyl starch (gluten-free), magnesium stearate
• • Coating of the tablet : hypromellose, titanium dioxide, iron oxide black (E172), macrogol, polysorbate 80

Appearance of Epivir and contents of the package

Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blisters containing 30 tablets. The tablets are grey, rhomboid in shape, and have the code "GXEJ7" engraved on one side.

Holder of the marketing authorization and responsible for manufacturing

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Date of the last review of this leaflet: {MM/AAAA} .

The detailed information about this medication is available on the website of the European Medicines Agency: http://www.ema.europa.eu