EPIVIR 10 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Epivir 10mg/ml Oral Solution

lamivudine

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

• Keep this leaflet, 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 experience 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. Storage of 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 especially careful 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 get worse)
• if you are overweight(especially if you are a woman)
• if you or your child have kidney disease, your dose may need to be changed.

Consult your doctorif you have any of these conditions. You may need to have additional tests, including blood tests, while taking this medicine. For more information, see section 4.

Be aware of important symptoms

Some people who take medicines for HIV infection develop other conditions, which can be serious. You need to know what important 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 EpivirTell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Remember to tell your doctor or pharmacist if you start taking any new medicines 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 leukaemia).

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 infection 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.

Important information about some of the ingredients 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 an intolerance to some sugars, consult them before taking Epivir. Sucrose may be harmful to teeth.

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

Epivir contains sodium

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

3. How to take Epivir

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, talk to your doctor or pharmacist again.

Epivir can be taken with or without food.

Keep in regular contact with your doctor

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

Stay in contact 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 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 of 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 pack 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. Put 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 upside down.
7. Pull the syringe plungeruntil you get the first part of the full dose.
8. Turn the bottle back to its correct position and remove the syringefrom the adapter.
9. Place the syringe in your mouth, with the syringe end towards the inside of your cheek. Push the plunger slowly, allowing time to swallow the medicine. Do notintroduce the solution too quickly into the back of your throat, as you may 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 medicine.
11. Remove the syringe from the bottleand wash itwell with clean water. Allow it to dry completely before using it again.
12. Close the bottle tightlywith the cap, leaving the adapter inside.

Discard the oral solution one month after first opening.

If you or your child have kidney problems, your dose may need to be changed.

Consult your doctorif you are in this situation.

If you take more Epivir than you should

If you take more Epivir than you should, talk to your doctor or pharmacist, or go to the nearest hospital emergency department. If possible, show them the Epivir pack.

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 normal 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 in blood glucose and lipid levels. This may be partly due to the recovery of your health and your lifestyle, 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 Epivir or of other medicines you are taking, or if it is due to the HIV disease itself. Therefore, it is very important that you tell your doctor about any changes 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
• diarrhoea
• 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 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 (anaemia)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 in 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 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 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 weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old infections, which were hidden, 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 have started 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, 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 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. With 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 very weakened
• if they are overweight.

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:

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 via 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. Storage of 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.

Discard one month after first opening.

Do not store above 25°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: sugar (sucrose 3 g/15 ml), 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 container contents

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

Marketing authorization holder and manufacturer

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

Date of 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