patient information leaflet epivir oral solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

1. What Epivir is and what it is used for.
2. Before you take Epivir
3. How to take Epivir
4. Possible side effects
5. How to store Epivir
6. Further information

1. WHAT EPIVIR IS AND WHAT IT IS USED FOR

Epivir belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs). These are used to treat Human Immunodeficiency Virus (HIV) infection.

Epivir is used in antiretroviral combination therapy for the treatment of HIV infection in adults and children. Epivir reduces the amount of HIV virus in your body, and keeps it at a low level. It also increases CD4 cell counts. CD4 cells are a type of white blood cell, that play an important role in maintaining a healthy immune system to help fight infection. Response to treatment with Epivir varies between patients. Your doctor will be monitoring the effectiveness of your treatment.

2. BEFORE YOU TAKE EPIVIR

Do not take Epivir

if you are allergic (hypersensitive) to lamivudine or any of the other ingredients found in Epivir oral solution.

If you are not sure please ask your doctor.

Take special care with Epivir

Discuss the use of Epivir with your doctor if you have kidney disease. The standard recommended dose of Epivir may have to be reduced.

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

The class of medicines to which Epivir belongs (NRTIs) can cause a condition called lactic acidosis (build up of lactic acid in the body), together with an enlarged liver. Lactic acidosis, if it occurs, usually develops after a few months of treatment. Deep rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.

This rare, but serious side effect occurs more often in women, particularly if very overweight. If you have liver disease you may also be more at risk of getting this condition. While you are being treated with Epivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.

Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy. Contact your doctor if you notice changes in body fat.

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.

Please speak with your doctor if you have a history of liver disease. Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.

If you have a chronic hepatitis B infection, you should not stop your treatment with Epivir without instructions from your doctor, as you may have a recurrence of your hepatitis. This recurrence may be more severe if you have serious liver disease.

You will need to take Epivir every day. This medicine helps to control your condition, but it is not a cure for HIV infection. You may continue to develop other infections and other illnesses associated with HIV disease. You should keep in regular contact with your doctor.

Do not stop taking your medicine without first talking to your doctor.

Treatment with Epivir has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.

You should continue to use appropriate precautions to prevent this.

Bone problems: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

It is important that you tell your doctor about all the medicines you are taking including those you have bought yourself. These may affect the action of Epivir, or Epivir may affect their action. Epivir should not be given with zalcitabine, high doses of co-trimoxazole, or infusions of ganciclovir or foscarnet.

Pregnancy

If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child. Epivir is not recommended during the first three months of pregnancy.

If you have taken Epivir during your pregnancy, your doctor may request regular visits to monitor the development of your child. Such visits may include blood tests and other diagnostic tests.

In children whose mothers took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.

Breast-feeding

Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Epivir do not breast-feed their infants. It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV

Important information about some of the ingredients of Epivir

Epivir contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Epivir.

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

3. HOW TO TAKE EPIVIR

Always take Epivir exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual daily dose of Epivir in adults and adolescents over 12 years of age is 300 mg (30 ml). This can be taken either as 150 mg (15 ml) twice a day or 300 mg (30 ml) once a day.

In children three months to 12 years of age the recommended dose is 4 mg/kg twice daily up to a maximum of 300 mg daily.

Each dose of Epivir should be taken approximately 12 hours apart. Epivir can be taken with or without food.

If you have a kidney problem, your dose may be altered. Please follow the instructions of your doctor.

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

1. Remove the bottle cap.
2. Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
3. Insert the syringe firmly into the adapter.
4. Invert bottle.
5. Pull out syringe plunger until the correct amount is withdrawn.
6. Turn the bottle the correct way up and remove the syringe from the adapter.
7. Replace and tighten the bottle cap.
8. Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek. Slowly depress the plunger, allowing time to swallow. Forceful squirting to the back of the throat may cause choking.
9. After use, the syringe must not be left in the bottle and should be washed thoroughly in clean water.

If you take more Epivir than you should

Accidentally taking too much Epivir is unlikely to cause any serious problems. However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Epivir

If you forget to take a dose of Epivir, take it as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Epivir can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Epivir, by other medicines you are taking at the same time or by the HIV disease. For this reason it is very important that you inform your doctor about any changes in your health.

The most commonly reported (greater than 1 in every 100 patients treated) side effects are nausea, vomiting, stomach pain, diarrhoea, headache, joint pain, muscle disorders, cough, nasal symptoms (irritation, runny nose), fever, tiredness, general feeling of being unwell, skin rash, hair loss and difficulty in sleeping.

The following side effects are uncommon (between 1 in 1,000 and 1 in 100 patients treated); anaemia (low red blood cell count), neutropenia (low white blood cell count), and reductions in platelets (blood cells important for blood clotting). If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness. A reduction in your white blood cell count can make you more prone to infection. If you have a low platelet count you may notice that you bruise more easily. Increases in some liver enzymes have also been noted in blood samples from patients being treated with Epivir.

There are rare reports (between 1 in 10,000 to 1 in 1,000 patients treated) of inflammation of the liver (hepatitis), inflammation of the pancreas (pancreatitis), breakdown of muscle tissue.

There are very rare reports (less than 1 in 10,000 patients treated) of numbness, tingling sensation or sensation of weakness in the limbs, and severe anaemia and neutropenia.

Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see Take special care with Epivir for more information).

Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘buffalo hump’). The cause and long-term health effects of these conditions are not known at this time.

Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE EPIVIR

Keep out of the reach and sight of children

Do not use Epivir after the expiry date which is stated on the container. 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. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Epivir contains

The active substance in Epivir is called lamivudine. Epivir oral solution contains 10 mg of lamivudine in each ml of solution.

The oral solution also contains the following other ingredients: sugar (sucrose 3 g/15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavourings.

Medicine: epivir oral solution