What is it and how is it used?

Epivir is used to treat HIV (human immunodeficiency virus) infection in adults and children.

The active ingredient in Epivir is lamivudine. Epivir is a type of medicine known as an anti-retroviral. 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 your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.

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

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Don?t take Epivir:

  • if you?re allergic ( hypersensitive) tolamivudine or any of the other ingredients in Epivir oral solution ( listed in Section 6).

Check with your doctor if you think this applies to you.

Take special care with Epivir

Some people taking Epivir or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:

  • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don?t stop Epivir without your doctor?s advice, as your hepatitis may come back)
  • if you?re seriously overweight (especially if you?re a woman)
  • if you?re diabetic and using insulin.
  • if you or your child has a kidney problem, your dose may be altered. Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you?re taking your medicine. See Section 4 for more information.
Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you?re taking Epivir.

Read the information ?Other possible side effects of combination therapy for HIV? in Section 4 of this leaflet.

Protect other people

HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Epivir will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV:

  • Use a condom when you have oral or penetrative sex.
  • Don?t risk blood transfer ? for example, don?t share needles.
Other medicines and Epivir

Tell your doctor or pharmacist if you?re taking any other medicines, or if you?ve taken any recently, including herbal medicines or other medicines you bought without a prescription.

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

These medicines should not be used with Epivir:

  • other medicines containing lamivudine, (used to treat HIV infection or hepatitis B infection)
  • emtricitabine (used to treat HIV infection)
  • high doses of co-trimoxazole, an antibiotic. Tell your doctor if you?re being treated with any of these.
Pregnancy

If you are pregnant, if you become pregnant, or are planning to become pregnant, talk to your doctor about the risks and benefits and risks to you and your baby of taking Epivir.

Epivir and similar medicines may cause side effects in unborn babies. If you become pregnant while you?re taking Epivir, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

Children whose mothers took NRTIs (medicines like Epivir) during pregnancy had a reduced risk of being infected with HIV. This benefit is greater than the risk of having side effects.

Breast-feeding

Women who are HIV-positive must not breast-feed, because HIV infection can be passed on to the baby in breast milk.
If you?re breast-feeding, or thinking about breast-feeding:

Talk to your doctor immediately.

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 a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar. 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. Sucrose may be harmful to the teeth. Epivir also contains preservatives ( parahydroxybenzoates) which may cause allergic reactions (possibly delayed).

How is it used?

Always take Epivir exactly as your doctor has told you to. Check with your doctor or pharmacist if you?re not sure.

Epivir can be taken with or without food.

Stay in regular contact with your doctor

Epivir helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.

Keep in touch with your doctor, and don?t stop taking Epivir without your doctor?s advice.

How much to take

Adults and adolescents over 12 years of age
The usual dose of Epivir is 30 ml a day (300 mg)
to be taken as 15 ml (150 mg) twice a day at regular times, leaving approximately 12 hours between each dose.

Children 3 months to 12 years of age
The usual dose of Epivir is 4 mg/kg twice daily up to a maximum of 300 mg daily.
Give each dose to your child at regular times, leaving approximately 12 hours between each dose.

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

1. Remove the bottle cap. Keep it safely

2. Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.

3. Insert the syringe firmly into the adapter.

4. Turn the bottle upside down.

5. Pull out syringe plunger until the syringe contains the first part of your full dose.

6. Turn the bottle the correct way up. Remove the syringe from the adapter.

7. Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don?t push too hard and squirt the liquid into the back of your throat or you may choke.

8. Repeat steps 3 to 7 in the same way until you have taken your whole dose. For example, if your dose is 15 ml, you need to take one and a half syringe-fulls of medicine.

9. Take the syringe out of the bottle and wash it thoroughly in clean water. Let it dry completely before you use it again.

10. Close the bottle tightly with the cap, leaving the adaptor in place.

If you or your child has a kidney problem, the dose may be altered.
Talk to your doctor if this applies to you or your child.

