EPIVIR 300 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Epivir 300mg film-coated tablets

lamivudine

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Epivir is and what it is used for
2. What you need to know before you take Epivir
3. How to take Epivir
4. Possible side effects
5. Storing Epivir
6. Contents of the pack and other information

1. What Epivir is and what it is used for

Epivir is used in the treatment of HIV (Human Immunodeficiency Virus) infection in adults and children.

The active substance of Epivir is lamivudine. Epivir is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

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 cells are a type of white blood cell that plays an important role in helping your body fight infection.

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

2. What you need to know before you take Epivir

Do not take Epivir

• 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.

Be cautious with Epivir

Some people who take 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 had liver disease, including hepatitis B or C (if you have hepatitis B, do not stop taking Epivir without your doctor's advice, as it may worsen)
• if you are overweight(especially if you are a woman)
• if you have kidney disease, your dose may need to be adjusted.

Consult your doctorif any of these apply to you. You may need additional tests, including blood tests, while taking this medicine. See section 4 for more information.

Be aware of important symptoms

Some people who take HIV medicines develop other conditions, 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 combination HIV therapy" in section 4 of this leaflet.

Other medicines and Epivir

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

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

The following medicines must not be used with Epivir:

• 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 infectionor hepatitis B virus infection)
• emtricitabine (used to treat HIV infection)
• high doses of co-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine (used to treat hairy cell leukemia).

Tell 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 ask you to have regular blood tests and other diagnostic tests to monitor your baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

Breast-feeding

It is not recommendedthat women with HIV breast-feed their babies because HIV infection can be passed to the baby through breast milk.

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

If you are breast-feeding or thinking of breast-feeding, you should consult your doctor as soon as possible.

Driving and using machines

Epivir is unlikely to affect your ability to drive or use machines.

Epivir contains sodium

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

3. How to take Epivir

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Swallow the 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 liquid; take the whole dose immediately.

Stay in regular contact with your doctor

Epivir helps control your condition. You will need to take it every day to prevent your condition from getting worse. You may develop other infections and illnesses associated with HIV infection.

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

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

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

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

Consult your doctorif this applies to you.

If you take more Epivir than you should

If you take more Epivir than you should, tell your doctor or pharmacist, or contact the nearest hospital 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 schedule.

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

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

As with 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 distinguish between a side effect of Epivir or other medicines you are taking, or if it is due to the HIV disease 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 Epivir, other conditions can develop during combination HIV therapy.

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

Common side effects

May affect up to 1 in 10people:

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

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 liver enzyme levels.

Rare side effects

May affect up to 1 in 1,000people:

• 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
• 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 10,000people:

• lactic acidosis (excess 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 HIV therapy

Combination treatments like Epivir can cause other conditions to develop during HIV treatment.

Worsening of old infections

People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections become active again, 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) can also occur after you start taking medicines for 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 that spreads to 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

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 people who receive combination HIV therapy may develop a bone disease called osteonecrosis. In this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to develop 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 hips, knees, or shoulders)
• difficulty moving.

If you notice any of these symptoms:

Tell your doctor.

Reporting 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Epivir

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

Do not use this medicine after the expiry date stated on the carton.

Do not store Epivir above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

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, black iron oxide (E172), macrogol, polysorbate 80.

Appearance of Epivir and container contents

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

Marketing authorization holder and manufacturer

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

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

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu