Epivir 10 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Epivir 10mg/ml oral solution

lamivudine

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Epivir is and what it is used for
2. What you need to know before taking Epivir
3. How to take Epivir
4. Possible side effects
5. How to store 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 in Epivir is lamivudine. Epivir is a type of medicine known as an antiretroviral. It belongs to a group of medicines called nucleoside 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 play 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 taking Epivir

Do not take Epivir

• if you are allergic to lamivudine or to any of the other ingredients of this medicine (listed in section 6).

Consult your doctor if you think this applies to you.

Take special care with Epivir

Some people who take Epivir or other combination treatments for HIV infection are at increased risk of experiencing serious adverse effects. You should be aware that the risk is higher:

• 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 your condition may worsen)
• if you are significantly overweight (especially if you are a woman)
• if you or your child has kidney disease, your dose may need to be adjusted.

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

Be alert to important symptoms

Some people taking medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking Epivir.

Read the information on "Other possible side effects of combination antiretroviral therapy for HIV" 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 medicines, including herbal products and those obtained without a prescription.

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

The following medicines must not be used together with Epivir:

• medicines (usually liquids) containing sorbitol and other polyalcohols (such as xylitol, mannitol, lactitol, or maltitol), if taken regularly
• other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection)
• emtricitabine (used to treat HIV infection)
• high doses of cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), an antibiotic
• cladribine (used to treat hairy cell leukemia).

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

Pregnancy

If you are pregnant, become pregnant, or 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 adverse effects in babies during pregnancy. If you have taken Epivir during pregnancy, your doctor may recommend periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.

Breast-feeding

Breast-feeding is not recommended for women living with HIV 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 breast-feeding or planning to breast-feed, you should consult your doctor as soon as possible.

Driving and using machines

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

Important information about some of the ingredients of Epivir

If you are diabetic, please note that each dose (150 mg = 15 ml) contains 3 g of sugar.

Epivir contains sucrose. If your doctor has advised you that you have an intolerance to certain sugars, consult with them before taking Epivir. Sucrose may be harmful to teeth.

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

Epivir contains sodium

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

3. How to take Epivir

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Epivir may be taken with or without food.

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 worsening. You may develop other infections and illnesses associated with HIV infection.

Stay in contact with your doctor and do not stop taking Epivir without 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. This may be taken as 15 ml (150 mg) twice daily (approximately 12 hours apart), or as 30 ml (300 mg) once daily.

Children from 3 months of age weighing 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 daily (approximately 12 hours apart), or 1 ml/kg (10 mg/kg) once daily.

Use the oral dosing syringe supplied with the pack to measure your dose accurately.

1. Remove the plastic wrapping from the syringe/adapter.
2. Remove the adapter from the syringe.
3. Remove the cap from the bottle. Keep it in a safe place.
4. While holding the bottle firmly, insert the plastic adapter into the neck of the bottle.
5. Insert the syringe firmly into the adapter.
6. Turn the bottle upside down.
7. Pull back the syringe plunger to draw up the first part of the full dose.
8. Turn the bottle back upright and remove the syringe from the adapter.
9. Place the syringe in the mouth, positioning the tip towards the inside of the cheek. Slowly push the plunger, allowing time to swallow the medicine. Do not administer the solution too forcefully into the back of the throat, as this could cause choking.
10. Repeat steps 5 to 9 in the same way until the full dose has been taken. 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 bottle and wash it thoroughly with clean water. Allow it to dry completely before using it again.
12. Close the bottle tightly with the cap, leaving the adapter inside.

Discard the oral solution one month after first opening.

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

Consult your doctor if 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 nearest hospital emergency department for further advice. 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 regular dosing schedule.

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

4. Possible adverse effects

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

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When you are undergoing HIV treatment, it may be difficult to determine whether a symptom is an adverse effect of Epivir or of other medicines you are taking, or whether it is due to the HIV disease itself. Therefore, it is very important that you inform your doctor of any changes in your health.

In addition to the adverse effects listed below for Epivir, other disorders may develop during combination HIV treatment.

It is important that you read the information under the section “Other possible adverse effects of combination HIV treatment”.

Frequent adverse effects

May affect up to 1 in 10 people:

• headache
• malaise (nausea)
• vomiting
• diarrhoea
• stomach pain
• tiredness, lack of energy
• fever (high temperature)
• general feeling of discomfort
• muscle pain and discomfort
• joint pain
• difficulty sleeping (insomnia)
• cough
• irritated nose or excessive nasal discharge
• skin rash
• hair loss (alopecia).

Uncommon adverse effects

May affect up to 1 in 100 people:

Uncommon adverse 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)
• increased levels of liver-produced enzymes.

Rare adverse effects

May affect up to 1 in 1,000 people:

• severe allergic reaction causing swelling of the face, tongue or throat, which may cause difficulty swallowing or breathing

• inflammation of the pancreas (pancreatitis)

• muscle tissue breakdown

• inflammation (hepatitis).

A rare adverse effect that may appear in blood tests is:

• increase in an enzyme called amylase.

Very rare adverse effects

May affect up to 1 in 10,000 people:

• lactic acidosis (excess lactic acid in the blood)
• tingling or numbness in the arms, legs, hands or feet.

A very rare adverse 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 adverse effects

Inform your doctor or pharmacist if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet.

Other possible adverse effects of combination HIV treatment

Combination treatments, such as Epivir, may cause other disorders to develop during HIV treatment.

Exacerbation of previous infections

People with advanced HIV infection (AIDS) have weakened immune systems and are more likely to suffer from serious infections (opportunistic infections). When these people start treatment, they may find that previously hidden infections flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to an improved immune response, which enables the body to fight these infections.

In addition to these opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medicines for your HIV infection. Autoimmune disorders may 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 spreading towards the trunk of the body, palpitations, tremor 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 medicine for the infection unless your doctor advises you to do so.

You may have problems with your bones

Some people receiving combination HIV treatment may develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to reduced blood supply to the bone. People are more likely to develop this disease:

• if they have been on combination treatment for a long time
• if they also take 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 hip, knee or shoulder)
• difficulty moving.

If you notice any of these symptoms:

Inform your doctor.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse 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 packaging.

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 and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Epivir

The active substance 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 flavours.

This medicine contains 300 mg of propylene glycol in each 15 ml.

What Epivir looks like and contents of the pack

Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution. An oral dosing syringe and a plastic bottle adapter are included in the carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
[Company Name]
[Address]

Manufacturer:
[Company Name]
[Address]

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

Date of latest review of this leaflet: {MM/YYYY}.

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