Label: Information for the User

Epivir 10mg/ml oral solution

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 doubts, consult your doctor or pharmacist.
• This medication has been prescribedonly to you, and you should notgive it to other people, 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 or your child has 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 EpivirInform your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines based on plants 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
• cladribine (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 pregnant,talk to your doctor about the risks and benefits of taking Epivir for both 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 antiretrovirals during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Breastfeeding

Do not recommendthat 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 machinery

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

Important information about some of the components of Epivir

If you are diabetic, note that each dose (150mg=15ml) contains3gof sugar.

Epivir contains sucrose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking Epivir. Sucrose may be detrimental to teeth.

Epivir also contains preservatives (parahydroxybenzoates) that may cause allergic reactions (possibly delayed).

Epivir contains sodium

This medicine contains 39 mg of sodium (main component of table salt/for cooking) in each 15 ml. This is equivalent to 1.95% of the maximum daily sodium intake recommended for an adult.

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

Epivir can be taken with or without food.

Maintain regular contact with your doctor

Epivir helps control your disease. You will need to take it every day to avoid 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 Epivirwithout first talking to your doctor.

How much to take

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

The usual dose of Epivir is 30 ml (300 mg) per day.It can be taken as 15 ml (150 mg) twice a day (leaving approximately 12 hours between each dose), or as 30 ml (300 mg) once a day.

Children from 3 months of age with a weight less than 25 kg:

The dose depends on the child's body weight.The usual dose of Epivir is 0.5 ml/kg (5 mg/kg) twice a day (leaving approximately 12 hours between each dose), or 1 ml/kg (10 mg/kg) once a day.

Use the oral dosing syringe provided with the packaging to measure your dose accurately.

1. Remove the plastic wrapper from the syringe/adapter
2. Remove the adapter from the syringe.
3. Remove the cap from the bottle. Place it in a safe place.
4. While holding the bottle firmly,insert the plastic adapter into the neck of the bottle
5. Insert the syringefirmly into the adapter.
6. Turn the bottle around.
7. Pull the plunger of the syringeuntil the first part of the full dose is obtained.
8. Return the bottle to its correct position andremove the syringe
9. Place the syringe in the mouth, placing the tip of the syringe towards the inside of the cheek.Push the plunger slowly, giving time to swallow the medication.Do notintroduce the solution too abruptly into the throat, as you could choke.
10. Repeat steps 5 to 9in the same way until you have taken the full dose.For example, if your dose is 15 ml, you will need to take one and a half syringes of medication.
11. Remove the syringe from the bottleandrinse it well with clean water. Let it dry completely before using it again.
12. Close the bottle tightlywith the cap, leaving the adapter inside.

Discard the oral solution one month after the first opening.

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

Consult your doctorif you are in this situation.

If you take more Epivir than you should

If you take more Epivir than you should, inform your doctor or pharmacist, or contact the emergency service of the nearest hospital.If possible, show them the Epivir packaging.

If you forgot 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 compensate 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 red blood cell count(anemia)or low white blood cell count(neutropenia)
• increased levels 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 that may cause difficulty swallowing or breathing

• inflammation of the pancreas(pancreatitis)
• muscle tear
• inflammation (hepatitis).

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

• increase in an enzyme calledamylase.

Very rare side effects

May affectup to 1 in 10,000people:

• lactic acidosis (excess lactic acid in the blood)
• tingling or numbness in 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 are experiencing 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 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, 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 about 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.

Discard one month after it was first opened.

Do not store at a temperature above 25 °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:sugar (saccharose 3g/15ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavors.

This medication contains 300 mg of propylene glycol per 15 ml.

Appearance of Epivir and contents of the package

Epivir oral solution is supplied in a white polyethylene bottle containing 240ml of solution. The package includes a dosing syringe for oral administration and a plastic adapter for the bottle.

Holder of the marketing authorization and responsible for manufacturing

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

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