If you take too much Epivir

Accidentally taking too much Epivir is unlikely to cause any serious problems. If you take too much, 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, take it as soon as you remember. Then continue your treatment as before. Don?t take a double dose to make up for a missed dose.

What are possible side effects?

Like all medicines, Epivir can cause side effects, but not everyone gets them.

When you?re being treated for HIV, it can be hard to tell whether a symptom is a side effect of Epivir or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.

As well as the side effects listed below for Epivir, other conditions can develop during combination therapy for HIV.

It is important to read the information later in this section under ?Other possible side effects of combination therapy for HIV?.

Common side effects

These may affect up to 1 in 10 people:

  • headache
  • feeling sick ( nausea)
  • being sick ( vomiting)
  • diarrhoea
  • stomach pains
  • tiredness, lack of energy
  • fever (high temperature)
  • general feeling of being unwell
  • muscle pain and discomfort
  • joint pain
  • difficulty in sleeping ( insomnia)
  • cough
  • irritated or runny nose
  • rash
  • hair loss ( alopecia).

Uncommon side effects

These may affect up to 1 in 100 people:

Uncommon side effects that may show up in blood tests are:

  • a decrease in the number of cells involved in blood clotting ( thrombocytopenia)
  • a low red blood cell count ( anaemia) or low white blood cell count ( neutropenia)
  • an increase in the level of liver enzymes.

Rare side effects

These may affect up to 1 in 1000 people:

  • serious allergic reaction causing swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing
  • lactic acidosis ( see the next section, ?Other possible side effects of combination therapy for HIV?)
  • inflammation of the pancreas ( pancreatitis)
  • breakdown of muscle tissue
  • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis).

A rare side effect that may show up in blood tests is:

  • increase in an enzyme called amylase.

Very rare side effects

These may affect up to 1 in 10,000 people:

  • tingling or numbness of the arms, legs, hands or feet.

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

  • a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
If you get side effects

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy such as Epivir may cause other conditions to develop during HIV treatment.

Old infections may flare up

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, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body?s immune system becoming stronger, so that the body starts to fight these infections.
If you get any symptoms of infection while you?re taking Epivir:

Tell your doctor immediately. Don?t take other medicines for the infection without your doctor?s advice.

Your body shape may change

People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

  • Fat may be lost from the legs, arms or face.
  • Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs.
  • Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck. It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape: Tell your doctor.

Lactic acidosis is a rare but serious side effect

Some people taking Epivir, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.

Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs.

Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweight) people, especially women.

Signs of lactic acidosis include:

  • deep, rapid, difficult breathing
  • drowsiness
  • numbness or weakness in the limbs
  • feeling sick ( nausea), being sick ( vomiting)
  • stomach pain. During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above, or any other symptoms that worry you: See your doctor as soon as possible.

You may have problems with your bones

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

  • 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 systems are very weak
  • if they are overweight. Signs of osteonecrosis include:
  • stiffness in the joints
  • aches and pains (especially in the hip, knee or shoulder)
  • difficulty moving. If you notice any of these symptoms: Tell your doctor.

Other effects may show up in blood tests

Combination therapy for HIV can also cause:

  • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
  • increased levels of sugar and fats (triglycerides and cholesterol) in the blood
  • resistance to insulin (so if you?re diabetic, you may have to change your insulin dose to control your blood sugar).

How should it be stored?

Keep out of the reach and sight of children

Do not take Epivir after the expiry date shown on the container.

Discard one month after first opening.

Do not store above 25oC.

If you have any unwanted Epivir, don?t dispose of it in your waste water or your household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Epivir contains

The active substance is lamivudine.
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.

What Epivir looks like and the 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 adapter for the bottle is included in the pack.

Marketing Authorisation Holder and Manufacturer

Manufacturer Marketing Authorisation Holder

Glaxo Wellcome GmbH Co. KG Industriestrasse 32-36 23843 Bad Oldesloe Germany ViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom

For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.

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Lietuva

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